Cogent Biosciences announced pivotal phase 3 results for bezuclastinib in imatinib-resistant gastrointestinal stromal tumors, meeting the primary endpoint with a 50% reduction in risk of progression or death, and setting the company up for an NDA submission in the first half of 2026. The outcome also supports a second planned NDA for non-advanced systemic mastocytosis based on prior data. The trials’ success triggered a strong market reaction and accelerated regulatory planning; Cogent said it will prepare filings with FDA based on these registrational data. Clinical investigators and trial sponsors noted the result strengthens targeted KIT inhibition as a therapeutic strategy in refractory GIST and may change standard-of-care sequencing. Cogent plans to leverage the GIST outcome for global regulatory engagements and payer discussions ahead of its expected submissions.