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Orchard Therapeutics (NASDAQ: ORTX) Stock Quote

Last Trade: US$16.70
Volume: 0
5-Day Change: 1.58%
YTD Change: 1.52%
Market Cap: US$380.090M

Latest News From Orchard Therapeutics

Five specialized treatment centers being qualified across the U.S. to minimize travel burden on eligible patients and their families Orchard Assist patient services program to provide individualized support throughout the treatment process Lenmeldy wholesale acquisition cost of $4.25 million for one-time treatment reflects its clinical, economic and societal value Innovative outcomes- and value-based agreements are being... Read More
TOKYO and LONDON and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics , recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced the U.S. Food and Drug Administration (FDA) has approved Lenmeldy™ (atidarsagene autotemcel), formerly known as OTL-200, for the treatment of children with pre-symptomatic late infantile (PSLI),... Read More
Gene therapy being developed as a one-time treatment to address the underlying cause of the disease by inserting a functional copy of the human IDUA gene into a patient’s own hematopoietic stem cells HURCULES study to enroll 40 patients at clinical sites across the U.S. and Europe TOKYO, LONDON and BOSTON, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics , recently acquired by Kyowa Kirin with the goal of accelerating... Read More
BOSTON and LONDON, Feb. 02, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics , a global gene therapy leader recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced 10 presentations from across its neurometabolic portfolio will be featured at the 20th Annual WORLD Symposium™ taking place February 4-9, 2024, in San Diego, California. Featured... Read More
BOSTON and LONDON, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics , a global gene therapy leader, today announced the company has reached an agreement with the Beneluxa Initiative on Pharmaceutical Policy (Beneluxa) enabling reimbursed access to Libmeldy ® (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy, approved for the treatment of early-onset metachromatic leukodystrophy (MLD). The... Read More
TOKYO and LONDON and BOSTON, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) a Japan-based global specialty pharmaceutical company (J-GSP) discovering and developing novel medicines utilizing the latest biotechnology, and Orchard Therapeutics plc (Orchard Therapeutics, Nasdaq: ORTX), a global gene therapy leader, today announced Kyowa Kirin has successfully completed the acquisition of... Read More
BOSTON and LONDON, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the Swiss Agency for Therapeutic Products (Swissmedic) has approved Libmeldy ® (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy, for the treatment of early-onset metachromatic leukodystrophy (MLD). MLD is a rare, fatal genetic disorder caused by a mutation in the gene... Read More
Previously reported results from ongoing proof-of-concept study showed extensive metabolic correction, continued cognitive, motor, and physical development, as well as early improvements in skeletal health Additionally, study investigators presented favorable outcomes for other disease manifestations not effectively addressed by the current standard of care at ESGCT 2023 Global registrational trial expected to commence by... Read More
Reported $5.6 million in quarterly Libmeldy net revenue and $12.7 million year-to-date Planned acquisition by Kyowa Kirin valued at up to $477.6 million with an anticipated closing in the first quarter of 2024 Biologics License Application for OTL-200 in MLD accepted by U.S. FDA under Priority Review; PDUFA date set for March 18, 2024 Ten prospective newborn screening studies are active globally with approximately 200,000... Read More
BOSTON and LONDON, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced a range of interim clinical outcomes, in addition to the previously reported neurological and skeletal results, from the company’s ongoing proof-of-concept (PoC) study of OTL-203, a hematopoietic stem cell (HSC) gene therapy in development for the treatment of the Hurler subtype of... Read More
Eight presentations highlight the differentiated profile and broad applicability of the company’s HSC gene therapy platform Data from proof-of-concept study of OTL-203 in MPS-IH demonstrate favorable outcomes for clinical manifestations of the disease not well addressed by the current standard-of-care Chief Technical Officer Nicoletta Loggia, Ph.D., to give invited talk on manufacturing strategies and innovations aimed at... Read More
Orchard Therapeutics is a global gene therapy leader with experience successfully developing and commercializing medicines for rare diseases Acquisition enriches Kyowa Kirin’s portfolio, enables the development of numerous promising candidates with a clinically differentiated platform, and helps resource the ongoing and future launches of Libmeldy ® (atidarsagene autotemcel) Acquisition price of $16.00 per ADS in cash plus... Read More
PDUFA date set for March 18, 2024 OTL-200 would be the first and only treatment in the U.S. for early-onset MLD Previously published data demonstrated administration of one-time gene therapy enables sustained preservation of motor function and cognitive development BOSTON and LONDON, Sept. 18, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug... Read More
Administration of one-time gene therapy resulted in statistically significant improvement in severe motor impairment-free survival with up to 12 years of follow-up (median 6.76 years) Composite primary endpoint used in analysis was developed through discussions with the U.S. Food and Drug Administration Extended follow-up continues to demonstrate sustained preservation of cognitive function and motor development in most... Read More
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... Read More
