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Orchard Therapeutics plc (ORTX) Create: Alert

All | News | Filings
Date FiledTypeDescription
10/05/2023 8-K Entry into a Material Definitive Agreement, Departure of Directors or Certain Officers; Election of Directors; Appointment of...
Docs: "Form of Irrevocable Undertaking",
"TRANSACTION AGREEMENT by and between KYOWA KIRIN CO., LTD. and ORCHARD THERAPEUTICS PLC Dated as of October 5, 2023",
"Form of Irrevocable Undertaking",
"Kyowa Kirin to Acquire Orchard Therapeutics"
08/03/2023 8-K Investor presentation, Quarterly results
Docs: "Orchard Therapeutics Completes Submission of Biologics License Application for OTL-200 in MLD to U.S. FDA Reported $6.6M in Q2’23 Libmeldy net sales, representing the highest quarter to date $34.0M of additional capital from second closing of strategic financing extends runway to mid-2025 Four MLD patients identified from ~150,000 newborns screened in prospective studies suggests significantly higher incidence than previously estimated in the medical literature Six presentations at ASGCT demonstrate the ability of HSC gene therapy to address neurometabolic and CNS disorders, as well as larger indications Company to host conference call and live webcast today at 8:00 a.m. EDT",
"FTD BONE INTESTINE BRAIN LIVER MPS-IH HSC"
05/23/2023 8-K Regulation FD Disclosure, Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "TIME AGENDA TOPIC SPEAKERS 8:00",
"Orchard Therapeutics Presents Data from Research Programs at ASGCT Demonstrating the Ability of HSC Gene Therapy to Address Larger Indications Preclinical proof-of-concept data show the therapeutic potential of OTL-104 for NOD2 Crohn’s disease, a severe and treatment-refractory form of the disease In vivo data demonstrate the development of CAR-Treg cells from genetically engineered HSCs as a potential one-time treatment for autoimmune disorders Company to host conference call and webcast Tuesday, May 23 at 8:00 a.m. EDT BOSTON and LONDON, May 18, 2023, -- Orchard Therapeutics , a global gene therapy leader, today presented new data from the company’s hematopoietic stem cell gene therapy research pipeline targeting larger indications at the ongoing 26th Annual Meeting of the American Socie...",
"Orchard Therapeutics Announces Positive Clinical and Preclinical Data in Programs Targeting Neurometabolic and CNS Disorders at ASGCT New OTL-203 proof-of-concept data demonstrate extensive metabolic correction in the skeletal system of patients with MPS-IH including normal growth rates, improvement in joint function and progressive acquisition of motor skills Updated OTL-201 data from ongoing proof-of-concept study in MPS-IIIA patients show additional favorable neurocognitive outcomes compared to disease natural history with median follow-up of 2.5 years First preclinical data for OTL-204 highlight ability of HSC gene therapy to restore microglial function, modulate neuroinflammation, and normalize predictive biomarkers in the progranulin form of frontotemporal dementia Company to host co..."
05/15/2023 8-K Quarterly results
Docs: "Orchard Therapeutics Reports First Quarter 2023 Financial Results and Announces Initiation of Rolling Submission for Biologics License Application of OTL-200 for Metachromatic Leukodystrophy to U.S. FDA OTL-200 Biologics License Application submission completion anticipated in mid-2023 Libmeldy revenue and commercial patients treated expected to grow year-over-year in 2023 New clinical data in MPS-I and MPS-IIIA and pre-clinical data in genetic subsets of frontotemporal dementia and Crohn’s to be presented this week at ASGCT Closed initial $34M of potential $188M in proceeds as part of strategic financing and ended Q1 2023 with $146M of cash and investments and runway into 2025"
03/27/2023 8-K Quarterly results
03/10/2023 8-K Regulation FD Disclosure  Interactive Data
03/06/2023 8-K Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Regulation FD Disclosure, Financial Stat...
