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Aldeyra Therapeutics, Inc.

Lead Plaintiff Deadline 09/29/2023
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of Massachusetts on behalf of those who acquired Aldeyra Therapeutics, Inc. (“Aldeyra” or the “Company”) (NASDAQ: ALDX) securities during the period from March 17, 2022 through June 20, 2023 (the “Class Period”). Investors have until September 29, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Aldeyra, a biotechnology company, develops and commercializes medicines for immune-mediated diseases.
On June 21, 2023, Aldeyra issued a press release “announc[ing] receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the 505(b)(2) New Drug Application (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 “[a]lthough 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, the price of Aldeyra shares declined by $2.92 per share, or approximately 27.44%, from $10.64 per share to close at $7.72 on June 21, 2023.
The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose that: (i) the ADX2191 NDA did not include adequate and well-controlled investigations and thus failed to show substantial evidence of ADX-2191’s effectiveness; (ii) as a result, the FDA was unlikely to approve the ADX-2191 NDA in its current form; and (iii) accordingly, the Company had overstated ADX-2191’s clinical and/or commercial prospect.

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