Aldeyra Therapeutics, Inc. (ALDX) Investigation

On April 3, 2025 investors in Aldeyra Therapeutics, Inc. saw the price of their shares crash over 70% after the company announced that it received a Complete Response Letter (“CRL”) from the FDA for the resubmission of the New Drug Application (“NDA”) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. 

The investigation is focused on the propriety of Aldeyra’s statements about the prospects for FDA approval of the NDA of reproxalap.

In the past, Aldeyra touted the success of its Phase 3 dry eye clinical chamber trial for the drug and said the “results are uniquely supportive of the potential acute clinical effect of reproxalap on reducing ocular discomfort[.]” More recently, the company assured investors that “reproxalap is going to get approved on April 2[.]”

Instead, on April 3, 2025, Aldeyra announced that it received the FDA’s CRL. Aldeyra revealed that:

• “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[;]’”
• “‘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[;]” and
• “[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.”

In response to this news, the market swiftly reacted by sending the price of Aldeyra shares down over 70%, wiping out over $200 million of shareholder value.

FREQUENTLY ASKED QUESTIONS ABOUT THE CASE

What is the ALDX investigation about?

We are investigating whether Aldeyra may have misrepresented the propriety of its reproxalap study and results to investors.

WHAT SHOULD I DO?

I worked at ALDX. What should I do?

If you were an employee of ALDX, you may have valuable information that could be relevant to the investigation. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, contact Reed Kathrein at 844-916-0895 or [email protected].

There are multiple law firms participating, do I need to contact all of them?

No, you do not need to contact all participating law firms. Generally, class-action investigations and lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing of other powerful institutions.

AM I ELIGIBLE?

What is the threshold amount to be eligible? What are “substantial” losses?

The threshold amount and the definition of "substantial" losses may vary depending on a number of factors specific to the case, including the size of the company, market cap, shares outstanding and who holds them and the damages alleged by the fraud. In general, to be eligible to participate in a class-action lawsuit, you must be able to demonstrate that you suffered financial losses as a result of the alleged wrongdoing and that your losses meet the criteria set by the court or law firm. Fill out the form and submit your losses.

CAN I PARTICIPATE?

Am I affected? What do I need to do to participate?

If you were an investor in ALDX, you may be affected and eligible to participate in the case. To determine your eligibility and potential involvement, fill out the form and submit your losses.

Can any ALDX investor participate?

In most class-action investigations and cases, any investor who meets the eligibility criteria, including purchasing the shares during the relevant period, can participate, regardless of the size of their investment. Fill out the form to find out your rights.

I bought on a non-U.S. Exchange. Can I participate?

No. This investigation only covers shares bought on a U.S. exchange, i.e. NASDAQ or NYSE. Fill out the form to find out your rights.

Am I included if I still hold my shares, or do I need to sell to participate?

Participation is based on purchasing shares during the relevant period, rather than your current holdings. Accordingly, you do not need to sell to participate. Fill out the form to find out your rights.