FDA Calendar

Liquidia Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Jaguar Health, Inc nnounced the results of a new survey of 27 board certified veterinary oncologists practicing in the U.S. regarding Canalevia-CA1 and the treatment of chemotherapy-induced diarrhea (CID) in dogs.

Corbus Pharmaceuticals Holdings, Inc announced today the dosing of the first subject in the single ascending dose / multiple ascending dose (SAD/MAD) portion of the Phase 1 trial of CRB-913 for the treatment of obesity.

RenovoRx, Inc announced today that a new human pharmacokinetic (PK) data abstract was presented at the Society of Surgical Oncology (SSO) 2025 Annual Meeting on March 27 – 29, 2025 in Tampa, FL: ePoster P379.

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a new Opdivo® (nivolumab) formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).

Purple Biotech Ltd announced upcoming poster presentations including one for CM24 in the treatment of pancreatic cancer, and two for NT219 in the treatment of colorectal and head and neck cancers, at the 2025 American Association for Cancer Research Meeting (2025 AACR), scheduled to take place from April 25th to April 30th in Chicago.

Palatin Technologies, Inc. announced positive topline results from its Phase 2 study of PL8177, a selective melanocortin-1 receptor (MC1R) agonist, in patients with active ulcerative colitis (UC).

Sensei Biotherapeutics, Inc. provided corporate updates.

Lexicon Pharmaceuticals, Inc announced that it has entered into an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development candidate in obesity and associated metabolic disorders.

Milestone® Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of PSVT to sinus rhythm in adults.

FibroGen announced the peer-reviewed publication titled "A Phase 1, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients with Metastatic Castration Resistant Prostate Cancer" in the Journal of Clinical Oncology.

Regeneron Pharmaceuticals, Inc. announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.

Lantern Pharma Provides Business Updates

Spero Therapeutics provided a business update.

Crinetics Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment and long-term maintenance therapy of acromegaly, a serious, rare and progressive endocrine disorder characterized by consistently elevated levels of growth hormone.

Relmada Therapeutics, Inc. provided a corporate update

Clearside Biomedical, provided a corporate update.

Tyra Biosciences, Inc. highlighted recent corporate progress.

Elutia Inc. announced that it has entered into an agreement with Advantus Health Partners ("Advantus"), to provide access of Elutia's EluPro™ Antibiotic Eluting BioEnvelope to Advantus' core group purchasing organizations (GPO) solutions portfolio.

INmune Bio provides a business update.

Tempest Therapeutics, provided a corporate update.

TransCode Therapeutics, Inc. announced that the first patient in Cohort 4 of its Phase I clinical trial has received their initial dose.

NANOBIOTIX announced the first data from the completed dose escalation part of a Phase 1 study sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson") evaluating radiotherapy-activated NBTXR3 (JNJ-1900)1 as a second or later line (2L+) therapy for patients with locally advanced non-small cell lung cancer ("NSCLC") amenable to re-irradiation.

Sensei Biotherapeutics announced initial results from the dose expansion portion of its Phase 1/2 trial evaluating solnerstotug (formerly SNS-101), a conditionally active monoclonal antibody targeting VISTA (V-domain Ig suppressor of T cell activation).

Spyre Therapeutics, Inc. announced that it has initiated dosing in a healthy volunteer, Phase 1 clinical trial of its investigational half-life extended anti-IL-23 monoclonal antibody, SPY003.

Beam Therapeutics announced that the United States (U.S.) Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for BEAM-302 for the treatment of alpha-1 antitrypsin deficiency (AATD).

Merck announced the first data presentation from the pivotal 3475A-D77 Phase 3 trial, evaluating the subcutaneous administration of pembrolizumab, together with berahyaluronidase alfa (MK-3475A; from now on referred to as "subcutaneous pembrolizumab").

ZyVersa Therapeutics, Inc. Provides Business Update

Polyrizon Ltd announced the structuring of its clinical strategy for PL-14, the Company's proprietary intranasal allergy blocker for seasonal allergic rhinitis.

PDS Biotechnology Provides Clinical Programs Update

Liquidia Corporation nnounced the company will present three posters at the American Thoracic Society (ATS) 2025 International Conference, taking place May 18-21, 2025, in San Francisco.

Lucid Diagnostics and subsidiary of PAVmed Inc. announced a campaign, entitled "Embrace the Future", designed to showcase its groundbreaking EsoCheck® Esophageal Cell Collection Device, with Collect+Protect™ Technology, to gastroenterologists and the broader medical community.

Rigel Pharmaceuticals, Inc announced that it has entered into a settlement agreement with Annora Pharma Private Ltd., Hetero Labs Ltd., and Hetero USA, Inc. (collectively "Annora") resolving patent litigation related to Rigel's product TAVALISSE® (fostamatinib disodium hexahydrate).

NeOnc Technologies Holdings announced a strategic partnership with CBCC Global Research (CBCC), a premier full-service clinical research organization (CRO).

CERo Therapeutics Holdings, Inc. announces that the Company has received positive review from the U.S. Food and Drug Administration (FDA) on an amendment to its IND around Chemistry, Manufacturing and Controls (CMC), which marks completion of the Company's final commitment to FDA prior to initiating patient dosing and shortens the manufacturing timeline by about a week. ,

Septerna, Inc Provides Corporate Overview

Dermata Therapeutics, Inc. announced positive topline results from the Company's first pivotal Phase 3 trial of XYNGARI™, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne.

Actinium Pharmaceuticals provided a business update detailing recent achievements and anticipated milestones from its revitalized and expanding clinical pipeline.

ADC Therapeutics SA Provides Operational Update

Alterity Therapeutics announced that the last patient in the ATH434-202 Phase 2 trial has completed the study.

Arvinas, Inc. a clinical-stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, today announced that data from the first-in-human study evaluating single-ascending and multiple-ascending doses in healthy volunteers of ARV-102 will be presented at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD™), April 1-5, 2025 in Vienna, Austria.

Gain Therapeutics, Inc. provided a corporate update.

BioXcel Therapeutics, provided a business update.

Acumen Pharmaceuticals, provided a business update.

Gyre Therapeutics announced the publication of the manuscript titled "Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial" in the Journal of Clinical and Translational Hepatology.

Immatics N.V. provided a business update

Tonix Pharmaceuticals announced that Seth Lederman, M.D., Chief Executive Officer, will present a poster at the AAPM 2025 Annual Meeting, PainConnect, in Austin, Texas on April 5, 2025, at 11:45 a.m. CT. The meeting will take place from April 3-6, 2025.

BridgeBio Pharma, Inc. announced the Japanese Ministry of Health, Labour and Welfare has approved acoramidis, under the brand name Beyonttra, for the treatment of adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

Equillium, Inc announced topline data from the Phase 3 EQUATOR study evaluating itolizumab in first-line treatment of patients with acute graft-versus-host disease (aGVHD).

CalciMedica Inc. provided clinical and corporate updates.

BeyondSpring Inc. Highlights Key Clinical & Strategic Milestones

Regulus Therapeutics Inc. announced positive topline results from all patients in the fourth cohort in its Phase 1b MAD study of farabursen for the treatment of ADPKD.

Innate Pharma SA provided Business Update

Soleno Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS).

Candel Therapeutics announced final survival data from a phase 2a clinical trial of CAN-2409 in patients with stage III/IV NSCLC, inadequately responding to ICI treatment.

Savara Inc. nnounced that it has completed submission of the BLA to the FDA for MOLBREEVI as a treatment for aPAP.

Rani Therapeutics Holdings, Inc. announced pharmacokinetic and pharmacodynamic data from a preclinical study evaluating RT-114, a GLP-1/GLP-2 dual agonist (PG-102). PG-102 delivered orally via the RaniPill® capsule demonstrated comparable bioavailability and weight loss to subcutaneously (SC) injected PG-102 ("SC PG-102").

Leap Therapeutics, Inc presented updated preliminary data on Wednesday from Part B of the DeFianCe Phase 2 trial of sirexatamab (DKN-01) in combination with bevacizumab and chemotherapy (Experimental Arm) compared to bevacizumab and chemotherapy (Control Arm).

Johnson & Johnson announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) significantly extended OS in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.

