Checkpoint Therapeutics Says FDA Accepted For Review Its Resubmission Of Its Biologics License Application For Cosibelimab

7/25/24 7:33:16 AM ET

Biotechnology: Pharmaceutical Preparations

Health Care

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Cosibelimab is its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation.

The resubmission has been accepted as a complete response to the FDA's December 2023 complete response letter ("CRL") and the FDA has set a Prescription Drug User Fee Act ("PDUFA") goal date of December 28, 2024.

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Date	Price Target	Rating	Analyst
7/14/2022	$7.00	Buy	B. Riley Securities
1/25/2022	$17.00 → $26.00	Buy	HC Wainwright & Co.

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Fortress Biotech Reports Third Quarter 2024 Financial Results and Recent Corporate Highlights
Emrosi approved by FDA on November 4 for the treatment of inflammatory lesions of rosacea in adults Cosibelimab PDUFA goal date of December 28 for potential approval to treat metastatic or locally advanced cutaneous squamous cell carcinoma MIAMI, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ:FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2024. Lindsay A. Rosenwald, M.D., Fortress' Chairman,
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Checkpoint Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Updates
Biologics License Application for cosibelimab under review by U.S. FDA PDUFA goal date of December 28, 2024 WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the third quarter ended September 30, 2024, and recent corporate updates. "With the Prescription Drug User Fee Act ("PDUFA") goal date set for next month, we await the decision by the U.S. Food and Drug Administration ("FDA") on our Biologics License Application ("BLA") resubmission for cosibelimab, our anti-programmed death ligand-1 ("PD-L1") antibody," said James Oliviero
11/12/24 4:30:33 PM ET
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Checkpoint Therapeutics Announces Cosibelimab Longer-Term Results in Advanced Cutaneous Squamous Cell Carcinoma Presented at ESMO Congress 2024
WALTHAM, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the presentation of longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma ("cSCC") during the European Society for Medical Oncology ("ESMO") Congress 2024, which is taking place in Barcelona, Spain, from September 13 to 17, 2024. Poster Presentation Title: Cosibelimab in Advanced Cutaneous Squamous Cell Carcinoma (CSCC): Longer-term Efficacy and Safety Results from Pivotal Study
9/16/24 7:30:48 AM ET
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Checkpoint Therapeutics Says FDA Accepted For Review Its Resubmission Of Its Biologics License Application For Cosibelimab

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