Bionovo Inc., which focuses on developing treatments for women's health and cancer, said Thursday federal regulators have approved its chemistry, manufacturing and controls plan for lead drug candidate Menerba.
Menerba aims to treat menopausal hot flashes.
The Emeryville, Calif., company said it is in final discussions with the Food and Drug Administration to complete the design of late-stage trials for the drug candidate in the United States.
Bionovo shares climbed 73 cents, or nearly 60 percent, to $1.95 in Thursday afternoon trading.