ALDX SHAREHOLDER REVIEW: Aldeyra Therapeutics (NASDAQ:ALDX) is being Investigated after 75% Stock Drop – Investors are Urged to Contact BFA Law

Core Viewpoint - Aldeyra Therapeutics, Inc. is under investigation for potential violations of federal securities laws following the failure of its Phase III clinical trial for reproxalap, which was intended to treat dry eye disease [1][4]. Company Overview - Aldeyra Therapeutics is a biotechnology company focused on developing therapies for immune-mediated and metabolic diseases, with reproxalap as its lead drug candidate for dry eye disease [2]. Clinical Trial Results - The company announced success in its Phase III dry eye chamber clinical trial, claiming the results were "uniquely supportive" and met FDA requirements for New Drug Application (NDA) resubmission [3]. - However, the trial ultimately failed to demonstrate the drug's efficacy, with methodological issues identified, including differences in baseline scores across treatment arms [4]. Regulatory Response - On April 3, 2025, the FDA issued a Complete Response Letter for the NDA for reproxalap, stating that the application "failed to demonstrate efficacy in adequate and well-controlled studies" [5]. - The FDA's concerns were linked to the trial data's methodological issues, which did not satisfy the requirements for NDA resubmission [5]. Market Reaction - Following the FDA's announcement, Aldeyra Therapeutics' stock price plummeted nearly 75% in a single trading day, dropping from a closing price of $5.33 per share on April 2, 2025 [5].