Docs: "FORM 8-K",
"Form of Warrant",
"Securities Purchase Agreement dated March 6, 2023, by and among Orchard Therapeutics plc and the Purchasers named therein",
"Orchard Therapeutics Announces Strategic Financing Totalling up to $188 Million"
03/06/2023 8-K Quarterly results
Docs: "Orchard Therapeutics Provides Business Update and Reports 2022 Financial Results OTL-200 pre-BLA meeting granted for second quarter of 2023 following productive clinical Type B meeting with the U.S. Food and Drug Administration Strategic financing from leading healthcare investors provides up to $188 million of additional capital upon achievement of key milestones $18.8M of Libmeldy revenue in 2022 with growth expected in 2023 from ongoing commercial expansion activities in Europe Newborn screening studies have confirmed three cases of metachromatic leukodystrophy with 96,000 babies screened globally to date Company to webcast conference call today at 8:00 a.m. ET"
02/27/2023 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Orchard Therapeutics Announces Agreement Enabling Reimbursed Access to Libmeldy for All Eligible MLD Patients in Sweden"
02/24/2023 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Orchard Therapeutics Announces Presentation of Updated Integrated Analysis of OTL-200 in MLD and Reports Progress with Newborn Screening Efforts at the 19th Annual WORLDSymposium™ Administration of one-time gene therapy resulted in statistically significant improvement in severe motor impairment-free survival with up to 11 years of follow-up Composite primary endpoint used in analysis was developed through ongoing discussions with the U.S. Food and Drug Administration and has been agreed to as clinically meaningful Three genetically confirmed cases of MLD following screening of 96,000 newborns globally to date"
02/10/2023 8-K Quarterly results
01/09/2023 8-K Investor presentation
Docs: "Orchard Therapeutics Highlights Recent Progress Across HSC Gene Therapy Portfolio and Outlines Key 2023 Milestones Libmeldy® revenue totaled $5.8M in Q4 2022 and $18.8M for the full year with commercial expansion activities continuing in Europe Clinical Type B meeting with U.S. FDA to take place in early 2023 prior to OTL-200 BLA submission Ended 2022 with approximately $144M in cash and investments and reduced burn rate to support operations into Q2 2024 OTL-203 IND application cleared by U.S. FDA with global registrational trial to initiate in the second half of 2023 Preclinical proof-of-concept data for OTL-104 expected in the first half of 2023; initiating IND-enabling activities ahead of 2024 filing",
"0 1 2 5 6 8 0 1 2 3 4 5 6 7 8 10 9 4 3 7 11 12 13 14 15 16"
01/05/2023 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Orchard Therapeutics Announces U.S. FDA Clearance of IND Application for OTL-203 in MPS-IH Global registrational trial expected to commence in the second half of 2023"
12/12/2022 8-K Quarterly results
11/14/2022 8-K Quarterly results
10/06/2022 8-K Quarterly results
08/04/2022 8-K Quarterly results
Docs: "Orchard Therapeutics Reports Second Quarter 2022 Financial Results and Reviews Recent Business Highlights Additional Libmeldy® reimbursement discussions advancing across Europe with product sales totaling $3.1M in Q2 and $8.2M YTD OTL-200 U.S. BLA filing for MLD on track for late 2022 / early 2023 Seven abstracts accepted at SSIEM highlight potential of HSC gene therapy platform to address difficult-to-treat neurodegenerative disorders Ended Q2 with $170.9M of cash and investments and runway into 2024; R&D expenses in Q2 declined 22% from the prior quarter"
06/10/2022 8-K Quarterly results
05/12/2022 8-K Quarterly results
04/08/2022 8-K Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing  Interact...
03/30/2022 8-K Quarterly results
Docs: "Orchard Therapeutics Extends Runway into 2024, Focusing HSC Gene Therapy Platform Exclusively on Severe Neurometabolic Diseases and Research Platform Libmeldy European launch momentum building with multiple MLD patients treated and strong recognition of value proposition; U.S. BLA filing of OTL-200 on track for late 2022 / early 2023"
02/04/2022 8-K Quarterly results
01/21/2022 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Orchard Therapeutics Announces Publication in The Lancet of Long-term Clinical Outcomes with Libmeldy for the Treatment of Children with Early-onset MLD Administration of one-time hematopoietic stem cell gene therapy resulted in sustained, clinically meaningful benefits by preserving cognitive function and motor development in most patients"
01/10/2022 8-K Investor presentation
Docs: "Orchard Therapeutics Announces Recent Commercial and Regulatory Progress for Late-stage HSC Gene Therapy Programs and Outlines Key 2022 Milestones Launch Momentum Building for Libmeldy® in Europe with Health Technology Assessments Progressing Favorably and Treatment Underway for Multiple Commercial Patients",
"Presentation of Orchard Therapeutics plc"
11/18/2021 8-K Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Orchard Therapeutics Announces New England Journal of Medicine Publication of Interim Proof-of-concept Study Results of OTL-203 for Hurler Syndrome 100 percent overall survival with median follow-up of two years post-treatment with HSC gene therapy"
11/04/2021 8-K Quarterly results
Docs: "Orchard Therapeutics Reports Third Quarter 2021 Financial Results and Highlights Recent Business Updates Updates from OTL-201 Clinical Proof-of-Concept Study in MPS-IIIA and OTL-204 Preclinical Study for GRN-FTD at ESGCT Showcase Potential for HSC Gene Therapy in Multiple Neurodegenerative Disorders"
09/14/2021 8-K Quarterly results
09/14/2021 8-K Quarterly results
08/04/2021 8-K Quarterly results
07/01/2021 8-K Regulation FD Disclosure, Other Events, Financial Statements and Exhibits  Interactive Data
Docs: "Orchard Therapeutics and Pharming Group Announce Collaboration to Develop and Commercialize ex vivo autologous HSC Gene Therapy for Hereditary Angioedema Highlights the broader potential of Orchard’s ex vivo HSC gene therapy platform approach in new and larger indications"
06/29/2021 8-K Quarterly results
06/22/2021 8-K Quarterly results
06/04/2021 8-K Quarterly results
05/28/2021 8-K Quarterly results
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