Novavax shares surge on promising H1N1 trial data

Shares of Novavax (NVAX) spiked as high as 16 percent on Wednesday after the vaccine developer reported some encouraging results from its clinical trial in Mexico for its experimental H1N1 vaccine. Novavax, which has gained considerable attention for its VLP technology, says that all three of its vaccine dose levels triggered a protective immune response among the 1,000 healthy volunteers recruited for the trial.

Based on those results, Novavax has filed for regulatory approval in Mexico. It also has partnered in the country with Avimex Laboratories. And they're reportedly ready to launch the second phase of the trial after enrolling more than 3,500 volunteers. Novavax is also studying its seasonal flu vaccine in the U.S.

"We are highly encouraged by these results as the data meet the immunogenicity criteria of both the United States and European regulatory authorities. These data enable potential emergency use of the vaccine in pandemic situations and could be supportive in other countries in addition to Mexico," says Dr. Rahul Singhvi, the CEO of Novavax. "The substantial safety dataset and strong immunogenicity signal from this large study provide us confidence as we plan Phase III studies of our seasonal trivalent influenza VLP vaccine, pending results from the ongoing Phase IIa trial in older volunteers and discussions with the FDA."

The Rockville, MD-based vaccine company also has a joint development project in India with Cadila.

- here's the Novavax press release
- and here's the story from the Washington Business Journal