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 positive results from 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 efficacy of reproxalap in treating ocular symptoms associated with dry eyes, with methodological issues identified in the trial data [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 highlighted concerns regarding the trial data, particularly methodological issues such as differences in baseline scores across treatment arms [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].
ALDX INQUIRY NOTICE: Aldeyra Therapeutics (NASDAQ:ALDX) Investors may have been affected by Securities Violations -- Contact BFA Law