Orchard Therapeutics plc - ADR

Orchard Therapeutics Plc is a biopharmaceutical company, which engages in discovering, acquiring, developing and commercializing gene therapies for patients with rare disorders. The company focuses on its autologous ex vivo gene therapy approach on three therapeutic rare disease franchise areas: primary immune deficiencies, neurometabolic disorders, and hemoglobinopathies. Its portfolio includes Strimvelis, a commercial-stage gamma retroviral-based product for the treatment of Adenosine deaminase deficiency (ADA-SCID). The company was founded by Nicolas Koebel and Andrea Spezzi in August 2018 and is headquartered in London, the United Kingdom.

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Orchard Therapeutics is a fully integrated commercial-stage company dedicated to treating the lives of patients with rare diseases through innovative gene therapies. Orchard’s portfolio of autologous ex vivo gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas. These programs include Strimvelis®, the first autologous ex vivo gene therapy approved by the EMA in 2016, 3 programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott-Aldrich syndrome), and ADA-SCID (adenosine deaminase severe combined immunodeficiency), 2 other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline. The company is partnered with world-leading institutions in gene therapy, including University College London, Great Ormond Street Hospital, the University of Manchester and Central Manchester University Hospitals, the University of California Los Angeles and Boston Children’s Hospital, and Telethon Institute of Gene Therapy/Ospedale San Raffaele.

Ten presentations at ESGCT 2024 detail the therapeutic potential and applicability of the company's platform in rare neurometabolic diseases and beyond

Orchard Therapeutics Announces Multiple Data Presentations and Publications

ISTANBUL and LONDON, and BOSTON, Oct. 07, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe and Er-Kim, an international pharmaceutical company specializing in the commercialization of novel therapies, today announced the companies have signed an exclusive distribution agreement to commercialize Libmeldy® (atidarsagene autotemcel), the only approved therapy for eligible children with early-onset metachromatic leukodystrophy (MLD).

Orchard Therapeutics and Er-Kim Announce Partnership to Broaden Access to Libmeldy to Eligible Patients in Turkey and Certain Eurasian Countries

LONDON and BOSTON, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced nine presentations from across its late-stage neurometabolic hematopoietic stem cell (HSC) gene therapy portfolio will be featured at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium taking place September 3-6 in Porto, Portugal.

Orchard Therapeutics Announces Multiple Presentations from across its Late-stage Neurometabolic Portfolio at SSIEM 2024

A nomination to add MLD to the U.S. Recommended Uniform Screening Panel has been submitted by a multi-disciplinary expert working group

Orchard Therapeutics Celebrates Global Progress toward Advancing Newborn Screening for MLD on International Neonatal Screening Day

Eight presentations showcase the broad applicability of HSC gene therapy to address rare neurometabolic diseases and beyond Eight presentations showcase the broad applicability of HSC gene therapy to address rare neurometabolic diseases and beyond

Orchard Therapeutics Announces Multiple Presentations at ASGCT 2024

TOKYO, LONDON and BOSTON, May 03, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced that Bobby Gaspar, M.D., Ph.D., co-founder and chief executive officer, has been named to the inaugural 2024 TIME100 Health, an annual list recognizing the impact, innovation, and achievement of the world's most influential individuals in health this year. The full list and related tributes will appear in the May 13, 2024 issue of TIME and is available online at https://time.com/collection/time100-health/.

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

Five specialized treatment centers being qualified across the U.S. to minimize travel burden on eligible patients and their families

Orchard Therapeutics Outlines U.S. Launch Plans for Lenmeldy™ (atidarsagene autotemcel), the Only Approved Therapy for Children with Early-onset Metachromatic Leukodystrophy

One-time treatment with Lenmeldy has shown the potential to restore enzymatic function to stop or slow disease progression, with up to 12 years of follow-up (median 6.76 years) One-time treatment with Lenmeldy has shown the potential to restore enzymatic function to stop or slow disease progression, with up to 12 years of follow-up (median 6.76 years)

Orchard Therapeutics Receives FDA Approval of Lenmeldy™ (atidarsagene autotemcel), the Only Therapy for Eligible Children with Early-onset Metachromatic Leukodystrophy in the U.S.

The U.S. Food and Drug Administration said on Monday it had approved UK-based Orchard Therapeutics' gene therapy for the treatment of children with a rare hereditary disease called metachromatic leukodystrophy (MLD).

US approves first gene therapy for rare genetic disease

Gene therapy being developed as a one-time treatment to address the underlying cause of the disease by inserting a functional copy of the human IDUA gene into a patient's own hematopoietic stem cells

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

Three oral presentations and seven posters highlight transformative potential of HSC gene therapy and newborn screening to address severe neurometabolic diseases Three oral presentations and seven posters highlight transformative potential of HSC gene therapy and newborn screening to address severe neurometabolic diseases

Orchard Therapeutics Announces Multiple Presentations at the 20th Annual WORLDSymposium

BOSTON and LONDON, Jan. 25, 2024 (GLOBE NEWSWIRE) -- 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). The agreement covers several member countries, including Belgium, The Netherlands, and Ireland. It follows similar arrangements made with reimbursement authorities in the United Kingdom (UK), Italy, Germany, Sweden, Iceland, Finland and Norway, and is a key component of the company's geographic expansion plans.

