Sign In
Step 1
Unite with Fellow Investors
Step 2
Choose the Best Attorney
Step 3
Provide Documents
Step 4
Follow Case Progress
Step 5
Get Payout
CKPT.US
id: 1076

Checkpoint Therapeutics (CKPT) Cosibelimab FDA Rejection Case

S.D. New York
Court
1:24-cv-02613
Case number
10 Mar 2021
Class period Start
15 Dec 2023
Class period End
04 Jun 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
Alleged Offence
Misleading Statements
Failure to Disclose
Omissions
Suspected Party
Directors
Management
Security Type
Stocks
Trade Direction
Long
Shock Event Date
18 December 2023
Filing date
05 April 2024
Lead Plaintiff Deadline
04 June 2024
Collecting participants…

Checkpoint Therapeutics Inc

Checkpoint Therapeutics, Inc., a clinical-stage immunotherapy and targeted oncology company, focuses on the acquisition, development, and commercialization of novel treatments for patients with sol...

    Ticker
    CKPT.US
    ISIN
    US1628281073
    CIK
    1651407
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    95 Sawyer Road, Waltham, MA, United States, 02453