Overview

• The FDA rejected Aldeyra Therapeutics' resubmitted New Drug Application (NDA) for reproxalap, citing insufficient efficacy data and methodological concerns in clinical trials.
• The agency raised issues about differences in baseline scores across treatment arms but confirmed no manufacturing or safety concerns with the drug.
• Aldeyra plans to release results from ongoing clinical trials in Q2 2025 and resubmit the NDA by mid-2025 if the data supports efficacy.
• Shares of Aldeyra plummeted nearly 75% to an all-time low following the FDA's decision, reflecting investor concerns over regulatory setbacks.
• With $101 million in cash reserves as of December 2024, the company remains financially positioned to continue its development efforts.