Aldeyra Therapeutics to Appeal FDA Rejection of Dry Eye Drug Reproxalap

Key Facts

1Aldeyra Therapeutics announced its intention to appeal the U.S. FDA's rejection of its dry eye disease drug, reproxalap.

Aldeyra Therapeutics announced its intention to appeal the U.S. Food and Drug Administration's (FDA) rejection of its dry eye disease drug, reproxalap. Reuters reported that the company seeks to overturn the regulatory decision regarding its New Drug Application, as the treatment remains a critical asset in Aldeyra's pipeline.

ALDX closed at $1.16 on September 28, 2026, with the stock reaching a session high of $1.22 and a low of $1.15. The formal appeal follows the FDA's previous decline to approve the drug, leading the company to seek a reconsideration through the agency's Office of New Drugs.