Atara reports FDA meeting progress on tabelecleucel BLA resubmission, trims costs

Atara Biotherapeutics reported on August 12, 2026 that it and partner Pierre Fabre Pharmaceuticals held a productive Type A meeting with the FDA where the companies confirmed a path to resubmit the tabelecleucel BLA relying on the existing Phase 3 single-arm ALLELE trial.¹ Pierre Fabre plans to include an updated dataset with additional patients and longer follow-up as part of the resubmission.¹

Atara said it expects to give a further regulatory update later in the quarter, as previously indicated. Under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible for a $31 million milestone payment if the tabelecleucel BLA is approved by the FDA, along with tiered double-digit royalties on net sales and additional milestones tied to commercial sales of EBVALLO.¹

On financials, Atara reported cash, cash equivalents and short-term investments of $9.9 million as of June 30, 2026, up from $8.4 million at March 31, 2026.¹ The company said that cash position, combined with efficiencies achieved in 2025 and the first half of 2026, is expected to fund planned operations into mid-2027.¹ Total costs and operating expenses fell sharply year over year, which the company attributed to cost-reduction steps taken across 2025 and the first half of 2026, and it said operating expenses are expected to decline significantly for the full year as those savings compound.¹

Net loss for the quarter was $4.8 million, or $0.32 per basic and diluted share, compared with net income of $2.4 million a year earlier.¹ CEO Cokey Nguyen said the company remains focused on getting the therapy to patients with EBV-driven PTLD while managing expenses to preserve flexibility.