Exelixis, Inc announced that the U.S. Food and Drug Administration (FDA) has approved CABOMETYX® (cabozantinib) for the treatment of 1) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET); and 2) adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET).

Sonnet BioTherapeutics announced positive findings from the first safety review of the expansion cohort in its Phase 1 SB101 clinical trial evaluating SON-1010, the Company's proprietary version of recombinant human interleukin-12 (rhIL-12) configured using genetic fusion to Sonnet's Fully Human Albumin Binding (FHAB®) platform, in combination with trabectedin (Yondelis®) in adult patients with advanced leiomyosarcoma (LMS) or liposarcoma (LPS).

Silo Pharma, Inc announced first dosing in an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).

Genprex, Inc. announced that its research collaborators will present at the upcoming 2025 American Association for Cancer Research (AACR) Annual Meeting being held April 25-30, 2025 in Chicago, Illinois.

Johnson & Johnson announced today that 12 abstracts, including two oral presentations, highlighting the Company's innovative autoantibody disease research and the potential of nipocalimab to provide long-term sustained disease control in the treatment of generalized myasthenia gravis (gMG), will be presented at the 2025 American Academy of Neurology (AAN) Annual Meeting from April 5 – 9 in San Diego, California.

Calidi Biotherapeutics, Inc. announce progress from a phase 1 clinical trial utilizing Calidi's CLD-101 investigational agent (neural stem cell-based oncolytic virotherapy) that is administered intracerebrally.

Nuvectis Pharma, Inc announced upcoming presentations for NXP900 at the upcoming 2025 American Association for Cancer Research Meeting (2025 AACR), taking place from April 25th to April 30th in Chicago, IL.

Aligos Therapeutics, Inc announced positive data from three oral presentations at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025, being held March 26 - 30, 2025 in Beijing, China.

Lipocine Inc. announced the initiation of a Phase 3 trial for LPCN 1154 (oral brexanolone) which is in development for the treatment of postpartum depression (PPD).

Acumen Pharmaceuticals,announced the completion of enrollment in its ALTITUDE-AD Phase 2 trial of sabirnetug (ACU193) in patients with early Alzheimer's disease.

Wave Life Sciences announced positive data from the Phase 2 FORWARD-53 trial of WVE-N531, which is an exon skipping oligonucleotide being investigated in boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping.

Kura Oncology, Inc announced that an abstract containing preclinical data for KO-2806, the Company's next-generation farnesyl transferase inhibitor (FTI), in combination with cabozantinib, a tyrosine kinase inhibitor (TKI), in clear cell renal cell carcinoma (ccRCC), has been accepted for an oral presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL on April 29, 2025.

Intellia Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to nexiguran ziclumeran (nex-z, also known as NTLA-2001) for the treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy (ATTR-CM).

Viking Therapeutics, Inc announced the completion of subject enrollment in its Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.

Vivani Medical Tells Benzinga Co. Announces Preclinical Weight Loss Data For NPM-139 Semaglutide Implant, With Potential For Once-Year Dosing

Zai Lab Limited announced that data from preclinical studies of the Company's internally discovered and developed next-generation, investigational oncology therapies, ZL-6201, an LRRC15 antibody-drug conjugate (ADC) for the treatment of sarcoma, and ZL-1222, a PD-1 targeted IL-12 immunocytokine for cancer immunotherapy, will be presented during poster sessions at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2025 taking place April 25-30, 2025 in Chicago, Illinois.

Merck announced today that the European Commission (EC) has approved CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.

Compass Pathways plc announced the completion of recruitment in the COMP005 phase 3 trial for treatment resistant depression (TRD).

IDEAYA Biosciences, Inc. announced the publication of abstracts for an oral presentation in the New Drugs on the Horizon series, and three poster presentations on IDE275 (GSK959) at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.

Relmada Therapeutics, Inc announced the completion of an exclusive licensing agreement with Trigone Pharma, Ltd. (Trigone) for NDV-01, a novel sustained-release intravesical formulation of gemcitabine and docetaxel (gem/doce) for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

AstraZeneca announces New study results presented at the European Lung Cancer Congress (ELCC) 2025, March 26 to 29, demonstrate the role of AstraZeneca's TAGRISSO® (osimertinib), as monotherapy and as the backbone for novel combinations, across stages and settings of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

GSK plc announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.

Theratechnologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection.

ADC Therapeutics SA announced abstracts detailing multiple preclinical programs have been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025, in Chicago, Illinois.

Nuvalent, Inc. announced upcoming poster presentations further characterizing the preclinical profiles of its novel ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib, at the American Association for Cancer Research (AACR) Annual Meeting 2025 from April 25-30, 2025, in Chicago.

Exelixis, Inc. announced that preclinical data will be presented for four pipeline molecules at the American Association for Cancer Research (AACR) Annual Meeting 2025 taking place April 25-30 in Chicago, IL.

Exelixis, Inc. announced that preclinical data will be presented for four pipeline molecules at the American Association for Cancer Research (AACR) Annual Meeting 2025 taking place April 25-30 in Chicago, IL.

Schrödinger, Inc announced that new preclinical data on SGR-3515, its investigational Wee1/Myt1 inhibitor, and SGR-4174, its SOS1 inhibitor, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25 - 30, 2025 in Chicago, IL.

Bicara Therapeutics Inc. announced that three abstracts relating to the company's lead product candidate, ficerafusp alfa, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, which will be held from April 25-30, 2025 in Chicago, IL.

Nuvation Bio Inc. announced that new nonclinical data for taletrectinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place April 25–30, 2025 in Chicago, Illinois.

Agenus Inc. announced two upcoming presentations at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25–30, 2025 in Chicago, Illinois.

IO Biotech announced that two abstracts have been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025 taking place April 25-30 in Chicago, Illinois.

Eli Lilly and Company announced that preclinical data for agents targeting SMARCA2 (BRM) and multiple KRAS mutations will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25 - 30 in Chicago.

iTeos Therapeutics, Inc announced the poster presentations of preclinical data on EOS-215, a potential best-in-class antibody targeting TREM2, and a novel small molecule inhibiting PTPN1/2 at the American Association for Cancer Research (AACR) Annual Meeting, being held April 25-30, 2025 in Chicago, Illinois.

Verastem Oncology announced today multiple oral and poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2025 to be held on April 25-30 in Chicago, Illinois.

Foghorn® Therapeutics Inc. announced that new preclinical combination data for FHD-909, a potential first-in-class selective SMARCA2 inhibitor will be presented as an oral presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting being held April 25-30, 2025, in Chicago, Illinois.

Erasca, Inc. announced the company will present three poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting, taking place April 25 - 30, 2025, in Chicago, Illinois.

Erasca, Inc. announced the company will present three poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting, taking place April 25 - 30, 2025, in Chicago, Illinois.

Olema Pharmaceuticals, announced it will present a poster highlighting preclinical anti-tumor activity of OP-3136, a novel small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), in prostate, ovarian, and non-small cell lung cancer models in a late-breaking session at the American Association for Cancer Research (AACR) Annual Meeting taking place April 25-30 in Chicago, Illinois.

Evaxion Biotech A/S a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will present new data for its lead asset EVX-01 at a poster session at the American Association for Cancer Research (AACR) Annual Meeting taking place in Chicago April 25-30, 2025. Designed with Evaxion's AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer).

Zymeworks Inc announced the acceptance of six abstracts for poster presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting being held April 24-30, 2025 in Chicago, IL.

Abpro Holdings, Inc. announced an oral presentation of preclinical data for ABP-102/CT-P72 at the American Association for Cancer ResearchⓇ Annual Meeting 2025 ("AACR 2025") in the New Drugs on the Horizon session. AACR 2025 is taking place April 25-30, at the McCormick Place Convention Center in Chicago.

ORIC Pharmaceuticals, Inc. announced that a preclinical abstract highlighting the potential of ORIC-944, a potent and selective allosteric inhibitor of PRC2 to treat prostate cancer, has been accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting taking place April 25-30, 2025 in Chicago, IL.

Elevation Oncology, Inc. announced that it will present preclinical data for its novel HER3 ADC, EO-1022, in a late-breaking poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025, being held April 25-30 in Chicago, Illinois.