Orchard Therapeutics Announces Agreement with the Beneluxa Consortium Enabling Reimbursed Access to Libmeldy

TOKYO & LONDON & BOSTON--(BUSINESS WIRE)--Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) a Japan-based global specialty pharmaceutical company (J-GSP) discovering and developing novel medicines utilizing the latest biotechnology, and Orchard Therapeutics plc (Orchard Therapeutics, Nasdaq: ORTX), a global gene therapy leader, today announced Kyowa Kirin has successfully completed the acquisition of Orchard Therapeutics. The acquisition of all outstanding shares of Orchard Therapeutics by way of.

Kyowa Kirin Successfully Completes Acquisition of Orchard Therapeutics, a Global Gene Therapy Leader for Rare Diseases

TOKYO and LONDON and BOSTON, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) a Japan-based global specialty pharmaceutical company (J-GSP) discovering and developing novel medicines utilizing the latest biotechnology, and Orchard Therapeutics plc (Orchard Therapeutics, Nasdaq: ORTX), a global gene therapy leader, today announced Kyowa Kirin has successfully completed the acquisition of Orchard Therapeutics.

Kyowa Kirin successfully completes acquisition of Orchard Therapeutics, a global gene therapy leader for rare diseases

BOSTON and LONDON, Dec. 11, 2023 (GLOBE NEWSWIRE) -- 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).

Orchard Therapeutics Receives Swissmedic Approval for Libmeldy in Early-onset MLD

Previously reported results from ongoing proof-of-concept study showed extensive metabolic correction, continued cognitive, motor, and physical development, as well as early improvements in skeletal health Additionally, study investigators presented favorable outcomes for other disease manifestations not effectively addressed by the current standard of care at ESGCT 2023 Global registrational trial expected to commence by year-end BOSTON and LONDON, Nov. 30, 2023 (GLOBE NEWSWIRE) -- 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). Fast Track designation is intended to expedite the development of promising medicines that address serious medical needs.

Orchard Therapeutics Receives U.S. FDA Fast Track Designation for OTL-203 in MPS-IH

NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Orchard Therapeutics plc (NasdaqCM: ORTX) to Kyowa Kirin Co., Ltd. Under the terms of the proposed transaction, shareholders of Orchard will receive $16.00 in cash, as well as a non-transferable contingent value right (for a cash payment of $1.00 per ADS related to the approval of OTL-200 for the treatment of.

ORCHARD THERAPEUTICS INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Orchard Therapeutics plc - ORTX

Reported $5.6 million in quarterly Libmeldy net revenue and $12.7 million year-to-date Planned acquisition by Kyowa Kirin valued at up to $477.6 million with an anticipated closing in the first quarter of 2024 Biologics License Application for OTL-200 in MLD accepted by U.S. FDA under Priority Review; PDUFA date set for March 18, 2024 Ten prospective newborn screening studies are active globally with approximately 200,000 babies screened Eight presentations at ESGCT highlighted the differentiated profile and potential broad applicability of the company's HSC gene therapy platform BOSTON and LONDON, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced several business accomplishments along with its financial results for the quarter ended September 30, 2023. “With strong execution across our key commercial, regulatory and clinical priorities, 2023 has been a transformational year for Orchard Therapeutics, culminating with the announcement of the planned acquisition by Kyowa Kirin,” said Bobby Gaspar, M.D.

Orchard Therapeutics Reports Third Quarter 2023 Financial Results and Highlights Recent Business Accomplishments

New clinical data beyond previously reported neurological and skeletal results demonstrate favorable outcomes for multiple disease manifestations not effectively addressed by the current standard of care New clinical data beyond previously reported neurological and skeletal results demonstrate favorable outcomes for multiple disease manifestations not effectively addressed by the current standard of care

Orchard Therapeutics Announces Presentation of Additional Positive Data from Proof-of-concept Study of OTL-203 in MPS-IH at ESGCT 2023

Eight presentations highlight the differentiated profile and broad applicability of the company's HSC gene therapy platform

Orchard Therapeutics Announces Multiple Presentations at ESGCT 2023

Orchard (ORTX) is set to be acquired by Kyowa Kirin for a consideration of $17 per American Depositary Share, which amounts to a total transaction value of approximately $478 million. Shares rise 97%.

Orchard (ORTX) Up 97% on $478M Acquisition Deal With Kyowa Kirin

Orchard Therapeutics PLC Sponsored ADR (ORTX) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

Orchard Therapeutics PLC Sponsored ADR (ORTX) Surges 96.0%: Is This an Indication of Further Gains?

Orchard Therapeutics, a small-cap gene therapy company, landed a premium-rich buyout offer from Kyowa Kirin today. With biotech valuations under pressure from high-interest rates, this deal may be the start of a broader consolidation phase for the industry.

Why Orchard Therapeutics Stock Is Soaring Today

Orchard scored a buyout deal worth up to $478 million from Japan's Kyowa Kirin on Thursday, pushing highly rated ORTX stock to a two-year high.

Highly Rated Biotech Orchard Therapeutics Scores A Takeover, Shares Nearly Double

Shares of Orchard Therapeutics (NASDAQ: ORTX) almost doubled this morning after Kyowa Kirin Co Ltd (TYO: 4151) announced plans of buying the gene therapy company. Details of Orchard-Kyowa definitive agreement The Japanese specialty pharmaceutical firm is willing to spend about $387.4 million on the acquisition.

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