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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"
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"
01/10/2022 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"
01/11/2021 8-K Quarterly results
01/13/2020 8-K Investor presentation
Docs: "MLD European MAA submission: The Marketing Authorization Application for OTL-200 for MLD was filed and accepted for review by the European Medicines Agency in November 2019, ahead of previous guidance. • Cryopreserved gene therapy formulations: Similar engraftment profiles have been observed between the cryopreserved and fresh formulations of OTL-200 for MLD and OTL-101 for ADA-SCID, which represents an important achievement toward the potential approvals of these investigational gene therapies and a key step toward global patient availability. • WAS registrational data set: The registrational trial for OTL-103 for WAS met its key primary and secondary endpoints , including the elimination of severe bleeding episodes and a significant reduction in the frequency of severe infe...",
"Presentation of Orchard Therapeutics plc"

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