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
ALDX.US
id: 792

Aldeyra (ALDX) ADX-2191 Failed NDA Case

D. Massachusetts
Court
1:23-cv-11737
Case number
17 Mar 2022
Class period Start
20 Jun 2023
Class period End
29 Sept 2023
Lead Plaintiff motion deadline
  • FDA stated that there was a lack of effectiveness evidence in NDA for Aldeyra's ADX-2191.
  • $ALDX fell over 27%, losing $170 million of its market cap.
  • Investors suspect Aldeyra of failing to disclose that the ADX-2191 application did not include adequate investigations.
On June 21, 2023, Aldeyra (ALDX) announced receipt of a CRL from the FDA for the NDA of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL). The press release stated that “although no safety or manufacturing issues with ADX-2191 were identified, the FDA stated that there was a lack of substantial evidence of effectiveness due to a lack of adequate and well-controlled investigations’ in the literature-based NDA submission.

On this news, $ALDX fell over 27%, losing more than $170 million of its market capitalization.

Taking all representations into account, Investors have reasons to suspect Aldeyra and its Accountables of misleading and failing to disclose that the ADX-2191 application did not include adequate and well-controlled investigations and thus failed to show substantial evidence of ADX-2191's effectiveness.
Case Status
Lead Plaintiff Appointed
Alleged Offence
Misleading Statements
Failure to Disclose
Negligence
Omissions
Suspected Party
Directors
Management
Service Provider
Security Type
Stocks
Trade Direction
Long
Shock Event Date
21 June 2023
Filing date
31 July 2023
Lead Plaintiff Deadline
29 September 2023
Judge
Hon. Denise J. Casper
Collecting participants…

Aldeyra The

Aldeyra Therapeutics, Inc., a biotechnology company, develops and commercializes medicines for immune-mediated diseases. Its lead product candidate is reproxalap, a reactive aldehyde species (RASP)...

    Ticker
    ALDX.US
    ISIN
    US01438T1060
    CIK
    1341235
    Sector
    Healthcare
    Industry
    Biotechnology
    Country
    USA
    Address
    131 Hartwell Avenue, Lexington, MA, United States, 02421