NEW YORK, Feb. 09, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) on behalf of long-term stockholders following a class action complaint that was filed against Aldeyra on July 31, 2023 with a Class Period from March 17, 2022 to June 20, 2023. Our investigation concerns whether the board of directors of Aldeyra have breached their fiduciary duties to the company.
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 this 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 are a long-term stockholder of Aldeyra, 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 investigations@bespc.com, by telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
Contact Information:
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com
