| | tafenoquine For treatment of babesiosis | — | 07/09/2024 6:34 AM | Provided Update | 60 Degrees Pharmaceuticals, announced ethics approval of an open label, expanded access study of the ARAKODA® regimen of tafenoquine in combination with standard of care regimens in immunosuppressed patients with persistent/relapsing babesiosis. View | Get Alert |
WENA | ANEW MEDICAL Inc
| Klotho Gene Therapy For neurodegenerative disorders. | — | 07/09/2024 6:30 AM | Provided Update | ANEW MEDICAL, INC announces plans to advance its recently patented Klotho gene therapy program for neurodegenerative disorders. View | Get Alert |
MEOBFMESO | Mesoblast Ltd
| RYONCIL For the treatment of severe and life-threatening inflammatory conditions. | Biologics License Applications (BLA) | 07/08/2024 6:28 AM | resubmitted | Mesoblst Limited announced it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD. View | Get Alert |
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KYMR | Kymera Therapeutics Inc
| KT-474 Hidradenitis Suppurativa or Atopic Dermatitis (AD) | Phase 2 | 07/08/2024 5:29 PM | Efficacy and Safety Data | Kymera Therapeutics, announced that following a review of preliminary KT-474 safety and efficacy data by an Independent Data Review Committee, Sanofi has informed Kymera that it intends to expand the ongoing Hidradenitis Suppurativa (HS) and Atopic Dermatitis (AD) Phase 2 trials to more rapidly progress towards pivotal studies. View | Get Alert |
IMMX | Immix Biopharma, Inc.
| NXC-201 NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis. | — | 07/08/2024 5:22 PM | Dose Update | Immix Biopharma, Inc announced that the 1st patient has been dosed at MSKCC in its U.S. NEXICART-2 trial with NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy.. View | Get Alert |
HLVX | HilleVax Inc
| NEST-IN1 In infants for a norovirus vaccine candidate | Phase 2b | 07/08/2024 8:53 AM | Top-line data | HilleVax, Inc announced topline data results from NEST-IN1. NEST-IN1 is a Phase 2b, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and immunogenicity of HIL-214 in infants of approximately 5 months of age at the time of initial vaccination at sites in the United States and Latin America. View | Get Alert |
SILO | SILO Pharma Inc
| SPC-15 Treatment for PTSD | — | 07/08/2024 8:50 AM | Regulatory Update | Silo Pharma, Inc. announced that it has entered into an exclusive, global license agreement with Columbia University to further develop, manufacture, and commercialize its lead drug candidate, SPC-15, an intranasal treatment for stress-induced affective disorders and PTSD. View | Get Alert |
SLS | SELLAS Life Sciences Group Inc
| SLS009 For Treatment of Acute Myeloid Leukemia | Orphan Drug Designation | 07/08/2024 8:50 AM | Designation Grant | SELLAS Life Sciences Group, Inc. announced that the European Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of acute myeloid leukemia (AML). View | Get Alert |
MIRM | Mirum Pharmaceuticals Inc
| Maralixibat Alagille Syndrome | European Commission Marketing Authorization | 07/08/2024 8:48 AM | Regulatory Update | Mirum Pharmaceuticals, Inc announced that the European Commission has granted marketing authorization for LIVMARLI® (maralixibat) oral solution for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients three months of age and older. View | Get Alert |
MBOT | Microbot Medical Inc
| LIBERTY® Robotic Surgical System Device | — | 07/08/2024 8:47 AM | Provided Update | Microbot Medical Inc. announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical System. View | Get Alert |
OTLK | Outlook Therapeutics Inc
| LYTENAVA For the Treatment of Wet AMD | UK MHRA Approval | 07/08/2024 8:45 AM | Regulatory Update | Outlook Therapeutics, Inc. announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the UK. View | Get Alert |
| | CER-1236 For Ovarian Cancer | — | 07/08/2024 8:18 AM | Presentation | CERo Therapeutics Holdings, Inc. announces presentation of a poster on its lead compound CER-1236 at the Global Cell & Gene Therapy Summit 2024. The conference is being held July 8-10 in Boston. View | Get Alert |
TNXP | Tonix Pharmaceuticals Holding Corp
| Tonmya For the management of fibromyalgia. | — | 07/08/2024 8:12 AM | FDA Meeting | Tonix Pharmaceuticals announced receipt of the formal minutes from a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. View | Get Alert |
PLSE | Pulse Biosciences Inc
| CellFX General dermatologic conditions | Breakthrough Device Designation | 07/08/2024 8:11 AM | Designation Grant | Pulse Biosciences, Inc announced that it has received the Breakthrough Device Designation from the U.S. FDA for the Company's Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation (AF). View | Get Alert |
