Abeona Therapeutics Announces Positive Pre-BLA Meeting With FDA for EB-101 And Plans For BLA Submission
Portfolio Pulse from Benzinga Newsdesk
Abeona Therapeutics Inc. (NASDAQ:ABEO) has announced its intention to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EB-101, its investigational autologous, engineered cell therapy, for patients with recessive dystrophic epidermolysis bullosa (RDEB). This follows a successful pre-BLA meeting with the FDA.
August 30, 2023 | 11:33 am
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POSITIVE IMPACT
Abeona Therapeutics' announcement of its intention to submit a BLA for EB-101 to the FDA could potentially boost investor confidence in the company's pipeline.
The announcement of a BLA submission is a significant regulatory milestone that often leads to increased investor confidence in a company's pipeline. This is particularly true if the therapy in question, in this case EB-101, is a major part of the company's pipeline. Therefore, this news could potentially have a positive impact on Abeona Therapeutics' stock price in the short term.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 100