Aldeyra Therapeutics, Inc. (ALDX)
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Aldeyra Therapeutics, Inc. (“Aldeyra” or “the Company”) (NASDAQ: ALDX). Investors who purchased Aldeyra securities are encouraged to obtain additional information and assist the investigation.
The investigation concerns whether Aldeyra has violated federal securities laws.
Investigation Details
On April 3, 2025, Aldeyra issued a press release “announc[ing] receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease.” The press release specified that “[a]lthough no manufacturing or safety issues with reproxalap were identified, the FDA stated in the letter that the NDA ‘failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes’ and that ‘at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye’ should be conducted.” The press release further stated that “[t]he letter identified concerns with the data from the trial submitted to the NDA that may have affected interpretation of the results, which the FDA stated may be related to methodological issues, including a difference in baseline scores across treatment arms.” On this news, Aldeyra’s stock price fell sharply during intraday trading on April 3, 2025.
What’s Next?
If you are aware of any facts relating to this investigation or purchased Aldeyra securities, you can assist this investigation. You can also contact Peretz Bronstein or his client relations manager, Nathan Miller, of Bronstein, Gewirtz & Grossman, LLC: 332-239-2660
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Contact
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Nathan Miller
332-239-2660 | [email protected]