FDA Calendar

INNOVATE Corp. announced that it has received approval from the National Medical Products Administration (NMPA) for Lumitrace® (relmapirazin) injection, a non-radioactive, non-iodinated fluorescent GFR agent, has been approved by the National Medical Products Administration (NMPA). Lumitrace will be sold as an integral component of the Transdermal GFR System in China.

Nexalin Technology, Inc. announced that three independently published, peer-reviewed clinical studies, coupled with a growing body of internal data, collectively demonstrate the ability of its proprietary 15 milliamp (mA) Gen-2 Nexalin DIFS™ technology—to improve cognition, restore brain activity, and enhance neuron connectivity in patients with Alzheimer's disease (AD).

Ardelyx, Inc. announced upcoming data presentations supporting XPHOZAH® (tenapanor) at the American Society of Nephrology's Kidney Week, to be held November 5-9, 2025, in Houston.

Pacira BioSciences, Inc. today reported it has received a Paragraph IV Certification Notice Letter (PIV Notice) from The WhiteOak Group, a subsidiary of a small private Chinese company.

Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead product candidate, QRX003, for the treatment of Netherton Syndrome.

Fortress Biotech, Inc announced that Crystalys Therapeutics, Inc. ("Crystalys"), in which Urica maintains an equity position, dosed first patients in its two randomized, double-blind, multicenter global Phase 3 trials, the RUBY study (NCT07089875) and the TOPAZ study (NCT07089888), evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout.

Hyperfine, Inc. announced plans for clinical use expansion into the operating room environment, advancing its mission to make brain MRI more accessible across a diversity of care settings.

Hoth Therapeutics, Inc. today highlighted FDA Orphan Drug Designation for HT-KIT and new preclinical data demonstrating >80% suppression of KIT expression and significant tumor-volume reduction by Day 8 in systemic mastocytosis and GIST models. HT-KIT, a precision antisense oligonucleotide (ASO) targeting KIT mRNA, also completed GLP-validated bioanalytical methods supporting IND-enabling studies; Japan Patent No. 7677628 extends platform protection to 2039.

CERo Therapeutics Holdings, Inc. announced that investigators have been authorized under the study protocol to administer a third infusion of CER-1236 to a patient enrolled in the first cohort of its ongoing Phase 1 clinical trial.

Xencor, Inc. will host a conference call and webcast on Friday, October 24 at 1:30 p.m. ET (10:30 a.m. PT) to discuss initial results from the ongoing Phase 1 dose-escalation study of XmAb819, an ENPP3 x CD3 T-cell engaging bispecific antibody, in development for patients with advanced clear cell renal cell carcinoma.

Allergan Aesthetics, an AbbVie company announced this year's grant recipients of The Confidence Project: Empowering Women Entrepreneurs.

Atossa Therapeutics, Inc. announced that Laura J. Esserman, MD, MBA, Professor of Surgery and Radiology at the University of California, San Francisco and Principal Investigator of RECAST™, will speak at the Early Detection Research Conference in Portland, OR, about the Company's collaborative work in the RECAST platform trial for ductal carcinoma in situ (DCIS), a biologically heterogeneous, non-invasive breast condition that can progress to invasive breast cancer in a subset of patients.

Cidara Therapeutics, Inc. announced it presented late-breaking Phase 2b clinical data on its non-vaccine influenza preventative candidate, CD388, during ID Week 2025, taking place October 19-22, 2025, in Atlanta, GA.

Mineralys Therapeutics, Inc. announced that data from the Phase 2 Explore-CKD trial evaluating the safety and efficacy of 25 mg of lorundrostat in participants with hypertension and comorbid CKD will be presented in a late-breaking clinical trials session at American Society of Nephrology (ASN) Kidney Week 2025, being held November 6 -9 in Houston, Texas.

BriaCell Therapeutics Corp. is pleased to announce the addition of several key large cancer centers to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612), notably Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University. BriaCell anticipates reporting top line data as early as H1-2026.

Cardiol Therapeutics To Present New Data From ARCHER Trial, Highlighting Magnitude Of Reduction In LV Mass And Read Through To Heart Failure, At Cardiology Conference In November

BriaCell Therapeutics Corp is pleased to announce a collaboration with Memorial Sloan Kettering Cancer Center's (MSK's) Therapeutics Accelerator Cohort program to accelerate the clinical development of Bria-OTS+, BriaCell's next generation personalized off-the-shelf immunotherapy, for multiple cancer indications including metastatic breast cancer, prostate cancer, and other cancers.

Clearmind Medicine Inc. announced the enrollment of the last patient for the first cohort of its Phase I/IIa clinical trial evaluating CMND-100, the Company's proprietary MEAI-based oral drug candidate for the treatment of Alcohol Use Disorder (AUD).

Viking Therapeutics, Inc announced the initiation of an exploratory maintenance dosing study of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.

Gilead Sciences, Inc announced that Health Canada has approved LYVDELZI (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA alone, or as monotherapy in patients unable to tolerate UDCA..

Sionna Therapeutics, announced initiation of the PreciSION CF Phase 2a proof-of-concept (POC) trial evaluating SION-719, a first-in-class nucleotide binding domain 1 (NBD1) stabilizer, when added to Trikafta® (elexacaftor/tezacaftor/ivacaftor), the current standard of care (SOC) in CF.

iBio, Inc. announced that Cory Schwartz, Ph.D., Director of Research and Early Development at iBio, will deliver an oral presentation at ObesityWeek 2025 November 4-7 in Atlanta. In addition, Martin Brenner, DVM, Ph.D., Chief Executive Officer and Chief Scientific Officer of iBio, will deliver an oral presentation at PEGS Europe 2025 November 11–13 in Lisbon.

Q32 Bio Inc announced that it has completed enrollment in Part B of its SIGNAL-AA Phase 2a clinical trial evaluating bempikibart in patients with severe or very severe AA.

SpringWorks Therapeutics, Inc announced that long-term efficacy and safety data from the Phase 3 DeFi trial of OGSIVEO® (nirogacestat), an oral gamma secretase inhibitor for the treatment of adults with progressing desmoid tumors who require systemic treatment, were published in the Journal of Clinical Oncology (JCO).

Spero Therapeutics, Inc. and GSK plc announced efficacy and safety results of the positive pivotal phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis (NCT06059846).

Verrica Pharmaceuticals Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive feedback that supports the filing of a Marketing Authorization Application (MAA) for Verrica's product, YCANTH®, as a treatment for molluscum contagiosum ("molluscum").

Pacira BioSciences, Inc. announced that new data from its Phase 1 clinical trial evaluating PCRX-201 (enekinragene inzadenovec), a novel gene therapy candidate for osteoarthritis of the knee, will be presented at the American College of Rheumatology (ACR) Convergence 2025 meeting, taking place from October 24-29 in Chicago, Il.

Neuphoria Therapeutics Inc. announced that the AFFIRM-1 Phase 3 trial of BNC210 for the acute treatment of social anxiety disorder (SAD) did not meet its primary endpoint of change from baseline to the average of the performance phase of the public speaking challenge in Subjective Units of Distress Scale (SUDS) scores.

Immatics N.V. announced the presentation of updated data from 16 patients with metastatic uveal melanoma treated with anzu-cel PRAME cell therapy.

