Investigation Launched into Aldeyra Therapeutics, Inc. following FDA’s Second Complete Response Letter
On April 3, 2025, Levi & Korsinsky, a leading securities law firm, announced the commencement of an investigation into Aldeyra Therapeutics, Inc. (NASDAQ: ADLX) following the company’s disclosure of receiving a second Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding Aldeyra’s lead dry eye disease drug candidate, reproxalap.
Background on Reproxalap and Aldeyra Therapeutics, Inc.
Reproxalap is a topical ophthalmic formulation of the RPE65 activator, designed to address the underlying cause of dry eye disease. The FDA first issued a CRL for reproxalap in October 2024, citing the need for additional information related to the drug’s safety and efficacy. After addressing the concerns raised in the initial CRL, Aldeyra submitted a resubmission of the New Drug Application (NDA) in January 2025.
The Second Complete Response Letter
In the second CRL, the FDA raised new concerns regarding Aldeyra’s nonclinical data, specifically related to the potential for systemic exposure to reproxalap following topical administration. The FDA requested additional data and information to further evaluate these concerns.
Impact on Aldeyra Therapeutics, Inc. and Investors
The issuance of a second CRL for reproxalap has raised significant concerns among investors. The stock price of Aldeyra Therapeutics, Inc. (ADLX) experienced a sharp decline following the announcement, dropping approximately 30% in after-hours trading. The company’s failure to gain FDA approval for reproxalap could result in delays and increased costs, as well as potential damage to the company’s reputation.
Global Implications
The failure of Aldeyra Therapeutics, Inc. to gain FDA approval for reproxalap has broader implications for the pharmaceutical industry and the field of dry eye disease research. The setback highlights the challenges faced by biotech companies in bringing new drugs to market, particularly those targeting complex and chronic conditions like dry eye disease. It also underscores the importance of robust nonclinical data and thorough communication with regulatory agencies to ensure a successful approval process.
Conclusion
The investigation launched by Levi & Korsinsky into Aldeyra Therapeutics, Inc. following the second CRL for reproxalap marks a significant setback for the company and its investors. The failure to gain FDA approval for the drug could result in significant delays and increased costs, as well as potential damage to the company’s reputation. The global implications of this development extend beyond Aldeyra, highlighting the challenges faced by biotech companies in bringing new drugs to market and the importance of robust nonclinical data and effective communication with regulatory agencies.
- Levi & Korsinsky announces investigation into Aldeyra Therapeutics, Inc.
- Company receives second Complete Response Letter from FDA for reproxalap.
- FDA raises concerns related to nonclinical data.
- Impact on Aldeyra Therapeutics, Inc. and investors: stock price drops approximately 30%.
- Global implications: highlights challenges in bringing new drugs to market and importance of robust nonclinical data.
