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Orchard Therapeutics plc (ORTX) Create: Alert

All | News | Filings
Date FiledTypeDescription
12/02/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Announces the Filing and Validation of Marketing Authorization Application by European Medicines Agency for OTL-200 for the Treatment of Metachromatic Leukodystrophy Application Being Evaluated Under Accelerated Assessment"
11/18/2019 6-K Quarterly results
11/13/2019 6-K Quarterly results
11/07/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
11/06/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Lentiviral Hematopoietic Stem and Progenitor Cell Gene Therapy for Wiskott-Aldrich Syndrome : Up to 8 Years of Follow up in 17 Subjects Treated Since 2010 Publication Number: 3346 Session: 801. Gene Therapy and Transfer: Poster II Date and time: Sunday, December 8, 6:00-8:00pm ET This presentation includes results from an integrated analysis of 17 patients treated with OTL-103 for the treatment of WAS, including the complete data set for the eight patients from the registrational study and nine who received OTL-103 as part of an expanded access program . Participants have been followed for a median of three years. In the eight-patient registrational trial, investigators reported that the study achieved its key primary and secondary endpoints at three years, including the elimination of sev...",
": The registrational trial has met its key primary and secondary endpoints with data from an integrated analysis reinforcing the treatment benefits of gene therapy and durability of effect in additional patients. Successful engraftment was observed within three months, leading to an increase in WAS protein expression and a vector copy number that has been maintained for up to eight years."
10/22/2019 6-K Quarterly results
09/30/2019 6-K Quarterly results
09/13/2019 6-K Quarterly results
09/04/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K - 4 SEPT 2019",
"Efficacy Data from the Integrated Analysis With the addition of nine patients treated through expanded access programs, the integrated analysis of OTL-200 has demonstrated the following: • Consistent with the results from the registrational study, patients treated with OTL-200 in the integrated data analysis demonstrated a reconstitution of arylsulfatase-A enzyme activity in the hematopoietic system and stable engraftment of gene-corrected cells within one-month of receiving treatment. • The treatment difference in gross motor function, as measured by gross motor function measurement total score, continued to increase with the addition of more patients. A statistically significant treatment difference in GMFM – above the pre-specified 10 percentage point improvement threshold...",
"About Orchard Orchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies. Orchard’s portfolio of ex vivo, autologous, hematopoietic stem cell based gene therapies includes Strimvelis®, a gammaretroviral vector-based gene therapy and the first such treatment approved by the European Medicines Agency for severe combined immune deficiency due to adenosine deaminase deficiency . Additional programs for neurometabolic disorders, primary immune deficiencies and hemoglobinopathies are all based on lentiviral vector-based gene modification of autologous HSCs and include three advanced registrational studies for metachromatic leukodystrophy , A..."
08/30/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K 8-30-2019",
"Orchard Therapeutics Further Strengthens Board of Directors with Appointment of John Curnutte, M.D., Ph.D."
08/08/2019 6-K Quarterly results
07/30/2019 6-K Quarterly results
07/01/2019 6-K Quarterly results
06/06/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Launches Proposed Public Offering BOSTON AND LONDON, June 3, 2019 - Orchard Therapeutics , a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced the launch of a proposed public offering of 9,000,000 American Depositary Shares representing 9,000,000 ordinary shares. Each of the ADSs are being offered by Orchard. Orchard expects to grant the underwriters a 30-day option to purchase up to 1,350,000 additional ADSs. Orchard intends to use the net proceeds of the offering to fund ongoing development of its product candidates, ongoing commercialization of Strimvelis ® in the European Union and the expansion of Orchard's marketing a...",
"Orchard Therapeutics Announced Pricing of Public Offering BOSTON AND LONDON, June 5, 2019 - Orchard Therapeutics , a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced the pricing of its public offering of 9,000,000 American Depositary Shares representing 9,000,000 ordinary shares, for total gross proceeds of approximately $128 million. Each of the ADSs will be offered by Orchard. In addition, the underwriters have a 30-day option to purchase from Orchard up to 1,350,000 additional ADSs at the public offering price, less underwriting discounts and commissions. The offering is expected to close on June 10, 2019, subject to customary closing condi..."
