Allogene reports Q2 2026 results, cites ALPHA3 futility data and FDA designations for cema-cel

Allogene Therapeutics reported financial results and a business update for the quarter ended June 30, 2026 on August 12, 2026.

In July 2026, the FDA granted Regenerative Medicine Advanced Therapy and Fast Track designations for cema-cel as first-line consolidation therapy for high-risk large B-cell lymphoma, following its review of an interim futility analysis.¹ In that analysis, taken at a cutoff tied to the 24th patient completing a Day 45 minimal residual disease (MRD) assessment, just over 58% of patients (7 of 12) in the cema-cel arm reached MRD negativity, most of them by the first post-treatment check, versus about 17% (2 of 12) in the observation arm¹, a gap the company put at 41.6 percentage points. The company said published literature and cross-study comparisons indicate that MRD clearance gaps of 25 to 30 percentage points can translate into clinically meaningful improvement by the end of a study.¹

Allogene said cema-cel was well tolerated through the cutoff, with no treatment-related serious adverse events, no cases of cytokine release syndrome, ICANS, graft-versus-host disease or high-grade infections, and no use of tocilizumab or steroids for toxicity, nor any related hospitalizations.¹

Site activation is ahead of schedule: Allogene said it hit its 2026 goal of more than 80 active sites about six months early and now expects roughly 100 sites active by year-end, mostly in the U.S. with additional sites in Canada, Australia and South Korea.¹ ALPHA3 is expected to enroll about 220 MRD-positive patients by the end of 2027, with the next update tied to an interim event-free survival analysis expected in mid-2027.¹

In autoimmune disease, enrollment in the Phase 1 RESOLUTION trial of ALLO-329 continues at a brisk pace across cohorts, dose levels and lymphodepletion strategies, with a clinical and translational update still expected in the fourth quarter of 2026.¹

On finances, Allogene held $423.6 million in cash, cash equivalents and investments as of June 30, 2026, and said this funds operations into 2029.¹ The company guided to about $165 million in operating expense for 2026, with GAAP operating expenses of about $225 million including roughly $35 million in non-cash stock-based compensation.¹