Coherus BioSciences, Inc announced that an abstract highlighting interim data from its ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), has been selected for a poster presentation at the upcoming 2025 AACR Annual Meeting, being held April 25-30, 2025, at McCormick Place Convention Center in Chicago, Illinois.

Pyxis Oncology, Inc. announced that the Company will present new, positive preclinical data highlighting the potential of micvotabart pelidotin (MICVO, formerly referred to as PYX-201), a first-in-concept antibody-drug conjugate (ADC) that targets EDB+FN, a non-cellular structural component of the tumor extra-cellular matrix.

Affimed N.V. announced an abstract on AFM24 dose optimization using exposure response analysis has been accepted for presentation as a poster at the Annual Meeting of the American Association for Cancer Research (AACR) taking place April 25-30, 2025 in Chicago, Illinois.

Nurix Therapeutics, Inc announced that company scientists will present preclinical data from its proprietary DEL-AI platform and several degrader programs in two oral presentations and two poster presentations at the American Association for Cancer Research (AACR) 2025 Annual Meeting, which will be held from April 25-30, 2025, in Chicago, IL..

Bolt Biotherapeutics announced it will present data from the Phase 1 dose-escalation clinical study of BDC-3042 in patients with advanced cancers at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois.

Oncotelic Therapeutics, Inc announced the successful completion of a Phase 1 clinical trial evaluating OT-101, in combination with IL-2 for advanced or metastatic solid tumors.

Inspira™ Technologies OXY B.H.N. Ltd. announced that it has successfully completed the installation, training program and operational readiness for its INSPIRA ART100 system for cardiopulmonary bypass procedures at one of New York's premier hospitals.

Genelux Corporation announced preliminary safety and anti-tumor activity data from the dose escalation Phase 1b portion of the companies' co-sponsored ongoing Phase 1b/2 clinical trial (OLVI-VEC-SCLC-202) of Olvi-Vec immunochemotherapy in patients with platinum-relapsed or platinum-refractory extensive small cell lung cancer.

OS Therapies announced that OST-HER2 is featured in the upcoming movie Shelter Me: The Cancer Pioneers.

Cassava Sciences, Inc. today shared topline results from the Phase 3 REFOCUS-ALZ study of simufilam in mild-to-moderate AD.

Nuvation Bio Inc announced that new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus crizotinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be reported in a mini oral presentation at the European Lung Cancer Congress taking place March 26–29, 2025 in Paris, France.

Tiziana Life Sciences, Ltd. announced dosing of new patients at Yale MS Center which is participating in our multicenter Phase 2 clinical trial evaluating intranasal foralumab for non-active Secondary Progressive Multiple Sclerosis (na-SPMS).

Immutep Limited announces the first patient has been successfully dosed in the Company's pivotal TACTI-004 Phase III trial.

Kezar Life Sciences, Inc today reported positive topline results from the PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a novel, first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH) and reported fourth quarter and year end 2024 financial results.

Cognition Therapeutics, will be presenting biomarker results from the Phase 2 SHINE (COG0201) study of zervimesine (CT1812) in mild-to-moderate Alzheimer's disease at the AD/PD™ 2025 Alzheimer's & Parkinson's Diseases Conference taking place April 1-5, 2025 in Vienna, Austria.

Traws Pharma, Inc. announced that positive data supporting the potential for ratutrelvir, a main protease inhibitor, as a treatment for COVID-19, were presented on March 20, 2025 in a poster at the International Conference for Antiviral Research (ICAR 2025), held in Las Vegas, Nevada.

Scholar Rock announced that FDA to review BLA application under priority review, with a PDUFA date of September 22, 2025

Scholar Rock announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for apitegromab, an investigational muscle-targeted treatment that is being developed to provide clinically meaningful improvement in motor function for people living with spinal muscular atrophy (SMA) who are receiving an SMN-targeted treatment.

Palatin Technologies, Inc. announced the US Food & Drug Administration (FDA) has granted "orphan drug" designation to PL7737, an oral treatment that activates the melanocortin-4 receptor, for leptin receptor (LEPR) deficiency, including obesity caused by this condition.

Axsome Therapeutics, Inc. announced that the FOCUS Phase 3 trial of solriamfetol in the treatment of attention deficit hyperactivity disorder (ADHD) achieved its primary and key secondary endpoints demonstrating statistically significant improvements in ADHD symptoms and disease severity with solriamfetol compared to placebo.

KalVista Pharmaceuticals, Inc announced the completion of enrollment in the open-label KONFIDENT-KID clinical trial of sebetralstat, an investigational, novel, oral plasma kallikrein inhibitor, in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE).

KalVista Pharmaceuticals, Inc announced the completion of enrollment in the open-label KONFIDENT-KID clinical trial of sebetralstat, an investigational, novel, oral plasma kallikrein inhibitor, in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE).

Merck announced that the companies have entered into an exclusive license agreement for HRS-5346, an investigational oral small molecule Lipoprotein(a), or Lp(a), inhibitor currently being evaluated in a Phase 2 clinical trial in China.

Teleflex Incorporated announced that new findings from the CLEAR study were presented at the 40th Annual European Association of Urology (EAU) Congress in Madrid, which took place March 21-24, 2025.

Mural Oncology plc announced that the ARTISTRY-7 phase 3 trial of nemvaleukin alfa in combination with Merck's (known as MSD outside the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus investigator's choice chemotherapy in patients with platinum-resistant ovarian cancer (PROC) will not continue to final analysis and the company will cease development of nemvaleukin for PROC.

Alumis Inc announced that the companies have entered into a collaboration and licensing agreement to develop, manufacture and commercialize ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, for dermatology indications in Japan, with the option to expand the license to include rheumatological and gastrointestinal diseases.

Sanofi announced that The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients.

Quince Therapeutics, Inc Provides Business Update

Artiva Biotherapeutics, announced Recent Business Highlightsnc.

CEL-SCI Corporation announced new data has been published from its prior Phase 3 study of Multikine* (Leukocyte Interleukin, Injection) in newly diagnosed, treatment naïve, resectable, locally advanced head and neck cancer patients in the highly regarded peer reviewed journal Pathology and Oncology Research (POR).

Can-Fite BioPharma Ltd announced that it initiated a pivotal phase 3 psoriasis study of its oral drug Piclidenoson with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) - approved clinical study protocol.

Tenaya Therapeutics, Inc announced the publications of positive preclinical data for TN-201, the company's gene therapy candidate for Myosin-Binding Protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM), in Nature Communications.

Tonix Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) will not require an Advisory Committee meeting to discuss the Company's New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia.

Clene Inc. provided recent operating highlights for the clinical programs in ALS and MS.

Agilent Technologies Inc. announce its role in supporting Autolus Therapeutics' FDA approval for AUCATZYL®, a recently approved CAR T therapy.

Kezar Life Sciences, Inc announced that it will present topline results from the PORTOLA Phase 2a trial evaluating zetomipzomib for the treatment of patients with autoimmune hepatitis (AIH) on Tuesday, March 25, 2025, at 8:00 a.m. ET.

IMUNON, Inc. announced that the U.S. Food and Drug Administration (FDA) is aligned with the protocol for the Phase 3 pivotal trial, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer.

Clearside Biomedical, announced that six abstracts related to the Company's suprachoroidal drug delivery platform have been accepted for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting, to take place May 4-8, 2025 in Salt Lake City, UT.

Entrada Therapeutics, Inc. announced it has received authorization from the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate ELEVATE-45-201.

Verve Therapeutics announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for VERVE-102 for the treatment of patients living with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD).

Aura Biosciences, Inc. announced positive data from a completed Phase 1 window of opportunity trial of bel-sar (AU-011) in patients with NMIBC.

DBV Technologies announced that in a Written Responses Only to the Company's Type D IND meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company's proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a Biologics License Application (BLA) filing in this age group.

Abivax SA provided company updates

UNITY Biotechnology to Host Virtual Investor Event to Discuss 24- and 36-Week Data from the Phase 2b ASPIRE Study of UBX1325 in Patients with Diabetic Macular Edema (DME) on March 24, 2025

Clearmind Medicine announced today that its innovative drug candidate, CMND-100, has arrived in the United States following successful manufacturing.

