WALTHAM, Mass. - Checkpoint Therapeutics , Inc. (NASDAQ: NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced a strategic alignment with the U.S. Food and Drug Administration (FDA) regarding its biologics license application (BLA) for cosibelimab.
The company is set to resubmit its BLA mid-year, seeking U.S. marketing approval for the drug as a treatment for patients with advanced cutaneous squamous cell carcinoma (cSCC) who are ineligible for curative surgery or radiation.
President and CEO James F. Oliviero expressed optimism about the FDA's agreement on the resubmission strategy to address all deficiencies identified in the complete response letter (CRL) received in December 2023. The CRL had pointed out issues during an inspection of a third-party contract manufacturing organization (CMO) but did not raise concerns about cosibelimab's clinical data, safety, or labeling.
Checkpoint Therapeutics, founded by Fortress Biotech, Inc. (NASDAQ: NASDAQ:FBIO), focuses on developing novel treatments for patients with solid tumor cancers. Cosibelimab, an anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, is being evaluated for its potential as a new therapy for various recurrent or metastatic cancers, including cSCC. Another product candidate, olafertinib, is under evaluation as a potential treatment for non-small cell lung cancer with EGFR mutations.
The company did not specify the exact date for the BLA resubmission but indicated its intent for a mid-year timeline. The CRL issues solely related to the third-party CMO's compliance, not the drug's clinical performance, which remains unchallenged by the FDA based on the current data.
Checkpoint's forward-looking statements involve risks and uncertainties, including the possibility that the third-party CMO may not pass regulatory inspections or meet regulatory standards. Moreover, the company acknowledges the need for substantial additional funding and the inherent risks in research and development.
This announcement is based on a press release statement from Checkpoint Therapeutics, Inc. Investors are advised that the company's statements are subject to various risks, including the potential impact of the COVID-19 pandemic and geopolitical events such as the Russia/Ukraine conflict.
InvestingPro Insights
Checkpoint Therapeutics has been navigating a critical period as it works towards FDA approval for its promising drug, cosibelimab. As investors consider the company's future, certain financial metrics and expert observations can provide a more comprehensive view of Checkpoint's market position and potential challenges.
InvestingPro Data shows a market capitalization of $66.33 million USD for Checkpoint, reflecting the company's current valuation in the market. However, the financial health of the company is under scrutiny, with a negative P/E Ratio of -1.23, indicating that the company is not currently profitable. Moreover, the revenue for the last twelve months as of Q1 2024 stands at a mere $0.07 million USD, coupled with a significant decline in revenue growth at -61.14%.
InvestingPro Tips highlight critical aspects of Checkpoint's situation. The company holds more cash than debt on its balance sheet, which can be a positive sign of financial stability. Yet, it is important to note that Checkpoint has taken a substantial hit over the last week, with a 1-week price total return of -11.33%. The company does not pay dividends, which may influence the investment decisions of those seeking regular income from their stock holdings.
For investors seeking deeper analysis and more InvestingPro Tips, there are 7 additional insights available for Checkpoint Therapeutics. These insights can be accessed through InvestingPro's platform, and by using the coupon code PRONEWS24, new subscribers can receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
Investors should consider these financial metrics and expert observations from InvestingPro when evaluating Checkpoint Therapeutics, especially in light of the company's strategic alignment with the FDA and the potential market impact of its drug candidates.
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