Cogent Biosciences reported Phase III success for bezuclastinib in imatinib‑resistant gastrointestinal stromal tumors, showing a 50% reduction in risk of progression or death versus sunitinib and driving a strong stock rally. The company said the data support an NDA submission in the first half of 2026 and signaled parallel filings based on additional datasets for systemic mastocytosis. Company briefings and coverage highlighted the magnitude of the efficacy signal and the program’s potential to establish bezuclastinib as a new standard in select KIT‑mutant indications. Cogent characterized the readouts as two wins that de‑risk regulatory pathways and commercial positioning. Analysts and investors focused on manufacturing scale, label breadth and payer positioning ahead of the planned regulatory filings.