Atara: naganap ang miting sa FDA; planong muling isumite ng PFP ang BLA ng tab-cel

Pierre Fabre Pharmaceuticals held a productive FDA meeting and received agreement that a single-arm study with historical control could support a marketing application. PFP intends to submit an updated ALLELE dataset with additional patients and longer follow-up as part of the resubmission plan. Atara expects to provide a further regulatory update in the third quarter.

Mahahalagang fact

Na-file: May 12, 2026, 08:10 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: ATRAAtara Biotherapeutics, Inc
Asset: tabelecleucel
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 atra-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Atara Biotherapeutics Announces First Quarter 2026 Financial Results and Operational Progress Productive meeting held with the FDA; planning for tabelecleucel BLA resubmission Operating efficiencies and ATM proceeds extend cash runway into mid-2027 THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the first quarter 2026 and business updates. Tabelecleucel (tab-cel ® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD) As previously communicated, Pierre Fabre

SEC 8-K