By Michael Dabaie

VBI Vaccines Inc. said the U.S. Food and Drug Administration approved PreHevbrio for the prevention of hepatitis B in adults.

Shares of the biopharmaceutical company rose 12%, to $3.41, in premarket trading.

VBI said PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S.

The company said it expects to make PreHevbrio available in the U.S. in the first quarter of 2022, and has partnered with Syneos Health for the past two years to ensure commercial readiness.

Outside of the U.S., VBI said it continues to support the European Medicines Agency's review of the marketing authorization application for VBI's 3-antigen HBV vaccine.

VBI said it expects to complete regulatory submissions to the U.K.'s Medicines and Healthcare products Regulatory Agency and to Health Canada in 2022.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

December 01, 2021 08:02 ET (13:02 GMT)