06/03/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Notice of Annual General Meeting",
"Form of Proxy",
"Depositary's Notice of Annual General Meeting",
"Voting Instructions for holders of American Depositary Shares"
05/28/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "Senior Term Facilities Agreement by and among Orchard Therapeutics plc, as borrower and guarantor, the other guarantors from time to time party thereto and MidCap Financial (Ireland) Limited, as agent, arranger and as a lender, and the additional lenders from time to time party thereto",
"Senior Term Facilities Agreement by and among Orchard Therapeutics plc, as borrower and guarantor, the other guarantors from time to time party thereto and MidCap Financial (Ireland) Limited, as agent, arranger and as a lender, and the additional lenders from time to time party thereto"
05/28/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Mucopolysaccharidosis Type I : Orchard has been granted an exclusive worldwide license from Fondazione Telethon and Ospedale San Raffaele to research, develop, manufacture and commercialize an ex vivo autologous HSC gene therapy program for the treatment of MPS-I, which will be referred to as OTL-203. The program has currently shown encouraging preliminary data with signs of metabolic correction in patients with the most severe subtype of MPS-I, known as Hurler syndrome, in the ongoing proof-of-concept clinical trial being conducted at San Raffaele-Telethon Institute for Gene Therapy in Milan, Italy. As of the data presented at the American Society of Gene & Cell Therapy annual meeting in April 2019, four patients have been enrolled in the trial with follow-up of up to nine months. The tri..."
05/28/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics, Fondazione Telethon and Ospedale San Raffaele Announce Exclusive Worldwide License Agreement for the Treatment of MPS-I"
04/29/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Announces Clinical Proof-of-Concept Data for Gene Therapy OTL-300 Demonstrating Efficacy in Transfusion-Dependent Beta-Thalassemia Study Used the GLOBE Lentiviral Vector and Treated Adult and Pediatric Patients with Severe Phenotypes"
04/25/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Announces First Patient Dosed with Cryopreserved Formulation of OTL-103 Gene Therapy for the Treatment of Wiskott-Aldrich Syndrome Program on Track for MAA and BLA Regulatory Submissions in 2021"
04/15/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Announces Presentation of Clinical Proof-of-Concept for OTL-300 for the Treatment of Transfusion-Dependent Beta-Thalassemia at the 22nd American Society of Gene & Cell Therapy Annual Meeting Data Supports Achievement of Proof-of-Concept Milestone for OTL-300"
03/27/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Presents New Registrational Data Demonstrating Sustained Clinical Benefit of OTL-200 for the Treatment of MLD Compared to Natural History, Late Infantile Patients Demonstrated Gross Motor Function Scores Higher by 65 and 72 Percentage Points at 2- and 3-Years Post Gene Therapy; Early Juvenile Patients Demonstrated Scores Higher by 40 Percentage Points at Both Time Points"
03/21/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Reports 2018 Financial Results and Reviews Recent Business Highlights Three Lead Programs for MLD, ADA-SCID and WAS on Track for Regulatory Filings Over the Next Three Years, with MLD and ADA-SCID Expected in 2020"
03/19/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Strengthens Global Manufacturing and Supply Chain Leadership with Appointment of Ran Zheng as Chief Technical Officer"
02/25/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Presents Two-Year Follow-Up Data Versus Historical Control from Registrational Trial of OTL-101 for the Treatment of ADA-SCID 100% Overall Survival and 100% Event Free Survival in Patients Treated with OTL-101 Compared to 88% OS and 56% EvFS with Historical HSCT Overall at 24 months",
"Orchard Therapeutics Presents Clinical Proof-of-Concept Data for OTL-102 for the Treatment of X-CGD"
02/06/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Announces Acceptance of Late-Breaking Abstracts of OTL-101 for ADA-SCID and OTL-102 for X-CGD at the 2019 Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR"
01/22/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K FILING",
"Orchard Announces Publication by San Raffaele-Telethon Institute for Gene Therapy of OTL-300 Clinical Data for the Treatment of Transfusion-Dependent Beta-Thalassemia in Nature Medicine Publication Highlights Encouraging Evidence of OTL-300’s Safety and Efficacy in Transfusion-Dependent Beta-Thalassemia Patients"
01/07/2019 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Highlights Recent Accomplishments and 2019 Strategic Priorities as a Global Leader in Gene Therapy",
"Orchard Therapeutics plc Presentation at the 37th Annual J.P. Morgan Healthcare Conference"
12/14/2018 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics and SIRION Biotech Announce Licensing Agreement to Enhance Gene Therapy Manufacturing Efficiency BOSTON, USA, LONDON, UK, and MARTINSRIED, Germany, December 14, 2018"
12/14/2018 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Announces the Build-out of New Gene Therapy Manufacturing Facility in California"
12/07/2018 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Orchard Therapeutics Appoints Industry Veteran Alicia Secor to its Board of Directors BOSTON and LONDON, Dec. 7, 2018 -"
12/06/2018 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "FORM 6-K",
"Donald B. Kohn, MD, Orchard Therapeutics Scientific Advisory Board Member, Presents Clinical Proof-of-Concept Data for OTL-102 Gene Therapy for the Treatment of Patients with X-CGD at the Presidential Symposium at the 2018 ASH Annual Meeting"
11/05/2018 6-K Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]:
Docs: "6-K",
"Orchard Therapeutics Announces Pricing of Initial Public Offering",
"Orchard Therapeutics Announces Closing of $225 Million Initial Public Offering, Including the Partial Exercise of Underwriters' Option"

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