Omeros Corporation today reported that clinical trial site activation for enrollment is underway for the company's Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH).

iECURE, Inc announced that data presented at the 2025 ACMG Annual Clinical Genetics Meeting from the ongoing OTC-HOPE Phase 1/2 study of ECUR-506 suggest partial restoration of functional ornithine transcarbamylase (OTC) enzyme activity in the first patient dosed.

Traws Pharma, Inc. announced that positive data supporting the potential for tivoxavir marboxil (TXM) as a bird flu treatment was presented yesterday in a poster at the International Society for Antiviral Research (ICAR 2025), being held in Las Vegas, Nevada.

Rapport Therapeutics, Inc. announced two encore poster presentations at the 2025 American Academy of Neurology (AAN) Annual Meeting, taking place from April 5 to April 9, 2025, in San Diego, California. The data from these posters was originally presented at the American Epilepsy Society (AES) Annual Meeting in December 2024.

Telix Pharmaceuticals Limited announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's next-generation PSMA-PET imaging1 agent for prostate cancer.

HUTCHMED (China) Limited announces that the New Drug Application ("NDA") for TAZVERIK® (tazemetostat) has been granted conditional approval in China for the treatment of adult patients with relapsed or refractory ("R/R") follicular lymphoma ("FL") with EZH2 mutation who have received at least two prior systemic therapies.

NuCana plc provided an update on its clinical development program with its two lead anti-cancer medicines.

Verastem Oncology highlighted recent progress.

Erasca, Inc. provided business updates

Skye Bioscience, Inc announced key accomplishments and upcoming milestones.

Senti Biosciences, Inc. provided a summary of recent pipeline and corporate highlights.

Monte Rosa Therapeutics reported a clinical update, business highlights

NeuroSense Therapeutics Ltd. announced significant progress toward the early commercialization of PrimeC in Canada.

NuCana plc provided an update on its clinical development program with its two lead anti-cancer medicines.

MacroGenics, Inc. provided an update on its recent corporate progress

Vor Bio provided a business update.

Terns Pharmaceuticals, Inc provided corporate updates.

Assembly Biosciences, Inc provides recent highlights.

SELLAS Life Sciences Group provided a corporate update.

Alto Neuroscience, Inc. highlighted recent progress across its pipeline of clinical-stage product candidates.

NANOBIOTIX announced poster presentations from two Phase 1 studies evaluating JNJ-1900 (NBTXR3) for patients with lung cancer (NSCLC) to be presented at the 2025 European Lung Cancer Conference ("ELCC").

vTv Therapeutics Inc. Provides Corporate Update

Alnylam Pharmaceuticals, Inc announced the U.S. Food and Drug Administration (FDA) approval of the supplemental New Drug Application (sNDA) for its RNAi therapeutic, AMVUTTRA® (vutrisiran), for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits.

Armata Pharmaceuticals, Inc. provided a corporate update.

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn's disease (CD), a chronic inflammatory condition of the gastrointestinal tract.1

Novartis announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition1-4.

IGC Pharma, Inc. announced the expansion of its ongoing Phase 2 CALMA trial for IGC-AD1 with the addition of a new clinical site at Hamilton Health Sciences (HHS) in Ontario, Canada.

Longeveron Inc announced the positive outcome of a Type B meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of laromestrocel (Lomecel-BTM), a proprietary, scalable, allogeneic, investigational cellular therapy, as a potential treatment for Alzheimer's disease (AD).

BioMarin Pharmaceutical announced positive new data from studies of VOXZOGO® (vosoritide) in children with achondroplasia and in ongoing clinical trials investigating other skeletal conditions, as well as PALYNZIQ® (pegvaliase-pqpz) in adults with phenylketonuria (PKU).

Galmed Pharmaceuticals Ltd. announced the grant of a new patent related to its lead compound, Aramchol.

Aptevo Therapeutics announced two additional frontline AML patients have achieved remission* within 30 days of treatment in the Company's RAINIER dose optimization trial evaluating mipletamig in combination with standard of care for patients unfit for intensive chemotherapy.

IceCure Medical Ltd announced it is in continued discussions with the U.S. Food and Drug Administration ("FDA") regarding its De Novo marketing authorization request for ProSense® in early-stage low risk breast cancer with endocrine therapy.

Neurocrine Biosciences, presented new data from the long-term, open-label KINECT® 4 study demonstrating remission of tardive dyskinesia among the majority of patients treated with once-daily INGREZZA® (valbenazine) capsules. This analysis was presented at the 2025 Psychiatry Update Conference in Chicago.

BriaCell Therapeutics Corp announces that the external Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor the safety data of the BriaCell clinical study to determine if the study should continue, be modified, or be halted, has completed its second safety data review of BriaCell's pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer (NCT06072612) and recommended continuation of the ongoing study without any modifications.

- Corvus Pharmaceuticals, Inc. announced that additional data from the Company's Phase 1/1b clinical trial of soquelitinib for the treatment of patients with T cell lymphoma (TCL) is being presented at the 16th Annual T-Cell Lymphoma Forum taking place March 20-22, 2025 in San Diego, CA.

Esperion announced that following meetings with the U.S. Food and Drug Administration (FDA), it has gained alignment on a regulatory path forward for initiating Phase 3 studies of bempedoic acid alone and in combination with ezetimibe in pediatric patients with heterozygous and homozygous familial hypercholesterolemia (HeFH and HoFH, respectively). Based on these discussions with the FDA, the Company plans to initiate Phase 3 clinical studies this year.

Immutep Limited announces an upcoming poster presentation for the pivotal TACTI-004 Phase III trial.

Indaptus Therapeutics, Inc. y provided an update on key pharmacodynamic findings from the weekly dosing cohort of its ongoing Phase 1 trial of Decoy20.

Milestone® Pharmaceuticals Inc announced that it will present a moderated poster presentation at the American College of Cardiology annual meeting (ACC25), to be held March 29th to 31st, 2025 in Chicago, Illinois.

Medera Inc. announced that the independent Data and Safety Monitoring Board (DSMB) has completed its planned review of the MUSIC-HFrEF Phase 1b/2 clinical trial data, recommending the completion of the Phase 1b portion and clearance to initiate the Phase 2 portion of the trial evaluating the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction (HFrEF).

Johnson & Johnson announced today that new data from its industry-leading oncology pipeline will be presented at the 2025 European Lung Cancer Congress (ELCC), including overall survival (OS) results from the Phase 3 MARIPOSA study evaluating RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) versus osimertinib in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.

PTC Therapeutics, Inc. today shared new data being presented from the Phase 3 APHENITY trial and subsequent open-label extension study at the 2025 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting.

BioAtla, Inc announced two abstracts accepted for poster presentations at the upcoming European Lung Cancer Congress (ELCC) 2025 Scientific Committee and Mayo Clinic Multidisciplinary Head and Neck Cancer Symposium 2025, to be held in Paris, France from March 26–29, 2025 and in Scottsdale, AZ from March 27–29, 2025, respectively.

Creative Medical Technology announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded dose escalation for its ongoing Phase 1/2 trial of StemSpine® using AlloStem™ (CELZ-201-DDT), the Company's proprietary allogeneic (donor) cell therapy for chronic lower back pain caused by degenerative disc disease (DDD).

MetaVia Inc. Provides Corporate Update

Plus Therapeutics, Inc. announces the U.S. Food and Drug Administration (FDA) has conditionally accepted the Company's new proprietary name, REYOBIQ™, for its lead therapeutic candidate.

Abeona Therapeutics Inc. announced progress in the ongoing review with the U.S. Food and Drug Administration (FDA) regarding prademagene zamikeracel (pz-cel) and plans for the U.S. commercial launch of pz-cel for recessive dystrophic epidermolysis bullosa (RDEB), if approved.

Kairos Pharma, Ltd announces a peer-reviewed publication highlighting a potentially significant breakthrough in addressing drug resistance to EGFR-targeted therapies for non-small cell lung cancer (NSCLC) patients.

