Fortress' late-stage pipeline continues to advance and may generate up to three regulatory approvals on NDAs and BLAs in the next 12 months and potentially a fourth BLA filing as early as 2025 potential BLA resubmission, which is currently targeted for mid-year. Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc. (NASDAQ:CKPT) ("Checkpoint"). Based on its public statements, AstraZeneca plc has estimated that it expects the FDA to accept its BLA submission of CAEL-10 ...

CHECKPOINT THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☒ NO ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-acc ...

Checkpoint Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Updates · Checkpoint submitted a BLA to the FDA in January 2023 seeking approval of cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation, and the FDA accepted the BLA for filing in March 2023. In December 2023, the FDA issued a CRL for the cosibelimab BLA. The CRL only cited ...

WALTHAM, Mass., May 10, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the first quarter ended March 31, 2024, and recent corporate updates. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "Over the past few months, we have worked closely with our third-party contract manufacturing organization ("CMO") for cosibelimab to resolve their inspect ...

UNITED STATES Page CHECKPOINT THERAPEUTICS, INC. ANNUAL REPORT ON FORM 10-K TABLE OF CONTENTS | --- | --- | --- | |------------|------------------------------------------------------------------------------------------------------------|-------| | | | | | Item 5. | Equity Securities | 48 | | Item 6. | Reserved | 48 | | Item 7. | Management's Discussion and Analysis of Financial Condition and Results of Operations | 49 | | Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 55 | | Item 8. ...

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our ability to work with our third- ...

WALTHAM, Mass., March 22, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the full-year ended December 31, 2023, and recent corporate highlights. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We continue to work closely with our third-party contract manufacturing organization to expeditiously resolve the deficiencies noted in the complete r ...

WALTHAM, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the appointment of Amit Sharma, M.D., FACP, FASN, FNKF, to its Board as an independent, non-executive director, effective immediately. Dr. Sharma currently serves as Vice President of Clinical Development and Therapeutic Head for Nephrology and Hematology at Alexion, AstraZeneca Rare Disease, where he guides and executes ...

WALTHAM, Mass., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that it has entered into a definitive agreement with a single healthcare-dedicated institutional investor for the issuance and sale of an aggregate of 7,756,233 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.805 per share of common stock (or per common stock equivalent in ...

Table of Contents FORM 10-Q For the transition period from _________ to _________ Commission File Number 001-38128 Class of Common Stock Outstanding Shares as of November 10, 2023 Class A Common Stock, $0.0001 par value 700,000 Common Stock, $0.0001 par value 22,826,035 Table of Contents Risks Related to Reliance on Third Parties ● We rely, and will rely in the future, on third-party contract research organizations and contract manufacturers for the conduct of our preclinical and clinical studies and trials ...