Orchard Therapeutics
101 Seaport Boulevard, 7th Floor
Boston
MA
02210
United States
Website: http://www.orchard-tx.com/
Email: careers@orchard-tx.com
205 articles about Orchard Therapeutics
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With several recent approvals in the space and more on the horizon, BioSpace looks at some of the key decisions and their larger significance both for patients and science.
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Orchard Therapeutics Outlines U.S. Launch Plans for Lenmeldy™ (atidarsagene autotemcel), the Only Approved Therapy for Children with Early-onset Metachromatic Leukodystrophy
3/20/2024
Orchard Therapeutics today announced the details of its U.S. commercial launch of Lenmeldy™ (atidarsagene autotemcel), formerly known as OTL-200.
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Two days after winning FDA approval, Orchard Therapeutics on Wednesday provided its U.S. launch plans for metachromatic leukodystrophy gene therapy Lenmeldy, which has a wholesale acquisition cost of $4.25 million for the one-time treatment.
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Orchard Therapeutics on Monday secured the FDA’s first approval for an autologous gene therapy to treat the rare metabolic disease metachromatic leukodystrophy in children.
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Orchard Therapeutics Receives FDA Approval of Lenmeldy™ (atidarsagene autotemcel), the Only Therapy for Eligible Children with Early-onset Metachromatic Leukodystrophy in the U.S.
3/18/2024
Orchard Therapeutics announced the U.S. Food and Drug Administration has approved Lenmeldy™, formerly known as OTL-200, for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile —collectively referred to as early-onset—metachromatic leukodystrophy.
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The FDA will close out a hectic month of March with a flurry of target action dates, including ones for lymphoma and CKD anemia treatments.
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Orchard Therapeutics Announces First Patient Randomized in Registrational Trial of OTL-203 for MPS-I Hurler Syndrome
2/5/2024
Orchard Therapeutics today announced the first patient has been randomized at the M Health Fairview Masonic Children’s Hospital in a registrational trial evaluating the efficacy and safety of OTL-203, an investigational hematopoietic stem cell (HSC) gene therapy, in patients with the Hurler subtype of mucopolysaccharidosis type I (MPS-IH).
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Orchard Therapeutics Announces Multiple Presentations at the 20th Annual WORLD Symposium
2/2/2024
Orchard Therapeutics today announced 10 presentations from across its neurometabolic portfolio will be featured at the 20th Annual WORLD Symposium™ taking place February 4-9, 2024, in San Diego, California.
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Orchard Therapeutics Announces Agreement with the Beneluxa Consortium Enabling Reimbursed Access to Libmeldy
1/25/2024
Orchard Therapeutics, a global gene therapy leader, today announced the company has reached an agreement with the Beneluxa Initiative on Pharmaceutical Policy (Beneluxa) enabling reimbursed access to Libmeldy ® (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy, approved for the treatment of early-onset metachromatic leukodystrophy (MLD).
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Kyowa Kirin successfully completes acquisition of Orchard Therapeutics, a global gene therapy leader for rare diseases
1/24/2024
Kyowa Kirin Co., Ltd. a Japan-based global specialty pharmaceutical company discovering and developing novel medicines utilizing the latest biotechnology, and Orchard Therapeutics plc, a global gene therapy leader, announced Kyowa Kirin has successfully completed the acquisition of Orchard Therapeutics.
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Orchard Therapeutics Receives Swissmedic Approval for Libmeldy in Early-onset MLD
12/11/2023
Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the Swiss Agency for Therapeutic Products (Swissmedic) has approved Libmeldy ® (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy, for the treatment of early-onset metachromatic leukodystrophy (MLD).
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Orchard Therapeutics Receives U.S. FDA Fast Track Designation for OTL-203 in MPS-IH
11/30/2023
Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OTL-203, an investigational hematopoietic stem cell gene (HSC) therapy being developed for the potential treatment of the Hurler subtype of mucopolysaccharidosis type I (MPS-IH).
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Orchard Therapeutics Reports Third Quarter 2023 Financial Results and Highlights Recent Business Accomplishments
11/13/2023
Orchard Therapeutics, a global gene therapy leader, announced several business accomplishments along with its financial results for the quarter ended September 30, 2023.
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Orchard Therapeutics Announces Presentation of Additional Positive Data from Proof-of-concept Study of OTL-203 in MPS-IH at ESGCT 2023
10/26/2023
Orchard Therapeutics, a global gene therapy leader, announced a range of interim clinical outcomes, in addition to the previously reported neurological and skeletal results, from the company’s ongoing proof-of-concept study of OTL-203, a hematopoietic stem cell gene therapy in development for the treatment of the Hurler subtype of mucopolysaccharidosis type I.
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Orchard Therapeutics Announces Multiple Presentations at ESGCT 2023
10/24/2023
Orchard Therapeutics, a global gene therapy leader, announced eight presentations from across its hematopoietic stem cell gene therapy platform will be featured at the European Society of Gene and Cell Therapy 30th Annual Congress taking place October 24-27, 2023, in Brussels.
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The first two weeks of October saw BMS’s $4.8 billion buyout of Mirati, Lilly’s $1.4 billion purchase of Point, Kyowa Kirin’s $387 million acquisition of Orchard and AbbVie’s $110 million Mitokinin deal.
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Kyowa Kirin to Acquire Orchard Therapeutics
10/5/2023
Kyowa Kirin Co., Ltd. and Orchard Therapeutics plc announced the companies have entered into a definitive agreement under which Kyowa Kirin will acquire Orchard Therapeutics for $16.00 per American Depositary Share in cash, under which Orchard shareholders will hold an additional contingent value right of $1.00 per ADS.
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The Japan-based pharma is acquiring Orchard Therapeutics for approximately $477.6 million, if all conditions are met. Orchard’s pediatric gene therapy has a PDUFA date set for March 2024.
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Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.
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Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review
9/18/2023
Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review.