Precision BioSciences, Inc presents preclinical data supporting repeat dosing of PBGENE-HBV in the ELIMINATE-B trial to treat patients with chronic HBV.

Cognition Therapeutics, provided a business update.

Autolus Therapeutics provided Business Updates

Monte Rosa Therapeutics, Inc. Provides Corporate Update Including New Clinical Results from MRT-6160 and MRT-2359 Programs

Avalo Therapeutics, Inc provided Recent Business Updates

ARS Pharmaceuticals, Inc. Provides Business Updates

BD (Becton, Dickinson and Company) announced the first patient treated in an Investigational Device Exemption (IDE) clinical trial intended to advance BD's efforts to achieve Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the use of GalaFLEX LITE™ Scaffold in decreasing capsular contracture (CC) recurrence during breast revision surgery.

Pharming Group N.V. announces that the first patient has been dosed in a Phase II, proof of concept, clinical trial evaluating leniolisib in common variable immunodeficiency (CVID) patients with immune dysregulation.

Alumis Inc. highlighted recent achievements and upcoming milestones.

LENZ Therapeutics, Inc provided recent corporate highlights..

Century Therapeutics, Inc provided business highlights for the full year 2024..

Novartis AG announced safety and efficacy results from the Phase 3 program for investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in a broad population of patients aged two to <18 years with spinal muscular atrophy (SMA).

Rhythm Pharmaceuticals, Inc. announced it has received orphan drug designation from Japan's Ministry of Health, Labour and Welfare (MHLW) for setmelanotide as a treatment for acquired hypothalamic obesity.

Tandem Diabetes Care, Inc announced publication by The New England Journal of Medicine (NEJM) of positive results from the company's pivotal trial of Control-IQ+ automated insulin delivery (AID) technology in people with type 2 diabetes.

REGENXBIO today reported new, positive interim data from two additional patients in the Phase I/II portion of the AFFINITY DUCHENNE® trial of RGX-202, a differentiated investigational gene therapy for Duchenne muscular dystrophy (Duchenne).

Can-Fite BioPharma Ltd announced that a Phase II design is completed and preparatory work is undergoing for the initiation of clinical study in the rare genetic disease Lowe Syndrome.

bioAffinity Technologies, Inc today released a study of a complex clinical case in which CyPath® Lung's real-time assessment of the lung microenvironment identified a hidden recurrence of breast cancer in an 80-year-old high-risk patient.

Conduit Pharmaceuticals Inc today provides an R&D update on the development progress of pipeline assets AZD1656, AZD5658, and AZD5904.

Tenaya Therapeutics, Inc announced that new clinical and disease burden data pertaining to the company's MYBPC3-associated hypertrophic cardiomyopathy (HCM) program will be presented at the upcoming American College of Cardiology's Annual Scientific Session being held March 29-31, 2025 in Chicago, IL.

CERo Therapeutics Holdings, Inc announces an agreement with the University of California Davis for the manufacturing of CER-1236 to be used in the Company's upcoming Phase 1 clinical trial for Acute Myeloid Leukemia (AML).

Acumen Pharmaceuticals announced topline results from its Phase 1 study comparing pharmacokinetics (PK) between subcutaneous (SC) and intravenous (IV) formulations of sabirnetug in healthy volunteers.

Onconetix, Inc. announced that an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain.

Protara Therapeutics, Inc. announced that data from THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS), will be featured during an oral session at the American Society for Parenteral and Enteral Nutrition (ASPEN) 2025 Nutrition Science & Practice Conference, taking place March 22 through March 25, 2025 in Columbus, Ohio.

Orthofix Medical Inc announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and the European CE Mark for the TrueLok™ Elevate Transverse Bone Transport (TBT) System.

Acrivon Therapeutics, Inc announced it will be holding a virtual R&D event on March 25, 2025 from 4:00 p.m. to 5:15 p.m. ET.

RenovoRx, Inc. announce a presentation of a new pre-clinical clinical data abstract at the upcoming Society of Surgical Oncology (SSO) 2025 Annual Meeting.

Immunovant, Inc reported topline results from its Phase 3 study of batoclimab in MG and initial results from Period 1 of its Phase 2b study in CIDP.

Precision BioSciences, Inc announced the presentation of preclinical data for its PBGENE-DMD development program for the treatment of Duchenne muscular dystrophy (DMD) during an oral presentation at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference being held March 16-19, 2025 in Dallas, TX.

Servier and Black Diamond Therapeutics, Inc announced a strategic worldwide licensing agreement for BDTX-4933, a potential best-in-class targeted therapy for solid tumors.

Benitec Biopharma Inc. announces continued durable improvements in swallowing function and reductions in total dysphagic symptom burden following administration of the low-dose of BB-301 in the first three Subjects treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD).

Atea Pharmaceuticals, Inc. announced the poster presentation of bemnifosbuvir preclinical data at the 38th International Conference on Antiviral Research (ICAR) 2025 taking place March 17-21, 2025 in Las Vegas, Nevada.

MediWound Ltd. Provides Corporate Update

Merck announced that Health Canada approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA® as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

Biodexa Pharmaceuticals PLC announced that it is making progress in readying the launch of a phase 3 trial for eRapa, its proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP)..

Merck announced that new clinical and outcomes research data will be presented at the American College of Cardiology's Annual Scientific Session and Expo (ACC.25) in Chicago from March 29-31.

Liquidia Corporation Provides Corporate Update

Virpax Pharmaceuticals, Inc announced positive results from a beagle dog dose range finding ("DRF") study. .

Olema Pharmaceuticals provided updates

Trevi Therapeutics, provided business updates.

Tonix Pharmaceuticals provided an overview of recent operational highlights.

Innovent Biologics, Inc and HUTCHMED (China) Limited jointly announce that the FRUSICA-2 Phase 2/3 clinical trial evaluating sintilimab in combination with fruquintinib as second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China has met its primary endpoint of progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR).

Biofrontera Inc. announced the enrollment of the final patient in its Phase 3 clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk.

Dogwood Therapeutics, Inc. announces the dosing of the first patient in its Phase 2b clinical trial, referred to as HALT-CINP (Halneuron® Treatment of Chemotherapy-Induced Neuropathic Pain), evaluating Halneuron® for the treatment of neuropathic pain associated with prior chemotherapy treatment ("CINP").

Dr. Reddy's Laboratories Ltd and Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted a 351(k) Biologic License Application (BLA) submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia® (denosumab) and Xgeva® (denosumab).

Can-Fite BioPharma Ltd. announced that it received a single FDA approval for the compassionate use treatment of a U.S. based pancreatic cancer patient with its anti-cancer drug Namodenoson.

Alpha Cognition Inc announced the official commercial launch of ZUNVEYL, a new treatment for mild to moderate Alzheimer's disease.

Aptevo Therapeutics a leader in the development of novel bispecific antibodies for cancer treatment, based on its proprietary ADAPTIR® and ADAPTIR-FLEX® platform technologies provided an overview of solid tumor anti-cancer compound APVO603, currently in preclinical development for the treatment of solid tumors.

Hoth Therapeutics, Inc. announced breakthrough preclinical findings demonstrating the efficacy of HT-KIT, a novel targeted therapy for gastrointestinal stromal tumors (GIST). T

SCIENTURE HOLDINGS, announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc., with the brand name ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL.

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with moderate-to-severe Sjögren's disease (SjD), having previously been granted Breakthrough Therapy designation (BTD) for the investigational therapy late last year.

Ocugen, Inc. announced that the Data and Safety Monitoring Board (DSMB) for the OCU200 clinical trial recently convened and reviewed safety data following dosing of the first cohort in the dose-escalation portion of the Phase 1 study and approved continuation of dosing in the second cohort.

Cidara Therapeutics, Inc. announced two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR).

ZyVersa Therapeutics, Inc. highlights newly published animal model data demonstrating that inflammasome inhibition attenuates obesity-associated cardiomyopathy, which has a 5-year survival rate <50%.

Indaptus Therapeutics Tells Benzinga Co. Initiates Phase I Combination Study Of Decoy20 With PD-1 Checkpoint Inhibitor Tislelizumab

Clearmind Medicine announces that it initiated its Phase I/IIa clinical trial investigating the safety, tolerability and full pharmacokinetic profile of its innovative treatment, CMND-100, in Alcohol Use Disorder (AUD) patients.

