Avanir (AVNR) plunged 40% early Tuesday after the Food and Drug Administration indicated the pharmaceuticals company will need to provide additional data to win approval of its Zenvia drug for emotional expression disorder.
The San Diego-based company said it got a letter indicating the drug is approvable "subject to the FDA and Avanir reaching agreement on what additional safety and efficacy data will be required." Avanir expects to schedule a meeting with the agency to discuss the matter.
"We will be working closely with the agency to determine the next steps required for the drug to receive marketing approval," said CEO Eric K. Brandt. "We believe Zenvia can significantly improve the lives of patients, their families and their caregivers by reducing the emotional and social toll taken by IEED."
Shares fell $3 to $4.40.