- Obexelimab met primary endpoint with a 95% relative reduction in new gadolinium (Gd)-enhancing T1 lesions compared with placebo, p=0.0009 - WALTHAM, Mass., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced positive results from the P ...

NMRA-898 is structurally distinct from NMRA-861 and is the second M4 PAM in Neumora’s M4 franchise; both programs have potential best-in-class pharmacology No convulsions observed in pre-clinical studies conducted in multiple species, including rabbits Neumora plans to provide a comprehensive M4 franchise update by mid-2026 WATERTOWN, Mass., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company redefining neuroscience drug development, today ...

Data from the Phase 1 CARLYSLE study in severe refractory systemic lupus erythematosus (srSLE) suggests obe-cel is well tolerated with no ICANS or high-grade CRS; 50 million cell dose selected for Phase 2 pivotal studyPreliminary efficacy data demonstrate achievement of definition of remission in SLE (DORIS) in 83% of patients and complete renal response (CRR) in 50% of patients; all responses and remissions are ongoing with no evidence of disease activity at a median follow-up of 8.9 monthsAll patients had ...

- All primary and secondary interim analysis endpoints in FORTIFY Phase 3 study successfully achieved with well-tolerated safety profile consistent with the Company’s prior studies - Primary interim analysis endpoint, glycosylated αDG, significantly increased by 1.8x change from baseline at 3 months (p<0.0001), and improvements were sustained at 12 months (p<0.0001) in BBP-418 treated individuals versus placebo - Average reduction in serum CK, a marker of muscle damage, of 82% change from baseline and stati ...

Houston, Texas and Tuebingen, Germany, October 27, 2025 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, today announced the appointment of Amie Krause as Chief People Officer (“CPO”) effective October 27, 2025. Ms. Krause brings more than 20 years of experience in shaping culture, leading organizational growth and aligning talent with business strategy, including across global biopharmaceutical com ...

NEW YORK, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that it will report its third quarter 2025 financial results and provide a business update on Monday, November 3, 2025. In connection with the earnings release, Syndax's management will host a conference call and live audio webcast at 4:30 p.m. ET on Monday, November 3, 2025. The live audio webcast and accompanying slides may b ...

SAN FRANCISCO, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines in oncology and autoimmune disease, today announced the closing of its previously announced underwritten registered offering of 24,485,799 shares of its common stock at a purchase price of $10.21 per share. The gross proceeds to Nurix from the offering were $250.0 million, be ...

Core Insights - Neumora Therapeutics announced positive preclinical data for NMRA-215, showing class-leading weight loss of up to 19% as a monotherapy and 26% in combination with semaglutide [1][2] - The company plans to initiate a Phase 1 clinical study for NMRA-215 in the first quarter of 2026 [1][2] Company Overview - Neumora Therapeutics is a clinical-stage biopharmaceutical company focused on redefining neuroscience drug development, with a pipeline of seven programs targeting novel mechanisms for various diseases [5] - NMRA-215 is a highly brain-penetrant, oral NLRP3 inhibitor being developed for obesity treatment, with potential implications for Parkinson's disease as well [4][5] Research and Development - NMRA-215 demonstrated significant weight loss in diet-induced obesity mouse studies, indicating its potential as a next-generation oral treatment for obesity [2][4] - The company emphasizes the potential for NMRA-215 to enable incretin-sparing dosing regimens, enhancing its therapeutic profile [2]

Core Insights - Rakovina Therapeutics presented new data on its AI-driven kt-5000AI drug discovery program for ATR inhibitors at the AACR-NCI-EORTC conference, highlighting promising results for cancer therapy targeting CNS penetration [1][2][3] Company Developments - The collaboration with Variational AI utilized the Enki™ generative AI platform to identify novel small-molecule candidates for CNS-penetrant ATR inhibition, with multiple lead compounds achieving the desired profile [2][3] - Rakovina's kt-5000AI program is advancing next-generation ATR inhibitors that have confirmed CNS exposure, potentially benefiting patients with primary brain tumors and brain metastases [3][5] - The company aims to advance one or more drug candidates into human clinical trials in collaboration with pharmaceutical partners [6] Scientific Findings - In cell-based assays, lead compounds demonstrated over 50% inhibition of ATR activity below 200 nM, with potency exceeding reference compounds such as ceralasertib, tuvusertib, and elimusertib [7] - In vivo pharmacokinetic studies showed measurable drug concentrations in plasma and brain tissue after intraperitoneal dosing at 5 mg/kg, indicating CNS penetration and good tolerability after single-dose administration [7]

Core Insights - CSL's Broadmeadows facility has been awarded the Overall Winner of the 2025 Facility of the Year Award (FOYA) by the International Society for Pharmaceutical Engineering (ISPE), highlighting its commitment to responsible innovation and operational excellence [1][5]. Group 1: Facility Features and Innovations - The Broadmeadows facility is designed to optimize the production of plasma-derived therapies for various medical conditions, utilizing advanced technologies and a hybrid manufacturing platform [3]. - Key features include advanced automation, real-time production monitoring, robotics, and a digital twin infrastructure, enabling flexible multi-process manufacturing and fully paperless execution [3][6]. - The facility's modular design allows for scalability and long-term adaptability, enhancing its operational efficiency [3]. Group 2: Production Capacity and Impact - The advancements at the Broadmeadows facility have increased plasma processing capacity nine-fold, allowing it to handle over 10 million liters annually [4]. - This increase in capacity and efficiency enables CSL to positively impact the lives of more patients globally [4]. Group 3: Sustainability and Future Readiness - The facility incorporates sustainable infrastructure, including reusable filters and energy-efficient systems, contributing to CSL's commitment to responsible innovation [6]. - A fully automated warehouse powered by robotic vehicles enhances material handling efficiency, aligning with the company's sustainability goals [6]. Group 4: Recognition and Previous Achievements - The Broadmeadows facility previously received the ISPE FOYA award in May 2025 for its advanced use of digital technologies and automation in pharmaceutical manufacturing [7].