Bezuclastinib + sunitinib

Note: Cogent IR release dated 2026-05-28: 'the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026. In addition, the FDA communicated that at this time, there is no plan to hold an advisory committee, nor have they identified any potential review issues.' Reviewed under Real-Time Oncology Review (RTOR); previously granted Breakthrough Therapy Designation in GIST. Basis = Phase 3 PEAK: median PFS 16.5 vs 9.2 months (HR 0.50, 95% CI 0.39-0.65, p<0.0001) vs sunitinib alone. DISAMBIGUATION - Cogent has TWO bezuclastinib NDAs pending and only this one is November: the NonAdvanced Systemic Mastocytosis (NonAdvSM) NDA carries a PDUFA of DECEMBER 30, 2026 per Cogent's 8-K Exhibit 99.1 filed 2026-05-05 (https://www.sec.gov/Archives/edgar/data/0001622229/000119312526205124/cogt-ex99_1.htm). A third NDA (APEX, AdvSM) was guided for 1H 2026 submission. Do not merge these. This Nov 30 date collides with Vertex povetacicept and Genentech giredestrant - three different companies, not duplicates.