Autolus Reports FDA Approval and NCCN Inclusion of AUCATZYL, Sets Milestones for Pipeline Growth

Autolus Therapeutics plc (NASDAQ:AUTL), a commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies to patients, today announces business updates and an overview of 2025 milestones.

"We enter 2025 with good momentum following the recent U.S. Food and Drug Administration (FDA) approval of AUCATZYL® (obecabtagene autoleucel, or "obe-cel") and publication of the FELIX trial data in the New England Journal of Medicine. In addition, the inclusion of AUCATZYL® in the NCCN Guidelines, noting the lack of REMS program associated with our therapy, provides further validation of the demonstrated clinical benefit, favorable safety profile and the potential impact of the therapy for patients in need," said Dr. Christian Itin, Chief Executive Officer of Autolus. "We are executing to plan with the commercial launch and are encouraged to enter the year with 24 authorized treatment centers out of the 30 we anticipated by end of Q1."

"With the AUCATZYL® launch on track, we look forward to updating the market on additional clinical pipeline programs that we believe will drive future growth," Dr. Itin continued. "In the second half of 2024, we undertook an R&D portfolio review to evaluate the highest priority areas for strategic investment. In our upcoming R&D investor event we will provide an outlook and plan to share initial data from the ongoing CARLYSLE Phase 1 trial in systemic lupus erythematosus (SLE)."