SAN DIEGO, Aug. 04, 2023 (GLOBE NEWSWIRE) —

Robbins LLP reminds investors that a shareholder filed a class action on behalf of investors who purchased or otherwise acquired Aldeyra ALDX securities between March 17, 2022 and June 20, 2023. Aldeyra, a biotechnology company, develops and commercializes medicines for immune-mediated diseases. The Company is currently developing ADX-2191, a dihydrofolate reductase inhibitor for the treatment of primary vitreoretinal lymphoma cancer, proliferative vitreoretinopathy, and retinitis pigmentosa, as well as rare retinal diseases characterized by inflammation and vision loss.

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What is this Case About: Aldeyra Therapeutics, Inc. (ALDX) Misled Investors Regarding the Viability and Efficacy of its Drug Candidate

According to the complaint, during the class period, defendants made false and/or misleading statements and/or failed to disclose that: (i) the ADX-2191 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 prospects.

On June 21, 2023, Aldeyra announced “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 Company 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, Aldeyra’s stock price fell $2.92 per share, or…