Orchard Therapeutics Reports Acceptance Of Biologics License Application For OTL-200 In MLD And Receives Priority Review
Portfolio Pulse from Benzinga Newsdesk
Orchard Therapeutics has announced that the FDA has accepted its Biologics License Application for OTL-200, a gene therapy for Metachromatic Leukodystrophy (MLD), and granted it priority review status. This could potentially expedite the approval process for the therapy.

September 18, 2023 | 11:01 am
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Orchard Therapeutics' OTL-200 has been granted priority review by the FDA, which could expedite the approval process for the gene therapy. This could potentially lead to increased revenues for the company if the therapy is approved and successfully commercialized.
The FDA's acceptance of Orchard Therapeutics' Biologics License Application and granting of priority review status for OTL-200 is a significant regulatory milestone for the company. This could potentially expedite the approval process for the therapy, which, if approved and successfully commercialized, could lead to increased revenues for the company. Therefore, this news is likely to have a positive impact on the company's stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100