AMRN | Amarin Corp PLC
| VASCEPA/VAZKEPA (icosapent ethyl) Prior Peripheral Artery Disease (PAD) | — | 07/08/2024 8:10 AM | Regulatory Update | Amarin Corporation plc announced that its commercial partner in Mainland China ("China"), EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China's National Medical Products Administration (NMPA). View | Get Alert |
ACET | Adicet Bio Inc
| ADI-270 An Armored Allogeneic "Off-the-Shelf" CAR gamma delta T Cell therapy Targeting CD70+ Cancers | Fast Track Designation | 07/08/2024 7:20 AM | Designation Grant | Adicet Bio, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-270 for the potential treatment of patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor. View | Get Alert |
IDYA | IDEAYA Biosciences Inc
| IDE397 Solid Tumors | Phase 2 | 07/08/2024 7:19 AM | Positive Data | IDEAYA Biosciences, announced positive clinical data for the IDE397 Phase 2 monotherapy expansion dose in methylthioadenosine phosphorylase (MTAP)-deletion urothelial and non-small cell lung cancer (NSCLC) patients. View | Get Alert |
IDYA | IDEAYA Biosciences Inc
| IDE397 Solid Tumors | Phase 2 | 07/05/2024 4:59 PM | Clinical Update | IDEAYA Biosciences announced that the company plans to issue a pre-market press release and conduct an investor webcast on Monday, July 8, 2024, at 8:00 a.m. EST to provide a clinical data update for the IDE397 Phase 2 monotherapy expansion dose in MTAP-deletion urothelial and non-small cell lung cancer (NSCLC) patients. View | Get Alert |
IVAIVEVF | Inventiva SA
| NATiV3 In adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis. | — | 07/05/2024 4:12 PM | Provided Update | Inventiva provided an update on its clinical program evaluating lanifibranor for the treatment of MASH/NASH and its financial position. View | Get Alert |
AZNAZNCF | AstraZeneca PLC
| TAGRISSO® (osimertinib) Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. | European Commission | 07/05/2024 6:47 AM | Foreign Approval | AstraZeneca’s Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been approved in the European Union (EU) for the 1st-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations. View | Get Alert |
RHHBFRHHBYRHHVF | Roche Holding AG
| Vabysmo (faricimab-svoa) For People With Two Leading Causes of Vision Loss | FDA Approved | 07/05/2024 5:27 AM | FDA Approval | Roche Group announced the U.S. Food and Drug Administration (FDA) has approved the Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). View | Get Alert |
CALTCLTEF | Calliditas Therapeutics AB
| Nefecon Primary IgA Nephropathy (IgAN) | Phase 3 | 07/04/2024 6:44 AM | Clinical Trial | Calliditas Therapeutics AB announces that its partner Viatris Pharmaceutical Japan G.K. ("Viatris") has initiated a phase III clinical trial in Japan with Nefecon, named VR-205 in the Japanese market, in Japanese patients with IgA nephropathy (IgAN). View | Get Alert |
RHHBFRHHBYRHHVF | Roche Holding AG
| SKYSCRAPER-06 An initial treatment versus pembrolizumab and chemotherapy | Phase 2/3 | 07/04/2024 6:21 AM | Endpoint Missed | Roche Group that the Phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (nSq NSCLC), did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature. View | Get Alert |
EPZM | Epizyme Inc
| Tazemetostat + rituximab + lenalidomide (SYMPHONY-1) Relapsed/refractory follicular lymphoma (R/R FL) | New Drug Application (NDA) | 07/03/2024 6:26 AM | Regulatory Update | HUTCHMED (China) Limited announces that the New Drug Application ("NDA") for tazemetostat for the treatment of adult patients with relapsed or refractory ("R/R") follicular lymphoma ("FL") has been accepted for review and granted Priority Review by the China National Medical Products Administration ("NMPA"). View | Get Alert |
ICU | SeaStar Medical Holding Corporation
| QUELIMMUNE For the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT). | — | 07/03/2024 9:32 AM | Provided Update | SeaStar Medical Holding announces that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has agreed to the final labeling for SeaStar Medical's QUELIMMUNE™, the Selective Cytopheretic Device for pediatric patients, paving the way under the Humanitarian Use Device (HUD) designation to market the therapeutic device in the U.S. for the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT). View | Get Alert |
ARTL | Artelo Biosciences Inc
