Dynavax Clears Heplisav-B Hurdle With CDC Recommendation

What Happened

Dynavax Technologies Corporation DVAX traded up 3.7 percent Wednesday after management announced the Centers for Disease Control and Prevention will recommend HEPLISAV-B as an adult vaccination for hepatitis B.

The official nod from the Advisory Committee on Immunization Practices, which voted unanimously to add the compound to its recommended product list, is significant to Dynavax as it satisfies coverage requirements for some health insurers.

Why It's Important

"With the ACIP's recommendation, HEPLISAV-B has cleared an important milestone needed to position Dynavax to meet our long-term commercial goals,” Dynavax CEO Eddie Gray said in a press release. “Additionally, this recognition emphasizes the important role of HEPLISAV-B in the prevention of hepatitis B infection in adults, reinforcing our belief that our unique two-dose vaccine with demonstrated higher rates of protection versus ENGERIX-B, and a safety profile similar to three-dose vaccines, will become the new standard of care for adults.”

The U.S. Food and Drug Administration had approved HEPLISAV-B in November, prompting momentary stabilization in the otherwise plummeting stock.

What's Next

January saw commercial launch in the U.S., and Dynavax will begin actively selling the vaccine next week.

At time of publication, Dynavax's stock was trading around $17.55 per share.

Related Links:

The Companies That Led 2017's Biotech Rally

FDA Watchlist: Catalysts To Look Out For This February