Autolus Therapeutics Secures EC Approval for AUCATZYL in Leukemia Treatment, Stock Up 301.24%

Autolus Therapeutics has secured European Commission approval for AUCATZYL to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The drug's approval is based on findings from the FELIX study. Analysts forecast an average target price of $9.67 with a potential upside of 301.24%. The company has a strong cash position of $516.6 million.

Autolus Therapeutics has received European Commission (EC) approval for its CAR T cell therapy, AUCATZYL (Obecabtagene Autoleucel), to treat adult patients (26 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The approval, based on data from the FELIX study, marks a significant milestone for the company.

The FELIX study, an open-label, single-arm, phase 1b/2 trial, demonstrated that AUCATZYL was both efficacious and safe in this patient population. In cohort 2A, the overall remission rate among patients who received at least one infusion of AUCATZYL was 77%, with 55% achieving complete remission and 21% experiencing complete remission with incomplete hematologic recovery. The median duration of response was 14.1 months, and the median event-free survival (EFS) was 9.0 months [1].

The EC approval applies to all 27 European Union Member States, Iceland, Norway, and Liechtenstein. AUCATZYL is currently approved by the U.S. Food and Drug Administration (FDA) and authorized by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) [2].

Analysts have forecasted an average target price of $9.67 for Autolus Therapeutics, with a potential upside of 301.24%. The company's strong cash position of $516.6 million supports its market entry strategy in EU countries [3].

References:
[1] https://www.cancernetwork.com/view/european-commission-grants-marketing-authorization-to-obe-cel-in-r-r-b-all
[2] https://www.marketscreener.com/news/autolus-therapeutics-plc-car-t-therapy-aucatzyl-obecabtagene-autoleucel-granted-european-market-ce7c5cdcd888f427
[3] https://www.marketbeat.com/earnings/reports/2025-8-14-autolus-therapeutics-plc-stock/