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ALDX.US
id: 792
Aldeyra (ALDX) ADX-2191 Failed NDA Case
D. Massachusetts
Court 1:23-cv-11737
Case number03/17/2022
Class period Start06/20/2023
Class period End09/29/2023
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
Motion to dismiss
Alleged Offence
Misleading Statements,
Failure to Disclose,
Negligence,
Omissions
Suspected Party
Directors,
Management,
Service Provider
Security Type
Stocks
Trade Direction
Long
Shock Event Date
06/21/2023
Filing date
07/31/2023
Lead Plaintiff Deadline
09/29/2023
Judge
Hon. Denise J. Casper