| ART12.11 For overcoming problematic drug properties which allows for precise control over purity, potency, and consistency. | — | 07/03/2024 9:12 AM | Data Presentation | Artelo Biosciences announced several presentations about ART12.11, Artelo's proprietary cocrystal combination drug candidate, were delivered at the 34th Annual International Cannabinoid Research Society (ICRS) Symposium held June 30 through July 5, 2024 in Salamanca, Spain. View | Get Alert |
| | TACTI-003 Treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). | Phase 2b | 07/03/2024 8:10 AM | Oral presentation | Immutep Limited announces details for an upcoming oral presentation at the European Society for Medical Oncology (ESMO) Virtual Plenary session on July 11, 2024, featuring new clinical data in patients with negative PD-L1 expression (Cohort B) in the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, and a webcast to discuss these clinical results. View | Get Alert |
GHJNJ | Guardant Health Inc Johnson & Johnson
| RYBREVANT (amivantamab-vmjw) Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations | — | 07/03/2024 8:08 AM | Regulatory Update | Johnson & Johnson announced that that Health Canada, through a Priority Review, has issued a Notice of Compliance (NOC) for RYBREVANT® (amivantamab) in combination with platinum-based chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.1 View | Get Alert |
REGNSNYSNYNF | Regeneron Pharmaceuticals Inc Sanofi SA
| Dupixent (dupilumab) Moderate-to-severe asthma | European Commission Approval | 07/03/2024 6:59 AM | Foreign Approval | Regeneron Pharmaceuticals, Inc announced that the European Commission (EC) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. View | Get Alert |
GYRE | Gyre Therapeutics
| Avatrombopag For the Treatment of CLD-Associated Thrombocytopenia | China National Medical Products Administration (NMPA) Approval | 07/02/2024 5:39 PM | Foreign Approval | Gyre Therapeutics announced that China's National Medical Products Administration ("NMPA") has approved Gyre Pharmaceuticals' (Gyre's indirectly controlled subsidiary) avatrombopag maleate tablets for the treatment of thrombocytopenia ("TP") associated with chronic liver disease ("CLD") in adult patients undergoing elective diagnostics procedures or therapy. View | Get Alert |
| | TYRA-300 For the Treatment of Achondroplasia | — | 07/02/2024 5:37 PM | Results | Tyra Biosciences, Inc. announced preclinical proof-of-concept results with TYRA-300, an investigational oral FGFR3 selective inhibitor, in hypochondroplasia (HCH). View | Get Alert |
LLY | Eli Lilly and Co
| Donanemab Alzheimer's disease (AD) | FDA Approved | 07/02/2024 5:34 PM | FDA Approval | Eli Lilly announced that The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion) View | Get Alert |
| | AVT03 For Prolia® and Xgeva® | — | 07/02/2024 5:32 PM | Top-line results | Alvotech announced positive topline results from a confirmatory patient study for AVT03, a proposed biosimilar to Prolia® (denosumab) and Xgeva® (denosumab). View | Get Alert |
VRTX | Vertex Pharmaceuticals Inc
| vanza triple Vanzacaftor/Tezacaftor/Deutivacaftor, Next-In-Class Triple Combination Treatment for Cystic Fibrosis | New Drug Application (NDA) | 07/02/2024 5:30 PM | PDUFA Date | Vertex used a priority review voucher for this submission reducing the review time from 10 months to 6 months, resulting in a Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025. View | Get Alert |
VRTX | Vertex Pharmaceuticals Inc
| vanza triple Vanzacaftor/Tezacaftor/Deutivacaftor, Next-In-Class Triple Combination Treatment for Cystic Fibrosis | New Drug Application (NDA) | 07/02/2024 5:29 PM | FDA Accepted | Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for investigational once-daily vanzacaftor/tezacaftor/deutivacaftor triple combination therapy (vanza triple) for people living with cystic fibrosis (CF) ages 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene responsive to the vanza triple. View | Get Alert |
INZY | Inozyme Pharma Inc
| INZ-701 ABCC6 Deficiency | Fast Track Designation | 07/02/2024 5:28 PM | Designation Grant | Inozyme Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to INZ-701 for the treatment of ABCC6 Deficiency. View | Get Alert |
MTP | Midatech Pharma PLC
| MTX110 Recurrent Glioblastoma multiforme (rGBM) | Phase 1 | 07/02/2024 5:25 PM | Data | Biodexa Pharmaceuticals PLC announces data from a Phase 1 study of MTX110 in Diffuse Midline Glioma ("DMG") f/k/a Diffuse Intrinsic Pontine Glioma, or DIPG, an orphan pediatric brain cancer were presented over the weekend at the 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) in Philadelphia, PA. View | Get Alert |
