Dr. Seth Gale points out evidence of Alzheimer’s disease on an MRI at the Center for Alzheimer Research and Treatment at Brigham And Women’s Hospital in Boston, Massachusetts, U.S., March 30, 2023. REUTERS/Brian Snyder/File Photoflagged issues related to the recording of safety data at one of the sites for late-stage trial of its Alzheimer's drug, sending its shares plunging more than 67% in premarket trading on Thursday.
This was initially observed by the U.S. Food and Drug Administration after an inspection of the site in December after which the company started an investigation. Truist Securities analyst Robyn Karnauskas, however, said the issue was "likely to have minimal impact" on the drug's approval. The drug met the main goal and showed statistically significant reduction in acute agitation after two hours compared with 5.4 hours for patients who were given a placebo.