原始来源记录
重大申请已受理
吉利德：FDA受理anito-cel的BLA；PDUFA日期为2026年12月23日
FDA已受理anito-cel作为复发/难治性多发性骨髓瘤四线治疗的BLA申请，该申请基于1期和关键2期iMMagine1研究数据。PDUFA行动日期定为2026年12月23日。吉利德计划收购Arcellx将使其完全掌控该资产，消除利润分成和特许权使用费。
关键事实
来源摘录
EX-99.1 4 tm267044d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 CONTACTS: Gilead Ashleigh Koss, Media public affairs@gilead.com Jacquie Ross, Investors investor relations@gilead.com Arcellx Kristalle Cooks, Media pr@Arcellx.com Myesha Lacy, Investors ir@Arcellx.com GILEAD SCIENCES TO ACQUIRE ARCELLX TO MAXIMIZE LONG-TERM POTENTIAL OF ANITO-CEL – Builds on Successful 2022 Collaboration on Anito-cel, a Potentially Transformative Treatment for Patients with Multiple Myeloma – – FDA Accepted Anito-cel BLA for the Treatment of Adult Patients with Relapsed/Refractory Multiple Myeloma – – Provides Gilead with Full Control of Anito-cel, Accelerating Development and Commercialization while Eliminating Profit-Share, Milestones, and Royalties – FOSTER CITY, Calif. & REDWOOD CITY, Calif. –