News & Press Releases

Year

Dec 16, 2025

Orchard Therapeutics Celebrates Addition of Metachromatic Leukodystrophy to the U.S. Recommended Uniform Screening Panel

Newborn screening is the only practical means of diagnosing MLD prior to the onset of symptoms, which is key to achieving optimal outcomes for children and their families with this rapidly progressive disease As of today, 14 states—representing more than 50 percent of U.S.

Oct 28, 2025

Kyowa Kirin and Orchard Therapeutics Announce OTL-200 Granted Orphan Regenerative Medicine Product Designation for Early-onset MLD in Japan

– First and only disease-modifying therapy for the treatment of eligible children with MLD also receives Orphan Drug Designation and Priority Review in the Kingdom of Saudi Arabia – TOKYO, LONDON and BOSTON, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd., (TSE: 4151, President and COO:

Jul 07, 2025

Orchard Therapeutics Announces Last Patient Treated in Registrational Trial of OTL-203 for MPS-I Hurler Syndrome

Completion of enrollment achieved nearly one year ahead of schedule Primary analysis anticipated two years post-treatment TOKYO and LONDON and BOSTON, July 07, 2025 (GLOBE NEWSWIRE) -- Orchard Therapeutics, a Kyowa Kirin company, today announced the last patient has been treated in a registrational

May 13, 2025

Orchard Therapeutics Announces New England Journal of Medicine Publication of Long-term Clinical Outcomes from its HSC Gene Therapy for MLD and Multiple Presentations at ASGCT 2025

LENMELDY™ is the first and only disease-modifying intravenous infusion proven to extend life expectancy in pre-symptomatic late infantile (PSLI) patients and mitigate the cognitive and/or physical impact of early-onset MLD Six accepted abstracts at ASGCT 2025 detail the therapeutic potential of HSC

Feb 12, 2025

Orchard Therapeutics Appoints Robin Kenselaar to Chief Commercial Officer and Announces Multiple Business Updates Pertaining to its Approved HSC Gene Therapy for MLD

First U.S. patients being treated with Lenmeldy™ (atidarsagene autotemcel) in a commercial setting; other launch efforts progressing well following Food and Drug Administration approval last year Reimbursement agreement for Libmeldy ® reached with Spanish National Health System enabling access to

Feb 03, 2025

Orchard Therapeutics Announces Multiple Data Presentations and Receives 2025 New Treatment Award at the 21st Annual WORLDSymposium™

Featured data showcase the transformative potential of HSC gene therapy to enable cross-correction and restore enzymatic function in a variety of tissues and organs, including the CNS TOKYO, LONDON and BOSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Orchard Therapeutics, a Kyowa Kirin company, today

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News & Press Releases