Stoke Therapeutics, Inc provided business updates.

RedHill Biopharma Ltd announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of helicobacter pylori (H. pylori) infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process for UK drug approvals based on a recognized reference approval..

Compass Pathways plc announced the publication of results from the COMP004 study, an observational 52-week follow-up from the Phase 2 COMP001 and COMP003 trials of COMP360 psilocybin treatment in patients with treatment-resistant depression (TRD).

Genmab A/S announced today updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S®), an investigational folate receptor-alpha (FRα)-targeted, TOPO1 antibody-drug conjugate (ADC) that showed Rina-S 120 mg/m2 every 3 weeks (Q3W) resulted in a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer (OC) patients regardless of FRα expression levels.

Capricor Therapeutics announced positive long-term data from its ongoing HOPE-2 open label extension ("OLE") clinical trial, demonstrating the potential of the Company's lead asset, deramiocel, to slow disease progression and preserve upper limb function in patients with Duchenne muscular dystrophy ("DMD").

Actinium Pharmaceuticals, Inc. announced that results from the clinical trial evaluating Actimab-A in combination with the chemotherapy CLAG-M in patients with relapsed/refractory acute myeloid leukemia (r/r AML) have been published in the peer-reviewed journal Leukemia.

Neurocrine Biosciences, Inc. presented data from the KINECT®-HD study showcasing significant improvements in chorea across body regions with once-daily INGREZZA® (valbenazine) capsules in adults with Huntington's disease.

vTv Therapeutics Inc. announced that the United States Food and Drug Administration (FDA) has lifted the clinical hold on the cadisegliatin clinical program, which includes the CATT1 Phase 3 trial in type 1 diabetes (T1D).

Savara Inc announced the acceptance of two abstracts for poster presentation at the American Thoracic Society (ATS) International Conference taking place May 16-21, 2025, in San Francisco, CA.

GRI Bio, Inc provided a corporate update.

Allarity Therapeutics, Inc. announced the presentation of new clinical data from its ongoing Phase 2 trial with stenoparib monotherapy in advanced Ovarian Cancer at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer, held March 14-17 in Seattle, Washington.

Xeris Biopharma Holdings, Inc. announced that its supplemental new drug application (sNDA) of Gvoke VialDx™ has received U.S Food and Drug Administration (FDA) approval for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

CEL-SCI Corporation announced it received comments from the U.S. Food and Drug Administration (FDA) on the confirmatory Registration Study's Statistical Analysis Plan (SAP) submitted in December of 2024 for the study of Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer.

MBX Biosciences, Inc. highlighted recent corporate progress.

CervoMed Inc Provides Corporate Updates

atai Life Sciences Recent Corporate Highlights

Mineralys Therapeutics, Inc. announced that data from the Phase 2 Advance-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) will be presented in a late-breaking clinical trials session at the American College of Cardiology's Annual Scientific Session & Expo (ACC.25), which is being held in Chicago on March 29-31, 2025.

Pliant Therapeutics, Inc announced data from the first three of five potential cohorts of its ongoing Phase 1 dose escalation clinical trial evaluating PLN-101095, an integrin αvβ8 and αvβ1 inhibitor, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI) -refractory advanced or metastatic solid tumors.

ProKidney Corp. provided business highlights for the year ended December 31, 2024.

Arcutis Canada, Inc announced that Health Canada has approved PrZORYVE® (roflumilast cream 0.15%), for the treatment of mild to moderate atopic dermatitis (AD) in adults and children ages 6 years and older.

Precision BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PBGENE-HBV.

Travere Therapeutics, Inc., announced the Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking priority review for traditional approval of FILSPARI® (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS).

Avidity Biosciences, Inc. announced positive del-zota topline data from the Phase 1/2 EXPLORE44® trial in people living with Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44) demonstrating consistent, statistically significant improvements in dystrophin, exon skipping and creatine kinase as well as favorable safety and tolerability across the dose cohorts.

Incyte announced positive topline results from its pivotal Phase 3 STOP-HS clinical trial program evaluating the safety and efficacy of povorcitinib (INCB054707), an oral small-molecule JAK1 inhibitor, in adult patients (≥18 years) with moderate to severe hidradenitis suppurativa (HS).

Harrow today introduced VEVYE® Access for All, a groundbreaking initiative that underscores Harrow's long‑standing commitment to access and affordability.

Nurix Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to bexobrutideg (NX-5948) for the treatment of Waldenström macroglobulinemia (WM).

Perspective, Therapeutics, Inc. announced that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-particle therapy (TAT), in patients with histologically confirmed melanoma and positive melanocortin 1 receptor (MC1R) imaging scans.

Monogram Technologies announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance

Greenwich LifeSciences, announced the following update on FLAMINGO-01 open label safety data.

Cidara Therapeutics, Inc. announced the publication of preclinical data assessing CD388, the company's influenza DFC, in the peer-reviewed scientific journal Nature Microbiology.

AstraZeneca announced High-level results from the CALYPSO Phase III trial showed that eneboparatide (AZP-3601), an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with statistical significance in adults with chronic hypoparathyroidism (HypoPT) at 24 weeks, compared to placebo.

Scholar Rock announced that new efficacy and safety data from the Phase 3 pivotal SAPPHIRE trial (NCT05156320) will be presented in multiple clinical presentations at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Dallas, Texas.

Dyne Therapeutics, Inc. announced that Potential for Biologics License Application submission for U.S. accelerated approval in early 2026 -

Dyne Therapeutics, Inc. announced new long-term clinical data from its ongoing Phase 1/2 DELIVER trial of DYNE-251 demonstrating unprecedented and sustained functional improvement at the selected registrational dose of 20 mg/kg Q4W (approximate PMO dose).

Sutro Biopharma, Inc announced expanded data in a late-breaking oral presentation from the dose-optimization portion of the REFRαME-O1 trial with luveltamab tazevibulin (luvelta) in patients with platinum resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer®.

Zentalis® Pharmaceuticals, announced updated clinical data from Part 1b of the ongoing DENALI clinical trial of azenosertib in patients with PROC in an oral presentation at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting on Women's Cancer.

Palisade Bio, Inc today provided an update on its ongoing Phase 1a/b study of PALI-2108 for the treatment of Ulcerative Colitis (UC).

Korro Bio, Inc announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the investigational medicine KRRO-110 for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

Gain Therapeutics, Inc announced the dosing of the first participant with Parkinson's disease (PD) in its Phase 1b clinical trial of GT-02287, the Company's lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation.

Bristol Myers Squibb announced that the European Commission (EC) has granted approval to Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Eton Pharmaceuticals, Inc announced positive results from its bioequivalence study of ET-600, a proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus.

ANI Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).

CERo Therapeutics Holdings, Inc announces it is presenting encouraging preclinical results of lead compound CER-1236 in ovarian cancer during the 2025 SITC Spring Scientific Cellular Therapy for Solid Tumors in San Diego, March 12-14.

bioAffinity Technologies, Inc announced the release of physicians' case studies showing the benefit to patients and their doctors of using CyPath® Lung, the Company's noninvasive test for early detection of lung cancer.

ImmunityBio, Inc announced U.S. Urology Partners, one of the nation's largest independent providers of urology and related specialty services, is one of the first providers to participate in ImmunityBio's Expanded Access Program (EAP) for recombinant Bacillus Calmette-Guérin (rBCG) to address the current shortage of TICE® BCG in the U.S.

Allarity Therapeutics, Inc announced that it has reached a final settlement with the U.S. Securities and Exchange Commission (SEC) relating to the previously disclosed investigation regarding the Company's past disclosures concerning its interactions with the U.S. Food and Drug Administration (FDA) regarding its New Drug Application ("NDA") for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.

Femasys Inc announces Conformité Européene (CE) mark certification under European Union Medical Device Regulation (EU MDR) as the first regulatory approval in the world for the FemBloc® delivery system for non-surgical female permanent birth control.

