- Shares of Aldeyra Therapeutics fell more than 73% after a warning from the FDA
- The FDA expressed concerns about the new drug application for reproxalap
- Aldeyra followed up with the FDA, but there is no legal obligation for the agency to review the additional information
- The FDA may require Aldeyra to conduct more clinical trials
Shares of Aldeyra Therapeutics plummeted over 73% after the company received a warning from the FDA regarding its new drug application for reproxalap. The FDA expressed concerns about the application for the treatment of dry eye disease. Although Aldeyra provided responses to the FDA’s questions, there is no legal obligation for the agency to review the additional information. As a result, the FDA may require Aldeyra to conduct additional clinical trials.
