41 results
F-1
EX-1.1
ORTX
Orchard Therapeutics plc
3 Jun 19
Registration statement (foreign)
4:33pm
prepared the following information (collectively with the pricing information set forth on Annex A, the “Pricing Disclosure Package”): a Preliminary … a public offering of the ADSs, and initially to offer the Offered ADSs on the terms set forth in the Pricing Disclosure Package. The Company acknowledges
F-1/A
EX-1.1
ORTX
Orchard Therapeutics plc
23 Oct 18
Registration statement (foreign) (amended)
6:15am
information (collectively with the pricing information set forth on Annex A, the “Pricing Disclosure Package”): a Preliminary Prospectus dated [ ], 2018 … intend to make a public offering of the ADSs, and initially to offer the Offered ADSs on the terms set forth in the Pricing Disclosure Package
8-K
EX-99.1
ORTX
Orchard Therapeutics plc
29 Jun 21
Orchard Therapeutics Announces Regulatory and Clinical Updates for Lead Gene Therapy Programs
7:05am
EXHIBIT 99.1
Orchard Therapeutics Announces Regulatory and Clinical Updates for Lead Gene Therapy Programs
Expected clinical package for OTL-200 … recently held a productive meeting with the U.S. Food and Drug Administration (FDA) and has received written feedback concerning the clinical package
8-K
EX-99.2
ORTX
Orchard Therapeutics plc
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
. Regulatory Discussions RMAT meeting with confirmation of expected clinical package Productive Type B CMC meeting Clarity on manufacturing facility FDA … interaction planned in early 2022 to discuss elements of a potential BLA filing package OTL-200: Planned BLA submission for MLD in late 2022 / early
8-K
EX-99.2
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
initiated Apr. 2023 Pre-BLA meeting held with multi-disciplinary review team at the FDA to align on final BLA package, rolling BLA timeline and content … from members of the BLA review team Jan. 2023 Productive Type B meeting with the FDA to align on clinical package, including natural history, etc. BLA
8-K
EX-99.1
o1h5ag6vzoei4
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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11 Jan 21
Results of Operations and Financial Condition
7:05am
8-K
EX-99.1
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7 May 20
Orchard Therapeutics Unveils New Strategic Plan and Reports First Quarter 2020 Financial Results
7:03am
DRS
EX-10.5
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6 Aug 18
Draft registration statement
12:00am
F-1
EX-10.5
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4 Oct 18
Registration statement (foreign)
4:48pm
8-K
EX-99.1
cfhitisb
14 Nov 22
Orchard Therapeutics Reports Third Quarter 2022 Financial Results and Reviews Recent Business Highlights
7:10am
8-K
EX-99.1
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4 Aug 21
Orchard Therapeutics Reports Second Quarter 2021 Financial Results and Highlights Recent Business Updates
7:05am
10-Q
EX-10.1
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7 May 20
Quarterly report
4:03pm
F-1/A
EX-10.5
8purbju54k463k
23 Oct 18
Registration statement (foreign) (amended)
6:15am
8-K
EX-99.1
7prkvc
13 Nov 23
Orchard Therapeutics Reports Third Quarter 2023 Financial Results and Highlights Recent Business Accomplishments
7:05am