Abeona rises on plans to submit marketing application for skin disease therapy

Abeona Therapeutics

30/08/2023 13:39

** Shares of therapy developer Abeona Therapeutics Inc
 ABEO.O  rise 5.6% to $4.34 premarket
    ** Co says it plans to submit its marketing application to
the U.S FDA for its cell therapy, EB-101, being studied as
treatment for skin disease Recessive Dystrophic Epidermolysis
Bullosa (RDEB), which causes fragile, blistering skin
    ** This comes after a recent meeting with the FDA; co
believes it has 'aligned' with the FDA on what is needed for the
submission
     ** FDA has requested that supplemental data pertaining to
certain chemistry, manufacturing, and controls and clinical
topics be included in the application package - ABEO 
    ** In a late stage study, the therapy showed statistically
significant improvements in wound healing and pain reduction in
patients with chronic RDEB wounds
    ** Up to last close, stock was up ~33% YTD

 (Reporting by Sriparna Roy in Bengaluru)
 ((Sriparna.Roy@thomsonreuters.com;))