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Orchard Therapeutics Plc - ORTX STOCK NEWS

Welcome to our dedicated page for Orchard Therapeutics Plc news (Ticker: ORTX), a resource for investors and traders seeking the latest updates and insights on Orchard Therapeutics Plc stock.

Orchard Therapeutics Plc (ORTX) delivers groundbreaking gene therapies for rare inherited disorders, focusing on transformative treatments for pediatric patients. This page provides centralized access to all official company announcements, regulatory filings, and clinical development updates.

Investors and researchers will find timely information on clinical trial progress, regulatory milestones, and strategic partnerships shaping the future of gene-based medicine. The curated news collection spans therapy approvals, research collaborations with leading institutions, and manufacturing advancements critical to orphan disease treatment accessibility.

Regular updates ensure stakeholders maintain current awareness of ORTX's innovations in hematopoietic stem cell therapies and neurometabolic disorder treatments. Bookmark this page for efficient tracking of material developments affecting the company's position in the advanced therapies sector.

News

Orchard Therapeutics Announces Multiple Presentations at ASGCT 2024

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Orchard Therapeutics, acquired by Kyowa Kirin, announced multiple presentations at the ASGCT 2024, showcasing HSC gene therapy for rare diseases. Data includes positive results for atidarsagene autotemcel, OTL-203 for MPS-IH, and OTL-104 for Crohn's disease. The presentations demonstrate the transformative impact of Orchard's approach and the potential of its pipeline.

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Orchard Therapeutics Co-founder and Chief Executive Officer Dr. Bobby Gaspar Named to Inaugural 2024 TIME100 Health List

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Dr. Bobby Gaspar, co-founder and CEO of Orchard Therapeutics, has been named to the 2024 TIME100 Health list for his contributions to gene therapy. Orchard Therapeutics, now owned by Kyowa Kirin, aims to advance gene therapies globally. Dr. Gaspar's recognition highlights his significant impact on transforming treatment for genetic diseases, with key achievements in HSC gene therapy and regulatory approvals in Europe and the U.S.

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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

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Orchard Therapeutics announces the U.S. commercial launch of Lenmeldy, the first FDA-approved therapy for early-onset metachromatic leukodystrophy. Lenmeldy aims to correct the underlying genetic cause of the disease with a one-time treatment, offering potential long-term clinical benefits. The wholesale acquisition cost is set at $4.25 million, reflecting its clinical, economic, and societal value. Innovative outcomes- and value-based agreements are being offered to ensure broad access to the therapy.
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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.

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Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) receives FDA approval for treating early-onset metachromatic leukodystrophy, offering hope to children facing a rare, fatal genetic disorder. The therapy aims to restore enzymatic function with a single treatment, potentially halting or slowing disease progression.
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Orchard Therapeutics Announces First Patient Randomized in Registrational Trial of OTL-203 for MPS-I Hurler Syndrome

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Orchard Therapeutics, acquired by Kyowa Kirin, announced the first patient has been randomized in a trial evaluating the efficacy and safety of OTL-203, a gene therapy, in patients with MPS-IH. The trial aims to enroll 40 patients in the U.S. and Europe. OTL-203 has shown potential to positively impact various clinical manifestations of MPS-IH, with favorable results in a proof-of-concept study. The therapy has received Fast Track and Rare Pediatric Disease designations from the FDA and PRIME status from the EMA.
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Orchard Therapeutics Announces Multiple Presentations at the 20th Annual WORLDSymposium

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Orchard Therapeutics, recently acquired by Kyowa Kirin, announced 10 presentations on its neurometabolic portfolio at the 20th Annual WORLDSymposium™. The presentations include updated neurocognitive and biochemical results from an ongoing proof-of-concept study of investigational OTL-201 in MPS-IIIA, newborn screening efforts for MLD, and long-term results from an integrated analysis of patients with MLD treated with investigational OTL-200. The company will also host a sponsored symposium titled 'Momentum, Leadership & Diagnosis: Changing the paradigm for MLD'.
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Orchard Therapeutics Announces Agreement with the Beneluxa Consortium Enabling Reimbursed Access to Libmeldy

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Orchard Therapeutics has reached an agreement with the Beneluxa Initiative on Pharmaceutical Policy for reimbursed access to Libmeldy, a gene therapy for early-onset metachromatic leukodystrophy (MLD). The agreement covers several member countries, expanding the company's geographic reach. Libmeldy aims to correct the genetic cause of MLD by inserting a working copy of the ARSA gene into the patient's own HSCs, with positive clinical trial results. The therapy is approved in Europe and under Priority Review in the U.S.
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Kyowa Kirin successfully completes acquisition of Orchard Therapeutics, a global gene therapy leader for rare diseases

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Kyowa Kirin Co., Ltd. has completed the acquisition of Orchard Therapeutics plc, making it a wholly-owned subsidiary. This acquisition will enable Kyowa Kirin to enrich its portfolio and develop promising candidates with a clinically differentiated platform. Orchard Therapeutics' focus on gene therapy will help Kyowa Kirin meet the needs of people with devastating genetic and severe diseases. The portfolio includes Libmeldy® (atidarsagene autotemcel) for early-onset metachromatic leukodystrophy (MLD) and other clinical-stage programs for rare diseases. Libmeldy is approved in Europe and under review in the U.S. The acquisition positions Kyowa Kirin as a global leader in gene therapy.
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Orchard Therapeutics Receives Swissmedic Approval for Libmeldy in Early-onset MLD

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Orchard Therapeutics (Nasdaq: ORTX) has received approval from the Swiss Agency for Therapeutic Products for Libmeldy, a gene therapy for the treatment of early-onset metachromatic leukodystrophy (MLD). Libmeldy aims to correct the underlying genetic cause of MLD by inserting a working copy of the ARSA gene into the genome of a patient's own HSCs. The therapy has shown positive results in preserving cognitive development and motor function in clinical trials, with more than a cumulative 250 patient-years of follow-up. The approval opens up new treatment possibilities for children with MLD and demonstrates the clinical impact of Libmeldy.
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Orchard Therapeutics Receives U.S. FDA Fast Track Designation for OTL-203 in MPS-IH

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Orchard Therapeutics (Nasdaq: ORTX) announced that the U.S. FDA granted Fast Track designation to OTL-203, a potential gene therapy for the treatment of MPS-IH. The therapy has shown extensive metabolic correction, cognitive and physical development, and improvements in skeletal health. A global registrational trial is expected to commence by year-end.
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Orchard Therapeutics Plc

Nasdaq:ORTX

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380.11M
20.54M
12.21%
103.6%
0.14%
Biotechnology
Healthcare
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United Kingdom
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