What happened
Shares of VBI Vaccines (VBIV) were vaulting 5.9% higher as of 11:19 a.m. EST on Friday after rising as much as 20.5% earlier in the day. The nice gain came after the company announced positive results from a phase 4 study of its three-antigen hepatitis B virus (HBV) vaccine Sci-B-Vac in younger adults.
So what
VBI said that Sci-B-Vac achieved a seroprotection rate of at least 95% in adults between the ages of 20 and 40 within two months after the second dose of the vaccine. This reflected relatively quick protection against HBV infection in younger adults.
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Sci-B-Vac has already been approved and launched commercially in Israel. The phase 4 study was conducted in support of establishing the batch included in the study as a new reference standard. Before vaccines are made available in Israel, they must first be tested against a reference vaccine batch that has been evaluated in a clinical study.
Investors' enthusiastic reaction to VBI's news, though, probably didn't relate much to the prospects for Sci-B-Vac in Israel. The company hopes to win regulatory approvals for the vaccine in the U.S., Canada, and Europe. The positive phase 4 results no doubt increased investors' optimism that VBI will be successful in expanding the markets for Sci-B-Vac.
Now what
The European Medicines Agency (EMA) accepted VBI's filing for approval of its HBV vaccine in December. VBI also submitted a Biologics Licensing Application (BLA) to the U.S. Food and Drug Administration (FDA) last month. The next big catalyst for the biotech stock could come later this year if Sci-B-Vac gets a thumbs-up from the FDA and/or the EMA.
