Aldeyra Therapeutics, Inc.

Case Overview
Status: | Status: Investigating |
Company Name: | Company Name: Aldeyra Therapeutics, Inc. |
Ticker: | Ticker: ALDX |
Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
Related Practices: | Related Practices: Securities |
The law firm of Kirby McInerney LLP is investigating potential claims against Aldeyra Therapeutics, Inc. (“Aldeyra” or the “Company”) (NASDAQ:ALDX). The investigation concerns whether Aldeyra and/or certain of its officers have violated the federal securities laws and/or engaged in other unlawful business practices.
On April 3, 2025, Aldeyra Therapeutics issued a press release stating that the FDA issued a Complete Response Letter for the New Drug Application (“NDA”) for reproxalap, the Company’s lead drug candidate. The FDA stated that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes.” The FDA identified concerns with the trail data submitted with the NDA, which the FDA stated may be related to methodological issues, including a difference in baseline scores across treatment arms. On this news, the price of Aldeyra shares declined by $3.90 per share, or approximately 73%, from $5.32 per share on April 2, 2025, to close at $1.42 on April 3, 2025.
On April 3, 2025, Aldeyra Therapeutics issued a press release stating that the FDA issued a Complete Response Letter for the New Drug Application (“NDA”) for reproxalap, the Company’s lead drug candidate. The FDA stated that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes.” The FDA identified concerns with the trail data submitted with the NDA, which the FDA stated may be related to methodological issues, including a difference in baseline scores across treatment arms. On this news, the price of Aldeyra shares declined by $3.90 per share, or approximately 73%, from $5.32 per share on April 2, 2025, to close at $1.42 on April 3, 2025.