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C4 Therapeutics (CCCC) FDA Events

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FDA Events for C4 Therapeutics (CCCC)

This section highlights FDA-related milestones and regulatory updates for drugs developed by C4 Therapeutics (CCCC). Over the past two years, C4 Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as cemsidomide, CFT1946, and CFT8919. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

C4 Therapeutics' Drugs in FDA Review

cemsidomide - FDA Regulatory Timeline and Events

cemsidomide is a drug developed by C4 Therapeutics for the following indication: IKZF1/3 Degrader. 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.

CFT1946 - FDA Regulatory Timeline and Events

CFT1946 is a drug developed by C4 Therapeutics for the following indication: A novel BiDAC™ degrader in mutant BRAF V600 solid tumors. 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.

CFT8919 - FDA Regulatory Timeline and Events

CFT8919 is a drug developed by C4 Therapeutics for the following indication: Designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC) patients. 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.

C4 Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, C4 Therapeutics (CCCC) has reported FDA regulatory activity for the following drugs: CFT1946, cemsidomide and CFT8919.

The most recent FDA-related event for C4 Therapeutics occurred on February 27, 2025, involving CFT1946. The update was categorized as "Provided Update," with the company reporting: "C4 Therapeutics, Inc. provided Recent Business Highlights"

Current therapies from C4 Therapeutics in review with the FDA target conditions such as:

  • A novel BiDAC™ degrader in mutant BRAF V600 solid tumors - CFT1946
  • IKZF1/3 Degrader - cemsidomide
  • Designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC) patients. - CFT8919

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:CCCC) was last updated on 7/10/2025 by MarketBeat.com Staff
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