First patient dosed in the pediatric cohort of the Phase 1/2 trial of OPGx-LCA5; initial data on the cohort anticipated by Q3 2025 New 12-month data on the first three adult OPGx-LCA5 patients to be presented at a major medical conference in Q2 2025 FDA meeting scheduled in March 2025 to discuss Phase 3 trial design and registrational endpoints for OPGx-LCA5 Feb. 18, 2025 -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the tr

Trial decision follows unanticipated events of elevated unconjugated bilirubin levels Company advancing multiple next-generation PTH1R agonists with distinct and unrelated chemical structures relative to SEP-786 Feb. 18, 2025 -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of GPCR drug discovery, today announced its decision to discontinue the Phase 1 single- and multiple-ascending dose (SAD/MAD) clinical trial of SEP-786 in healthy volunteers. SEP-

Data reinforce unique clinical advantages of sotagliflozin Published study is aligned with research presented in December 2024 at the American Society of Hematology showing clinical benefits of sotagliflozin compared to empagliflozin Feb. 18, 2025 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced The Lancet Diabetes & Endocrinology has published a research paper analyzing the ability of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, to reduce the risks of life-threatening cardio

In January 2025, a series of collaborative agreements were successively reached in the field of antibody-based pharmaceuticals in China: WuXi Biologics partnered with Candid Therapeutics to advance the development of a BCMA, CD20, and CD19 tri-specific antibody therapy through its WuXiBody™ platform. This groundbreaking partnership indicates a new direction for future oncological immunotherapy. Concurrently, Keymed Biomedical's CD38 monoclonal antibody, CM313, was successfully licensed to Timber

In January 2025, China’s innovative pharmaceutical sector continues to make its mark on the global stage. The collaboration between Innovent Biologics and Roche marks the international launch of IBI3009, an antibody-drug conjugate (ADC) targeting small cell lung cancer (SCLC). Meanwhile, the partnership between Duality Biologics and Avenzo Therapeutics concerning the EGFR/HER3 bispecific ADC, DB-1418/AVZO-1418, further demonstrates China’s progress in developing complex and efficient cancer ther

Feb. 18, 2025 -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of presentations highlighting data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS) to be presented at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 27 – March 1, 2025, in West Palm Beach, Florida. Abstracts are n

$3.7 Million Private Placement Financing from Existing Investors $2.0 Million Funding Advance from the Cancer Prevention and Research Institute of Texas (CPRIT) Feb. 18, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company,” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announced today that it has closed a private placement with aggregate initial upfront p

Feb. 18, 2025 -- Bionic Sight, Inc., a company developing a novel gene therapy for retinal degenerative diseases, announced today that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational product BS01 for the treatment of retinitis pigmentosa (RP) patients with advanced stage vision loss. RMAT designation is part of the 21st Century Cures Act, which aims to accelerate the development of regenerative medicine therapies, including gene therapy, for se

Feb. 18, 2025 -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept), a biologic used to treat eye disorder

Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid If approved, Dupixent would be the first and only targeted medicine to treat BP in the US; FDA decision expected by June 20, 2025 Priority review granted based on positive pivotal results demonstrating significant improvements in sustained disease remission with Dupixent compared to placebo BP is a chronic, debilitating and relapsing skin disease with underlying type 2 inflammation characterized by in