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ALDX SECURITIES ALERT: Lose Money on Aldeyra Therapeutics, Inc.? Contact BFA Law about Securities Investigation (NASDAQ:ALDX)
Aldeyra TherapeuticsAldeyra Therapeutics(US:ALDX) GlobeNewswire News Room·2025-05-05 11:53

Core Viewpoint - Aldeyra Therapeutics, Inc. is under investigation for potential violations of federal securities laws following the failure of its lead drug candidate, reproxalap, to demonstrate efficacy in treating dry eye disease, leading to a significant stock price decline [1][4][5]. 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 clinical trial for reproxalap, 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 regarding the trial data contributed to the stock price plummeting nearly 75% from $5.33 per share on April 2, 2025 [5].