HRTX | Heron Therapeutics Inc
| ZYNRELEF (bupivacaine and meloxicam HTX-011) Postoperative pain | — | 07/02/2024 5:22 PM | Regulatory Update | Heron Therapeutics, Inc. announced that the FDA acknowledged the receipt of the Company's Prior Approval Supplement ("PAS") application for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution VAN. View | Get Alert |
ANVS | Annovis Bio Inc
| Buntanetap Parkinson's Disease (PD) | Phase 3 | 07/02/2024 5:02 PM | New Data | Annovis Bio Inc. announced new data from its Phase III PD study demonstrating that buntanetap is safe and effective in improving motor and non-motor activities and improving cognitive functions in patients with early Parkinson's disease. View | Get Alert |
PAVM | PAVmed Inc
| EsoGuard Esophageal DNA Test | — | 07/02/2024 8:05 AM | Positive Data | Lucid Diagnostics subsidiary of PAVmed Inc announced positive data from its ESOGUARD BE-1 prospective, international, multicenter, single-arm study conducted to clinically validate performance of the EsoGuard® Esophageal DNA test on samples collected with the EsoCheck® Esophageal Cell Collection Device for detection of esophageal precancer (Barrett's Esophagus or BE) and esophageal adenocarcinoma (EAC) in a screening population. View | Get Alert |
CGTX | Cognition Therapeutics, Inc.
| CT1812 (DLB) Dementia with Lewy bodies (DLB) | Phase 2 | 07/02/2024 7:48 AM | Findings Update | Cognition Therapeutics, announced that abstracts summarizing clinical efficacy, safety and biomarker findings from the Phase 2 COG0201 "SHINE" study of CT1812 have been accepted for poster presentation at the upcoming Alzheimer's Association's International Conference being held in Philadelphia, PA from July 28-August 1, 2024. View | Get Alert |
LEGN | Legend Biotech Corp
| Ciltacabtagene Autoleucel (cilta-cel) Relapsed and/or Refractory Multiple Myeloma | Phase 3 | 07/02/2024 7:46 AM | Positive Results | Johnson & Johnson announced positive results from a prespecified second interim analysis of the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy. View | Get Alert |
CKPT | Checkpoint Therapeutics Inc
| Cosibelimab (cSCC) Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC) | Biologics License Applications (BLA) | 07/02/2024 7:43 AM | Regulatory Update | Checkpoint Therapeutics announced it has completed the resubmission of its Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation., View | Get Alert |
ARDX | Ardelyx Inc
| tenapanor Control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis | — | 07/02/2024 7:42 AM | Provided Update | Ardelyx, Inc announced that, in an effort to preserve patient access to its phosphate absorption inhibitor XPHOZAH® (tenapanor), the Company has chosen not to apply to include XPHOZAH in the Centers for Medicare & Medicaid Services (CMS) End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Transitional Drug Add-on Payment Adjustment (TDAPA). View | Get Alert |
KRMD | KORU Medical Systems
| FreedomEdge Infusion system to deliver pegcetacoplan 20 mL solution | — | 07/02/2024 7:40 AM | Provided Update | KORU Medical Systems, Inc announced that its state-of-the-art FreedomEdge® System has received regulatory clearance in Japan for the delivery of multiple drugs, including CSL Behring's Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical's Cuvitru SCIg, and Sobi's Aspaveli paroxysmal nocturnal hemoglobinuria (PNH). View | Get Alert |
ANIP | ANI Pharmaceuticals Inc
| Naproxen To treat pain, menstrual cramps, and inflammatory diseases | Abbreviated New Drug Application (ANDA) | 07/02/2024 7:37 AM | FDA Approval | ANI Pharmaceuticals, Inc. announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) and launched Naproxen Delayed-Release Tablets, USP. ANI's Naproxen Delayed-Release Tablets is the generic version of the reference listed drug (RLD) EC-Naprosyn®. View | Get Alert |
| | Descartes-08 For autoimmune diseases | Phase 2b | 07/02/2024 7:35 AM | Top-line results | Cartesian Therapeutics announced positive topline results from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG). View | Get Alert |
IMRN | Immuron Ltd
| IMM-529 Oral polyclonal antibody, targeting toxin B in the human gut and neutralises main virulence factors of Clostridium infection | Pre-IND Filing | 07/02/2024 7:33 AM | IND Filing | Immuron Limited announce that it has filed a pre-IND (investigational new drug) application with the United States Food and Drug Administration (FDA) for IMM-529. View | Get Alert |
LBPH | Longboard Pharmaceuticals, Inc.
