Checkpoint Therapeutics faced a significant setback on Monday as the US Food and Drug Administration (FDA) declined approval for its experimental therapy designed to treat cutaneous squamous cell carcinoma, a prevalent form of skin cancer. The regulatory decision came in the aftermath of an inspection at a contract manufacturer, prompting a sharp decline of nearly 50% in the company’s shares.
In premarket trade, shares of the Waltham, Massachusetts-based biopharmaceutical company plummeted by 47.3%, settling at $1.7. This downturn positioned Checkpoint Therapeutics among the worst-performing stocks across various U.S. stock exchanges.
At the time of this publication, Checkpoint Therapeutics Inc stock (CKPT) has witnessed a decline.
Checkpoint Therapeutics Inc
Current Price: $1.50
Change : -1.82
Change (%): (-54.82%)
Volume: 3.0M
Source: Tomorrow Events Market Data
Checkpoint had submitted a marketing application earlier this year for its lead therapy in development, cosibelimab. Despite the setback, the company disclosed that the FDA’s complete response letter did not express any concerns regarding the safety or data associated with the experimental therapy.
CEO James Oliviero remained optimistic about the future, stating in a released statement, “We believe we can address the feedback in a resubmission to enable marketing approval in 2024.” This suggests that Checkpoint Therapeutics is committed to refining its application based on the feedback by FDA in pursuit of eventual approval.
Cosibelimab is aimed at treating cutaneous squamous cell carcinoma, the second most common type of skin cancer in the United States, with an estimated 1 million cases reported annually. The therapy, according to trial data, demonstrated a significant reduction or clearance of cancerous tumors by 47.4%.
Despite the setback, Checkpoint Therapeutics stressed that the FDA’s response did not raise any issues regarding the efficacy or safety of the experimental treatment. This leaves the door open for the company to address the concerns raised during the inspection and work towards securing approval for cosibelimab.
Highlighting the urgency of the matter, the company noted that approximately 40,000 cases of cutaneous squamous cell carcinoma progress to an advanced stage, with an estimated 15,000 individuals succumbing to the disease annually. The urgency to bring effective therapies to market is underscored by the significant impact of the disease on public health.
Investors will be closely watching Checkpoint Therapeutics’ next steps, particularly its response to the feedback by FDA and the timeline for a potential resubmission. The fate of cosibelimab’s approval hinges on the company’s ability to address regulatory concerns effectively and navigate the complex landscape of drug development and regulatory approval.