BOSTON and LONDON, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, expresses its strong appreciation for the passage of the Newborn Metabolic Screening Act in Illinois, also known as SB67. The law, anticipated to go into effect in January 2024, mandates the expansion of the Illinois Department of Public Health’s Newborn Screening program to include metachromatic... Read More
BOSTON and LONDON, July 25, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company will host a conference call and live webcast on Thursday, August 3, 2023, at 8:00 a.m. EDT to review business updates and its second quarter 2023 financial results. A live webcast will be available under "News & Events" in the Investors & Media section of the company's... Read More
Funding from second closing extends cash runway to mid-2025 to advance the company’s HSC gene therapy portfolio through several potential value-creating milestones OTL-200 (MLD) BLA submission initiated and on track for completion in mid-2023 with potential for U.S. approval in the first half of 2024 BOSTON and LONDON, June 26, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today... Read More
BOSTON and LONDON, May 24, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company will make a virtual presentation at Stifel’s Inaugural Genetic Medicines Day on Tuesday, May 30, 2023 at 5:00 p.m. EDT. A webcast of the presentation will be available under "News & Events" in the Investors & Media section of the company's website at www.orchard-tx.com . A... Read More
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... Read More
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 (GLOBE... Read More
OTL-200 Biologics License Application (BLA) 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... Read More
Six presentations showcase the differentiated profile and broad applicability of the company’s HSC gene therapy platform Oral presentations in MPS-IH and MPS-IIIA and the progranulin form of frontotemporal dementia highlight leadership in neurometabolic and CNS diseases Pre-clinical data in NOD2-Crohn’s disease and HSC-Tregs demonstrate potential in larger indications BOSTON and LONDON, May 03, 2023 (GLOBE NEWSWIRE) --... Read More
BOSTON and LONDON, March 30, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company will make a virtual presentation at the Guggenheim Genomic Medicines and Rare Disease Day on Tuesday, April 4, 2023 at 1:35pm ET. A live webcast of the presentation will be available under "News & Events" in the Investors & Media section of the company's website at... Read More
BOSTON and LONDON, March 10, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the Company’s previously disclosed change to its American Depositary Share ("ADS") to ordinary share ratio has been made effective. The ratio has changed from one ADS to one ordinary share to the new ratio of one ADS to ten ordinary shares. For the Company's ADS holders, the change in... Read More
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 (FDA) 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... Read More
Proceeds to accelerate commercialization of Libmeldy and advance the company’s HSC gene therapy R&D portfolio Initial closing of $34 million to support execution and extend cash runway into 2025 with potential for significant additional capital at increasing valuations BOSTON and LONDON, March 06, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that it has entered... Read More
BOSTON and LONDON, March 03, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that members of the management team will present at the following investor conferences: TD Cowen 43 rd Annual Healthcare Conference on March 7, 2023, at 10:30 a.m. ET as part of a panel discussion focused on orphan neurology drug discovery and development (Boston) Oppenheimer 33 rd Annual... Read More
BOSTON and LONDON, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced it has reached an agreement with the New Therapies (NT) Council which will result in reimbursed access to Libmeldy ® (atidarsagene autotemcel) for all metachromatic leukodystrophy (MLD) patients who fall within the scope of the European marketing authorization in Sweden. Libmeldy received... Read More
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 (median 6.15 years) 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... Read More
BOSTON and LONDON, Feb. 10, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that it plans to change the ratio of its American Depositary Shares ("ADSs") to its ordinary shares (the "ADS Ratio"), nominal value £0.10 per share, from the current ADS Ratio of one (1) ADS to one (1) ordinary share to a new ADS Ratio of one (1) ADS to ten (10) ordinary shares (the “ADS... Read More
BOSTON and LONDON, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced a series of presentations from across its neurometabolic portfolio will be featured at the 19th Annual WORLD Symposium taking place February 22-26, 2023, in Orlando, Florida. Featured presentations include results from an updated integrated analysis of 39 patients with metachromatic... Read More
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 (MLD) BLA submission Ended 2022 with approximately $144M in cash and investments and reduced burn rate to support operations into Q2 2024 OTL-203 (MPS-IH) IND application cleared by U.S. FDA with global... Read More
BOSTON and LONDON, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OTL-203, a hematopoietic stem cell (HSC) gene therapy being developed for the treatment of the Hurler subtype of mucopolysaccharidosis type I (MPS-IH). The company expects to initiate a... Read More
All patients achieved sustained engraftment and supraphysiological SGSH enzyme levels with median 1.5 years follow-up Four out of five patients demonstrated gain of cognitive skills in line with development in healthy children with one patient showing a marked improvement compared to disease natural history Treatment with OTL-201 was generally well-tolerated Company to host conference call and webcast at 5:00 p.m. EST BOSTON... Read More
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