Johnson & Johnso announced that new data from the primary analysis of the ongoing Phase 2b SunRISe-4 study demonstrated that treatment with INLEXZO™ (gemcitabine intravesical system) plus intravenous (IV) cetrelimab (CET) before radical cystectomy resulted in a clinically meaningful rate of pathologic complete response (pCR) and pathologic overall response (pOR) in patients with muscle invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant platinum-based chemotherapy and are scheduled for bladder removal.

Radiopharm Theranostics nnounced an update on its pipeline of clinical programs and outlined expected milestones through the end of 2025 and into 2026.

Palisade Bio, Inc. announced that the first patients have been dosed in its Phase 1b clinical study evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 inhibitor prodrug, for the treatment of fibrostenotic Crohn's disease (FSCD).

Cogent Biosciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients previously treated with avapritinib as well as in patients with Smoldering Systemic Mastocytosis; populations with no currently approved standard of care.

MetaVia Inc. announced that two abstracts highlighting data on DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), have been accepted for poster presentations at ObesityWeek® 2025, taking place in-person and virtually November 4-7, 2025 in Atlanta, GA.

ProQR Therapeutics N.V. announced that following review under the new European Medicines Agency (EMA) centralized review process, the Central Committee on Research Involving Human Subjects (CCMO) has authorized ProQR's Clinical Trial Application (CTA) for a Phase 1 study of AX-0810 in healthy volunteers. AX-0810 is the Company's lead investigational editing oligonucleotide (EON) targeting NTCP, which is being developed for the treatment of cholestatic diseases like primary sclerosing cholangitis and biliary atresia.

IMUNON, Inc. announced that it will host an R&D Day for investors at the Harvard Club (35 West 44th Street) in New York City on November 10, 2025, beginning at 8:00 a.m. ET.

Azitra, Inc will present positive preclinical progress for its ATR-01 program, targeting the treatment of ichthyosis vulgaris, a disease caused by missing or abnormal filaggrin levels.

Immutep Limited announces positive data from the EFTISARC-NEO Phase II trial were shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the 2025 European Society of Medical Oncology (ESMO) Congress in Berlin, Germany.

AbbVie announced positive topline results from the Phase 3b/4 head-to-head SELECT-SWITCH study evaluating the efficacy and safety of upadacitinib (RINVOQ®) 15 mg, once daily, compared to adalimumab (HUMIRA®) 40 mg, every other week, in adult patients with moderate to severe rheumatoid arthritis (RA) on a stable background of methotrexate (MTX) who had an inadequate response or intolerance to a TNF inhibitor (TNFi) other than adalimumab.1

bioAffinity Technologies, Inc announced it will present research at CHEST 2025, the annual meeting of the American College of Chest Physicians.

Immutep Limited announces two poster presentations at the European Society for Medical Oncology (ESMO) Congress 2025 highlight the Company's focus on changing the treatment paradigm in first line non-small cell lung cancer (1L NSCLC).

Kairos Pharma, Ltd today presents on the positive interim efficacy data from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) at the annual European Society Medical Oncologists meeting in Berlin, Germany.

Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc will share new data on zoliflodacin during the Infectious Disease Society of America's IDWeek 2025 annual meeting in Atlanta, GA, October 19-22, 2025. Zoliflodacin is a first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhea.

RAPT Therapeutics, Inc. announced positive topline data from Jeyou's Phase 2 trial of RPT904 (JYB1904) as monotherapy in chronic spontaneous urticaria (CSU).

BioAtla, Inc announced preliminary clinical data from a Phase 1 study of BA3182 during a poster presentation titled "Preliminary Results from a First-in-Human Phase 1 Study of BA3182, a Dual-Conditionally Binding Biologic (CAB) EpCAM x CD3 Bispecific T-cell Engager in Patients with Treatment Refractory Metastatic Adenocarcinoma" at the European Society for Medical Oncology (ESMO) Congress 2025, held in Berlin, Germany.

ProKidney Corp.announced that the Company will present two posters, including a late-breaking poster on the Phase 2 REGEN-007 study results, at the upcoming American Society of Nephrology's (ASN) Kidney Week being held from November 6-9, 2025, in Houston, TX.

BriaCell Therapeutics Corp. announces encouraging clinical biomarker data in its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer.

Stoke Therapeutics, Inc announced the presentation of two-year data from the FALCON study, a prospective natural history study in people with Autosomal Dominant Optic Atrophy (ADOA) (n=47).

Altimmune, announced that 24-week data from its Phase 2b IMPACT trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) will be presented in late-breaking oral and poster presentations at The Liver Meeting® 2025, hosted by the American Association for the Study of Liver Diseases (AASLD) in Washington, D.C., November 7–11, 2025.

Alto Neuroscience, Inc. announced today that, following a successful outcome from a recent FDA meeting, it plans to accelerate the development of ALTO-207 for people with treatment resistant depression (TRD).

Glaukos Corporation announced today the U.S. Food and Drug Administration (FDA) approved its Epioxa™ HD / Epioxa™ ("Epioxa") New Drug Application (NDA).

Enanta Pharmaceuticals, Inc announced that new data for zelicapavir, its oral, once-daily, N-protein inhibitor, and EDP-323, its oral, once-daily L-protein inhibitor, both in development for the treatment of respiratory syncytial virus (RSV), will be presented at IDWeek™ 2025 being held October 19 – 22, 2025, virtually and in Atlanta, Georgia.

Autolus Therapeutics plc announces that the first patient has been dosed in its Phase 1 BOBCAT trial of obecabtagene autoleucel (obe-cel) in patients with progressive multiple sclerosis (PMS).

Replimune Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen.

Leap Therapeutics, Inc. announced final results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease.

Apellis Pharmaceuticals, announced new data from the open-label period of the Phase 3 VALIANT study that reinforce the robust and sustained efficacy of EMPAVELI® (pegcetacoplan), a C3 inhibitor, in patients with C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare and debilitating kidney diseases.

SINTX Technologies, Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, enabling SINTX's commercial entry into reconstructive foot and ankle surgery in the United States. SINTX plans a U.S. commercial launch in Q1 2026, leveraging its U.S.-based manufacturing to drive revenue acceleration and operating efficiency.

IDEAYA Biosciences, Inc announced the first reported median overall survival (OS) results from their Phase 1/2 clinical trial (OptimUM-01) evaluating darovasertib, the company's investigational oral protein kinase C (PKC) inhibitor, in combination with Pfizer's crizotinib1, a c-MET inhibitor, as a first-line treatment for patients with metastatic uveal melanoma (mUM).

Fulgent Genetics, Inc. announced preliminary clinical data as of September 25, 2025, the preliminary data cutoff from its ongoing phase 2 clinical trial investigating FID-007 in combination with cetuximab in ≤ 2nd line treatment of patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

BeOne Medicines Ltd. announced the presentation of data from two pivotal Phase 3 trials – RATIONALE-307 and 312 – offering new evidence of the benefits of its PD-1 inhibitor, TEVIMBRA® (tislelizumab), at the European Society of Medical Oncology 2025 Congress (ESMO 2025) in Berlin, Germany, October 17-21.

GRAIL, Inc. announced that positive long-term results from an extended registry follow-up of the SYMPLIFY study will be presented on Oct. 21 at the Early Detection of Cancer Conference (EDCC) in Portland, Oregon.

Arvinas, Inc. announced new patient-reported outcomes (PRO) data from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant, which are being presented in a mini oral session at the 2025 European Society for Medical Oncology (ESMO) Congress.

Exelixis, Inc announced detailed results from STELLAR-303, a global phase 3 pivotal trial evaluating zanzalintinib in combination with atezolizumab (Tecentriq®) versus regorafenib in patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (CRC).

