Overview
- The FDA issued a Complete Response Letter citing a lack of substantial efficacy evidence from adequate, well‑controlled studies.
- Regulators flagged inconsistent results across trials that call the reported positive findings into question, with no safety or manufacturing concerns noted.
- The agency suggested analyzing failed studies and potential responsive subpopulations, and it did not request additional trials at this time.
- Aldeyra says it will seek a Type A meeting to clarify requirements for approval and will not initiate new clinical studies.
- Shares fell roughly 68% to 70% toward a 52‑week low, and the company reports about $70 million in cash expected to fund operations into 2028.