LONDON and GAITHERSBURG, Md., July 21, 2025 - Autolus Therapeutics plc (Nasdaq: AUTL), a biopharmaceutical company focusing on next-generation T cell therapies, announced that the European Commission $(EC)$ has granted marketing authorization for their CAR T Therapy, AUCATZYL® (obecabtagene autoleucel or "obe-cel"). This approval is for adult patients 26 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The decision follows a positive opinion from the Committee for Medicinal Products for Human Use $(CHMP)$, as well as conditional marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and approval from the U.S. Food and Drug Administration (FDA). The EC approval is applicable across all 27 European Union Member States, in addition to Iceland, Norway, and Liechtenstein. Autolus is now exploring market entry opportunities within these regions.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.