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