The action taken by the FDA is related to concerns over some preclinical animal data and not results from any human clinical trials, the company said.
“Until Cortex receives the formal notification and has had a chance to review its contents, it is unable to describe the exact terms of the notice,” the company said in a statement.
The company has so far only been informed of the clinical hold via a telephone call but should receive formal written notification within the next 7-10 days.
CX717 is in development for the treatment of attention deficit hyperactivity disorder, schizophrenia, Alzheimer’s disease and narcolepsy.