Autolus Therapeutics Announces FDA Acceptance of IND Application for AUTO1 for Adult Acute Lymphoblastic Leukemia
Autolus Therapeutics plc - American Depositary Shares (AUTL)
Last autolus therapeutics plc - american depositary shares earnings: 11/7 07:06 am
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Source: GlobeNewswire
LONDON, April 16, 2020 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announces that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for AUTO1, its lead CAR T product candidate for the treatment of adults with acute lymphoblastic leukemia (ALL). The active IND allows initiation of the US sites in the company’s first pivotal study, AUTO1-AL1. The AUTO1-AL1 study clinical trial application was approved by the MHRA in January 2020 and the first site opened in the UK in March of this year. The COVID-19 situation has had varying degrees of impact on the ability of clinical sites to operate normally; however, based on current expectations, the company anticipates that the impact on the AUTO1-AL1 clinical study will be minimal. The AUTO1-AL1 study has a run in phase, with a small number of pati
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AUTL
Earnings
- 11/12/25 - Miss
AUTL
Sec Filings
- 2/17/26 - Form SCHEDULE
- 2/13/26 - Form SCHEDULE
- 1/26/26 - Form 424B3
- AUTL's page on the SEC website