Autolus Receives positive CHMP opinion for Aucatzyl in r/r adult ALL in the EU

Friday during trading hours, Autolus announced the EMA's CHMP issued a positive opinion for Aucatzyl (CD19 CAR-T) in r/r adult ALL. The European Commission is expected to make a decision on marketing approval in the EU within approx. 2 months, and usually follows the CHMP opinion. Commercial launch in Europe is expected to be on a country by country basis, and the company has previously indicated that the initial focus in Europe will be on Germany and the UK. With initial US sales showing solid uptake in 1Q25, we look forward to longer follow up from the phase 2 (FELIX) trial at EHA in June 2025, which could further boost uptake. We increase our POS for the EU to 100% (from 90%), and maintain our $ 10 TP and Buy rating.