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Checkpoint Therapeutics (CKPT) FDA Refusal to Issue Treatment License Case
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- On December 18, 2023, Checkpoint (CKPT) announced that the FDA has denied Company’s biologic license application for a new treatment.
- On it, $CKPT fell 44.88%, losing $34M+ of shareholder value.
- Investors may have grounds to suspect Checkpoint of regulatory setbacks, which led to their losses.
On December 18, 2023, Checkpoint issued a press release announcing that the FDA has issued a complete response letter (‘CRL’) for the biologic license application (‘BLA’) for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.
- The CRL only cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission.
- The Company’s President and CEO stated that “we believe we can address the feedback in a resubmission to enable marketing approval in 2024”.
On this news, $CKPT fell 44.88% and lost over $34 million of its market capitalization, seriously damaging shareholders.
Considering all the information, investors might have grounds to suspect Checkpoint of having regulatory problems delay FDA approval of a treatment for an indeterminate period, which led to their losses.
The case is already under investigation by at least one of the reputable law firms.
Failure to Disclose,
Shock Event Date
18 December 2023