Atara Biotherapeutics provides regulatory, business updates

Atara Biotherapeutics provides regulatory, business updates

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, has resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (EBVALLO™ or tab-cel®). The BLA is indicated as monotherapy for the treatment of adult and pediatric patients aged two and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. There are no FDA-approved therapies in this treatment setting [1].

The resubmission follows a collaborative effort with Pierre Fabre Laboratories to address the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter. Atara Biotherapeutics aims to continue engaging with the FDA throughout the review process and with Pierre Fabre Laboratories for potential launch preparations [1].

Tabelecleucel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases, including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p0.0001) and a favorable safety profile consistent with previous analyses [1].

The approval of the BLA would trigger a $40 million milestone payment from Pierre Fabre Laboratories, along with significant double-digit tiered royalties as a percentage of net sales and milestones related to commercial sales of EBVALLO [1].

Atara Biotherapeutics projects that its cash, cash equivalents, and short-term investments of approximately $22 million as of June 30, 2025, combined with cost reduction initiatives implemented in the first half of 2025, will enable funding of all currently planned operations into the first quarter of 2026 [1].

References:
[1] https://investors.atarabio.com/news-events/press-releases/detail/375/atara-biotherapeutics-provides-regulatory-and-business