Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
FEATURED STORIES
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Janssen Pharmaceutical announced data on Monday from two Ulcerative colitis (UC) trials: the UNIFI trial studying Stelara and the VEGA trial studying guselkumab and golimumab.
Top-line data from the Phase III STELLAR trial revealed that Merck’s activin receptor candidate sotatercept reached its primary endpoint in pulmonary arterial hypertension.
The FDA had a fairly quiet week, approving drugs, providing clearance, greenlighting clinical trials, and other regulatory activities for Alnylam, Eli Lilly, Cytokinetics, and more.
Allogene Therapeutics is launching what it calls the first pivotal Phase II trial of an allogeneic CAR T product in the industry. The ALPHA2 trial will evaluate ALLO-501A in LBCL.
Evommune’s novel human tissue-based assay system is proving to be a key differentiator as the company develops therapies to control chronic inflammation in autoimmune diseases.
Eli Lilly gained ground in the obesity market Thursday as the FDA granted Fast Track designation to Mounjaro (tirzepatide), an investigational drug for adults with obesity.
After an earlier stumble this year with its investigational major depressive disorder therapeutic, Eliem Therapeutics appears to be back on track with a planned Phase II study of ETX-155.
TauRx announced preliminary results from the Phase III study, showing HMTM, its potent inhibitor of tau aggregates, could slow Alzheimer’s disease progression or cognitive decline.
Provention Bio entered a co-promotion agreement with Sanofi ahead of the possible November approval of teplizumab. If approved, the drug would be the first approved to modify T1D.
Adocia, Allecra Therapeutics and Aldeyra Therapeutics announced promising results in Type I Diabetes, urinary tract infections and retinal diseases.