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| Cogent Biosciences, Inc.: Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM) | NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM PDUFA target action date set... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) | Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria with a well-tolerated... ► Artikel lesen |
| Cogent Biosciences, Inc.: Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) Congress | -- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an updated objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria... ► Artikel lesen |
| Vera Therapeutics Announces ORIGIN 3 Final Efficacy Analysis of TRUTAKNA (atacicept-vymj) in IgA Nephropathy Will be A Featured Late-breaking Oral Presentation at the Opening Plenary Session of ASN Kidney Week 2026 | BRISBANE, Calif., Oct. 02, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today announced that there will be multiple presentations at the... ► Artikel lesen |
| Vera Therapeutics Announces TRUTAKNA (atacicept-vymj) Stabilized eGFR and Prevented Kidney Disease Progression Through Two Years in ORIGIN 3 Final Efficacy Analysis in IgA Nephropathy | TRUTAKNA, the first and only FDA-approved BAFF and APRIL inhibitor, met all prespecified endpoints, including unprecedented placebo-adjusted estimated glomerular filtration rate (eGFR) and composite... ► Artikel lesen |
| Weekly Buzz: Johnson & Johnson, Vera Therapeutics Get FDA Nod; Vertex Pharmaceuticals Snaps Up Crinetics Pharmaceuticals; Satellos Bioscience Aces DMD Trial; Ionis Pharmaceuticals Misses Key Goal | NEW BRUNSWICK (dpa-AFX) - This week featured a steady stream of regulatory milestones, strategic dealmaking, and pivotal clinical trial updates, alongside missed trial goals across the biotech... ► Artikel lesen |
| Kymera International Appoints Willson Ropp as Chief Executive Officer | Experienced specialty materials executive brings more than 30 years of leadership experience across global manufacturing, operational excellence, business integration, and long-term value... ► Artikel lesen |
| Kymera Therapeutics, Inc.: Kymera Therapeutics Appoints Terence Rooney, MD, as Chief Medical Officer | Dr. Rooney, former immunology leader at Johnson & Johnson, will lead clinical development strategy across Kymera's industry-leading oral immunology portfolio Jared Gollob, MD, will retire from his... ► Artikel lesen |
| Kymera Therapeutics, Inc.: Kymera Therapeutics Appoints Elizabeth Laws, Ph.D., as Senior Vice President, Global Program Team Leader for KT-621, First-in-Class, Oral STAT6 Degrader | Dr. Laws, former immunology leader at Sanofi, will oversee global development of Kymera's KT-621 program KT-621 parallel Phase 2b trials advancing in AD and asthma, with data expected by year-end... ► Artikel lesen |
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