NEW YORK, NY - April 8, 2025 (NEWMEDIAWIRE) - Kaplan Fox & Kilsheimer LLP is investigating potential securities violations against Aldeyra Therapeutics, Inc. (“Aldeyra Therapeutics” or the “Company”) (NASDAQ: ADLX).
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If you are an Aldeyra Therapeutics investor and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing jcampisi@kaplanfox.com or by calling (212) 329-8571.
On April 3, 2025, before the market opened, Aldeyra Therapeutics disclosed that the FDA issued a second Complete Response Letter (“CRL”) for reproxalap, its lead dry eye disease drug candidate. According to the Company, the CRL stated that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes” and that the Company should conduct “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment for ocular symptoms of a dry eye.” The Company further stated that the CRL “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 treatments arms.” Todd C. Brady, the President and Chief Executive Officer of the Company stated that “[p]ending positive results from the ongoing clinical trials and discussions with the FDA, we look forward to a potential NDA resubmission mid-year 2025.”
Following this news, the price of Aldeyra Therapeutics stock fell $3.91 per share, or over 73%, to close at $1.42 per share on heavier than average trading volume.
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If you have any questions about this investigation, please contact:
CONTACT:
Jeffrey P. Campisi
KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(212) 329-8571
jcampisi@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
lking@kaplanfox.com
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https://www.kaplanfox.com/case/aldeyra-therapeutics-inc/
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