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ORTX News and Press, Orchard Therapeutics plc From 09/18/23

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Company Name: Orchard Therapeutics plc
Stock Symbol: ORTX
Market: NASDAQ
Website: orchard-tx.com

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ORTX - Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review

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 ...

ORTX - Orchard Therapeutics Announces Presentation of Data Comprising the Clinical Package for the OTL-200 BLA in MLD at the SSIEM Annual Symposium 2023

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 Dr...

ORTX - Orchard Therapeutics plc (ORTX) Q2 2023 Earnings Call Transcript

2023-08-03 13:26:16 ET Orchard Therapeutics plc (ORTX) Q2 2023 Earnings Conference Call August 03, 2023, 08:30 AM ET Company Participants Bobby Gaspar - Chief Executive Officer Frank Thomas - President and COO Braden Parker - Chief Commercial Officer Confer...

ORTX - Orchard Therapeutics GAAP EPS of -$0.07 beats by $0.55, revenue of $7.3M beats by $0.81M

2023-08-03 08:44:39 ET Orchard Therapeutics press release ( NASDAQ: ORTX ): Q2 GAAP EPS of -$0.07 beats by $0.55 . Revenue of $7.3M (+67.0% Y/Y) beats by $0.81M . The company expects its cash used to fund operations in 2023 to decline as compared to 2022 due ...

ORTX - 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 sugg...

ORTX - Orchard Therapeutics Q2 2023 Earnings Preview

2023-08-02 16:08:29 ET Orchard Therapeutics ( NASDAQ: ORTX ) is scheduled to announce Q2 earnings results on Thursday, August 3rd, before market open. The consensus EPS Estimate is -$0.62 (-55.0% Y/Y) and the consensus Revenue Estimate is $6.49M (+48.5% Y/Y). Over the ...

ORTX - Orchard Therapeutics Strongly Supports Enactment of Newborn Metabolic Screening Act in Illinois, Adding Metachromatic Leukodystrophy to Statewide Panel

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,...

ORTX - Orchard Therapeutics: Highly Valued Once, Undervalued Today

2023-07-29 00:49:07 ET Summary ORTX has been a terrible destroyer of investor value. Today, it has an upcoming BLA and a decent cash runway. There are various risks here, but if things work out, there may be some upside here. I have been covering Orchard Therapeutics ( ...

ORTX - Orchard Therapeutics to Webcast Conference Call of Second Quarter 2023 Financial Results

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 202...

ORTX - Orchard raises additional $34M, initiates BLA for drug OTL-200

2023-06-26 14:29:18 ET Orchard Therapeutics ( NASDAQ: ORTX ) said that it has closed on a second $34M financing as part of a larger agreement that could garner the company up to $188M if certain regulatory milestones are met. The second financing included the issuance of 4.25M A...

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