Record mula sa primary source
MateryalTinanggap ang aplikasyon
Gilead: Tinanggap ng FDA ang anito-cel BLA; PDUFA 23 Dis 2026
Tinanggap ng FDA ang BLA para sa anito-cel bilang paggamot sa ika-apat na linya para sa relapsed/refractory multiple myeloma, suportado ng Phase 1 at pivotal Phase 2 iMMagine1 data. Ang PDUFA action date ay itinakda sa Disyembre 23, 2026. Ang planadong pagkuha ng Gilead sa Arcellx ay magbibigay dito ng buong kontrol sa asset, na inaalis ang profit-sharing at royalties.
Mahahalagang fact
- Na-file
- Peb 23, 2026, 11:46 AM
- Kaganapan
- Tinanggap ang aplikasyon
- Direksyon
- Positibo
- Kumpanya
GILDGilead- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Dis 23, 2026
Sipi mula sa source
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. –