05:58 PM EDT, 04/22/2024 (MT Newswires) -- Abeona Therapeutics ( ABEO ) was plunging 50% in after-hours activity Monday after the company said the US Food and Drug Administration issued a complete response letter to its application of pz-cel drug to treat a disorder that causes chronic open wounds on the skin.

The FDA asked for more data for chemistry manufacturing and controls requirement. The company said it would submit the data by mid-2024, but the FDA said that would not provide it with enough time to complete its review before a May 25 deadline.

The company is now expecting to resubmit its biologic license application for pz-cel during Q3.