Cogent faces a run of three FDA rulings on bezuclastinib by mid-2027

Cogent Biosciences has put a calendar around the commercial prospects of its lead drug. Bezuclastinib, a KIT inhibitor, now has three US regulatory verdicts due between the end of November 2026 and late June 2027, the company disclosed with its third-quarter results on 5 November.

The first ruling is scheduled for 30 November 2026, in gastrointestinal stromal tumour (GIST). A second follows on 30 December 2026, for non-advanced systemic mastocytosis. The last, on 29 June 2027, covers advanced systemic mastocytosis, after the FDA accepted Cogent's new drug application in that setting.

The balance sheet for the quarter showed $791.1m in cash against a net loss of $111.4m. The filing does not set out how long that cash is expected to last, and the material available does not detail the data behind the three applications.

Cogent also said it intends to submit investigational new drug applications for its KRAS and JAK2 programmes in the fourth quarter of 2026. No further information on either programme was provided.

Context: a PDUFA date is the goal date set under the Prescription Drug User Fee Act by which the FDA aims to finish reviewing a marketing application. Outcomes are not guaranteed, and the agency can approve, reject or, in some cases, miss or extend its target.