Cogent reports Q3 2026 results, three bezuclastinib PDUFA dates ahead

Cogent Biosciences reported business updates and third quarter 2026 financial results on November 5, 2026. Chief Executive Officer Andrew Robbins said the company's commercial team is in place and prepared to execute on the anticipated launch of bezuclastinib in GIST.¹

The company has three pending regulatory decisions for bezuclastinib. The PDUFA date for GIST is November 30, 2026, for NonAdvSM it is December 30, 2026, and for AdvSM it is June 29, 2027.¹ Cogent also announced that the FDA has accepted the New Drug Application for bezuclastinib in Advanced Systemic Mastocytosis.¹

On the pipeline side, Cogent announced the initiation of a single-arm, 40 patient extension cohort of the PEAK trial studying bezuclastinib combined with sunitinib in first-line GIST patients, designed to prospectively measure ORR and PFS in patients with exon 9 or exon 11 primary mutations.¹ The company also plans to submit INDs for CGT1815, a pan-KRAS(ON) inhibitor, and CGT1145, a JAK2 V617F inhibitor, in the fourth quarter of 2026, and to complete dose escalation for CGT4255, a CNS-penetrant ErbB2 inhibitor.¹

Cogent plans to present additional bezuclastinib data at the American Society of Hematology meeting in New Orleans, December 12-15, 2026, including more detailed SUMMIT trial analyses on skin and neurocognitive symptoms, longer-term pathobiology follow-up, a symptom burden comparison in NonAdvSM patients versus the general population, and the first look at results from a SUMMIT sub-study on switching patients from avapritinib to bezuclastinib.¹

On finances, cash, cash equivalents and marketable securities were $791.1 million as of September 30, 2026, compared with $792.3 million as of June 30, 2026.¹ The company said this is expected to fund operations into late 2028, past all three pending PDUFA dates.¹ Net loss for the quarter was $111.4 million, compared with $80.9 million in the same period of 2025.¹