News & Events zu Atara Biotherapeutics, Inc. (ATRA)ATRAAtara Biotherapeutics, Inc.

Atara Biotherapeutics Partners with Pierre Fabre, FDA Accepts tabelecleucel Application

Atara Biotherapeutics announced that its partner, Pierre Fabre Pharmaceuticals, PFP, has received acceptance by the U.S. Food and Drug Administration, FDA, of the Biologics License Application, BLA, resubmission for tabelecleucel, with a proposed indication as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease, EBV+ PTLD, who have received at least one prior therapy. The BLA has a Class 2 Resubmission Prescription Drug User Fee Act target action date of March 31, 2027.

Atara and Pierre Fabre Resubmit tabelecleucel BLA

Atara Biotherapeutics provided an update that its partner, Pierre Fabre Pharmaceuticals, has resubmitted the tabelecleucel Biologics License Application to the U.S. Food and Drug Administration. PFP, with Atara's support, has resubmitted the BLA based on the feedback received from the Type A meeting held in April. The resubmission includes an updated data package with additional patients, plus longer follow up from the ongoing, pivotal Phase 3 single arm ALLELE study of tabelecleucel in adults and children two years of age and older with relapsed/refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease following solid organ transplant or hematopoietic cell transplant The resubmission also includes additional supplemental data from the expanded access programs, a separate clinical study, and commercial experience in Europe. Under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $31M milestone payment upon FDA approval of the tabelecleucel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales.

Atara Expects Significant Decline in Operating Expenses into Mid-2027

Operating expenses are expected to decline significantly year-over-year, reflecting the full-year benefit of cost-reduction initiatives implemented in 2025 and first half of 2026. Atara expects its cash, cash equivalents, and short-term investments as of June 30, 2026, combined with operating efficiencies achieved in 2025 and first half of 2026, will be sufficient to fund planned operations into mid-2027.