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)
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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
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News
- CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market to Register Stunning Growth by 2032, Predicts DelveInsight | Key Companies - AUTOLUS THERAPEUTICS, CELLECTIS, WUGEN, SERVIER, ALLOGENE, PRECISION BIOSCIENCES [Yahoo! Finance]Yahoo! Finance
- CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market to Register Stunning Growth by 2032, Predicts DelveInsight | Key Companies - AUTOLUS THERAPEUTICS, CELLECTIS, WUGEN, SERVIER, ALLOGENE, PRECISION BIOSCIENCESPR Newswire
- CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market to Register Stunning Growth by 2032, Predicts DelveInsight | Key Companies - AUTOLUS THERAPEUTICS, CELLECTIS, WUGEN, SERVIER, ALLOGENE, PRECISION BIOSCIENCESPR Newswire
- Autolus Therapeutics plc (NASDAQ: AUTL) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $9.00 price target on the stock.MarketBeat
- Autolus Therapeutics Reports First Quarter 2024 Financial Results and Business Updates [Yahoo! Finance]Yahoo! Finance
AUTL
Earnings
- 5/17/24 - Miss
AUTL
Sec Filings
- 5/21/24 - Form SC
- 5/17/24 - Form 10-Q
- 5/17/24 - Form 8-K
- AUTL's page on the SEC website