Emergent BioSolutions Inc. is strengthening relationships with partners across sectors and continuing its commitment to ensuring widespread opioid emergency preparedness as opioid overdose death rates continue to decline nationwide for the first time in five years.1 These efforts include working with organizations to expand access to NARCAN® Nasal Spray and educate the public on how to respond to an opioid overdose emergency.

Amgen announced new data from the Phase 3, registrational MINT trial evaluating the efficacy and safety of UPLIZNA® (inebilizumab-cdon) in adults living with generalized myasthenia gravis (gMG).

Vir Biotechnology, Inc announced the enrollment of the first patient in its Phase 3 ECLIPSE registrational program.

PDS Biotechnology announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug ("IND") application filed in January 2025 to evaluate a combination of Versamune® MUC1 (formerly PDS0103), its novel investigational MUC1-targeted immunotherapy candidate + PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma ("mCRC") in patients who failed previous treatment.

Tempest Therapeutics, announced that the Cancer Prevention Clinical Trials Network received a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA) to evaluate TPST-1495, the company's novel dual receptor inhibitor of prostaglandin (PGE2) signaling, in a Phase 2 clinical trial for the treatment of patients with Familial Adenomatous Polyposis (FAP).

TransCode Therapeutics, Inc. announced that the Safety Review Committee (SRC) monitoring its Phase I clinical trial has unanimously approved opening of the fourth cohort of patients based on the SRC's favorable review of Cohort 3 safety data.

MIRA Pharmaceuticals Inc announced the formulation of Ketamir-2 as a topical treatment for localized neuropathic and inflammatory pain.

OS Therapies, Inc announced that it has been awarded a presentation slot at the MIB Agents Factor Osteosarcoma Conference to be held June 26-28, 2025 in Salt Lake City, Utah.

Lucid Diagnostics and subsidiary of PAVmed Inc. announced that Highmark Blue Cross Blue Shield, an independent licensee of the Blue Cross and Blue Shield Association, has issued a positive coverage policy for non-invasive screening of esophageal precancer and cancer in New York state.

Vivani Medical, Inc announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1™ clinical trial.

MeiraGTx Holdings plc announced a broad strategic collaboration with Hologen Limited, a world-leading developer of multi-modal generative AI foundation models of real-world clinical data for clinical medicine and pharmaceutical drug development.

Indaptus Therapeutics, Inc provides a corporate update.

Akebia Therapeutics® recent business highlights.

Cellectar Biosciences, provided a corporate update.

Vigil Neuroscience, provided updates on recent progress.

Cartesian Therapeutics, outlined recent corporate updates.

Unicycive Therapeutics, announced that it will present patient reported outcomes data from its pivotal UNI-OLC-201 clinical study characterizing the potential impact of oxylanthanum carbonate (OLC) on the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

Seres Therapeutics provided business updates.

SCYNEXIS, Inc. Provides Corporate Update

Avidity Biosciences, Inc. announced that the company will be presenting one oral and two poster presentations at the 2025 MDA Clinical & Scientific Conference (MDA) in Dallas, Texas, being held March 16-19, 2025 and will host an investor and analyst webcast event on March 17, 2025.

aTyr Pharma, Inc. announced a publication demonstrating the mechanism of action for its lead therapeutic candidate, efzofitimod, in the journal Science Translational Medicine.

Merck announced the presentation of positive results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100mg/0.25mg)] in adults with HIV-1 infection that is virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamidei [BIC/FTC/TAF (50mg/200mg/25mg)] in trial MK-8591A-052) or antiretroviral therapy [baseline antiretroviral therapy (bART)] in trial MK-8591A-051.

Palisade Bio, Inc. announced that it has been selected to present data from its lead program PALI-2108 for the treatment of ulcerative colitis at Digestive Disease Week® (DDW) 2025 being held May 3–6, in San Diego, California.

Corvus Pharmaceuticals, Inc announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has initiated a Phase 2 clinical trial of soquelitinib for the treatment of patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease.

iECURE, Inc announced that initial data from the Phase 1/2OTC-HOPE clinical trial evaluating in vivo gene editing candidate ECUR-506 in neonatal onset ornithine transcarbamylase (OTC) deficiency will be presented at the 2025 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting taking place March 18-22, 2025 in Los Angeles.

Theratechnologies Inc. today presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV.

Sagimet Biosciences provided recent corporate updates.

KalVista Pharmaceuticals, Inc provided an operational update.

RedHill Biopharma Ltd. announced plans to advance its groundbreaking late-stage program for Crohn's disease (CD) with initiation of an innovative Phase 2 study of RHB-204 in Mycobacterium avium subspecies paratuberculosis-positive (MAP+) moderate to severe CD, utilizing novel endpoints and the new gold standard in imaging techniques, pending Type C discussions on path to FDA approval with guidance from FDA anticipated next quarter.

Geron Corporation announced that the European Commission (EC) has granted marketing authorization for RYTELO® (imetelstat) as a monotherapy for the treatment of adult patients with transfusion-dependent (TD) anemia due to very low, low or intermediate risk myelodysplastic syndromes (lower-risk MDS or LR-MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (ESAs).

Dianthus Therapeutics, Inc. provided an update on recent business achievements.

Gilead Sciences, Inc. today presented the first data from its ongoing Phase 1 study investigating two novel, once-yearly formulations of lenacapavir, the company's injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention as pre-exposure prophylaxis (PrEP).

Medera Inc announced that patient dosing has been completed in its MUSIC-HFrEF Phase 1/2a clinical trial of the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction (HErEF).

Actinium Pharmaceuticals, Inc. announced that the first clinical trial under its previously announced Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for Actimab-A has been initiated.

Longeveron Inc announced the publication in Nature Medicine of results from the CLEAR MIND Phase 2a clinical trial evaluating laromestrocel (Lomecel-B™) as a potential cellular therapy for mild Alzheimer's disease (AD).

Astria Therapeutics, Inc provided a corporate update.

Corbus Pharmaceuticals provided a corporate update

Vaxart, Inc announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs.

Biogen Inc announced the initiation of dosing in the global clinical study, TRANSCEND.

Guardant Health, Inc. announced the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for the Shield™ blood test for colorectal cancer (CRC) screening.

atai Life Sciences announced that the first patient has been dosed in the Phase 2 Elumina trial of VLS-01, atai's proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) applied to the buccal surface, in people suffering from treatment-resistant depression (TRD).

PolyPid Ltd. announced the successful completion of enrollment in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.

BioXcel Therapeutics, announced that, following the successful raise of $14 million gross proceeds in an equity financing that closed on March 4, 2025, it has approximately $35 million in cash. The strengthened cash position will support continued advancement of the Company's pivotal Phase 3 SERENITY At-Home trial. T

Harrow announced the execution of a five-year strategic supply and development ("SSD") agreement for TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative-free synthetic corticosteroid that is approved by the U.S. Food and Drug Administration (FDA) for visualization during vitrectomy and the treatment of ocular inflammatory conditions that are unresponsive to topical corticosteroids.

Q32 Bio Inc. provided recent corporate updates.

Arvinas, Inc. and Pfizer announced positive topline results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. Inc.

Immunocore Holdings plc today shared initial data from the multiple ascending dose (MAD) portion of its Phase 1/2 STRIVE trial of IMC-M113V, its functional cure candidate for human immunodeficiency virus (HIV).

Caribou Biosciences, Inc reviewed recent pipeline progress.

Lineage Cell Therapeutics, Inc provide a business update.

Kodiak Sciences Inc. announced that it has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with diabetic retinopathy ("DR").

NS Pharma, Inc. announced that acceptance has been received by Capricor Therapeutics, Inc from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) filing for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy ("DMD") cardiomyopathy.

LIXTE Biotechnology announced online publication of new pre-clinical data in BioXriv and International Journal of Pharmaceutics demonstrating how the Company's lead clinical compound, LB-100, is converted into its active form, endothall, a protein phosphatase (PP2A) inhibitor that has been found to be effective in cancer treatment in combination with immunotherapy.

Biodexa Pharmaceuticals PLC announced the results of its Type C meeting with the U.S. Food and Drug Administration ("FDA") regarding the protocol for the planned registrational Phase 3 study of eRapa in familial adenomatous polyposis ("FAP").