IO Biotech today presented detailed results from its global Phase 3 trial (IOB-013/KN-D18) of Cylembio® (imsapepimut and etimupepimut, adjuvanted), in combination with Merck's (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the first-line treatment of patients with unresectable or metastatic (advanced) melanoma.

Pharming Group N.V. announced that 12 abstracts have been accepted for presentation at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting taking place in Orlando, Florida on November 6-10.

Jade Biosciences, Inc. announced that it will present new preclinical safety and translational data for JADE101, its lead investigational candidate for immunoglobulin A nephropathy (IgAN), during two poster sessions at the American Society of Nephrology (ASN) Kidney Week 2025, taking place November 5–9 in Houston, Texas.

Incyte announced the first clinical data evaluating its TGFβR2×PD-1 bispecific antibody (INCA33890) for patients with microsatellite stable (MSS) colorectal cancer; and its potent, selective and orally bioavailable KRAS G12D inhibitor (INCB161734) for patients with KRAS G12D mutations, specifically pancreatic ductal adenocarcinoma (PDAC).

Summit Therapeutics Inc. announced results from the Phase III HARMONi-6 trial, conducted in China and sponsored by our partner, Akeso, Inc. (HKEX Code: 9926.HK), featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab.

Daiichi Sankyo and Merck announced Results from the phase 2 (dose optimization) part of the REJOICE-Ovarian01 phase 2/3 trial showed that raludotatug deruxtecan (R-DXd) demonstrated clinically meaningful response rates in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer.

Gilead Sciences, Inc will present new findings from its antiviral research and development programs at IDWeek, taking place October 19-22 in Atlanta, GA. Data from 34 presentations across HIV, respiratory viruses, viral hepatitis, and viruses of pandemic potential including six oral presentations underscore Gilead's leadership in advancing antiviral science and its ongoing efforts to bring forward innovative solutions for people and communities most affected by infectious diseases.

Moderna, Inc announced data regarding two of its investigational influenza candidates will be presented at IDWeek 2025, October 19-22, 2025, in Atlanta, GA.

Replimune Group, Inc. announced data from a new ad hoc analysis from the IGNYTE phase 2 cohort of RP1 plus nivolumab was presented by Caroline Robert, M.D., Ph.D., at the European Society for Medical Oncology (ESMO) Congress 2025 being held in Berlin (Poster 1644P).

RAPT Therapeutics, Inc. announced that the Company plans to report topline data from the Phase 2 clinical trial of RPT904 (JYB1904) in patients with Chronic Spontaneous Urticaria (CSU) conducted by its partner, Shanghai Jeyou Pharmaceutical Co., Ltd.

Corcept Therapeutics Incorporated today shared new late-breaking data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the European Society for Medical Oncology (ESMO) 2025 Annual Meeting.

Pfizer Inc and Astellas Pharma U.S. Inc. announced final overall survival (OS) results from the Phase 3 EMBARK study evaluating XTANDI® (enzalutamide), in combination with leuprolide and as monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis.

Verastem Oncology announced positive, updated efficacy and safety data from partner GenFleet Therapeutics' Phase 1/2 monotherapy study in China of GFH375, an oral KRAS G12D (ON/OFF) inhibitor (VS-7375 outside of China) for patients with KRAS G12D mutant advanced pancreatic ductal adenocarcinoma (PDAC).

Gilead Sciences, Inc today shared positive data from the Phase 3 ASCENT-03 study demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) for Trodelvy® (sacituzumab govitecan-hziy) compared to chemotherapy as first-line treatment in patients with metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors.

Daiichi Sankyo and AstraZeneca announced Positive results from the TROPION-Breast02 phase 3 trial showed DATROWAY®(datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator's choice of chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy was not an option.

Pfizer Inc announced updated follow-up results from the single-arm Phase 2 PHAROS trial evaluating BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for the treatment of adults with metastatic non-small cell lung cancer (mNSCLC) with a BRAF V600E mutation.

Merck announced the first presentation of results from the pivotal Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for the treatment of patients with platinum-resistant recurrent ovarian cancer.

Daiichi Sankyo and AstraZeneca announced Positive results from the DESTINY-Breast11 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab and pertuzumab (THP) in the neoadjuvant setting (before surgery) demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response (pCR) rate.

Daiichi Sankyo and AstraZeneca announced Positive results from the DESTINY-Breast11 phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) in the neoadjuvant setting (before surgery) demonstrated a statistically significant and clinically meaningful improvement in the pathologic complete response (pCR) rate when compared with dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer.

Astellas Pharma Inc. and Pfizer Inc announced positive results from the pivotal Phase 3 EV-303 clinical trial (also known as KEYNOTE-905) for PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA™ (pembrolizumab), a PD-1 inhibitor.

NuCana plc presented data at the European Society for Medical Oncology Congress 2025 ("ESMO") on a new model system investigating the synergistic effects of NUC-7738 and PD-1 inhibition in primary organoids derived from patients with renal cell carcinoma ("RCC").

Genmab A/S announced today updated data from cohort B2 of the Phase 1/2 RAINFOL™-01 trial evaluating rinatabart sesutecan (Rina-S®), an investigational folate receptor alpha (FRα)-targeted, TOPO1-inhibitor antibody-drug conjugate (ADC).

Merck announced long-term follow-up data continued to show durable benefit of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, compared to chemotherapy for patients with advanced endometrial carcinoma following at least one prior platinum-based regimen in any setting.

Nuvalent, announced preliminary data from the ongoing ALKOVE-1 Phase 1/2 clinical trial of neladalkib, an investigational ALK-selective inhibitor, in patients with advanced ALK-positive solid tumors outside of non-small cell lung cancer (NSCLC).

Kura Oncology, Inc. announced new preliminary data from its farnesyl transferase inhibitor (FTI) programs – darlifarnib (KO-2806) and tipifarnib – presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany, from October 17 – 21, 2025.

Olema Pharmaceuticals, announced updated data from the Phase 1b/2 study of palazestrant in combination with ribociclib in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

Nurix Therapeutics, Inc. announced the presentation of new clinical data from its first-in-human Phase 1a study of NX-1607, a first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) in patients with relapsed/refractory solid tumors.

Exelixis, Inc announced results from a subgroup analysis of the CABINET phase 3 pivotal trial evaluating CABOMETYX® (cabozantinib) versus placebo in patients with previously treated advanced neuroendocrine tumors (NET) originating in the lungs or thymus.

Celcuity Inc announced updates on the status of the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutant ("MT") tumors, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

Corbus Pharmaceuticals announced data from its Phase 1/2 clinical study of CRB-701 (SYS6002) will be presented as a poster at the 2025 European Society for Medical Oncology (ESMO25) Congress being held in Berlin, Germany.

Novo Nordisk announced today that the US Food and Drug Administration (FDA) has approved Rybelsus®, the only oral GLP-1 medication available, for reducing the risk of major adverse cardiovascular events (MACE) such as cardiovascular (CV) death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they've had a prior CV event or not (primary and secondary prevention).

Amgen and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) approved TEZSPIRE® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.

Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease

SystImmune Inc. and Bristol Myers Squibb announced the oral presentation of the first disclosure of the safety and efficacy data from the global phase I US-Lung-101 study (NCT05983432) of iza-bren (BL-B01D1), a potentially first-in-class EGFR x HER3 bispecific antibody-drug conjugate (ADC), at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany. Iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of Mainland China.

