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Orchard Therapeutics plc - ORTX STOCK NEWS

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

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Orchard Therapeutics plc's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Orchard Therapeutics plc's position in the market.

News
Orchard Therapeutics Outlines U.S. Launch Plans for Lenmeldy™ (atidarsagene autotemcel), the Only Approved Therapy for Children with Early-onset Metachromatic Leukodystrophy
Rhea-AI Summary
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 Reports Third Quarter 2023 Financial Results and Highlights Recent Business Accomplishments
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Orchard Therapeutics (Nasdaq: ORTX) reported $5.6 million in quarterly Libmeldy net revenue and $12.7 million year-to-date. The company announced a planned acquisition by Kyowa Kirin valued at up to $477.6 million, with the U.S. FDA accepting the Biologics License Application for OTL-200 in MLD under Priority Review. Orchard Therapeutics highlighted ten active newborn screening studies globally and presented eight sessions at ESGCT. The company's CEO expressed optimism for the future and provided an overview of the 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
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Orchard Therapeutics announces positive clinical outcomes for gene therapy treatment of MPS-IH
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Orchard Therapeutics plc

Nasdaq:ORTX

ORTX Rankings

N/A Ranked by Market Cap
#21 Ranked by Stock Gains
N/A Ranked by Dividends

ORTX Stock Data

380.11M
117.51M
12.21%
103.6%
0.14%
Research and Development in Biotechnology
Professional, Scientific, and Technical Services
Link
United Kingdom
108 Cannon Street

About ORTX

orchard therapeutics is dedicated to bringing transformative gene therapies to children with life-threatening orphan diseases. we work in partnership with the world’s most prestigious research centres to harness the life-giving potential of gene therapy. orchard’s leadership team and collaborators have more than a decade of experience in the development, manufacturing and commercialization of advanced therapies for orphan diseases. our mission is to provide the ideal environment and expertise to translate promising pre-clinical and early clinical results into commercially approved medicines available to patients around the world.