ORTX - Orchard Therapeutics' OTL-103 US application for immunodeficiency disorder pushed to 2022

Citing the impact of the COVID-19 pandemic on certain development activities, Orchard Therapeutics ([[ORTX]] -3.9%) now expects to file US marketing application for OTL-103 in Wiskott-Aldrich Syndrome ((WAS)), in 2022.The company said that delayed activities is impacting the timeline to develop a specific functional potency assay for OTL-103, as requested by the FDA. European application is on track for this year end.Preparations on track for 1H 2021 commercial launch of Libmeldy (OTL-200), the first approved product for Metachromatic Leukodystrophy ((MLD)) in the EU.Filing strategy for OTL-200 US marketing application to be announced by mid-2021 following additional regulatory interactions.New clinical data for OTL-203 (for MPS-I) and OTL-201 (for MPS-IIIA) accepted for oral presentation at February 2021 WORLD Symposium; preclinical data from research programs in larger indications expected in 2021.Ended the quarter with cash/investments of ~$192M to support strategic execution into 1H of 2022.

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Orchard Therapeutics' OTL-103 US application for immunodeficiency disorder, pushed to 2022