Johnson & Johnson announced today that Health Canada has issued a Notice of Compliance (NOC) for LAZCLUZE® (lazertinib) in combination with RYBREVANT® (amivantamab) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.1

OKYO Pharma announce the filing of its application for Fast Track designation with the U.S. Food and Drug Administration (FDA) for urcosimod (formerly known as OK-101) for the treatment of neuropathic corneal pain, which is a debilitating condition affecting many tens of thousands worldwide, and is characterized by chronic, severe eye discomfort for which there is no FDA-approved, effective treatment.

Protagonist Therapeutics, Inc. announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC).

Tonix Pharmaceuticals announced it has been awarded a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801 (recombinant horsepox virus, live vaccine).

Aethlon Medical, announced the publication of a pre-clinical study in the peer-reviewed journal Transplant Immunology (https://doi.org/10.1016/j.trim.2025.102215) on February 28, 2025, entitled, " A lectin affinity plasmapheresis device removes extracellular vesicles and microRNAs from renal perfusates following controlled oxygenated rewarming of discarded donor kidneys."

Northstrive Biosciences Inc announced that it has scheduled a pre-Investigational New Drug ("pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") for Wednesday, April 23, 2025.

4D Molecular announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating 4D-150 for the treatment of wet age-related macular degeneration (wet AMD).

UroGen Pharma Ltd provided an overview of recent developments.

Immunome, Inc. announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC.

REGENXBIO Inc. announced new interim biomarker data from the Phase I/II portion of the AFFINITY DUCHENNE® trial of RGX-202 for the treatment of Duchenne muscular dystrophy will be presented at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, taking place in Dallas, TX, March 16-19, 2025.

Mineralys Therapeutics, Inc. announced positive topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).

Ionis Pharmaceuticals, Inc. announced that Ionis and AstraZeneca's WAINZUA (eplontersen) has been approved in the European Union (EU) for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy, commonly referred to as hATTR-PN or ATTRv-PN.

BioNTech SE provided an update on its corporate progress.

Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo.

MannKind Corporation a company focused on the development and commercialization of inhaled therapeutic products and delivery devices for patients with endocrine and orphan lung diseases, will showcase data from recent studies of inhaled insulin across five presentations at the 18th International Conference on Advanced Technologies and Treatments for Diabetes to be held March 19-22 in Amsterdam.

Trevi Therapeutics, Inc. announced positive topline results from its Phase 2a RIVER trial of Haduvio for the treatment of patients with RCC (N=66).

Beam Therapeutics announced initial safety and efficacy data from its Phase 1/2 trial of BEAM-302, establishing clinical proof-of-concept as a potential treatment for alpha-1 antitrypsin deficiency (AATD) and for in vivo base editing. Preliminary results from the first three single-ascending dose cohorts demonstrated that BEAM-302 was well tolerated, with single doses of BEAM-302 leading to durable dose-dependent correction of the disease-causing mutation.

Trevi Therapeutics, announced a conference call and live webcast taking place tomorrow, Monday, March 10th, 2025, at 8:30 a.m. ET, to share topline results from the Phase 2a RIVER trial of Haduvio in patients with refractory chronic cough.

Protagonist Therapeutics announced new icotrokinra (JNJ-2113) data from the comprehensive Phase 3 clinical program and the planned initiation of the first-ever head-to-head study in plaque psoriasis (PsO) seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab.

Q32 Bio Inc. announced additional results from Part A of its SIGNAL-AA Phase 2a clinical trial of bempikibart in patients with alopecia areata (AA) at the 2025 American Academy of Dermatology (AAD) Meeting in Orlando, FL.

Regeneron Pharmaceuticals, Inc today presented positive results from the pivotal ADEPT Phase 2/3 trial evaluating the investigational use of Dupixent® (dupilumab) in adults with moderate-to-severe bullous pemphigoid (BP).

Incyte announced results from its pivotal Phase 3 TRuE-PN clinical trial program –TRuE-PN1 and TRuE-PN2 studies – evaluating the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura®), a topical JAK1/2 inhibitor, in adult patients (≥18 years) with prurigo nodularis (PN).

Bristol Myers Squibb announced positive data from the pivotal Phase 3 POETYK PsA-2 trial (IM011-055) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA).

Organon announced results from an analysis of the Phase 3 ADORING 3 open-label, long-term extension study evaluating VTAMA® (tapinarof) cream, 1% once daily in adults and children 2 years of age and older with atopic dermatitis (AD), also known as eczema.

Alumis Inc. announced positive 52-week data from the open-label extension (OLE) of its Phase 2 STRIDE clinical trial evaluating ESK-001 in patients with moderate-to-severe plaque psoriasis.

Amgen announced new results from the ongoing ROCKET Phase 3 clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD).

Mineralys Therapeutics, Inc. announced it will host a conference call and webinar to announce topline results from its Launch-HTN and Advance-HTN pivotal trials on Monday, March 10, 2025, at 8:00 a.m. ET.

Eli Lilly and Company's announced that New results show Eli Lilly and Company's EBGLYSS achieved deep and sustained response for patients with moderate-to-severe atopic dermatitis (eczema) at three years.

PDS Biotechnology announced the initiation of the VERSATILE-003 Phase 3 clinical trial. The trial is now open to patient enrollment.

Oruka Therapeutics, announced new preclinical data on ORKA-002, a novel extended half-life monoclonal antibody targeting IL-17A/F, from its presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting.

InflaRx N.V announced the presentation of multiple posters describing the utility of vilobelimab in pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS), including clinical efficacy data, safety assessments, and pharmacokinetic (PK) and pharmacodynamic (PD) analyses.

Arcutis Biotherapeutics, Inc. announced new data from two posters shared at the 2025 American Academy of Dermatology Annual Meeting (AAD).

Plus Therapeutics, Inc. announces the publication of results in a peer-reviewed manuscript titled, "Treatment of Recurrent Glioma by Rhenium (186Re) Obisbemeda (186RNL): a Phase 1 clinical trial" in the peer-reviewed medical journal Nature Communications.

TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the American Academy of Neurology 2025 annual meeting, being held April 5 - 9, 2025, in San Diego, California.

BioXcel Therapeutics, announced it has reached 33% enrollment in its 200-patient SERENITY At-Home trial.

I-Mab announced that enrollment has been completed ahead of schedule in the first dose expansion cohort in the Phase 1b givastomig combination study, with continued momentum in the second dose expansion cohort.

AstraZeneca announced Positive high-level results from the MATTERHORN Phase III trial showed perioperative treatment with AstraZeneca's IMFINZI® (durvalumab) in combination with standard-of-care FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS).

Castle Biosciences, Inc announced that it will share new data on its DecisionDx-Melanoma and DecisionDx-SCC tests for patients with skin cancers at the 2025 AAD Annual Meeting, taking place March 7-11 in Orlando, Florida.

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo®(nivolumab) plus Yervoy®(ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC).

argenx SE announced clinical trial and real-world data for VYVGART® (efgartigimod alfa-fcab) and VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) will be presented at the American Academy of Neurology (AAN) Annual Meeting, taking place in San Diego, CA from April 5-9, 2025.

CERo Therapeutics Holdings, Inc., announces the execution of an agreement with contract research organization (CRO) CellCarta to manage translational assays for the Company's upcoming Phase 1 clinical trial of CER-1236 for Acute Myeloid Leukemia (AML).

Nuvation Bio Inc provided a business update.

Centessa Pharmaceuticals plc announced that data from the Phase 1 clinical trial of ORX750, an investigational novel highly potent and selective OX2R agonist being progressed for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), will be presented in a poster session at the American Academy of Neurology (AAN) 2025 Annual Meeting being held April 5-9, 2025, in San Diego, CA

Solid Biosciences provided a business update.

CytomX Therapeutics, Inc. provided a business update.

Theriva™ Biologics provided a corporate update.

Oruka Therapeutics, provided a corporate update.

Atea Pharmaceuticals, Inc. provided a business update.

Contineum Therapeutics, Inc affirmed its key clinical development milestones.

Foghorn® Therapeutics Inc provided a business update

NextCure, Inc. provided a business update

aTyr Pharma, Inc announced the outcome of a fourth, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™ study of the Company's lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis.