Allogene Therapeutics Inc

Allogene Therapeutics announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy and Fast Track designations to its investigational CAR-T therapy cemacabtagene ansegedleucel, or cema-cel, for high-risk large B-cell lymphoma. The designations apply to adult patients with large B-cell lymphoma who are in complete or partial response after first-line therapy, are suitable for observation, but test positive for minimal residual disease. The decision was supported by interim data from the ongoing Phase 2 ALPHA 3 trial, in which cema-cel achieved a minimal residual disease clearance rate of 58.3% compared with 16.7% in the observation arm, and a median decrease in plasma circulating tumor DNA at Day 45 of 97.7% versus a 26.6% median increase in the observation arm. The therapy was well-tolerated, with most patients treated in the outpatient setting and no treatment-related hospitalizations reported. Allogene shares closed Thursday up 9.04% at $1.81 and rose a further 0.55% in overnight trading to $1.82.

Novo Nordisk, Genentech, and Allogene Therapeutics have announced a series of executive departures and appointments signaling strategic shifts. At Novo Nordisk, John McDonald, corporate vice president and global head of business development and M&A, has left after nearly eight years to join venture capital firm Forbion, having overseen acquisitions including the up to $2.1 billion Corvidia Therapeutics deal and the $3.3 billion Dicerna purchase. Genentech laid off three senior leaders—Dr. Vishva Dixit, Todd McDevitt, and Man-Wah Tan—as part of a restructuring of its Research and Early Development group that shut down the physiological chemistry and infectious disease teams, following three rounds of layoffs in 2025 affecting nearly 350 people. Allogene Therapeutics appointed Chief Medical Officer Dr. Zachary Roberts as CEO effective July 1, succeeding Dr. David Chang in a planned transition, as the company advances its off-the-shelf CAR-T therapy cemacabtagene ansegedleucel after a phase 2 study showed a 41.6% absolute difference in minimal residual disease clearance.

Allogene Therapeutics announced that its pivotal Phase 2 ALPHA3 trial of cema-cel in first-line consolidation treatment for large B-cell lymphoma completed an interim futility analysis and will continue without modification. The company also expects initial data from the first dosing cohort of the Phase 1 RESOLUTION trial of ALLO-329 in June 2026, covering multiple autoimmune indications including lupus, scleroderma, and inflammatory myositis. Allogene ended the first quarter with $266.9 million in cash, cash equivalents, and investments, and said its April public offering extended its cash runway into the first quarter of 2029.