Investigation Launched Against Aldeyra Therapeutics, Inc. Following FDA’s Second Complete Response Letter
New York, NY – April 3, 2025 – Levi & Korsinsky, a leading securities law firm, notified investors that it has commenced an investigation of Aldeyra Therapeutics, Inc. (NASDAQ: ADLX) regarding potential securities laws violations. The investigation comes in the wake of the company’s disclosure that the Food and Drug Administration (FDA) issued a second Complete Response Letter (CRL) for Aldeyra’s lead dry eye disease drug candidate, reproxalap.
Background on Aldeyra Therapeutics and Repoxalap
Aldeyra Therapeutics is a clinical-stage biotech company dedicated to transforming the lives of patients with immune-driven diseases. The company’s lead drug candidate, reproxalap, is a topical ophthalmic formulation of an inhibitor of IKappaB kinase (IKK), a key regulator of inflammatory responses. Repoxalap was designed to treat dry eye disease, a chronic condition characterized by inflammation and damage to the ocular surface.
The FDA’s Complete Response Letters
On October 28, 2021, Aldeyra Therapeutics announced that the FDA had issued a CRL for reproxalap, citing the need for additional information regarding the drug’s manufacturing process and labeling. The company responded by providing the requested information and resubmitting its New Drug Application (NDA) on January 28, 2022. However, on April 3, 2025, Aldeyra disclosed that the FDA had issued another CRL for reproxalap, stating that additional clinical data were required to support the drug’s safety and efficacy.
Impact on Investors
The news of the second CRL sent Aldeyra Therapeutics’ stock price plummeting, with shares trading down more than 50% in after-hours trading on April 3, 2025. The sudden drop in value has left many investors questioning the future of Aldeyra Therapeutics and the viability of their investment.
- Investors who purchased Aldeyra Therapeutics stock prior to April 3, 2025, may be considering their options, including selling their shares to mitigate losses.
- Long-term investors may be holding onto their shares, believing that Aldeyra has the potential to overcome this setback and continue its research and development efforts.
- Institutional investors, including pension funds and mutual funds, may be reviewing their holdings and considering whether to maintain their positions or divest.
Impact on the World
The failure of Aldeyra Therapeutics to secure FDA approval for reproxalap is a setback for the millions of people worldwide who suffer from dry eye disease. The condition, which can lead to discomfort, pain, and even vision loss, has no FDA-approved treatments. Repoxalap was seen as a promising candidate due to its unique mechanism of action and its potential to address the underlying causes of dry eye disease.
- Patients with dry eye disease may continue to seek alternative treatments or live with their symptoms, which can impact their quality of life.
- The biotech industry may be affected as investors reassess the risks associated with clinical-stage companies and their ability to bring new treatments to market.
- Regulatory agencies, such as the FDA, may face increased scrutiny regarding the approval process and the role they play in bringing new drugs to market.
Conclusion
The second Complete Response Letter from the FDA has raised concerns among investors regarding Aldeyra Therapeutics and its lead drug candidate, reproxalap. The potential securities laws violations being investigated by Levi & Korsinsky add to the uncertainty surrounding the company’s future. The impact on investors, both in terms of financial losses and strategic considerations, is significant. Furthermore, the failure to secure FDA approval for reproxalap is a setback for the millions of people worldwide suffering from dry eye disease. As the situation unfolds, it will be crucial for all stakeholders to stay informed and assess the implications for their investments and the biotech industry as a whole.
For more information, please contact Levi & Korsinsky at 212-363-7500 or via email at [email protected].
