Atara Biotherapeutics, Inc.（ATRA）資訊與事件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 Reports Q2 Revenue of $600K, Exceeds Expectations

Reports Q2 revenue $600K, consensus $366.67K. As previously communicated, PFP has indicated they intend to submit an updated dataset with additional patients and longer follow-up from the pivotal Phase 3 single arm ALLELE study as well as supportive data. Atara anticipates providing a further regulatory update later this quarter. 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 of EBVALLO.