Breakthrough Trials, FDA Greenlights & Global Health Alerts: Biotech & Health News (Aug 10–11, 2025)
Novartis announced that two Phase III trials, NEPTUNUS-1 and NEPTUNUS-2, met their primary endpoints in Sjögren’s disease, marking the first global Phase III evidence of significant disease activity reduction with ianalumab and its dual B-cell depletion and BAFF signaling blockade. IO Biotech will disclose topline results from its Phase III melanoma trial of Cylembio (IO102-IO103) in combination with Merck’s Keytruda (pembrolizumab) as a first-line therapy, with an August 11 webcast planned and the therapy having earned Breakthrough Therapy designation. GSK’s gepotidacin received Priority Review from the U.S. FDA for uncomplicated gonorrhea, with a decision expected by December and the potential
