Abeona Therapeutics Shares Down 53% After FDA Complete Response Letter
By Josh Beckerman
Abeona Therapeutics shares fell 53%, to $3.45, after hours as its application for pz-cel received a Complete Response Letter from the U.S. Food and Drug Administration.
Abeona is seeking approval for pz-cel for treatment of patients with recessive dystrophic epidermolysis bullosa. The company said the letter didn't identify deficiencies related to clinical efficacy or clinical safety data, and said the FDA didn't request any new clinical trials or clinical data.
The letter is related to additional information needed to satisfy Chemistry Manufacturing and Controls requirements. Abeona expects to submit the requested information in the third quarter.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
April 22, 2024 19:00 ET (23:00 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
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