Dendreon (DNDN) Reports Phase 3 IMPACT Study of PROVENGE Meets Primary Endpoint
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Dendreon Corporation (Nasdaq: DNDN) announced today that the pivotal Phase 3 IMPACT study of PROVENGE in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of PROVENGE appeared to be consistent with prior trials.
The 512-patient, multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study enrolled men with metastatic androgen-independent prostate cancer was conducted under a Special Protocol Assessment agreement with the U.S. FDA.
Detailed results from the IMPACT study will be presented during a plenary session at the American Urological Association's Annual Meeting in Chicago on Tues., Apr. 28 at 2:20 pm CT.
Because the data meet the criteria and specifications outlined in its Special Protocol Assessment (SPA) agreement with the FDA, Dendreon intends to file an amendment to its existing Biologic License Application in the fourth quarter of this year to gain licensure of PROVENGE.
UPDATE: After opening around $25, shares of Dendreon are now trading around the $21 range, currently up nearly 200% from yesterday's closing price.
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-0.04Comments
analyst suck
hang murray the creep by his balls
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analysts suck
Count Spockula on Apr 14, 2009 11:38 PMI agree .. so why does everyone always listen to them like they are gods or something ... if these guys are so good why are they working and not billionaires?