A lawsuit was filed on behalf of investors in Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 08/17/2023 -- An investor, who purchased shares of Aldeyra Therapeutics, Inc. (NASDAQ: ALDX), filed a lawsuit over alleged violations of Federal Securities Laws by Aldeyra Therapeutics, Inc.
Investors who purchased shares of Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) have certain options and for certain investors are short and strict deadlines running. Deadline: September 29, 2023. NASDAQ: ALDX investors should contact the Shareholders Foundation at firstname.lastname@example.org or call +1(858) 779 - 1554.
Lexington, MA based Aldeyra Therapeutics, Inc., a biotechnology company, develops and commercializes medicines for immune-mediated diseases.
In December 2022, Aldeyra Therapeutics, Inc. 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 Therapeutics, Inc. 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."
Shares of Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) declined from $11.94 per share on June 09, 2023, to as low as $5.47 per share on June 21, 2023.
The plaintiff claims that between March 17, 2022 and June 20, 2023, the Defendants made false and/or misleading statements and/or failed to disclose that the ADX-2191 NDA did not include adequate and well-controlled investigations and thus failed to show substantial evidence of ADX-2191's effectiveness, that as a result, the FDA was unlikely to approve the ADX-2191 NDA in its current form, that accordingly, the Company had overstated ADX-2191's clinical and/or commercial prospects, and that as a result, the Company's public statements were materially false and misleading at all relevant times.
Those who purchased shares of Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) have certain options and should contact the Shareholders Foundation.
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