Abeona Therapeutics® Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa
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Abeona Therapeutics announced that the FDA has accepted the resubmission of its Biologics License Application for prademagene zamikeracel, a gene therapy for recessive dystrophic epidermolysis bullosa. The FDA has set a target action date of April 29, 2025.
November 12, 2024 | 12:45 pm
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Abeona Therapeutics' BLA resubmission for pz-cel has been accepted by the FDA, with a decision expected by April 29, 2025. This is a significant step for the company in bringing its gene therapy for RDEB to market.
The FDA's acceptance of the BLA resubmission is a critical regulatory milestone for Abeona Therapeutics. It indicates progress towards potential approval, which could significantly impact the company's market position and stock price positively.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100