The first clinical data from an FDA-approved trial of a CAR T-cell therapy in the treatment of multiple sclerosis (MS) show the cells cause complete B-cell depletion, leading on to a reset of the immune system that is accompanied by an improvement in symptoms.
Septerna Inc.’s stock plunged as much as 68% throughout the day Feb. 18 on news that the company was stopping a phase I trial of SEP-786 in healthy volunteers following two severe events of elevated unconjugated bilirubin in the highest dose cohort of the multiple ascending-dose portion of the study.
Corbus Pharmaceuticals Inc. has placed its chips on “bets where somebody else is ahead of us,” CEO Yuval Cohen said. “The idea is to have a de-risked asset” that proves better in the clinic. At the 2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium in San Francisco, Corbus offered data from the U.S. and U.K. first-in-human dose-escalation study – the Western trial – with Nectin-4-targeting antibody-drug conjugate (ADC) CRB-701 (SYS-6002).
Amid an overall positive earnings report of $3.2 billion in 2024 revenues, Moderna Inc. disclosed that the U.S. FDA placed its norovirus vaccine on a phase III clinical hold due to a single adverse event of Guillain-Barré syndrome (GBS).
Pliant Therapeutics Inc., which offered few details earlier this week when it voluntarily paused enrollment in the phase IIb Beacon-IPF trial testing bexotegrast in idiopathic pulmonary fibrosis (IPF), has taken an unusual step as it assembles a panel of outside experts to review unblinded data from the study with the goal of providing an independent recommendation.
While first-generation glucagon-like peptide-1 receptor agonists have clearly taken the obesity market by storm, generating billions of dollars for Novo Nordisk A/S and Eli Lilly and Co., several other companies are developing follow-on products that could clean up the tolerability and adherence issues of Wegovy (semaglutide) and Zepbound (tirzepatide).
The closely watched chronic spontaneous urticaria (CSU, or hives) space chalked more early stage KIT inhibitor data as Third Harmonic Bio Inc. rolled out results from the phase I single and multiple ascending-dose trial with THB-335 in healthy volunteers, along with plans to move the oral candidate into phase II development by the middle of 2025.
4D Molecular Therapeutics Inc.’s gene therapy, 4D-150, in wet age-related macular degeneration (wet AMD) produced positive phase IIb data as the company preps two phase III studies set to begin this year.
A mysterious turn in the phase IIb story with idiopathic pulmonary fibrosis (IPF) candidate bexotegrast sent shares of Pliant Therapeutics Inc. (NASDAQ:PLRX) down 60.6%, or $4.72, to close Feb. 10 at $3.07.
A large-scale study cross-referencing genomic data from multiple sources with primary care health records has identified genetic overlaps in 72 chronic diseases, opening the way for a more holistic approach to researching, treating and preventing multimorbidity.
RSS