Corvus Pharmaceuticals, Inc. announced that interim data from the Phase 1b/2 clinical trial of ciforadenant for patients with metastatic renal cell cancer (RCC) will be presented today in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2025, which is taking place October 17-21, 2025 in Berlin, Germany.

Vera Therapeutics, Inc. announced that data from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) will be delivered as a featured late-breaking oral presentation during the opening plenary session of the American Society of Nephrology (ASN) Kidney Week 2025 in Houston, Texas, being held November 6 to 9.

OS Therapies Inc. announced that the United States Food & Drug Administration ("FDA") has granted a second Type C Meeting, following its successful End of Phase 2 Meeting.

Vertex Pharmaceuticals Incorporated announced several important updates across its development program for povetacicept (pove), an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove has demonstrated best-in-class potential in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) and has pipeline-in-a-product potential across a range of B cell-mediated diseases.

Disc Medicine, Inc. nnounced it will present clinical data as a poster presentation at the upcoming 2025 American Society of Nephrology (ASN) Kidney Week, which will be held in Houston, TX on November 6-9, 2025.

Novartis announced results from the five-year analysis of the pivotal Phase III NATALEE trial of Kisqali® (ribociclib) that demonstrated a sustained benefit at a median of two years after a three-year treatment with Kisqali (median follow-up: 58.4 months). Results showed a 28.4% reduction in risk of recurrence (HR=0.716; 95% CI 0.618-0.829; nominal p-value <0.0001) in the broadest population of patients with high-risk stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) treated with Kisqali plus endocrine therapy (ET) compared to ET alone1.

Neurocrine Biosciences, Inc. announced the presentation of a new post-hoc analysis from the Phase 3, open-label KINECT® 4 study, demonstrating that patients treated continuously for 48 weeks with the 40 mg dose of once-daily INGREZZA® (valbenazine) capsules experienced clinically meaningful improvements in tardive dyskinesia symptoms.

BiomX Inc today provided an update on progress relating to the previously disclosed U.S. Food and Drug Administration (FDA) clinical hold placed on the U.S. portion of the BX004 Phase 2b trial in cystic fibrosis (CF).

Sensei Biotherapeutics, Inc announced 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).

Evaxion A/S announces new two-year unprecedented clinical efficacy data of its personalized cancer vaccine EVX-01 in patients with advanced melanoma.

Avanzanite Bioscience B.V. reported that its partner Agios Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the new indication for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia.

IMUNON, Inc. announced that members of its leadership team will deliver oral presentations highlighting IMNN-101, its investigational DNA plasmid vaccine based on the Company's proprietary PlaCCine® technology platform, including proof-of-concept clinical trial results at the following upcoming vaccine conferences:

Agenus Inc. announced new data from its botensilimab (BOT), a multifunctional, Fc-enhanced CTLA-4 antibody and balstilimab (BAL), a PD-1 inhibitor, combination demonstrating durable survival across multiple cancer types in late-stage patients who have limited treatment options.

Eli Lilly and Company announced results from the primary overall survival (OS) analysis of the Phase 3 monarchE trial showing that two years of adjuvant Verzenio plus endocrine therapy (ET) reduced the risk of death by 15.8% versus ET alone and resulted in sustained long-term improvements in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high-risk early breast cancer.

Positive 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 key secondary endpoint of overall survival (OS) versus chemotherapy alone.

Kiniksa Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis, which includes recurrent pericarditis.

Sensei Biotherapeutics, Inc. announced 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).

Vor Bio announced that clinical data from Stage A of a Phase 3 study in China sponsored by Vor Bio's collaborator RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), which evaluated telitacicept in adults with IgA neuropathy (IgAN), will be presented as a late-breaking oral presentation at American Society of Nephrology's (ASN) Kidney Week 2025 being held Nov 5-9, 2025, in Houston, Texas.

Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

Achieve Life Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has awarded the company a Commissioner's National Priority Voucher (CNPV) for cytisinicline as a treatment of nicotine dependence for e-cigarette or vaping cessation.

Insmed Incorporated announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of its DPP1 inhibitor BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months

Summit Therapeutics Inc. announced the expansion of its Phase III clinical development program of the novel, potential first-in-class investigational bispecific antibody, ivonescimab, into colorectal cancer (CRC) with the initiation of the global Phase III HARMONi-GI3 trial.

ViiV Healthcare and Pfizer announced 96-week findings from PASO DOBLE (GeSIDA 11720 study) showing that Dovato (dolutegravir/lamivudine [DTG/3TC]) is as effective as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate [BIC/FTC/TAF]) in maintaining virological suppression in adults with HIV-1.

Eledon Pharmaceuticals, Inc. announced an oral presentation will be featured at the American Society of Nephrology's upcoming Kidney Week 2025 Annual Meeting taking place in Houston, TX, from November 5-8, 2025.

Tonix Pharmaceuticals presented data in an oral presentation at the World Vaccine Congress–Europe 2025, held October 14–16, 2025, in Amsterdam, the Netherlands.

Climb Bio, Inc. announced the upcoming presentation of CLYM116 preclinical data and published budoprutug pMN Phase 1b long-term outcome data at the 2025 American Society of Nephrology (ASN) Kidney Week, which will be held in Houston, TX November 6-9, 2025.

Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, and Protalix BioTherapeutics, Inc. acknowledge that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on the request to approve the dosing regimen of 2 mg/kg body weight infused every 4 weeks (E4W) for Elfabrio (pegunigalsidase alfa, in addition to the currently approved dosing regimen of 1 mg/kg body weight infused every 2 weeks (E2W).

QuidelOrtho Corporation will highlight its ongoing commitment to transfusion medicine excellence at the Association for the Advancement of Blood & Biotherapies (AABB) 2025 Annual Meeting.

Disc Medicine, Inc. announced that it received a Commissioner's National Priority Voucher (CNPV) from the U.S. Food and Drug Administration (FDA) for bitopertin in erythropoietic protoporphyria (EPP), including X-linked protoporphyria (XLP).

atai Life Sciences announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD).

Artiva Biotherapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AlloNK® (also known as AB-101) for the treatment of refractory rheumatoid arthritis (RA) in combination with rituximab and that the Company has prioritized refractory RA as the program's lead indication.

Taysha Gene Therapies, Inc. announced that the Company has regained full rights to its lead TSHA-102 program in clinical evaluation for Rett syndrome.

Novartis A/S shared final results from the APPLAUSE-IgAN Phase 3 study evaluating Fabhalta (iptacopan) in adults with IgA nephropathy (IgAN).

Personalis, Inc. announced new data from an AstraZeneca phase 3 clinical trial in lung cancer (LAURA).

SCIENTURE HOLDINGS announced that Arbli™ (losartan potassium) Oral Suspension, 10mg/mL, is commercially available through full-line wholesalers nationwide.

Entera Bio Ltd. announced that it will present new clinical data from its Phase 2 trial of EB613 at the upcoming North American Menopause Society (NAMS) 2025 Annual Meeting, taking place October 21–25, 2025, in Orlando, Florida.

Omeros Corporation announced the publication of a peer-reviewed manuscript in Blood Advances, a journal of the American Society of Hematology,detailing survival outcomes in adult patients with life-threatening transplant-associated thrombotic microangiopathy (TA-TMA) treated with narsoplimab across both the pivotal clinical trial and the global expanded access program (EAP).

