- 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 ...

Core Insights - Immatics N.V. has appointed Amie Krause as Chief People Officer effective October 27, 2025, to lead human resources and organizational development as the company transitions to a commercial stage [1][2] - The company aims to strengthen its global leadership in precision targeting of PRAME, a target expressed in over 50 cancers, through enhanced organizational excellence and efficiency [2][3] Company Overview - Immatics is a clinical-stage biopharmaceutical company focused on precision targeting of PRAME, with a robust clinical pipeline that includes TCR T-cell therapies and TCR bispecifics [3] - The company is committed to making a meaningful impact on the lives of cancer patients by advancing its PRAME product candidates, including the lead candidate anzu-cel [3] Leadership and Experience - Amie Krause brings over 20 years of experience in organizational growth and talent alignment, having previously held senior HR roles at Dompé, Revance Therapeutics, Atara Biotherapeutics, and Amgen [2] - Krause's background includes leading global commercial operations and serving as an adjunct professor, indicating a strong blend of industry and academic experience [2]

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].

Core Viewpoint - Vivani Medical, Inc. has announced a registered direct offering and private placement of common stock, aiming to raise approximately $15.7 million to support ongoing research and clinical development of its product candidates [1][2]. Group 1: Offering Details - The company is offering 6,000,000 shares of common stock at $1.62 per share in a registered direct offering and an additional 3,703,703 shares in a concurrent private placement, also at $1.62 per share [1]. - The gross proceeds from both offerings are expected to be around $15.7 million before deducting fees and expenses [1]. - The offerings are set to close on or about October 28, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offerings will be utilized for ongoing research and clinical development of the company's product candidates, as well as for working capital and general corporate purposes [2]. Group 3: Company Overview - Vivani Medical, Inc. specializes in developing miniature, ultra long-acting drug implants using its proprietary NanoPortal™ platform, targeting metabolic diseases such as obesity and type 2 diabetes [5]. - The company's implants aim to improve patient adherence to medication by providing steady drug delivery over extended periods, addressing challenges associated with daily or weekly administration of oral and injectable medications [5]. - Approximately 50% of patients experience medication non-adherence, which Vivani aims to mitigate through its innovative drug delivery solutions [5].

A set of glass vials sit in a laboratory. Photographer: Carsten Snejbjerg/Bloomberg MapLight Therapeutics Inc. will raise $258.9 million in an initial public offering and private placement, becoming the first company to go public via an unusual route since the US government shutdown. The biotechnology firm developing treatments for neurological disorders sold 14.75 million shares Sunday for $17 each, according to a statement. Affiliates of funds managed by Goldman Sachs Group Inc. are also expected to bu ...

Core Points - MapLight Therapeutics, Inc. has priced its initial public offering (IPO) at $17.00 per share for 14,750,000 shares, with an additional option for underwriters to purchase 2,212,500 shares [1][2] - The total expected gross proceeds from the IPO and a concurrent private placement are approximately $258.9 million, excluding underwriters' options and expenses [2] - The shares are set to begin trading on the Nasdaq Global Market under the symbol "MPLT" on October 27, 2025, with the offering expected to close on October 28, 2025 [3] Company Overview - MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on central nervous system disorders, founded by leaders in psychiatry and neuroscience [7] - The company's lead product candidate, ML-007C-MA, is currently in Phase 2 clinical trials for treating schizophrenia and Alzheimer's disease psychosis [7]