Cogent Biosciences reports Q2 2026 results, two bezuclastinib PDUFA dates ahead

Cogent Biosciences reported second quarter 2026 financial results on August 10, 2026, with two regulatory decisions on bezuclastinib approaching this year. The company said it is on track for potential approval of bezuclastinib for GIST patients (PDUFA November 30) and NonAdvSM patients (PDUFA December 30) later this year; AdvSM New Drug Application submitted to FDA on June 30¹.

On the GIST program, Cogent presented Phase 3 PEAK trial data at ASCO showing that as of the September 30, 2025 cutoff, the bezuclastinib combination with sunitinib reduced risk of disease progression or death by 50% versus sunitinib alone (hazard ratio 0.50, 95% CI 0.39-0.65), with median PFS of 16.5 months versus 9.2 months¹. The company also announced FDA acceptance of the NDA with priority review for bezuclastinib in combination with sunitinib in GIST patients who received prior imatinib treatment¹, and separately initiated a single-arm, 40-patient extension cohort of PEAK in first-line GIST patients with KIT exon 9 mutations who have received limited or no imatinib¹.

In systemic mastocytosis, APEX trial data presented at EHA showed among 81 AdvSM patients treated with 150 mg bezuclastinib as of March 31, 2026, the primary endpoint response rate was 65% ORR among 68 evaluable patients, with 57% achieving CR, CRh or PR¹. Cogent also completed enrollment in the "avapritinib switch" SUMMIT extension trial, with preliminary results expected by end of 2026¹.

On finances, the company reported cash, cash equivalents and marketable securities of $792.3 million as of June 30, 2026¹, and said this, combined with $73.6 million in gross proceeds from its at-the-market facility after quarter end, is expected to fund operations into late 2028, including through potential approvals in GIST, NonAdvSM and AdvSM and early launch activities¹.