Checkpoint Therapeutics (CKPT) Cosibelimab FDA Rejection Case

S.D. New York

Court

1:24-cv-02613

Case number

03/10/2021

Class period Start

12/15/2023

Class period End

06/04/2024

Lead Plaintiff motion deadline

$CKPT stockholder filed a claim vs. Checkpoint for downplaying its regulatory setbacks. 
On December 18, 2023, news about the FDA rejection caused $CKPT to fall 44.8%, losing $34M+ in shareholder value. 
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 delaying FDA approval of a treatment for an indeterminate period, which led to their losses.

The first investor has filed the initial claim over this situation in S.D. New York court to recover thier losses.

Details: https://11thestate.com/cases/checkpoint-therapeutics-investor-case

Case Status

Motion to dismiss

Alleged Offence

Misleading Statements,

Failure to Disclose,

Omissions

Suspected Party

Directors,

Management

Security Type

Stocks

Trade Direction

Long

Shock Event Date

12/18/2023

Filing date

04/05/2024

Lead Plaintiff Deadline

06/04/2024

Judge

Paul A. Engelmayer

Checkpoint Therapeutics (CKPT) Cosibelimab FDA Rejection Case

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