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Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review
September 18, 2023 07:00 ET | Orchard Therapeutics (Europe) Limited
PDUFA date set for March 18, 2024 OTL-200 would be the first and only treatment in the U.S. for early-onset MLD Previously published data demonstrated administration of one-time gene therapy...
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Orchard Therapeutics Announces Presentation of Data Comprising the Clinical Package for the OTL-200 BLA in MLD at the SSIEM Annual Symposium 2023
August 31, 2023 07:00 ET | Orchard Therapeutics (Europe) Limited
Administration of one-time gene therapy resulted in statistically significant improvement in severe motor impairment-free survival with up to 12 years of follow-up (median 6.76 years) Composite...
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Orchard Therapeutics Completes Submission of Biologics License Application for OTL-200 in MLD to U.S. FDA
August 03, 2023 07:00 ET | Orchard Therapeutics (Europe) Limited
Reported $6.6M in Q2’23 Libmeldy net sales, representing the highest quarter to date $34.0M of additional capital from second closing of strategic financing extends runway to mid-2025 Four MLD...
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Orchard Therapeutics Strongly Supports Enactment of Newborn Metabolic Screening Act in Illinois, Adding Metachromatic Leukodystrophy to Statewide Panel
August 02, 2023 09:11 ET | Orchard Therapeutics (Europe) Limited
BOSTON and LONDON, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, expresses its strong appreciation for the passage of the Newborn Metabolic...
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Orchard Therapeutics to Webcast Conference Call of Second Quarter 2023 Financial Results
July 25, 2023 07:00 ET | Orchard Therapeutics (Europe) Limited
BOSTON and LONDON, July 25, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company will host a conference call and live webcast...
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Orchard Therapeutics Announces Second Closing of Strategic Financing, Resulting in $34 Million of Additional Capital
June 26, 2023 07:00 ET | Orchard Therapeutics (Europe) Limited
Funding from second closing extends cash runway to mid-2025 to advance the company’s HSC gene therapy portfolio through several potential value-creating milestones OTL-200 (MLD) BLA submission...
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Orchard Therapeutics to Present at Stifel’s Genetic Medicines Day
May 24, 2023 07:00 ET | Orchard Therapeutics (Europe) Limited
BOSTON and LONDON, May 24, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company will make a virtual presentation at Stifel’s...
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Orchard Therapeutics Announces Positive Clinical and Preclinical Data in Programs Targeting Neurometabolic and CNS Disorders at ASGCT
May 19, 2023 09:00 ET | Orchard Therapeutics (Europe) Limited
New OTL-203 proof-of-concept data demonstrate extensive metabolic correction in the skeletal system of patients with MPS-IH including normal growth rates, improvement in joint function and progressive...
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Orchard Therapeutics Presents Data from Research Programs at ASGCT Demonstrating the Ability of HSC Gene Therapy to Address Larger Indications
May 18, 2023 07:00 ET | Orchard Therapeutics (Europe) Limited
Preclinical proof-of-concept data show the therapeutic potential of OTL-104 for NOD2 Crohn’s disease, a severe and treatment-refractory form of the disease In vivo data demonstrate the development of...
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Orchard Therapeutics Reports First Quarter 2023 Financial Results and Announces Initiation of Rolling Submission for Biologics License Application of OTL-200 for Metachromatic Leukodystrophy to U.S. FDA
May 15, 2023 07:00 ET | Orchard Therapeutics (Europe) Limited
OTL-200 Biologics License Application (BLA) submission completion anticipated in mid-2023 Libmeldy revenue and commercial patients treated expected to grow year-over-year in 2023 New clinical data...