Aldeyra Therapeutics falls over 70% as FDA declines to approve eye disease drug

Aldeyra Therapeutics

03/04/2025 13:47

** Shares of drug developer Aldeyra Therapeutics ALDX.O down 75.4% at $1.31 premarket

** ALDX says the FDA declined to approve its treatment for dry eye disease, reproxalap, after it failed to show efficacy

** The health regulator asked the company to conduct at least one additional trial to show positive effect of the treatment, company says

** Company says no manufacturing or safety issues with reproxalap were identified

** The decision was based on a late-stage trial with 132 patients, where the drug reduced the symptoms of ocular discomfort, an unpleasant sensation in the eyes - ALDX

** As of December 31, 2024, ALDX reported cash, cash equivalents, and marketable securities of $101 million

** Company expects to resubmit the marketing application to the FDA by mid-year 2025

** Stock has risen 6.7% YTD as of last close

(Reporting by Siddhi Mahatole)

((siddhi.mahatole@thomsonreuters.com))