By Dhirendra Tripathi
Investing.com – Allogene stock (NASDAQ:ALLO) plunged more than 45% to hit its 52-week low of $13.36 after the U.S. Food and Drug Administration stopped all trials being conducted by the company.
The FDA’s order came in after a "chromosomal abnormality" was observed in a single patient who was treated with a cancer cell therapy of the company. The abnormality was found in ALLO-501A CAR T cells of the patient being treated in an ALPHA2 study.
The clinical hold follows the company’s notification to the FDA. The abnormality was detected when a bone marrow biopsy of the patient was undertaken to assess low blood counts.
The biotech company said an investigation is underway to further characterize the observed abnormality, including any clinical relevance, evidence of clonal expansion, or potential relationship to gene editing.
Allogene has dosed more than 100 patients with its gene edited AlloCAR T products, the company said in a note.