Orchard Therapeutics Receives U.S. FDA Fast Track Designation for OTL-203 in MPS-IH
November 30, 2023 07:00 ET
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Orchard Therapeutics (Europe) Limited
Orchard Therapeutics Receives U.S. FDA Fast Track Designation for OTL-203 in MPS-IH
Orchard Therapeutics Reports Third Quarter 2023 Financial Results and Highlights Recent Business Accomplishments
November 13, 2023 07:00 ET
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Orchard Therapeutics (Europe) Limited
Reported $5.6 million in quarterly Libmeldy net revenue and $12.7 million year-to-date Planned acquisition by Kyowa Kirin valued at up to $477.6 million with an anticipated closing in the first...
Orchard Therapeutics Announces Presentation of Additional Positive Data from Proof-of-concept Study of OTL-203 in MPS-IH at ESGCT 2023
October 26, 2023 07:00 ET
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Orchard Therapeutics (Europe) Limited
BOSTON and LONDON, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced a range of interim clinical outcomes, in addition to the...
Orchard Therapeutics Announces Multiple Presentations at ESGCT 2023
October 24, 2023 07:00 ET
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Orchard Therapeutics (Europe) Limited
Eight presentations highlight the differentiated profile and broad applicability of the company’s HSC gene therapy platform Data from proof-of-concept study of OTL-203 in MPS-IH demonstrate...
Kyowa Kirin to Acquire Orchard Therapeutics
October 05, 2023 03:35 ET
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Orchard Therapeutics (Europe) Limited; Kyowa Kirin Co., Ltd.
-Orchard Therapeutics is a global gene therapy leader with experience successfully developing and commercializing medicines for rare diseases--Acquisition enriches Kyowa Kirin’s portfolio, enables the...
Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review
September 18, 2023 07:00 ET
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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...
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
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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...
Orchard Therapeutics Completes Submission of Biologics License Application for OTL-200 in MLD to U.S. FDA
August 03, 2023 07:00 ET
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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...
Orchard Therapeutics Strongly Supports Enactment of Newborn Metabolic Screening Act in Illinois, Adding Metachromatic Leukodystrophy to Statewide Panel
August 02, 2023 09:11 ET
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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...
Orchard Therapeutics to Webcast Conference Call of Second Quarter 2023 Financial Results
July 25, 2023 07:00 ET
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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...