Microbot Medical Inc. announced that it will be exhibiting the LIBERTY® System at the upcoming Symposium on Clinical Interventional Oncology annual meeting (CIO), being held in Miami, FL on October 17-19.

Aligos Therapeutics, Inc. announced that the United States Adopted Names (USAN) Council has adopted pevifoscorvir sodium as the nonproprietary (generic) name for ALG-000184, under investigation for the treatment of chronic hepatitis B virus (HBV) infection.

NextCure, announced that the first patient in the U.S. has been dosed with SIM0505 in the ongoing Phase 1 trial (NCT06792552), which is evaluating safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors.

Johnson & Johnson announced positive topline results from the investigational Phase 3 MajesTEC-3 study.

Esperion announced the nomination of ESP-2001, the Company's highly-specific allosteric ATP citrate lyase (ACLY) inhibitor, as preclinical development candidate for the treatment of primary sclerosing cholangitis (PSC).

Vor Bio announced that results from a Phase 3 study in China evaluating telitacicept in systemic lupus erythematosus (SLE) sponsored by its collaborator, RemeGen Co., Ltd., (HKEX: 9995, SHA: 688331), were published in The New England Journal of Medicine (NEJM).

Nuvectis Pharma, Inc announced upcoming poster presentations for NXP900 at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place October 22-26, 2025 in Boston, MA.

Insmed Incorporated announced that it will present six abstracts from the Phase 3 ASPEN study of BRINSUPRI™ (brensocatib) at CHEST 2025, the American College of Chest Physicians Annual Meeting, taking place October 19 - October 22, 2025, in Chicago, IL.

Adicet Bio, Inc. announced that the first patient has been dosed in its Phase 1 clinical trial evaluating ADI-001 in treatment-refractory RA.

Praxis Precision Medicines, Inc. announced positive topline results for the Phase 3 Essential3 program of ulixacaltamide in essential tremor (ET).

Dianthus Therapeutics, Inc. announced it has entered into an exclusive licensing agreement with Nanjing Leads Biolabs Co., Ltd. ("Leads" (9887.HK) for DNTH212 (being developed in China by Leads Biolabs as LBL-047), a first and potentially best-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor.

Cellectis today hosts a R&D Day in New York City.

Merck announced that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its secondary endpoint of overall survival (OS) for the treatment of patients with platinum-resistant recurrent ovarian cancer in all comers.

MIRA Pharmaceuticals, Inc. (the “Company”) announced new preclinical data for Mira-55, its proprietary non-psychotropic marijuana analog, showing that oral administration of Mira-55 normalized pain and significantly reduced inflammation, outperforming injected morphine in an established animal model of chronic inflammatory pain.

Sonnet BioTherapeutics Holdings is collaborating with Spanios on a non-clinical study using New Alternate Methodologies (NAM)-based patient-derived tumoroid (PDT) platforms that emulate the tumor microenvironment (TME) ex vivo to evaluate the effect of SON-1010 (IL-12-FHAB) in soft tissue sarcoma.

Anteris Technologies Global Corp announced today it has received regulatory clearance from the Danish Medicines Agency to initiate the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic stenosis (the "PARADIGM Trial").

Artelo Biosciences, announced that Professor Saoirse O'Sullivan, Vice President of Translational Sciences at Artelo Biosciences, is presenting expanded data from Artelo's lead Fatty Acid Binding Protein 5 (FABP5) inhibitor, ART26.12, Single Ascending Dose (SAD) Study at the 8th Annual Cannabinoid & Endocannabinoid Drug Development Summit, taking place October 15–16, 2025, in Boston, Massachusetts.

NanoViricides, Inc reports that an analyst research report was published on the Company that explains its dual-track, rapid clinical development strategy for NV-387, going after MPox and also after all respiratory viral infections, that include Influenzas, Coronaviruses, RSV among others.

Belite Bio, Inc. announced that the Center for Drug Evaluation of China's National Medical Products Administration ("NMPA") has agreed to accept the New Drug Application (NDA) with priority review for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial.

Absci announced the company will host a virtual seminar on December 11, 2025 at 10:00am ET focused on the company's ABS-201 (anti-PRLR) program for androgenetic alopecia.

Monopar Therapeutics Inc announced that its abstract on the Phase 2 ALXN1840-WD-204 copper balance study has been selected for an oral presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2025, taking place in Washington, D.C., from November 7-11, 2025..

Aprea Therapeutics announced that it has determined the recommended Phase 2 dose (RP2D) of 1,100 mg once daily for ATRN-119, its oral ATR inhibitor in the monotherapy arm of the ongoing ABOYA-119 Phase 1/2a dose-escalation study, in patients with advanced solid tumors.

Stereotaxis announced it obtained CE Mark in Europe and submitted a 510(k) application to the FDA in the US for the Synchrony™ system.

60 Degrees Pharmaceuticals, announced that the first patient to have completed the regimen in the Company's trial of relapsing babesiosis in immunosuppressed patients has tested negative for babesiosis. The trial is an expanded access study of ARAKODA® (tafenoquine) in combination with conventional treatments for relapsing babesiosis (NCT06478641).

Novocure announced that it will present data at two upcoming oncology congresses, the 2025 European Association of Neuro-Oncology (EANO) Meeting, being held October 16-19 in Prague, Czech Republic, and the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21 in Berlin, Germany.

Gyre Therapeutics announced that its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial of its Class 1 drug, Pirfenidone capsules, for the treatment of pneumoconiosis.

Eli Lilly and Company announced positive topline results from the Phase 3 ACHIEVE-2 and ACHIEVE-5 trials. ACHIEVE-2, the second head-to-head trial in the program, evaluated orforglipron versus dapagliflozin, an SGLT-2 inhibitor, in adults with type 2 diabetes inadequately controlled on metformin.

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

Aurinia Pharmaceuticals Inc. announced that five posters will be presented in collaboration with independent investigators highlighting new data on LUPKYNIS® (voclosporin) at the American College of Rheumatology (ACR) Convergence 2025, taking place in Chicago, IL, October 24–29, and the American Society of Nephrology (ASN) Kidney Week 2025, taking place in Houston, TX, November 5–9.

argenx SE a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, will present data for VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) and pipeline candidate empasiprubart at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Session in San Francisco from October 29-November 1, 2025.

Alpha Cognition Inc. announced it will present new clinical insights on cholinesterase inhibitors and ZUNVEYL® (Benzgalantamine) at two upcoming scientific meetings: the American Society of Consultant Pharmacists (ASCP) Annual Meeting (October 23–25, 2025) and the Neuroscience Education Institute (NEI) Annual Congress (November 6–9, 2025).

Xencor, Inc. announced the upcoming presentation of initial results from the ongoing Phase 1 dose-escalation study of XmAb819, a bispecific ENPP3 x CD3 T-cell engaging bispecific antibody, in patients with clear cell renal cell carcinoma (ccRCC) in a poster at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics, being held October 22-26, 2025 in Boston, Massachusetts.

IGC Pharma, Inc. announced the expansion of its ongoing Phase 2 CALMA clinical trial evaluating investigational drug candidate IGC-AD1 for agitation in Alzheimer's disease.

Celularity Inc. announced the publication of its Phase 2 study titled "Human Placenta-Derived Cells (PDA-002) in Diabetic Foot Ulcer Patients With and Without Peripheral Artery Disease: A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial," in the International Wound Journal.

Cellectar Biosciences, announced that Jarrod Longcor, chief operating officer of Cellectar, presented positive preclinical data in a poster at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer Research that took place from September 28 through October 1, 2025, in Boston, Massachusetts.

