Shares of Autolus Therapeutics PLC (NASDAQ: AUTL) surged over 5% in pre-market trading on Monday, following the company's announcement that its lead product, AUCATZYL® (obecabtagene autoleucel), has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory (r/r) adult B-cell acute lymphoblastic leukemia (B-ALL).
The FDA approval of AUCATZYL®, a CD19-targeted chimeric antigen receptor (CAR) T-cell therapy, marks a significant milestone for Autolus as it becomes the company's first commercial product. The approval triggers a $30 million milestone payment to Autolus from its collaborator Blackstone, further strengthening the company's financial position.
In addition to the FDA approval, Autolus reported positive third-quarter 2024 financial results, with cash and cash equivalents totaling $657 million as of September 30, 2024. This strong cash position is expected to support the commercialization of AUCATZYL® and the advancement of the company's pipeline programs, including AUTO8 for multiple myeloma, AUTO6NG for neuroblastoma, and AUTO1/22 for pediatric acute lymphoblastic leukemia.
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