Shares of Aldeyra Therapeutics, Inc. (ALDX) fell nearly 65% after the company disclosed that the U.S. FDA issued a Complete Response Letter for its lead candidate Reproxalap, an investigational eye drops for the treatment of dry eye disease.
The FDA stated that the application lacked "substantial evidence" from adequate and well-controlled studies to demonstrate efficacy in relieving signs and symptoms of dry eye. Regulators also flagged inconsistencies across trial results, raising concerns about the reliability of positive findings.
Importantly, no safety or manufacturing issues were identified. Aldeyra said it will request a Type A meeting with the FDA to determine next steps.
Reproxalap, a first-in-class small-molecule modulator of reactive aldehyde species (RASP), has faced repeated regulatory setbacks. The drug was first rejected in November 2023, when the FDA requested additional well-controlled studies. A second attempt in April 2025 also failed, with the agency again citing insufficient efficacy data. Aldeyra resubmitted the NDA in June 2025, and after an extension in December, a decision was expected by March 16, 2026.
Dry eye disease is a common condition that can cause burning, irritation, and vision problems, and current therapies often take weeks or months to provide modest relief. Aldeyra has argued that Reproxalap shows activity within minutes of administration, but regulators remain unconvinced by the clinical evidence to date.
As of year-end 2025, Aldeyra reported $70 million in cash and marketable securities, expected to support operations into 2028.
ALDX has traded between $1.07 and $6.87 over the past year. The stock is currently trading at $1.46, down 65.37%, after touching a new 52-week low of $1.07 in today's session.
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