Allogene Therapeutics Tanks 40% After FDA Puts Clinical Hold On Cancer Drug Trial

(RTTNews) - Shares of Allogene Therapeutics, Inc. (ALLO) tanked over 40% in extended trading session on Thursday after the U.S. Food and Drug Administration put a clinical hold the clinical-state biotech company's cancer drug trial.

Allogene Therapeutics announced that that following a report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient treated in the ALPHA2 study, the FDA has placed a hold on the Company's AlloCAR T clinical trials.

The company said it will provide additional updates in the coming weeks following consultation with the FDA. The FDA continues to actively review the end of Phase 1 materials submitted in anticipation for an ALLO-501A pivotal Phase 2 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 Rafael Amado, Executive Vice President of Research and Development 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."

Allogene said it has dosed over 100 patients with its gene edited AlloCAR T products. The company believes the data generated from the ALPHA trials support a favorable clinical profile for ALLO-501A in patients with large B cell lymphoma.

ALLO closed Thursday's trading at $24.38, up $0.41 or 1.71%, on the Nasdaq. The stock, however, slipped $10.07 or 41.30%, in the after-hours trading.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


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