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

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

Through comprehensive searches in the Patsnap Synapse database, it has been found that the key drugs targeting ActRII mainly consist of fusion proteins and monoclonal antibodies. These drugs have shown significant potential in the treatment of various diseases, and understanding their characteristics and development progress is crucial for evaluating their clinical value and future research directions. When searching for “ActRII” under the “Target” section within the “Drug Finder” tool in Patsn

In January 2025, several significant mergers and acquisitions (M&A) took place in the biopharmaceutical industry. These transactions not only reflect the strategic positioning of major companies in specific therapeutic areas but also demonstrate the industry's continued focus on innovative technologies and unmet medical needs. Lantheus Holdings, a leader in the field of radiopharmaceuticals, has significantly strengthened its market position and technological portfolio through a series of ac