Dendreon Resubmits Provenge to FDA: BioBuzz

SEATTLE, Wash. (TheStreet) -- Dendreon(DNDN Quote) has re-submitted its approval package for Provenge to the Food and Drug Administration, the company said Monday.

Provenge is an immunotherapy, or cancer "vaccine" for the treatment of metastatic hormone-resistant prostate cancer. Data from a phase III study presented this spring demonstrated that Provenge could extend the survival of prostate cancer patients.

Dendreon's Provenge resubmission comes a bit earlier than the company's guidance. If the FDA accepts the Provenge application and grants a priority, six-month review, an approval decision will come on May 2, 2010.

Vertex Hep C Drug Emerges From Weekend Looking Stronger

(At 7:26 AM ET)

I hesitate before predicting a stock's movement in the hours before trading opens for the day, but by almost all measures, Vertex Pharmaceuticals(VRTX Quote) did yeoman's work this weekend with its experimental hepatitis C drug telaprevir, warranting a higher stock price Monday.

As I reported Saturday, a twice-daily dose of telaprevir led to cures in more than 80% of hepatitis C patients, according to data from a new phase II study. The study demonstrated quite convincingly that a more convenient twice-daily dose of telaprevir is just as effective and safe as the current thrice-daily dose.

The hepatitis C cure rates of greater than 80% across all four patient groups of the study are also the highest ever recorded in any telaprevir study to date and exceed the cure rates reported by any of telaprevir's competitors.

The strong data from the so-called C-208 study made for a lot of happy faces at an investor event put on by Vertex Sunday night at a Boston hotel. Analysts, investors and hepatitis C researchers (of course) are all in town this week for the annual meeting of the American Association for the Study of Liver Disease.

During prepared remarks at the Vertex shindig, chief financial officer Ian Smith, referring to both the C-208 trial data as well as Wednesday's new data in non-responding patients, said, "The bar we are setting with telaprevir is a high one."

Smith has a reputation for sometimes being overly confident, but in this case, he's right. Vertex is surely not making it easy for competitors to knock telaprevir off the top the Hep C mountain.