Checkpoint Therapeutics Earnings Reports

Checkpoint Therapeutics reported financial results for the third quarter ended September 30, 2024. The company awaits the FDA decision on its BLA resubmission for cosibelimab with a PDUFA goal date set for next month. $9.2 million in cash proceeds received from the exercise of existing warrants has strengthened the balance sheet to extend beyond the PDUFA date and into 2025.

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.

Checkpoint Therapeutics announced its Q1 2024 financial results, highlighting the progress with their CMO in addressing FDA's concerns regarding cosibelimab and plans for a potential BLA resubmission.

Checkpoint Therapeutics announced their full-year 2023 financial results, highlighting their ongoing efforts to address the CRL for cosibelimab and targeting a BLA resubmission by mid-year.

Checkpoint Therapeutics reported their Q3 2023 financial results, highlighting the ongoing FDA review of the BLA for cosibelimab with a PDUFA goal date of January 3, 2024, and the recent publication of cosibelimab pivotal trial results in the Journal for ImmunoTherapy of Cancer.

Checkpoint Therapeutics reported its Q2 2023 financial results, highlighting the ongoing FDA review of the cosibelimab BLA with a PDUFA goal date of January 3, 2024, and successful completion of a mid-cycle meeting with the FDA. Longer-term data from pivotal studies of cosibelimab in cSCC demonstrated substantially increased complete response rates and a continued favorable safety profile.

Checkpoint Therapeutics announced the FDA accepted the BLA filing for cosibelimab in March and is preparing for a potential commercial launch in 2024. The company is also progressing active discussions with third parties to evaluate potential partnerships and other corporate development transactions.

Checkpoint Therapeutics announced the FDA accepted the BLA filing for cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma with a PDUFA goal date of January 3, 2024. The initial indication for cosibelimab represents a potential $1.6 billion U.S. market opportunity.

Checkpoint Therapeutics reported its Q3 2022 financial results and highlighted the successful completion of pre-BLA meetings and the planned BLA submission for cosibelimab by January 2023.

Checkpoint Therapeutics announced positive interim results from the registration-enabling study of cosibelimab in locally advanced cutaneous squamous cell carcinoma and successful completion of pre-BLA meetings.

Checkpoint Therapeutics announced positive top-line results from the registration-enabling study of cosibelimab in metastatic cutaneous squamous cell carcinoma. The company is on track to submit the U.S. Biologics License Application for cosibelimab later this year and is evaluating partnership opportunities for commercialization in Europe and other key territories.

Checkpoint Therapeutics announced its full-year 2021 financial results, highlighting a transformational period with the foundation laid for value-enhancing catalysts in 2022, including a planned BLA submission for cosibelimab.

Checkpoint Therapeutics reported its Q3 2021 financial results, highlighting increased preparation activities for a potential Biologics License Application submission for cosibelimab next year. Substantial progress was made towards the near-term initiation of a Phase 3 registration-enabling trial for cosibelimab in first-line metastatic non-small cell lung cancer.

Checkpoint Therapeutics announced the completion of enrollment in the pivotal cohort of patients with metastatic cutaneous squamous cell carcinoma in the registration-enabling clinical trial for cosibelimab, with top-line data expected in the fourth quarter of this year.

Checkpoint Therapeutics reported its Q1 2021 financial results, highlighting the advancement of its lead drug candidates and an enhanced cash position. Enrollment in the registration-enabling study for cosibelimab in mCSCC is nearly complete, with top-line results expected by year-end. Neupharma Inc. is continuing enrollment in a Phase 3 study for olafertinib (CK-101) in NSCLC.

Checkpoint Therapeutics announced its full-year 2020 financial results, highlighting the progress of cosibelimab in metastatic cutaneous squamous cell carcinoma (mCSCC) and positive interim data from its Phase 1 program. The company's registration-enabling study in mCSCC is approximately 90% enrolled, with full enrollment anticipated shortly, and top-line results expected in the second half of 2021.

Checkpoint Therapeutics announced its third quarter 2020 financial results, highlighting the presentation of updated positive interim results from the ongoing registration-enabling clinical trial of cosibelimab for the treatment of metastatic cutaneous squamous cell carcinoma at the ESMO Virtual Congress 2020 and the completion of a $20.5 million financing during the third quarter.

Checkpoint Therapeutics reported their Q2 2020 financial results, highlighting the progress of cosibelimab's registration-enabling study in metastatic cutaneous squamous cell carcinoma, which is over 50% enrolled and expected to be fully enrolled by year-end.

Checkpoint Therapeutics reported its financial results for the first quarter of 2020, highlighting the progress of cosibelimab and the issuance of a composition of matter patent.

Checkpoint Therapeutics reported its full-year 2019 financial results, highlighting the progress of cosibelimab's clinical trial and the confirmation from the FDA regarding the registration submission pathway in CSCC. The company also closed a $20 million financing to extend its cash runway.