News & Press Releases

Year

Nov 30, 2023

Orchard Therapeutics Receives U.S. FDA Fast Track Designation for OTL-203 in MPS-IH

Previously reported results from ongoing proof-of-concept study showed extensive metabolic correction, continued cognitive, motor, and physical development, as well as early improvements in skeletal health Additionally, study investigators presented favorable outcomes for other disease

Nov 13, 2023

Orchard Therapeutics Reports Third Quarter 2023 Financial Results and Highlights Recent Business Accomplishments

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 quarter of 2024 Biologics License Application for OTL-200 in MLD accepted by U.S.

Oct 26, 2023

Orchard Therapeutics Announces Presentation of Additional Positive Data from Proof-of-concept Study of OTL-203 in MPS-IH at ESGCT 2023

New clinical data beyond previously reported neurological and skeletal results demonstrate favorable outcomes for multiple disease manifestations not effectively addressed by the current standard of care BOSTON and LONDON, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a

Oct 24, 2023

Orchard Therapeutics Announces Multiple Presentations at ESGCT 2023

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 favorable outcomes for clinical manifestations of the disease not well addressed by the current

Oct 05, 2023

Kyowa Kirin to Acquire Orchard Therapeutics

-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 development of numerous promising candidates with a clinically differentiated platform, and helps

Sep 18, 2023

Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review

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 enables sustained preservation of motor function and cognitive development BOSTON and LONDON, Sept.

Aug 31, 2023

Orchard Therapeutics Announces Presentation of Data Comprising the Clinical Package for the OTL-200 BLA in MLD at the SSIEM Annual Symposium 2023

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 primary endpoint used in analysis was developed through discussions with the U.S.

Aug 03, 2023

Orchard Therapeutics Completes Submission of Biologics License Application for OTL-200 in MLD to U.S. FDA

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 patients identified from ~150,000 newborns screened in prospective studies suggests significantly higher

Aug 02, 2023

Orchard Therapeutics Strongly Supports Enactment of Newborn Metabolic Screening Act in Illinois, Adding Metachromatic Leukodystrophy to Statewide Panel

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 Screening Act in Illinois, also known as SB67. The law, anticipated to go into effect in January 2024,

Jul 25, 2023

Orchard Therapeutics to Webcast Conference Call of Second Quarter 2023 Financial Results

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 on Thursday, August 3, 2023, at 8:00 a.m. EDT to review business updates and its second quarter 2023

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