IMUNON announced that a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, was accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21, 2025 in Berlin, Germany.

Vor Bio announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), reported positive 48-week results from its Phase 3 study conducted in China evaluating telitacicept in primary Sjögren's disease.

Krystal Biotech, Inc. announced today that the United States Food and Drug Administration (FDA) granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 (HSV-1) viral vector used in the Company's redosable eye drop gene therapy KB801, currently under evaluation in a randomized placebo controlled trial for the treatment of neurotrophic keratitis (NK).

NuCana plc announced the publication of new data on NUC-3373.

TransCode Therapeutics, Inc. announces completion of Phase 1a clinical trial with TTX-MC138, an investigational inhibitor of microRNA-10b, or miR-10b.

Telomir Pharmaceuticals, Inc. announced new laboratory findings demonstrating that Telomir-1 kills aggressive pancreatic cancer cells.

Candel Therapeutics, Inc announced encouraging interim data from its ongoing phase 1b clinical trial of CAN-3110 (linoserpaturev) in recurrent glioblastoma, and a publication in the high-impact scientific journal Science Translational Medicine..

Corbus Pharmaceuticals announced today the European Society for Medical Oncology (ESMO) Congress 2025 abstract for its Phase 1/2 clinical study has been released.

Spero Therapeutics announces presentations on tebipenem Hbr at the upcoming IDWeek annual meeting to take place Oct 19 – 22, 2025 in Atlanta, GA.

Aprea Therapeutics, Inc. y announced that two abstracts on its clinical programs, APR-1051 amd ATRN-119, have been accepted for poster presentation at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22 - 26, 2025 at the Hynes Convention Center in Boston, Massachusetts.

Lexicon Pharmaceuticals, Inc. announced the Company presented additional clinical data and program updates from its Phase 2 pilavapadin program at the 19th Annual Pain Therapeutics Summit.

Cingulate Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CTx-1301 (dexmethylphenidate), the company's lead candidate for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults.

Soligenix, Inc announced today the update of its United States (U.S.) Medical Advisory Board (MAB) for cutaneous T-cell lymphoma (CTCL) to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of HyBryte™ (synthetic hypericin) for the treatment of CTCL, a rare class of non-Hodgkin's lymphoma (NHL).

Merus N.V announced initial interim clinical data as of an April 28, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with standard of care FOLFOX/FOLFIRI in 1L, 2L metastatic CRC (mCRC) and petosemtamab monotherapy in 3L+ mCRC.

NeoGenomics, Inc announced the presentation of assay-relevant data, including interventional therapy trials in progress, to showcase how its molecular residual disease (MRD) assay may benefit pharmaceutical partners at the European Society for Medical Oncology (ESMO) Congress 2025, October 17–21, in Berlin, Germany. RaDaR ST, the company's circulating tumor DNA (ctDNA) assay, is designed to accelerate and optimize oncology drug development.

Tonix Pharmaceuticals Holding Corp announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, delivered a presentation titled "The History and Promise of anti-CD154 Monoclonal Antibody Immunomodulation for Transplantation," at the 61st Annual Congress of the Japan Society for Transplantation, which took place October 9–11, 2025, in Nagoya, Japan.

Armata Pharmaceuticals, Inc. announced it will be presenting late-breaking Phase 2a clinical data on its Staphylococcus aureus bacteriophage cocktail, AP-SA02, at IDWeek 2025™, which is being held October 19-22, 2025, in Atlanta, GA.

Precision BioSciences, Inc announced that it has been selected to deliver a late-breaking oral presentation at the Liver Meeting® 2025.

I-Mab announced that an abstract related to updated data from the Phase 1 study of givastomig as a monotherapy in heavily pre-treated patients with gastroesophageal carcinoma (GEC) has been accepted as a "short-talk" at the AACR-NCI-EORTC conference which will be held October 22-26 in Boston, Massachusetts.

Traws Pharma, Inc. announced the dosing of the first subject in a Phase 2 study to evaluate ratutrelvir, a ritonavir-free anti-viral treatment in newly diagnosed COVID subjects.

Rocket Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for KRESLADI™ (marnetegragene autotemcel; marne-cel), a lentiviral vector (LV)-based investigational gene therapy for severe Leukocyte Adhesion Deficiency-I (LAD-I), a rare genetic immune disorder that predisposes patients to recurrent and fatal infections and is near-uniformly fatal in childhood without an allogeneic hematopoietic stem cell transplant.

Seres Therapeutics, Inc. announced that new post hoc data from its SER-155 Phase 1b trial will be featured in an oral presentation at IDWeek 2025, taking place October 19–22 in Atlanta, Georgia.

Tonix Pharmaceuticals announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, delivered a presentation titled "The History and Promise of anti-CD154 Monoclonal Antibody Immunomodulation for Transplantation," at the 61st Annual Congress of the Japan Society for Transplantation, which took place October 9–11, 2025, in Nagoya, Japan.

Fulcrum Therapeutics, nnounced that it will present preclinical data for FTX-6274, an oral embryonic ectoderm development, or EED, inhibitor, in castration-resistant prostate cancer.

Gyre Therapeutics announced that it will be presenting results from its positive Phase 3 clinical trial evaluating Hydronidone, a novel anti-fibrotic agent that inhibits hepatic stellate cell (HSC) activation and promotes HSC apoptosis, for the treatment of liver fibrosis in chronic hepatitis B, at The Liver Meeting® 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

BioXcel Therapeutics, announced positive results from the correlation study related to exploratory efficacy outcomes from the SERENITY At-Home trial.

Pfizer Inc. announced positive topline results from the Phase 3 HER2CLIMB-05 trial of first-line combination therapy with the tyrosine kinase inhibitor TUKYSA® (tucatinib) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).

Ascletis Pharma Inc. announces today that it recently completed the pre-New Drug Application (NDA) consultation with China National Medical Products Administration (NMPA) for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and plans to submit an NDA soon.

Theravance Biopharma, Inc. announced that it will be presenting two rapid-fire presentations at CHEST 2025, the annual meeting of the American College of Chest Physicians taking place from October 19-22, 2025, in Chicago, IL.

Zai Lab Limited announced that a late-breaking abstract (LBA) featuring new data from its global Phase 1 clinical trial (NCT06179069) evaluating zocilurtatug pelitecan (zoci), formerly known as ZL-1310, has been selected for an oral presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22-26, 2025, in Boston, Massachusetts.

Actinium Pharmaceuticals, Inc. announced that the first-ever preclinical data from its ATNM-400 program in non-small cell lung cancer (NSCLC) has been accepted for presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22 – 26, 2025, at the Hynes Convention Center in Boston, Massachusetts.

Nuvalent, Inc. announced an upcoming poster presentation further characterizing the preclinical intracranial activity of its novel HER2-selective inhibitor, NVL-330, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22-26, 2025 in Boston.

PMV Pharmaceuticals, Inc. announced that two abstracts have been accepted for oral and poster presentations at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22-26, 2025 in Boston, MA.

Zymeworks announced the acceptance of a poster presentation discussing preliminary results from a Phase 1 study evaluating ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-⍺ (FR⍺), at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics, being held October 22-26, 2025, in Boston, MA.

Denali Therapeutics Inc announced that the U.S. Food and Drug Administration (FDA) has extended its review timeline of the Biologics License Application (BLA) seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome.

