Aldeyra Therapeutics Plunges 74.27% After FDA Rejection

Aldeyra Therapeutics' stock plummeted 74.27% in pre-market trading on April 3, 2025, marking a significant downturn for the biopharmaceutical company.

The dramatic decline in Aldeyra Therapeutics' stock price can be attributed to the company receiving a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its Reproxalap New Drug Application, which was intended for the treatment of dry eye disease. This letter indicates that the FDA will not approve the application in its current form, citing issues that need to be addressed before the drug can be approved.

Analysts had previously maintained a positive outlook for Aldeyra Therapeutics, with some setting a price target of $11.00 and a Buy rating. However, the FDA's decision has led to a significant reversal in sentiment, with the stock price dropping sharply in response to the news.

The FDA's Complete Response Letter is a setback for Aldeyra Therapeutics, as it means that the company will need to address the issues raised by the FDA before it can resubmit its application for approval. This process could take some time, and there is no guarantee that the FDA will ultimately approve the drug.