NEW YORK, Sept. 22, 2023 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Aldeyra Therapeutics, Inc. (NASDAQ:ALDX), RTX Corporation (NYSE:RTX), and Eos Energy Enterprises (NASDAQ:EOSE). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX)
Class Period: March 17, 2022 – June 20, 2023
Lead Plaintiff Deadline: September 29, 2023
Aldeyra, a biotechnology company, develops and commercializes medicnes 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 ...