Aldeyra Therapeutics, Inc.

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There is no cost or obligation associated with submitting your information. If you are a shareholder who suffered a loss, please submit your contact information and purchase information to participate in the putative class action.

We also encourage you to contact Lesley F. Portnoy of The Portnoy Law Firm, at 310.692.8883, to discuss your rights free of charge. You can also reach us through the firm’s website at www.portnoylaw.com, or by email at info@portnoylaw.com.

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CONTACT:
Portnoy Law Firm
Lesley F. Portnoy, Esq.,
www.portnoylaw.com
Office: 310.692.8883
1800 Century Park East, Suite 600
Los Angeles, CA 90067
info@portnoylaw.com

On June 21, 2023, Aldeyra made public that it had received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) in relation to its New Drug Application (NDA) for ADX-2191, a treatment for vitreoretinal lymphoma. The Company disclosed that the FDA pointed out a “lack of substantial evidence of effectiveness” due to insufficient and well-controlled investigations in the literature-based NDA submission, even though no safety or manufacturing issues were found with ADX-2191.

In response to this announcement, Aldeyra’s stock price experienced a sharp decline of $2.92, equivalent to a 27.4% drop, ultimately closing at $7.72 per share on June 21, 2023, thereby causing financial harm to investors.

The class action lawsuit contends that over the specified Class Period, the Defendants disseminated information that was either materially false or misleading, and they also neglected to reveal significant negative aspects concerning the Company’s operations, business, and future prospects. More specifically, the Defendants failed to inform investors that: (1) the NDA for ADX-2191 lacked sufficient and well-controlled investigations, thus failing to provide substantial evidence of its effectiveness; (2) consequently, the FDA was unlikely to approve the current form of the ADX-2191 NDA; (3) this overstatement led to an exaggeration of ADX-2191’s potential in both clinical and commercial aspects; and (4) as a result, the optimistic statements made by the Defendants about the Company’s business, operations, and future prospects were substantially deceptive and lacked reasonable grounding throughout the relevant time frame.