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Cogent Biosciences (COGT) FDA Events

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FDA Events for Cogent Biosciences (COGT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Cogent Biosciences (COGT). Over the past two years, Cogent Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as bezuclastinib and Bezuclastinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Cogent Biosciences' Drugs in FDA Review

bezuclastinib - FDA Regulatory Timeline and Events

bezuclastinib is a drug developed by Cogent Biosciences for the following indication: In patients with non-advanced systemic mastocytosis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Bezuclastinib - FDA Regulatory Timeline and Events

Bezuclastinib is a drug developed by Cogent Biosciences for the following indication: Advanced Systemic Mastocytosis (AdvSM). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Cogent Biosciences FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Cogent Biosciences (COGT) has reported FDA regulatory activity for the following drugs: Bezuclastinib and bezuclastinib.

The most recent FDA-related event for Cogent Biosciences occurred on July 7, 2025, involving bezuclastinib. The update was categorized as "Top-line results," with the company reporting: "Cogent Biosciences, Inc. announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM) demonstrating clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden."

Current therapies from Cogent Biosciences in review with the FDA target conditions such as:

  • Advanced Systemic Mastocytosis (AdvSM) - Bezuclastinib
  • In patients with non-advanced systemic mastocytosis - bezuclastinib

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:COGT) was last updated on 7/10/2025 by MarketBeat.com Staff
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