Tag: clinical trials

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CAMBRIDGE, Mass., June 18, 2025 (GLOBE NEWSWIRE) --  Biogen Inc. (Nasdaq: BIIB) announced the initiation of dosing in the BRAVE study, a global Phase 3 clinical trial. The BRAVE study will evaluate the efficacy and safety of omaveloxolone in children with Friedreich ataxia (FA) between the ages of 2 to <16. Both non-ambulatory and ambulatory participants may qualify for the study. Participants will be randomized 2:1 to receive omaveloxolone or placebo once a day for 52 weeks before having the opportunity to move into the open-label extension (OLE). Currently, omaveloxolone is commercialized under the brand name SKYCLARYS^® in over 40 countries, including in the U.S. and the European Union, and is the only approved product for FA in adults and adolescents aged 16 years and older.

Basel, Switzerland – June 18, 2025 - TOLREMO therapeutics AG (TOLREMO), a clinical-stage biotechnology company developing TT125-802, a best-in-class CBP/p300 bromodomain inhibitor for the treatment of solid tumors and multiple myeloma, today announced key leadership appointments. Alessandra Cesano, MD, PhD, who has served as Consulting Chief Medical Officer since April 2023, will join the company’s Board of Directors. Florian D. Vogl, MD, PhD, has been appointed as Chief Medical Officer (CMO), succeeding Alessandra Cesano on the executive team.

REDWOOD CITY, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, announced today that it has commenced an underwritten public offering of shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof) and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof). In addition, Biomea intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock and pre-funded warrants offered in the public offering. All of the shares, pre-funded warrants and accompanying common stock warrants to be sold in the proposed offering are to be sold by Biomea.

– Veteran executive with over 20 years of oncology leadership and clinical experience with proven track record of success in bringing development candidates through late-stage clinical development –

Fast Track status enables expedited regulatory review timelines and supports the development of recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for inflammatory diseases.

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