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Orchard Therapeutics plc (ORTX) Create: Alert

All | News | Filings
Date FiledTypeDescription
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"
05/15/2023 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"
03/06/2023 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"
11/14/2022 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"
05/12/2022 8-K Quarterly results
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"
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"
08/04/2021 8-K Quarterly results
03/02/2021 8-K Quarterly results
11/03/2020 8-K Quarterly results
Docs: "Orchard Therapeutics Reviews Recent Portfolio Progress and Reports Third Quarter 2020 Financial Results Libmeldy TM Receives Positive CHMP Opinion for the Treatment of Early-Onset Metachromatic Leukodystrophy ; U.S. IND Application on Track for Year End 2020"
08/06/2020 8-K Quarterly results
05/07/2020 8-K Quarterly results
Docs: "Orchard Therapeutics Unveils New Strategic Plan and Reports First Quarter 2020 Financial Results Portfolio Investments More Tightly Prioritized Around High Need, High Value Indications"
02/27/2020 8-K Quarterly results
Docs: "Orchard Therapeutics Reports 2019 Financial Results and Reviews Key Strategic Priorities for 2020 Commercial Preparations on Track for Potential Second Half 2020 EU Launch of OTL-200 for MLD with U.S. Regulatory Filing Expected Late 2020 / Early 2021"
08/08/2019 6-K Quarterly results

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