Repare Therapeutics Inc announced it will share initial topline safety, tolerability and early efficacy data from the Phase 1 LIONS trial in a poster presentation at the 37th AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, being held October 22-26, 2025 in Boston, MA.

Boundless Bio announced an upcoming poster presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place October 22-26, 2025 in Boston, MA.

AnaptysBio, Inc. announced that complete data from the Phase 2b trial of rosnilimab, a pathogenic T cell depleter, in rheumatoid arthritis (RA), was accepted for a late-breaking oral presentation at American College of Rheumatology (ACR) Convergence 2025 in Chicago, IL, Oct. 24 – 29, 2025.

Avidity Biosciences, Inc. announced that the Company completed a positive pre-BLA meeting with the U.S. Food and Drug Administration (FDA) regarding its upcoming BLA submission of delpacibart zotadirsen (del-zota).

Palisade Bio, Inc. announced that the Canadian Intellectual Property Office (CIPO) has granted patent number 3,174,137 titled, "Gut Microbiota Bioactivated PDE4 Inhibitor Precursors." The patent covers the composition of PALI-2108, the Company's orally administered, first-in-class, ileocolonic-targeted PDE4 B/D inhibitor in development for the treatment of FSCD and UC.

IceCure Medical Ltd. announced its participation at Aptitude Health's TME Take the Lead in Breast Cancer Care Fall Summit 2025, which took place on September 26–27, 2025, in New Orleans, Louisiana.

Actinium Pharmaceuticals, announced that compelling preclinical data for ATNM-400, its novel, first-in-class antibody radioconjugate armed with the potent alpha-emitter Actinium-225 (Ac-225), has been accepted for presentation at the 32nd Annual Prostate Cancer Foundation (PCF) Scientific Retreat being held on October 23 – 25, 2025 in Carlsbad, CA.

AngioDynamics, Inc. announced that its NanoKnife System has been selected as one of TIME's 2025 Best Inventions.

Gilead Sciences, Inc and Kite, a Gilead Company, will demonstrate progress in our commitment to transform how cancer is treated with new data at the European Society for Medical Oncology (ESMO) 2025 Congress October 17 – 21.

CERo Therapeutics Holdings, Inc. announces it has concluded the first cohort of its Phase 1 CER-1236 clinical trial focused on patients with acute myeloid leukemia (AML).

MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes.

Artivion, Inc announced data from its AMDS PERSEVERE and PROTECT trials were presented in Late-Breaking Science presentations at the 39th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Copenhagen, Denmark.

Atossa Therapeutics, Inc. announces key progress in its global intellectual-property strategy for Z-endoxifen, including the issuance of an Israeli patent and continued renewals that reinforce protection for the Company's lead program across major jurisdictions.

Apyx Medical Corporation announced the submission of a new 510(k) premarket notification to the U.S. Food and Drug Administration (the "FDA") for the label expansion of the AYON Body Contouring System ("AYON") to include power liposuction.

4D Molecular Therapeutics announced that the Cystic Fibrosis Foundation (CF Foundation) will provide up to $11 million in additional funding, with an initial tranche of $7.5 million, and technical support to accelerate the development of 4D-710 for the treatment of cystic fibrosis (CF) lung disease.

Evaxion A/S will present a wide range of data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025.

HUTCHMED (China) Limited announces results from the FRUSICA-2 registration clinical trial of the fruquintinib and sintilimab combination for the treatment of patients with locally advanced or metastatic renal cell carcinoma.

Immutep Limited announces that positive and straightforward feedback has been received from the US Food and Drug Administration ("FDA") regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti).

Cidara Therapeutics, Inc. announced it will be presenting late-breaking Phase 2 clinical data on its antiviral influenza candidate, CD388, during ID Week 2025, taking place October 19-22, 2025, in Atlanta, GA.

Theriva™ Biologics announced upcoming presentations at the European Society for Medical Oncology (ESMO 2025) Annual Congress and at Infectious Diseases Week (IDWeek) 2025 Annual Meeting.

SELLAS Life Sciences Group, Inc. announced that preclinical efficacy of its highly selective CDK9 inhibitor, SLS009 (tambiciclib), as a monotherapy and in combination with venetoclax in T-cell prolymphocytic leukemia (T-PLL), will be presented at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17 – 21, 2025, in Berlin, Germany.

Bicara Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma.

Palvella Therapeutics, Inc announced it has received the second year of funding under its FDA Office of Orphan Products Development grant.

Abeona Therapeutics Inc. announced that its ABO-503 gene therapy for X-linked retinoschisis (XLRS) has been selected to participate in the U.S. Food and Drug Administration (FDA) Rare Disease Endpoint Advancement (RDEA) Pilot Program.

Tvardi Therapeutics, Inc provided an update on preliminary data from the Phase 2 REVERT clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF).

BriaCell Therapeutics Corp will be presenting positive clinical biomarker data of its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer at its poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025 Annual Meeting taking place October 17 – 21 in Berlin, Germany.

AbbVie announced it will unveil new data from its robust antibody-drug conjugate (ADC) platform at the 2025 European Society for Medical Oncology (ESMO) Congress, taking place October 17-21, in Berlin, Germany.

Precigen, Inc. announced long-term follow-up data demonstrating durable responses to PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).

Compugen Ltd. announced that pooled analysis of previously presented data, supporting the anti-tumor activity and safety profile of COM701 in heavily pre-treated patients with platinum resistant ovarian cancer (PROC), has been published as an abstract released by the European Society of Medical Oncology (ESMO).

Arvinas, Inc. announced that new data for vepdegestrant will be presented at the European Society for Medical Oncology (ESMO) Congress to be held October 17 through 21, 2025, in Berlin, Germany.

AstraZeneca advances its ambition to redefine cancer care with new data across its diverse, industry-leading portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress, October 17-21, 2025.

Bristol Myers Squibb announced the presentation of data across its oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress 2025 to be held from October 17-21 in Berlin, Germany.

Eli Lilly and Company announced that new data from across its oncology portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) Annual Meeting, taking place October 17-21 in Berlin, Germany.

Pfizer Inc. will present data across its infectious disease portfolio at the upcoming IDWeek 2025 congress, held in Atlanta from October 19-22, 2025.

BeOne Medicines Ltd y announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Taiho Oncology, Inc., and Cullinan Therapeutics, Inc announced new data from the central nervous system (CNS) involvement cohort of the REZILIENT2 study of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (ex20ins) or uncommon non-ex20ins EGFR mutations and CNS involvement.

Moderna, Inc announced that clinical, safety and translational data from its Phase 1/2 study evaluating mRNA-4359 in combination with pembrolizumab in checkpoint inhibitor-resistant/refractory(CPI-R/R) melanoma patients will be presented at the 2025 European Society for Medical Oncology (ESMO) Congress, October 17-21, 2025, in Berlin, Germany.

Arcus Biosciences, Inc announced the first OS results from Arm A1 of the Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.

CRISPR Therapeutics today reported new preclinical data from its novel SyNTase™ gene editing platform for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).

Assembly Biosciences, Inc announced that interim Phase 1b clinical data for its long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate ABI-5366 are featured in a late-breaking oral presentation during the 38th Congress of the International Union Against Sexually Transmitted Infections (IUSTI)- Europe, taking place October 9-11, 2025, in Athens, Greece.

Cidara Therapeutics, Inc announced it will have a late-breaking presentation at the European Scientific Working Group on Influenza (ESWI)'s 10th Influenza Conference taking place October 20-23, 2025 in Valencia, Spain.

