Autolus Christmas came early! CAR-T hits the road with FDA approval in r/r ALL

Our life sciences top pick Autolus secured FDA approval for Aucatzyl (obe-cel, CD19 CAR-T) in r/r adult B-ALL ahead of the scheduled PDUFA date of 16 November. In our view Aucatzyl has a best in class safety profile, and the absence of a requirement for a REMS program from the FDA provides further validation of its differentiated safety. Based on KOL feedback, Aucatzyl's safety profile will be a key driver for adoption, and we think no REMS will give this a further boost! We look forward to the conference call today to learn about managements' expectations on the commercial ramp up – for now we have pencilled in peak sales of $ 380m by 2029. We update our model to lift our POS to 100% (from 90%), but maintain our $ 11 TP. Given the significant upside to the current valuation, we reiterate our Buy rating.