Autolus Therapeutics Soars 10.79% on EU Approval of AUCATZYL

On July 21, 2025, Autolus Therapeutics saw a significant pre-market rise of 10.79%, driven by the European Commission's (EC) approval of AUCATZYL® (obecabtagene autoleucel) for treating adult patients aged 26 and older with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

The approval is based on the FELIX clinical trial, which demonstrated a 76.6% complete response rate in the pivotal cohort, with a median response duration of 21.2 months. The therapy's favorable safety profile, including lower rates of severe cytokine release syndrome and neurotoxicity, sets it apart from other CAR T therapies. This approval follows previous authorizations from the FDA and MHRA, expanding AUCATZYL's market reach across North America and Europe.

Autolus Therapeutics is now evaluating market entry opportunities in EU countries, a strategic move given the complex reimbursement negotiations and high manufacturing costs associated with autologous cell therapies. The company's deliberate approach aims to navigate these challenges effectively, ensuring successful commercialization of AUCATZYL in the European market.