Cogent Biosciences announced Phase 3 success for bezuclastinib in imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST), reporting a median progression-free survival of 16.5 months versus 9.2 months for sunitinib in the Peak study. The result met the trial’s primary endpoint and materially lowered the risk of progression or death. The company said it will pursue an NDA submission in the first half of 2026 and plans an NDA for non-advanced systemic mastocytosis before year-end. The Phase 3 readouts sent Cogent shares sharply higher; management framed the results as the cornerstone for two regulatory filings and broader commercialization planning.