Autolus Therapeutics reports Q2 EPS (22c), consensus (19c)

“We are focused on driving commercial readiness activities across Autolus to bring our lead product obecabtagene autoleucel (obe-cel) to adult B-ALL patients. Applications for marketing authorizations are under review by regulatory agencies in the US, Europe and UK, and we are working towards a US Food and Drug Administration (FDA) PDUFA target date of November 16, 2024,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “Data from the FELIX Phase 1b/2 study with a median follow up of 21 months presented at ASCO and EHA indicate a long-term plateau forming in event-free and overall survival rates. Stem cell transplant post obe-cel did not appear to improve patient outcomes, and patients with long-term persisting obe-cel appear to have improved event free survival. The data support the potential for obe-cel as a stand-alone therapy in a portion of r/r adult ALL patients.”