51 results
8-K
EX-99.1
ORTX
Orchard Therapeutics plc
13 Nov 23
Orchard Therapeutics Reports Third Quarter 2023 Financial Results and Highlights Recent Business Accomplishments
7:05am
Fee Act (PDUFA) goal date of March 18, 2024.
OTL-200 previously received both Rare Pediatric Disease (RPD) and Regenerative Medicine Advanced Therapy
8-K
EX-99.1
ORTX
Orchard Therapeutics plc
18 Sep 23
Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review
7:07am
the devastation caused by severe genetic diseases a reality for MLD.”
OTL-200 previously received both Rare Pediatric Disease (RPD) and Regenerative Medicine
8-K
EX-99.1
ORTX
Orchard Therapeutics plc
3 Aug 23
Orchard Therapeutics Completes Submission of Biologics License Application for OTL-200 in MLD to U.S. FDA
7:05am
received both Rare Pediatric Disease (RPD) and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA. Orchard Therapeutics has
8-K
EX-99.1
7ogo2abd rox
10 Jan 22
Orchard Therapeutics Announces Recent Commercial and Regulatory Progress for Late-stage HSC Gene Therapy Programs and Outlines Key 2022 Milestones
7:05am
8-K
EX-99.1
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14 Sep 21
Orchard Therapeutics Bolsters R&D and Technical Operations Leadership with New Executive Appointments
7:00am
8-K
EX-99.1
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13 May 21
Orchard Therapeutics Reports First Quarter 2021 Financial Results and Provides Recent Business Updates
7:05am
8-K
EX-99.1
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11 May 21
Orchard Therapeutics Announces New England Journal of Medicine Publication of HSC Gene Therapy Data for ADA-SCID
6:05am