Phase III

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.
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.
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.
TrialSpark and Sanofi announced a new partnership to expedite drug development for areas with high unmet needs by licensing or acquiring six mid-to-late-stage drug candidates.
Early data from the Phase III TALAPRO-2 study showed Talzenna, Pfizer’s oral PARP inhibitor, met its primary endpoint in metastatic castration-resistant prostate cancer patients.
PRESS RELEASES