Aldeyra Therapeutics Shares Fall 73% After Warning That FDA Might Not Approve Drug
By Will Feuer
Shares of Aldeyra Therapeutics tumbled after the company warned that minutes from a recent Food and Drug Administration meeting indicate that the agency might not approve its new drug application for reproxalap.
The stock fell more than 73% to $1.44 in premarket trading. Shares were already down almost 22% so far this year through Friday.
The FDA minutes identified substantive review issues related to the application for reproxalap for the treatment of the signs and symptoms of dry eye disease.
Aldeyra said in a regulatory filing that it followed up with the FDA, offering responses to the questions raised. However, the FDA has no legal obligation to review the additional information. The company warned that the FDA might require Aldeyra to conduct additional clinical trials.
Write to Will Feuer at Will.Feuer@wsj.com
(END) Dow Jones Newswires
October 16, 2023 09:25 ET (13:25 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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