Autolus Aucatzyl gains EC approval in r/r adult ALL
Autolus announced that the European Commission (EC) has granted marketing authorization for Aucatzyl (obe-cel, CD19 CAR-T) for the treatment of adults aged 26+ years with r/r B-ALL. Autolus will now evaluate market entry opportunities in the EU, which we expect to take place on a country-by-country basis – the company has previously indicated that the initial focus in the EU will be on Germany. More broadly, the US commercial launch in r/r adult ALL began in early 2025, and the first quarter of sales demonstrated solid uptake (1Q25 $ 9 m with $ 4.7m in deferred revenue vs. KBCSe $ 5 m). With 2Q25 results around the corner, we believe Autolus is set up for another good quarter and reiterate our $ 10 TP and Buy rating.