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

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

21 June 2023

Filing date

31 July 2023

Lead Plaintiff Deadline

29 September 2023

Judge

Hon. Denise J. Casper

Aldeyra (ALDX) ADX-2191 Failed NDA Case

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