Jan 21, 2025 · U.S. FDA issues clinical hold on EBVALLO™ (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL). 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 ...

Jan 21, 2025 · Atara linked the hold to a recent FDA inspection of a third-party manufacturing facility for Ebvallo, which resulted in a U.S. rejection of the allogeneic cell therapy.

Jan 21, 2025 · Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219 U.S. FDA issues clinical hold on EBVALLO ™ (tabelecleucel) and ATA3219 studies linked ...

Jan 16, 2025 · Atara remains focused on preserving future EBVALLO financial value for the benefit of all stockholders. Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding, which Atara believes is sufficient to fund the ongoing activities required to achieve BLA approval

Dec 19, 2022 · EBV+ PTLD is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when a patient’s T-cell immune response is compromised by immunosuppression. It can impact patients who have undergone solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT).

Jan 21, 2025 · THOUSAND OAKS, Calif., January 21, 2025--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to ...

Jan 16, 2025 · Atara and Pierre Fabre are seeking approval for Ebvallo to treat patients two years and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+PTLD) who've...

Jan 21, 2025 · FDA places a clinical hold on Atara's EBVALLO and ATA3219 programs due to GMP compliance issues at a third-party facility. Atara to pause new participant enrollment; CAR-T programs may suspend in ...

Jan 16, 2025 · EBVALLO, which was granted marketing authorization by the European Commission in December of 2022, is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells.

Jan 21, 2025 · Atara says it remains eligible to receive a $60 million milestone payment from Pierre Fabre upon FDA approval of the EBVALLO BLA, as well as significant double-digit tiered royalties as a ...