Atara Biotherapeutics, Inc. (ATRA) has provided a regulatory update following a recent Type A meeting with the U.S. FDA to discuss the Complete Response Letter issued for the Biologics License Application (BLA) for Tabelecleucel (tab-cel), which is being developed in partnership with Pierre Fabre Pharmaceuticals (PFP).
According to Atara, PFP- with Atara's support- held a productive meeting with the FDA to discuss a potential path forward for resubmitting the BLA. The FDA indicated that a single-arm study using an appropriate historical control, conducted in a pre-specified manner, could serve as an adequate and well-controlled study to provide the necessary safety and efficacy data for a future marketing application for tab-cel in the proposed indication.
PFP plans to submit an updated dataset that includes additional patients and longer follow-up from the pivotal Phase 3 ALLELE study, which evaluated Tabelecleucel in adults and children aged two years and older with relapsed or refractory EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ or hematopoietic cell transplant. Supportive data will also be included as part of the resubmission plan being finalized with the FDA.
Atara CEO Cokey Nguyen said the company is encouraged by the FDA's engagement and alignment on the regulatory framework for resubmission, adding that Atara will continue supporting PFP as it prepares the updated filing. The company expects to provide another regulatory update in the third quarter of 2026.
Tabelecleucel is an allogeneic EBV-specific T-cell immunotherapy developed using Atara's off-the-shelf T-cell platform, which does not require T-cell receptor or HLA gene editing. Atara is the first company to receive regulatory approval for an allogeneic T-cell immunotherapy, and its platform underpins a broader pipeline targeting EBV-driven cancers and autoimmune diseases.
ATRA has traded between $3.92 and $19.15 over the past year. The stock closed Wednesday's trading at $5.15, up 8.19%. In pre-market trading, the stock is at $7.73, up 50.10%.
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