Aldeyra Therapeutics, Inc.

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Investigation Details

On April 3, 2025, 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.

Following this news, shares of Aldeyra Therapeutics, Inc. fell over 74% in intraday trading.