Autolus Reports $74.3M FY25 Revenue, Obe-cel Earns FDA RMAT for Pediatric B-ALL
Summary
Autolus Therapeutics announced its Q4 and full year 2025 financial results, reporting net product revenue of $74.3 million for the full year, driven by strong U.S. sales of AUCATZYL. The company also provided significant positive business updates, including the successful launch of AUCATZYL in the UK and compelling real-world data reinforcing its safety and efficacy profile. Critically, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel for pediatric relapsed or refractory B-ALL in October 2025, following positive preliminary Phase 1 data showing a 95.5% overall response rate. Further positive data was reported for obe-cel in lupus nephritis, with a Phase 2 trial now enrolling, and initial clinical development for progressive multiple sclerosis. These updates highlight strong commercial execution and significant pipeline advancement, particularly the RMAT designation which could accelerate development and regulatory review for a key indication. Investors will be watching for continued AUCATZYL adoption and further clinical data from the obe-cel programs.
At the time of this announcement, AUTL was trading at $1.32 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $343.3M. The 52-week trading range was $1.11 to $2.70. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.