Danish biotech Bavarian Nordic saw its stock shoot up after the FDA approved a Phase III trial design for Prostvac, the company's prostate cancer vaccine. The company's stock rose as much as 6.5 percent in Copenhagen trading on the news, according to Bloomberg.
The Phase III program will include a single global, randomized, double-blind, placebo-controlled study that is expected to enroll about 1,200 patients in three study arms. The primary endpoint is overall survival, the company says in a statement.
Bavarian President and CEO Anders Hedegaard expressed the company's excitement at the news, adding that he expects to start enrolling patients in the study later next summer.
If approved, Prostvac would compete against Dendreon's Provenge, which may generate as much as $1.75 billion in 2014 if the U.S. government agrees to pay for the $93,000 treatment, Bloomberg notes. Last week, the company said it has gathered between five and nine term sheets from potential partners for Prostvac. The company's business development chief, Juergen Langhaerig, told a conference that the mix of international companies included some of the "largest companies in the world, the top 10, and some are mid-sized, fast-growing companies."
- see the Bavarian Nordic release
- get more from Bloomberg