| LP352 For The Treatment Of Developmental And Epileptic Encephalopathies | Breakthrough Therapy Designation | 07/01/2024 9:39 AM | Designation Grant | Longboard Pharmaceuticals, Inc announced that the FDA has granted Breakthrough Therapy designation for its investigational drugbexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age or older. View | Get Alert |
BCLI | Brainstorm Cell Therapeutics Inc
| NurOwn Progressive Multiple Sclerosis (MS) | — | 07/01/2024 8:14 AM | Provided Update | BrainStorm Cell Therapeutics Inc. announced that that it will hold a mid-year corporate update to discuss recent positive developments in the NurOwn® program on Monday, July 8, at 8:00 a.m. U.S. Eastern Time View | Get Alert |
NBIX | Neurocrine Biosciences Inc
| crinecerfont For the Treatment of Congenital Adrenal Hyperplasia (CAH) | New Drug Application (NDA) | 07/01/2024 8:11 AM | FDA Accepted | Neurocrine Biosciences, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted its two New Drug Applications (NDA) with Priority Review designations for crinecerfont in the treatment of children, adolescents and adults with classic congenital adrenal hyperplasia (CAH). View | Get Alert |
| | BT-600 For the treatment of moderate to severe ulcerative colitis. | — | 07/01/2024 8:10 AM | Top-line results | Biora Therapeutics, Inc. shared positive topline results from its clinical trial of BT-600, an orally administered drug-device combination in development for the potential treatment of patients with ulcerative colitis (UC). View | Get Alert |
OVID | Ovid Therapeutics Inc
| OV888/GV101 For Cerebral Cavernous Malformations | Phase 1 | 07/01/2024 8:05 AM | Results | Ovid Therapeutics Inc. announced the results from their Phase 1 healthy volunteer study evaluating the safety, tolerability, and pharmacokinetic (PK) profile of multiple ascending doses of OV888/GV101 capsule. View | Get Alert |
NRSN | NeuroSense Therapeutics Ltd
| PrimeC Amyotrophic lateral sclerosis | Phase 2b | 07/01/2024 8:03 AM | Results | NeuroSense Therapeutics Ltd. reported statistically significant results from the 12-month data analysis of the PARADIGM Phase 2b study evaluating PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS). View | Get Alert |
HUMA | Humacyte, Inc.
| Human Acellular Vessel Coronary Artery Bypass Grafting | Regenerative Medicine Advanced Therapy (RMAT) Designation | 07/01/2024 7:46 AM | Designation Grant | Humacyte, Inc. announced that it has been granted the U.S. Food and Drug Administration's (FDA's) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD). View | Get Alert |
CANF | Can-Fite BioPharma Ltd
| Namodenoson (CF102) Liver Cancer Advanced liver cancer | — | 07/01/2024 7:46 AM | Provided Update | Can-Fite BioPharma Ltd. announced that that a patient with liver decompensated cirrhosis who was treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use showed an improvement in liver indices. View | Get Alert |
SWTX | SpringWorks Therapeutics Inc
| Mirdametinib Adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN) | New Drug Application (NDA) | 07/01/2024 7:42 AM | Regulatory Update | SpringWorks Therapeutics, Inc announced that the Company has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of pediatric and adult patients with neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN). View | Get Alert |
AZNAZNCF | AstraZeneca PLC
| sipavibart for COVID-19 prevention | European Medicines Agency (EMA) | 07/01/2024 7:37 AM | Regulatory Update | AstraZeneca’s Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. View | Get Alert |
MEOBFMESO | Mesoblast Ltd
| RYONCIL For the treatment of severe and life-threatening inflammatory conditions. | Biologics License Applications (BLA) | 07/01/2024 7:36 AM | Regulatory Update | Mesoblast Limited confirmed that it will file its Biologics License Application (BLA) for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) with the U.S. Food and Drug Administration (FDA) next week. View | Get Alert |