A formal disclosure from Aldeyra Therapeutics (Nasdaq: ALDX), suggesting a potential rejection from the US Food and Drug Administration, has stripped around 70% from the firm’s share price.
The filing with the US Securities and Exchange Commission follows the receipt of minutes from a late-cycle review meeting, where the agency discussed the firm’s submission for reproxalap.
Developed for the treatment of the signs and symptoms of dry eye disease, Aldeyra’s lead candidate has faced setbacks already, including the failure of the Phase III TRANQUILITY study in 2021.
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