Aldeyra Therapeutics, Inc. (NASDAQ: ALDX): Aldeyra Therapeutics is being investigated for violations of the federal securities laws in connection with potential false and misleading statements made to investors and a subsequent significant price decline in the stock.
 
If you incurred losses on your investments in Aldeyra Therapeutics, you are encouraged to submit your information.
 
Why is Aldeyra Therapeutics being Investigated?
 
Aldeyra Therapeutics is a biotechnology company focused on developing therapies designed to treat immune-mediated and metabolic diseases. The company’s lead drug candidate, reproxalap, is being developed for the treatment of dry eye disease.

During the relevant period, Aldeyra Therapeutics announced the success of its Phase III dry eye chamber clinical trial for reproxalap. The company stated that the trial’s results were “uniquely supportive” of reproxalap’s effect on reducing ocular discomfort and that reproxalap was the first investigational drug with “pivotal data” to support reducing redness. What’s more, the company stated that the trial “satisfies FDA requirements” for New Drug Application resubmission. On this news, Aldeyra Therapeutics stock price increased 56% over two consecutive trading days, to close at $5.10 per share on August 9, 2024.

In truth, Aldeyra Therapeutics’ Phase III trial failed to demonstrate reproxalap’s efficacy in treating ocular symptoms associated with dry eyes. The Phase III trial data suffered from potential methodological issues, including a difference in baseline scores across treatment arms, that did not satisfy the FDA requirements for NDA resubmission.

The Stock Declines as the Truth is Revealed

On April 3, 2025, Aldeyra Therapeutics issued a press release stating that the FDA issued a Complete Response Letter for the NDA for reproxalap. 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 trial data submitted with the NDA, which the FDA stated may be related to methodological issues, including a difference in baseline scores across treatment arms. This news caused the price of Aldeyra Therapeutics stock to fall nearly 75% over the course of the trading day, from a closing price of $5.33 per share on April 2, 2025.

What are my Rights?

If you incurred losses on your investments in Aldeyra Therapeutics, you are encouraged to submit your information to speak with an attorney about your rights.

You can also contact:
Ross Shikowitz
ross@bfalaw.com
212-789-3619

All representation is on a contingency fee basis. Shareholders are not responsible for any court costs or expenses of litigation. The Firm will seek court approval for any potential fees and expenses.

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BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs’ Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.’s Board of Directors, as well as $420 million from Teva Pharmaceutical Ind. Ltd.
 
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