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Cyclacel Pharmaceuticals (CYCCP) FDA Events

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FDA Events for Cyclacel Pharmaceuticals (CYCCP)

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

Cyclacel Pharmaceuticals' Drugs in FDA Review

DNAJ-PKAc - FDA Regulatory Timeline and Events

DNAJ-PKAc is a drug developed by Cyclacel Pharmaceuticals for the following indication: To treatment with plogosertib. 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.

Fadraciclib - FDA Regulatory Timeline and Events

Fadraciclib is a drug developed by Cyclacel Pharmaceuticals for the following indication: Advanced 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.

Cyclacel Pharmaceuticals FDA Events - Frequently Asked Questions

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

In the past two years, Cyclacel Pharmaceuticals (CYCCP) has reported FDA regulatory activity for the following drugs: DNAJ-PKAc and Fadraciclib.

The most recent FDA-related event for Cyclacel Pharmaceuticals occurred on July 7, 2025, involving DNAJ-PKAc. The update was categorized as "Highlights," with the company reporting: "Cyclacel Pharmaceuticals, Inc. highlighted a publication from independent investigators titled, "DNAJ-PKAc fusion heightens PLK1 inhibitor sensitivity in fibrolamellar carcinoma," published online in the journal Gut, a leading, peer-reviewed medical journal focused on gastroenterology and hepatology.1"

Current therapies from Cyclacel Pharmaceuticals in review with the FDA target conditions such as:

  • To treatment with plogosertib. - DNAJ-PKAc
  • Advanced Solid Tumors - Fadraciclib

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