Orchard Therapeutics Announced Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review
Portfolio Pulse from Charles Gross
Orchard Therapeutics (NASDAQ:ORTX) announced that the FDA has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review. The agency has set a goal date of March 18, 2024.
September 18, 2023 | 11:37 am
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Orchard Therapeutics' BLA for OTL-200 has been accepted by the FDA under Priority Review, potentially speeding up the approval process.
The acceptance of the BLA for OTL-200 by the FDA under Priority Review is a positive development for Orchard Therapeutics. This could potentially speed up the approval process for the drug, which would be beneficial for the company's stock in the short term.
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