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.
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.
- Drug:
- DNAJ-PKAc
- Announced Date:
- July 7, 2025
- Indication:
- To treatment with plogosertib.
Announcement
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
AI Summary
Cyclacel Pharmaceuticals recently highlighted an independent study titled "DNAJ-PKAc fusion heightens PLK1 inhibitor sensitivity in fibrolamellar carcinoma," published in Gut, a key medical journal in gastroenterology and hepatology. The study reveals that the DNAJ-PKAc fusion oncoprotein, which drives fibrolamellar carcinoma (FLC), causes cancer cells to become highly sensitive to PLK1 inhibitors like plogosertib. Researchers found that PLK1 is crucial for FLC cells, and its inhibition with plogosertib significantly reduced tumor growth in both in vitro and in vivo models, while sparing normal liver tissues. These promising preclinical results underscore the potential of plogosertib as a new treatment option for FLC—a rare liver cancer primarily affecting adolescents and young adults that currently lacks approved therapies.
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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.
- Drug:
- Fadraciclib
- Announced Date:
- September 25, 2024
- Indication:
- Advanced Solid Tumors
Announcement
Cyclacel Pharmaceuticals, Inc announced that enrollment of 12 patients has been completed as per protocol in Cohort 8 of its Phase 2 stage, proof of concept 065-101 study of fadraciclib ("fadra"), a CDK2/9 inhibitor, in patients with advanced solid tumors and lymphoma. Enrollment of Cohort 5 in patients with T-Cell Lymphoma is continuing.
AI Summary
Cyclacel Pharmaceuticals announced an important milestone in its Phase 2, proof-of-concept 065-101 study of fadraciclib (fadra), a CDK2/9 inhibitor targeting advanced solid tumors and lymphoma. The company has completed enrollment of 12 patients in Cohort 8, a group selected for specific CDKN2A and/or CDKN2B abnormalities. These genetic changes may make patients more likely to benefit from treatment, and this successful enrollment reflects the significant unmet need in this patient population.
In addition, Cyclacel is continuing enrollment in Cohort 5, which focuses on patients with T-cell lymphoma. The study uses an oral dosing schedule and has already shown promising signs including stable disease and tumor shrinkage in early cases. Updated safety and efficacy data are expected to be presented at an upcoming oncology medical conference, which may offer new insights into the drug’s potential benefits.
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