Pharmaceutical and biotech news covering drug approvals, clinical trials, FDA decisions, and pharmaceutical industry developments.
Vera Therapeutics announced positive final Phase 3 trial data for Trutakna, stabilizing kidney function and reducing mortality risks in IgA nephropathy patients. The stock rose Tuesday on the news as the company competes with rivals developing injectable treatments for kidney disease.
Johnson & Johnson reported its experimental treatment PIPE-307 missed its primary endpoint in the phase 2 MOONLIGHT-1 trial for major depressive disorder. This marks the second mid-stage setback for the molecule. Contineum Therapeutics shares fell 10% as the company shifts focus to its lung-disease program, PIPE-791.
GlaxoSmithKline agreed to acquire full global rights to Chimagen Biosciences' trispecific T-cell engager program targeting multiple myeloma for up to $750 million. The therapy aims fewer side effects than existing treatments and is expected to enter human trials in 2027, deepening the companies' prior partnership.
Johnson & Johnson released Phase 2b COPERNICUS study data showing that less-frequent dosing with RYBREVANT FASPRO and LAZCLUZE may enhance treatment experiences. The results target patients with previously untreated advanced non-small cell lung cancer, highlighting potential improvements in therapeutic protocols.
Danish pharmaceutical giant Novo Nordisk is rebranding as 'Novo' with an updated logo to strengthen its identity in the obesity-drug market. CEO Mike Doustdar will reveal his strategy at an upcoming investor day, emphasizing customer focus and competitiveness against rival Eli Lilly while maintaining the legal name Novo Nordisk A/S.
Corbus Pharmaceuticals shared positive results from a Phase 1b trial of its oral obesity drug CRB-913, which demonstrated statistically significant weight loss across 254 patients. The drug showed minimal brain penetration to reduce psychiatric risks, with no serious treatment-related adverse events recorded, paving the way for a Phase 2 monotherapy study in early 2027.
Moderna and Merck announced that their Phase 3 trial for intismeran autogene, an AI-built personalized cancer therapy, met its primary endpoint in melanoma patients. This marks the first positive Phase 3 outcome for individually constructed treatments, though manufacturing timelines of four to eight weeks remain a scaling constraint.
The Food and Drug Administration has opened applications for a new pilot program designed to reduce the time required for drugmakers to begin human testing. This initiative, part of the Department of Health and Human Services' Operation TrialBlazer, seeks to accelerate US biotech competitiveness against international rivals.
Lobe Sciences presents Phase 1a data for L-130, a low-dose psilocin derivative, arguing it enables daily outpatient use without hallucinogenic effects. The company contends its patented formulation offers consistent oral bioavailability, potentially transforming psychedelic therapeutics from supervised clinic visits to routine treatment.
Viking Therapeutics has moved its GLP-1/GIP dual agonist VK2735 into Phase 3 development following promising Phase 2 results showing 14.7% weight loss. Two injectable trials are enrolled, with data due in late 2027, while an oral formulation trial begins this quarter.