Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, reminds investors that a class action lawsuit has been filed against Aldeyra Therapeutics, Inc. (“Aldeyra” or the “Company”) (NASDAQ: ALDX) in the United States District Court for the District of Massachusetts on behalf of all persons and entities who purchased or otherwise acquired Aldeyra securities between March 17, 2022 and June 20, 2023, both dates inclusive (the “Class Period”). Investors have until September 29, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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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 pimentosa, as well as rare retinal diseases characterized by inflammation and vision loss.
In December 2022, Aldeyra submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma (the “ADX-2191 NDA”).
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 state 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 his news, Aldeyra’s stock price fell $2.92 per share, or 27.44%, to close at $7.72 per share on June 21, 2023.
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, 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; (iii) accordingly, the company had overstated ADX-2191’s clinical and/or commercial prospects; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
If you purchased or otherwise acquired Aldeyra shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Marion Passmore by email at email@example.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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