Aldeyra Therapeutics Shares Plunge 71% After Third FDA CRL on Reproxalap NDA
Aldeyra Therapeutics shares plunged 71% after the FDA issued a third complete response letter for reproxalap’s NDA for dry eye disease, citing inconsistent efficacy data and lack of substantial evidence. The company plans to request a Type A meeting within 30 days and has $70 million cash runway into 2028.
1. FDA Issues Third CRL
The FDA issued a third complete response letter for reproxalap’s NDA, stating that clinical trials showed inconsistent efficacy and insufficient evidence to support approval for dry eye disease.
2. Stock Market Reaction
Following the CRL announcement, Aldeyra Therapeutics shares fell 71% in intraday trading, marking the steepest single-day decline in the company’s history.
3. Next Regulatory Steps
Management plans to request a Type A meeting with the FDA within 30 days to clarify requirements for approval and discuss potential pathways forward.
4. Financial Outlook
As of December 31, 2025, the company held $70 million in cash, cash equivalents and marketable securities, which it expects to fund operations through 2028 despite regulatory setbacks.