Inspire Medical Systems, Inc. today published Inspire V clinical outcomes data from its Singapore clinical study as well as the Company's limited market release in the United States including single site experience at two leading centers.

Johnson & Johnson announced that 17 abstracts featuring new clinical and real-world data will be presented at the annual European College of Neuropsychopharmacology (ECNP) Congress, taking place October 11-14 in Amsterdam, The Netherlands.

Anavex Life Sciences Corp. announced that Prof. Dr. Timo Grimmer, MD, member of the Anavex Scientific Advisory Board and National Coordinating Investigator for the blarcamesine Phase IIb/III ANAVEX®2-73-AD-004 study gave an oral presentation titled, "Advancing Alzheimer's Disease Care: Convenience for Both Patients and Families with Oral Blarcamesine" at the 35th Alzheimer Europe Conference ‘Connecting Science and Communities

Pulse Biosciences, Inc. announced late-breaking clinical study results from the nPulse™ Cardiac Surgical System first-in-human feasibility study at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark.

OS Therapies Inc. announced statistically significant positive final 2-year overall survival data from the Company's Phase 2b trial of off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the "Fully Resected Metastatic Osteosarcoma Trial").

Stoke Therapeutics, Inc and Biogen Inc announced the presentation of longer-term follow-up analyses from the ongoing open-label extension (OLE) studies of zorevunersen that support the potential of zorevunersen as a disease-modifying medicine for Dravet syndrome.

Quince Therapeutics, Inc announced the poster presentation of patient-reported walking capacity in children with Ataxia-Telangiectasia (A-T) at the 54th Child Neurology Society (CNS) Annual Meeting.

Vir Biotechnology, Inc announced that the first patient has been dosed in Part 3 of the Company's Phase 1 clinical trial evaluating VIR-5500 in combination with androgen receptor pathway inhibitors (ARPIs).

Cabaletta Bio, Inc. today presented initial dose data from the RESET-PV™ trial evaluating rese-cel (resecabtagene autoleucel, formerly known as CABA-201) at 1 x 106 cells/kg without preconditioning in three evaluable patients with pemphigus vulgaris (PV).

Editas Medicine today reported in vivo preclinical proof-of-concept data for EDIT-401, an experimental, potential best-in-class, one-time therapy to significantly reduce LDL-cholesterol (LDL-C), at the 32nd Annual European Society of Gene and Cell Therapy (ESGCT) Congress in Seville, Spain.

Adial Pharmaceuticals, Inc announced the successful completion of the analytical validation of a cheek swab collection method for testing patients for both clinical trial usage as well as future commercial application.

Allergan Aesthetics, an AbbVie company announced the rollout of SkinMedica®'s reimagined packaging—a modernized look that elevates the consumer experience while advancing sustainability.

Astria Therapeutics, Inc. announced that it will present two posters at the Canadian Society of Allergy and Clinical Immunology (CSACI) 80th Anniversary Scientific Meeting, taking place October 15-18, 2025 in Vancouver, British Columbia.

Immutep Limited announces a patient enrolment update for the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and chemotherapy as first line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC).

Milestone® Pharmaceuticals Inc. announced that it will present a poster presentation at the American Heart Association Scientific Sessions 2025, to be held November 7-10th in New Orleans, Louisiana.

Orchestra BioMed Holdings, announced a data summary supporting the transformative potential of Atrioventricular Interval Modulation ("AVIM") Therapy in the management of hypertensive heart disease will be presented in a keynote talk at the Georgia Innovation Summit in Tbilisi, Georgia on October 10, 2025.

Taysha Gene Therapies, Inc. announced results from a new supplemental data analysis from Part A of the REVEAL Phase 1/2 adult/adolescent and pediatric trials evaluating TSHA-102 in females with Rett syndrome at the 54th Child Neurology Society (CNS) Annual Meeting.

Cidara Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications due to underlying immunodeficiency, are at higher risk of severe influenza despite influenza vaccination, or those for whom vaccines are contraindicated.

Acurx Pharmaceuticals, Inc. announced that a new patent has been granted by the Australian Patent Office.

OS Therapies Inc. announced a positive regulatory update following an October 6, 2025 meeting with its European Medicines Agency (EMA) rapporteur, the Dutch Medicines Evaluation Board (MEB).

Annovis Bio, Inc announced new results that demonstrate buntanetap's ability to attenuate inflammation and improve cellular health in Alzheimer's patients, suggesting potential disease-modifying effects beyond symptomatic relief.

Rein Therapeutics announced that it has received authorization from the European Medicines Agency (EMA) to initiate the Company's Phase 2 "RENEW" clinical trial of its lead candidate, LTI-03, for the treatment of idiopathic pulmonary fibrosis (IPF).

Alterity Therapeutics announced that data from the ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) was featured at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS) that took place in Honolulu, HI, USA.

60 Degrees Pharmaceuticals, Inc announced today the name of its chronic babesiosis trial is the B-FREE Chronic Babesiosis Study.

Tonix Pharmaceuticals announced that Dr. Sina Bavari, Ph.D., Executive Vice President, Infectious Disease Research, will present and Dr. Bavari and Dr. Zeil Rosenberg, M.D., Executive Vice President, Medical will participate in a panel discussion at the World Vaccine Congress–Europe 2025, taking place October 14–16, 2025, in Amsterdam, the Netherlands. Details on both sessions are provided below.

REGENXBIO Inc. announced that it will present interim data from the Phase II ALTITUDE® trial evaluating suprachoroidal delivery of surabgene lomparvovec (ABBV-RGX-314, sura-vec) for the treatment of diabetic retinopathy (DR) at the American Academy of Ophthalmology 2025 Annual Meeting.

Ligand Pharmaceuticals nnounced that its partner SQ Innovation Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Lasix® ONYU (furosemide injection), a novel drug-device combination for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure.

GH Research PLC announced the acceptance of a Novel Therapies Symposium Presentation at the 38th Annual European College of Neuropsychopharmacology Congress (ECNP) in Amsterdam, the Netherlands from October 11 – 14, where Professor Wiesław J. Cubała, MD, PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, will present long-term clinical data on the safety and efficacy from the open label extension (OLE) of a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with treatment-resistant depression (TRD) (GH001-TRD-201).

Neurogene Inc announced plans to initiate dosing in the fourth quarter of 2025

Neurogene Inc. announced the Company has completed discussions with the U.S. Food and Drug Administration (FDA) on its Embolden™ registrational trial protocol

Merck announced today that it will present new findings from its HIV treatment and prevention pipeline at the 20th European AIDS Conference (EACS 2025) taking place Oct.15-18, 2025, in Paris, France.

Gain Therapeutics, Inc. announced that it will host a virtual key opinion leader (KOL) event, "Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287" featuring Key Opinion Leaders (KOLs), Karl Kieburtz, M.D., M.P.H., Professor of Neurology, University of Rochester and Kenneth Marek, M.D., President and Senior Scientist, Institute for Neurodegenerative Disorders.

BD (Becton, Dickinson and Company) announced the enrollment of the first patient in the XTRACT™ Registry, a prospective, multi-center, single-arm, post-market registry study designed to evaluate the real-world performance of the Rotarex™ Catheter System in the treatment of patients with peripheral artery disease (PAD) lesions.

Merck announced new research from more than 100 abstracts across more than 20 types of cancer and multiple treatment settings from the company's broad and differentiated portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, from Oct. 17-21.