# Bezuclastinib + sunitinib PDUFA Event: Gastrointestinal stromal tumors after prior imatinib

Canonical URL: https://biopharmsignal.com/pdufa-calendar/COGT/bezuclastinib-sunitinib-gist-after-imatinib

Ticker: COGT

Company: Cogent Biosciences

Event date: 2026-11-30

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned a November 30, 2026 PDUFA target action date to the bezuclastinib combination NDA.

## Event Timeline

### November 30, 2026 — FDA decision expected

FDA assigned a November 30, 2026 PDUFA target action date to the bezuclastinib combination NDA.

[Cogent — NDA acceptance and PDUFA date](https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-announces-fda-acceptance-new-drug-0)

### May 30, 2026 — Detailed Phase 3 PEAK results were presented

The combination achieved median progression-free survival of 16.5 months versus 9.2 months with sunitinib alone and an objective response rate of 46% versus 26%.

[Cogent — Detailed PEAK results at ASCO 2026](https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-announces-detailed-clinical-data-peak-phase-3)

### May 28, 2026 — FDA accepted the NDA with Priority Review

FDA accepted the application under review following the Phase 3 PEAK results and said it did not then plan an advisory committee meeting.

[Cogent — NDA acceptance and Priority Review](https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-announces-fda-acceptance-new-drug-0)

### January 26, 2026 — FDA granted Breakthrough Therapy designation

FDA granted Breakthrough Therapy designation for bezuclastinib plus sunitinib in GIST after prior imatinib.

[Cogent — Breakthrough Therapy designation](https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-announces-breakthrough-therapy-designation)

### November 10, 2025 — PEAK reported positive topline results

The Phase 3 study showed statistically significant improvements in progression-free survival and objective response rate versus sunitinib monotherapy.

[Cogent — Positive Phase 3 PEAK topline results](https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-reports-positive-results-bezuclastinib-peak)

### April 14, 2022 — Phase 3 PEAK study started

The randomized pivotal trial began evaluating bezuclastinib plus sunitinib versus sunitinib alone in patients with gastrointestinal stromal tumors after prior imatinib.

[ClinicalTrials.gov — PEAK study record (NCT05208047)](https://clinicaltrials.gov/study/NCT05208047)

## Regulatory Designations

- Priority Review FDA: [Cogent — NDA acceptance and Priority Review](https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-announces-fda-acceptance-new-drug-0)

- Breakthrough Therapy FDA: [Cogent — Breakthrough Therapy designation](https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-announces-breakthrough-therapy-designation)

## Related Pages

- COGT PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/COGT.md

- COGT company profile: https://biopharmsignal.com/company/COGT.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-08-10 — Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2026 Financial Results: https://biopharmsignal.com/news/COGT/cogent-biosciences-reports-recent-business-highlights-and-second-quarter-2026-fi-3bc3208d.md

- 2026-06-30 — Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM): https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-submission-of-new-drug-application-nda-for-bezuclas-2951df92.md

- 2026-06-12 — Cogent Biosciences Announces Preclinical Data from Novel JAK2 V617F Inhibitor at the 2026 European Hematology Association (EHA) Congress: https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-preclinical-data-from-novel-jak2-v617f-inhibitor-at-915c4be5.md

- 2026-06-12 — Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) Congress: https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-detailed-data-from-apex-pivotal-trial-of-bezuclasti-cffdc7b4.md

- 2026-05-30 — Cogent Biosciences Announces Detailed Clinical Data from PEAK Phase 3 Trial with Bezuclastinib in Combination with Sunitinib in Gastrointestinal Stromal Tumors (GIST) at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting: https://biopharmsignal.com/news/COGT/cogent-biosciences-announces-detailed-clinical-data-from-peak-phase-3-trial-with-bezuclastinib-in-combination-with-sunitinib-in-gastrointestinal-stromal-tumors-gist-at-2026-american-society-of-clinical-oncology-asco-annual-meeting.md