Atara Resubmits Tabelecleucel BLA To FDA

(RTTNews) - On Wednesday, Atara Biotherapeutics (ATRA) said its partner, Pierre Fabre Pharmaceuticals, has resubmitted the Biologics License Application (BLA) for tabelecleucel to the U.S. Food and Drug Administration (FDA).

Tabelecleucel is an investigational allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy being developed for relapsed or refractory EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

The resubmission includes additional patients and longer follow-up from the pivotal Phase 3 ALLELE study in adults and children aged 2 years and older with EBV+ PTLD following solid organ or hematopoietic cell transplant.

The updated package also includes supplemental data from expanded access programs, a separate clinical study and commercial experience in Europe.

Atara is eligible for a $31 million milestone payment upon FDA approval of the BLA, along with tiered double-digit royalties on net sales and additional commercial milestones.

ATRA shares closed on Tuesday at $8.05, down 3.82%.

In the Premarket trading, shares are up 9.69% at $8.83.