Loading...
•
Jun 30, 2024
Checkpoint Therapeutics Q2 2024 Earnings Report
Checkpoint Therapeutics reported financial results for the second quarter ended June 30, 2024, and recent corporate updates.
Key Takeaways
Checkpoint Therapeutics announced that the FDA accepted the resubmitted Biologics License Application (BLA) for cosibelimab as a treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). The Prescription Drug User Fee Act (PDUFA) goal date is December 28, 2024.
Aligned with the FDA on the strategy to address deficiencies in the complete response letter (CRL) received last December.
Resubmitted the Biologics License Application (BLA), which was accepted by the FDA for review as a complete response to the CRL.
Looking forward to working with the FDA in advance of the Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.
Evaluating cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC).
Checkpoint Therapeutics
Checkpoint Therapeutics
Forward Guidance
Checkpoint Therapeutics is focused on obtaining approval for cosibelimab and developing novel treatments for solid tumor cancers.
Positive Outlook
- Potential approval of cosibelimab as a new treatment for metastatic or locally advanced cSCC.
- FDA acceptance of the resubmitted BLA for cosibelimab.
- Alignment with the FDA on the BLA resubmission strategy.
- Evaluation of olafertinib as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer.
- Focus on acquisition, development, and commercialization of novel treatments for solid tumor cancers.
Challenges Ahead
- Risks and uncertainties associated with the regulatory review process.
- Uncertainties regarding the timeline of FDA review of the resubmitted BLA.
- Potential inability to successfully work with the FDA to address concerns during the BLA review process.
- Dependence on third-party suppliers and contract manufacturing relationships.
- Risk of delays due to the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic.