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Gilead's Lenacapavir Plan Faces Global Hurdles As It Commits To No-Profit Access for 2 Million
Wednesday, July 9, 2025 - 12:40pm | 662Gilead Sciences, Inc. (NASDAQ:GILD) on Wednesday announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir — Gilead’s twice-yearly injectable HIV-1 capsid inhibitor — for the prevention of HIV as pre-exposure prophylaxis (...
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Capricor Reports 4-Year Data For Deramiocel, Shows Sustained Benefit In Duchenne Patients
Friday, June 20, 2025 - 3:11pm | 414Capricor Therapeutics (NASDAQ:CAPR) on Friday released four-year safety and efficacy results from its ongoing HOPE-2 Open-Label Extension (OLE) study of Deramiocel, the company’s lead cell therapy candidate for Duchenne Muscular Dystrophy (DMD). After four years of continuous treatment,...
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European Advisory Panel Backs Conditional Approval For Madrigal's Fatty Liver Disease Drug
Friday, June 20, 2025 - 2:56pm | 681The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted on Friday a positive opinion recommending approval for Madrigal Pharmaceuticals, Inc.’s (NASDAQ:MDGL) resmetirom (Rezdiffra) for adults with noncirrhotic MASH with moderate to advanced...
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Omeros Analyst Sees $1 Billion Potential For Narsoplimab Before FDA Decision
Tuesday, June 10, 2025 - 12:53pm | 554H.C. Wainwright analyst Brandon Folkes initiated coverage on Omeros Corporation (NASDAQ:OMER) with a Buy rating and a price forecast of $9. According to Brandon, Omeros holds significant long-term value potential due to its expansive rare disease pipeline. While the company has faced investor...
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Pfizer, Arvinas Partnered Breast Cancer Drug Cuts Progression Risk By 43% In Trial, Seeks FDA Approval
Friday, June 6, 2025 - 10:18am | 500Arvinas, Inc. (NASDAQ:ARVN) on Friday announced in a press release the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc. (NYSE:PFE). The application covers vepdegestrant for patients with ER-positive (ER+)/human epidermal growth factor...
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Valneva's Chikungunya Vaccine Advances With Pediatric Trial, Phase 3 In 2026
Thursday, June 5, 2025 - 3:09pm | 532Valneva SE (NASDAQ:VALN) on Thursday announced six-month antibody persistence and safety data for its Phase 2 trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, Ixchiq, in 304 children, according to a press release. Partially funded...
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Jazz Pharma's Zepzelca Combo Shows Survival Edge In Lung Cancer Study
Tuesday, June 3, 2025 - 2:37pm | 491Jazz Pharmaceuticals plc (NASDAQ:JAZZ) on Monday revealed results from the Phase 3 IMforte study of Zepzelca (lurbinectedin) in combination with Roche Holdings AG’s (OTC:RHHBY) Tecentriq (atezolizumab) as a first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC...
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Trevi Therapeutics Showcases Drug That Cuts Cough Frequency In Lung Disease Patients
Monday, June 2, 2025 - 1:42pm | 471Trevi Therapeutics, Inc. (NASDAQ:TRVI) revealed topline results on Monday from its Phase 2b CORAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) (N=165). The primary endpoint in the CORAL trial was achieved, demonstrating statistically...
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Bicara Therapeutics Shares Sink Over 43% On Mixed Phase 1/1b Trial Results: What's Going On?
Friday, May 23, 2025 - 4:46pm | 318Bicara Therapeutics Inc. (NASDAQ:BCAX) shares are trading lower Friday following the release of updated interim data from its Phase 1/1b trial of ficerafusp alfa in combination with pembrolizumab for patients with recurrent or metastatic head and neck squamous cell carcinoma. What To know: The...
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Brazil Approves Valneva's Mosquito-Borne Chikungunya Vaccine
Monday, April 14, 2025 - 2:28pm | 630The Brazilian Health Regulatory Agency (ANVISA) has granted marketing authorization to Valneva SE’s (NASDAQ:VALN) single-dose vaccine Ixchiq for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. Chikungunya virus is a mosquito-borne viral...
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Tempest Weighs M&A, Analyst Sees A "Broken Story" Despite Phase 2 Liver Cancer Study Success
Thursday, April 10, 2025 - 12:00pm | 536Tempest Therapeutics, Inc. (NASDAQ:TPST) said on Thursday it had retained MTS Health Partners as a financial advisor. The company plans to explore strategic alternatives to advance its clinical-stage programs and maximize stockholder value. Strategic alternatives may include M&A, partnerships,...
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Cartesian Therapeutics Reports Strong 12-Month Data For Lead Cell Therapy In Myasthenia Gravis Patients
Tuesday, April 8, 2025 - 2:22pm | 532Cartesian Therapeutics, Inc. (NASDAQ:RNAC) on Tuesday revealed 12-month efficacy and safety data from the Phase 2b trial of Descartes-08, lead cell therapy candidate, in participants with generalized myasthenia gravis (MG). MG is a chronic autoimmune disorder that causes muscle weakness and fatigue...
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Edgewise Therapeutics Sees Meaningful HCM Treatment Gains With EDG-7500 In Phase 2 Study
Wednesday, April 2, 2025 - 12:27pm | 539Edgewise Therapeutics, Inc., (NASDAQ:EWTX) on Wednesday reported topline data of EDG-7500 from the Phase 2 CIRRUS-HCM four-week trial in participants with obstructive or nonobstructive Hypertrophic Cardiomyopathy (HCM). HCM is a genetic heart condition where the heart muscle thickens, making...
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Vertex Discontinues Development Of Type 1 Diabetes Candidate After Disappointing Data
Monday, March 31, 2025 - 3:03pm | 519Vertex Pharmaceuticals Inc (NASDAQ:VRTX) announced on Friday updates about its type 1 diabetes (T1D) portfolio. The company said it would not be advancing further in VX-264 clinical trials. Vertex plans to conduct further analyses, including of explanted devices. Vertex completed enrollment and...
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Why Is Portage Biotech Stock Skyrocketing Friday?
Friday, March 28, 2025 - 1:13pm | 435Portage Biotech Inc. (NASDAQ:PRTG) on Thursday presented new preclinical data for PORT-7 (TT-4), a selective Adenosine A2B receptor inhibitor, at the 2025 European Lung Cancer Congress. The new data demonstrate both single-agent activity for PORT-7 and a dramatic >90% inhibition of tumor...