FDA clinical hold on AlloCAR T trials sees Allogene slump

Shares of US clinical-stage biotech Allogene Therapeutics (Nasdaq: ALLO) plunged more than 40% in after-hours trading yesterday, following its revelation of a Food and Drug Administration hold on the company’s AlloCAR T clinical trials.

The company expects to provide additional updates in the coming weeks following consultation with the FDA. The agency continues to actively review the end of Phase I materials submitted in anticipation for an ALLO-501A pivotal Phase II trial.

“Patient safety is our highest priority, and we are committed to working closely with the FDA to evaluate any potential clinical implications of this finding, and determine next steps for advancing ALLO-501A and our clinical programs,” said Dr Rafael Amado, executive vice president of R&D and chief medical officer. “As a leading developer of allogeneic cell therapies, we recognize our added responsibility to fully assess all aspects of our therapies to advance the field. We are grateful for the partnership with the patient community, clinical investigators, our Scientific Advisory Board, and the FDA as we work diligently toward understanding the clinical significance of this finding and to support the development of allogeneic CAR T therapy for cancer,” he noted.