Shares of Aldeyra Therapeutics (NASDAQ:ALDX) have lost two-thirds of their value Monday after the company warned the US Food and Drug Administration may not approve its new drug application.
Minutes from a recent FDA meeting revealed issues on the part of the agency with the company’s application for reproxalap for the treatment of dry eye disease symptoms.
Aldeyra said it followed up with the FDA with responses to the issues raised, but the company noted that the FDA could require the company to conduct additional clinical trials.
As a result, Aldeyra stock is down nearly 70% Monday morning to $1.66.
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