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Orchard Therapeutics plc (ORTX) Create: Alert

All | News | Filings
Date FiledTypeDescription
10/05/2023 DEFA14C Form DEFA14C - Additional information statement materials, definitive:
10/05/2023 DEFA14C Form DEFA14C - Additional information statement materials, definitive:
10/05/2023 DEFA14C Form DEFA14C - Additional information statement materials, definitive:
10/05/2023 DEFA14C Form DEFA14C - Additional information statement materials, definitive:
10/05/2023 DEFA14C Form DEFA14C - Additional information statement materials, definitive:
10/05/2023 DEFA14A Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material:
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"
08/22/2023 EFFECT Form EFFECT - Notice of Effectiveness:
08/21/2023 424B3 Form 424B3 - Prospectus [Rule 424(b)(3)]:
08/10/2023 S-8 Form S-8 - Securities to be offered to employees in employee benefit plans:
08/10/2023 S-3 Form S-3 - Registration statement under Securities Act of 1933:
08/10/2023 10-Q Quarterly Report for the period ended June 30, 2023
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 10-Q Quarterly Report for the period ended March 31, 2023
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"
04/27/2023 ARS Form ARS - Annual Report to Security Holders:
04/27/2023 DEF 14A Form DEF 14A - Other definitive proxy statements:
04/13/2023 PRE 14A Form PRE 14A - Other preliminary proxy statements:
03/27/2023 8-K Quarterly results
03/23/2023 D Form D - Notice of Exempt Offering of Securities:
03/20/2023 SC 13G Form SC 13G - Statement of acquisition of beneficial ownership by individuals:
03/20/2023 SC 13G RA CAPITAL MANAGEMENT, L.P. reports a 10% stake in ORCHARD THERAPEUTICS PLC
03/14/2023 10-K Annual Report for the period ended December 31, 2022
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"
02/13/2023 SC 13G/A Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend]
02/10/2023 SC 13G/A Flynn James E reports a 2.5% stake in Orchard Therapeutics plc
02/10/2023 F-6 POS Form F-6 POS - Post-effective amendments for immediately effective filing:
02/10/2023 8-K Quarterly results
02/09/2023 SC 13G/A Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend]
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