AUTL 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-14

• •We launched AUCATZYL in the U.K. in January 2026 and it is now available under routine commissioning.

• •Data from the Real-World Outcomes Collaborative for CAR T in Adult ALL (“ROCCA”) consortium database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL was presented at the TANDEM meeting in February 2026. Real-world data show consistency in both s…

• •The Phase 2 portion of the ongoing CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients is underway and we expect to report data at the end of 2027. The U.S. Food and Drug Administration (“FDA”) has granted regenerative medicine advanced therapy (“RMAT”) designa…

• •Data from the Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (“srSLE”) supported progression of obe-cel as a treatment for LN and selection of the recommended Phase 2 dose of 50 million cells. Following alignment with the FDA on a potential registrational pat…

• •We have advanced obe-cel into initial clinical development to explore treatment in progressive MS. The Phase 1 BOBCAT trial, expected to include up to 18 adult patients, is enrolling and will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory pro…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• •We have 60 cancer treatment centers fully activated in the United States of November 12, 2025, achieving the target of 60 activated centers prior to year-end.

• •Patient access to AUCATZYL continues to increase, with coverage secured for greater than 90% of total United States medical lives.

• •The United Kingdom Medicines and Healthcare products Regulatory Agency (“MHRA”) granted AUCATZYL conditional marketing authorization in April 2025, and Autolus has since engaged with the National Institute for Health and Care Excellence (“NICE”) to obtain its recommendation for reimbursement of AUC…

• •In July 2025, the European Commission granted marketing authorization for AUCATZYL in adult patients (age 26 and older) with r/r B-ALL. Evaluation of potential pricing and feasibility of market entry opportunities in certain EU countries is ongoing; however, at this time, launch in Germany is on ho…

• •Data from the Real-World Outcomes Collaborative for CAR T in Adult ALL database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL (obecabtagene autoleucel) and TECARTUS (brexucabtagene autoleucel) for relapsed acute lymphoblastic leukemia with r/r…

相对上期新增的文字 · 来源:10-Q · 2026-05-14

• On May 13, 2026, Mr. John Berriman, a member of the board of directors of the Company since 2014, notified the Company of his intention not to stand for re-election at the Company’s 2026 Annual General Meeting of Shareholders. Mr. Berriman has indicated that this decision was not the result of any d…

相对上期删除的文字 · 来源:10-Q · 2025-11-12

• The Company's Board of directors previously designated Rob Dolski, the Company’s Chief Financial Officer, as the Company’s Principal Financial Officer and the Company’s Principal Accounting Officer for purposes of the reporting requirements of the Securities Exchange Act of 1934. On November 7, 2025…