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Stock impact report

Autolus Therapeutics announces acceptance of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for obecabtagene autoleucel (obe-cel) for Patients with Relaps...

Autolus Therapeutics plc - American Depositary Shares (AUTL) 
Last autolus therapeutics plc - american depositary shares earnings: 11/7 07:06 am Check Earnings Report
US:NASDAQ Investor Relations: autolus.com/investor-relations
Company Research Source: GlobeNewswire
Submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in r/r B-ALLThe US marketing application is under review with a Prescription Drug User Fee Act (PDUFA) target action date of November 16, 2024 LONDON, April 02, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the European Medicines Agency (EMA) has accepted the Company’s Marketing Authorization Application (MAA) for obecabtagene autoleucel (obe-cel). Obe-cel is Autolus’ lead investigational chimeric antigen receptor (CAR) T cell therapy, for the treatment of patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL). The MAA submission was based on data from the pivotal Phase 2 FELIX study of obe-cel in adult r/r B-ALL. Autolus’ Nucleus site has recently received the formal certification from the MHRA following a full inspection of the si Show less Read more
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