Chapel Hill, NC-based Pozen saw its stock soar Thursday on the news that the FDA accepted its primary endpoint for two late-stage clinical trials PN 400, its arthritis drug. PN 400, which is being developed in partnership with AstraZeneca, combines the painkiller naproxen with AstraZeneca's Nexium (esomeprazole). Results from the trials showed that the investigational drug reduced the number of gastric ulcers, thus meeting the primary endpoint.
Back in October, the FDA informed the company that the agency would conduct a review of the acceptability of gastric ulcer incidence as a primary endpoint, raising concerns that Pozen would have to devote more time and resources to conduct further trials. Now that the company can move forward, Pozen says it plans to submit a new drug application to the FDA by mid-2009.
Investors were clearly excited about the news. According to Forbes, shares of Pozen rose 22 percent to $7.44 in midday trading.
- read the Pozen release
- read the AP article in Forbes article for more