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...
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...
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...
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...
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...
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...
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...
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...
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...
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...