Shares of Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) fell nearly 75% in intraday trading on April 3, 2025, after the company disclosed that the FDA issued a second Complete Response Letter (CRL) for reproxalap, Aldeyra's lead dry eye disease drug candidate. The FDA's CRL cited a failure to demonstrate efficacy for reproxalap and flagged concerns with the design of Aldeyra’s most recent trial, including differences in baseline symptom scores that may have impacted the reliability of their trial results. Block & Leviton is investigating whether Aldeyra adequately disclosed the risks related to its clinical data and regulatory approval process.
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