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.

The FDA bestows a Regenerative Medicine Advanced Therapy status on Orchard Therapeutics' (ORTX) investigational gene therapy, OTL-200, for treating early-onset metachromatic leukodystrophy. Shares up.

Orchard (ORTX) Gets FDA's RMAT Status for Gene Therapy in MLD

Orchard Therapeutics (ORTX) stock is on the rise Wednesday with heavy trading even with there being no major news about the company. The post ORTX Stock Alert: 8 Things to Know About Gene Therapy Play Orchard Therapeutics appeared first on InvestorPlace.

ORTX Stock Alert: 8 Things to Know About Gene Therapy Play Orchard Therapeutics

BOSTON and LONDON, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company is scheduled to present at the 39th Annual J.P. Morgan Healthcare Conference being held virtually on Wednesday January 13, 2021 at 9:10 AM ET.

Orchard Therapeutics to Present at the 39th Annual J.P. Morgan Healthcare Conference

First gene therapy to receive full EU marketing authorization for eligible MLD patients

Orchard Therapeutics Receives EC Approval for Libmeldy™ for the Treatment of Early-Onset Metachromatic Leukodystrophy (MLD)

Preliminary results from first patient treated with OTL-201 show over expression of the therapeutic enzyme and decrease in substrate levels three months following gene therapy Preliminary results from first patient treated with OTL-201 show over expression of the therapeutic enzyme and decrease in substrate levels three months following gene therapy

Orchard Therapeutics Reports OTL-201 Initial Clinical Data in Sanfilippo Syndrome Type A (MPS-IIIA)

BOSTON and LONDON, Nov. 24, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that its chief executive officer, Bobby Gaspar, M.D., Ph.D. will participate in a pre-recorded fireside chat as part of the Piper Sandler 32nd Annual Virtual Healthcare Conference. Management will also be available for one-on-one meetings on Tuesday, December 1, 2020.

Orchard Therapeutics to Present at Piper Sandler 32nd Annual Virtual Healthcare Conference

BOSTON and LONDON, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for OTL-200, an autologous, hematopoietic stem cell, lentiviral vector-based gene therapy in development for the treatment of metachromatic leukodystrophy (MLD). The company also has applied for Regenerative Medicine Advanced Therapy (RMAT) designation for OTL-200 to help facilitate additional dialogue with the FDA on this important therapy.

Orchard Therapeutics Announces FDA Clearance of IND Application for OTL-200 for Metachromatic Leukodystrophy (MLD)

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BOSTON and LONDON, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company is scheduled to present at the Barclays Gene Editing & Gene Therapy Summit on November 16, 2020 at 11:15 AM ET.

Orchard Therapeutics to Present at Barclays Gene Editing & Gene Therapy Summit

Preliminary results from first patient in ongoing proof-of-concept trial show evidence of engraftment of gene-modified cells three months following treatment Preliminary results from first patient in ongoing proof-of-concept trial show evidence of engraftment of gene-modified cells three months following treatment

Orchard Therapeutics Announces New OTL-201 Clinical Data in Sanfilippo Syndrome Type A (MPS-IIIA) Accepted for Oral Presentation at 62nd American Society of Hematology Annual Meeting

Orchard just received a positive node from CHMP for its lead drug candidate. US approval should be next.

Orchard Therapeutics: An Undervalued Stock With Upcoming Catalysts

BOSTON and LONDON, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company will webcast a virtual R&D event ‘New Horizons in Gene Therapy' on Friday, November 13, 2020 from 9:00 a.m. to 11:00 a.m. ET.

Orchard Therapeutics to Host Virtual R&D Investor Event on Friday, November 13, 2020

BOSTON and LONDON, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company's chief executive officer, Bobby Gaspar, M.D., Ph.D., has been appointed to the Alliance for Regenerative Medicine's (ARM) 2021 board of directors. In collaboration with the executive committee and board of directors, Dr. Gaspar will provide guidance supporting formation and implementation of ARM's strategic priorities and focus areas over the coming year.

Orchard Therapeutics CEO Bobby Gaspar, M.D., Ph.D., Appointed to the Alliance for Regenerative Medicine's 2021 Board of Directors

First therapy recommended for full marketing authorization in the EU for eligible patients with confirmed diagnosis of late infantile or early juvenile MLD variants

Orchard Therapeutics Receives Positive CHMP Opinion for Libmeldy™ for the Treatment of Early-Onset Metachromatic Leukodystrophy (MLD)

BOSTON and LONDON, Sept.  28, 2020  (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to OTL-203, an investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy in development for the treatment of mucopolysaccharidosis type I (MPS-I) at the San Raffaele Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy.

Orchard Therapeutics Receives EMA PRIME Designation for OTL-203 for the Treatment of MPS-I

BOSTON and LONDON, Sept.  09, 2020  (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company is scheduled to present at the following virtual investor conferences in September:

Orchard Therapeutics to Present at Upcoming Virtual Investor Conferences

Data on all eight patients demonstrate sustained engraftment and supranormal IDUA enzyme expression

Orchard Therapeutics Announces Additional Interim Results from Proof-of-Concept Study of OTL-203 for MPS-I

BOSTON and LONDON, Aug.  24, 2020  (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced presentations at the upcoming 46th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), taking place virtually from August 29 - September 1, 2020. New interim data from OTL-203, an investigational gene therapy for the treatment of mucopolysaccharidosis type I (MPS-I), will be shared as part of an invited oral presentation titled ‘Gene Therapy in Leucodystrophies and Other Metabolic Disorders’.

Orchard Therapeutics Announces Clinical Data Presentations at the 46th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT)

Orchard Therapeutics plc (ORTX) CEO Bobby Gaspar on Q2 2020 Results - Earnings Call Transcript

BOSTON and LONDON, Aug.  04, 2020  (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company is scheduled to present at the Wedbush PacGrow Healthcare Virtual Conference on August 11, 2020 at 9:10 AM ET.    

Orchard Therapeutics to Present at Wedbush PacGrow Healthcare Virtual Conference

Orchard Therapeutics: An Undervalued Gene Therapy Company

BOSTON and LONDON, July  20, 2020  (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company has received both orphan drug designation and rare pediatric disease designation from the U.S Food and Drug Administration (FDA) for OTL-203, an ex vivo autologous hematopoietic stem cell (HSC) gene therapy in development for the treatment of mucopolysaccharidosis type I (MPS-I). 

Orchard Therapeutics Announces Orphan Drug and Rare Pediatric Disease Designations for OTL-203 for the Treatment of MPS-I

BOSTON and LONDON, July  15, 2020  (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company has entered into two worldwide royalty-bearing license agreements with GlaxoSmithKline plc (GSK) (LSE/NYSE: GSK) for use of their proprietary lentiviral stable cell line technology (LV-SCLT) for Orchard’s investigational hematopoietic stem cell gene therapies for Wiskott Aldrich syndrome (OTL-103 for WAS) and transfusion-dependent beta thalassemia (OTL-300 for TDT).

Orchard Therapeutics Announces Global License Agreements for Stable Cell Line Technology from GSK

BOSTON and LONDON and MILAN, Italy, July  09, 2020  (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, and MolMed S.p.A (MLMD.MI), one of the company’s principal contract development and manufacturing partners, today announced that they have extended their collaboration –  initiated in April 2018  – for a period of five years through June 2025.

Orchard Therapeutics and MolMed Announce Extension of Gene Therapy Manufacturing Collaboration

BOSTON and LONDON, May  27, 2020  (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that presentations by the management team will be made at the following investor conferences in June:

News for Orchard Therapeutics plc - ADR Stock (ORTX)