RegulatoryCompany release

Cogent Biosciences sets three FDA decision dates for bezuclastinib between November 2026 and June 2027

🇺🇸 Cogent Biosciences, Inc. (COGT) · Thu 05 Nov 2026

The KIT inhibitor faces FDA action dates in GIST, non-advanced and advanced systemic mastocytosis, as Cogent reports $791.1 million in cash for Q3 2026.

Cogent Biosciences reported third-quarter 2026 results on 5 November, alongside a regulatory timeline for its KIT inhibitor bezuclastinib that now includes three FDA decision dates over roughly seven months.

The agency's PDUFA action dates are 30 November 2026 for gastrointestinal stromal tumour (GIST) and 30 December 2026 for non-advanced systemic mastocytosis. The third, 29 June 2027, applies to advanced systemic mastocytosis and follows the FDA's acceptance of that new drug application.

On the financial side, the company reported $791.1 million in cash and a net loss of $111.4 million for the quarter.

Cogent also said it plans to file investigational new drug applications (INDs) for its KRAS and JAK2 programmes in the fourth quarter of 2026. The source material provided does not include further detail on those programmes or on the data supporting the bezuclastinib filings.

For context, a PDUFA date is the target date by which the FDA aims to complete its review of a marketing application under the Prescription Drug User Fee Act.

What it means for your team

  • Three bezuclastinib decision points fall between 30 November 2026 and 29 June 2027, giving a clear calendar for regulatory and launch-readiness planning.
  • Market-access teams tracking GIST and systemic mastocytosis may need to prepare for possible new KIT-inhibitor options across both indications, depending on FDA outcomes.
  • The planned IND filings for KRAS and JAK2 programmes in Q4 2026 point to pipeline expansion beyond bezuclastinib.

Company's press release (SEC filing): Cogent Biosciences, Inc. ↗

Article written by VigiEye from the official source (Cogent Biosciences, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Regulatory All →