Orchard Therapeutics Announces the Filing and Validation of Marketing Authorization Application by European Medicines Agency for OTL-200 for the Treatment of Metachromatic Leukodystrophy
Orchard Therapeutics plc - American Depositary Shares (ORTX)
Last orchard therapeutics plc - american depositary shares earnings: 2/27 07:00 am
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Source: GlobeNewswire
BOSTON and LONDON, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced that the European Medicines Agency (EMA) has validated the company’s Marketing Authorization Application (MAA) for OTL-200, an ex vivo, autologous, hematopoietic stem cell-based gene therapy that has been developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy, for the treatment of metachromatic leukodystrophy (MLD). Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “We are pleased that OTL-200 for the treatment of MLD is now under review with the EMA, bringing us another step closer to potentially making an approved gene therapy treatment a reality for children and families affected
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News
- Orchard Therapeutics Announces Agreement with the Beneluxa Consortium Enabling Reimbursed Access to Libmeldy [Yahoo! Finance]Yahoo! Finance
- Orchard Therapeutics Announces Agreement with the Beneluxa Consortium Enabling Reimbursed Access to LibmeldyGlobeNewswire
- Kyowa Kirin Successfully Completes Acquisition of Orchard Therapeutics, a Global Gene Therapy Leader for Rare Diseases [Yahoo! Finance]Yahoo! Finance
- Kyowa Kirin Successfully Completes Acquisition of Orchard Therapeutics, a Global Gene Therapy Leader for Rare DiseasesBusiness Wire
- Kyowa Kirin successfully completes acquisition of Orchard Therapeutics, a global gene therapy leader for rare diseasesGlobeNewswire
ORTX
Sec Filings
- 1/24/24 - Form 4
- 1/24/24 - Form 4
- 1/24/24 - Form 4
- ORTX's page on the SEC website