New FDA Guidance Looks Good for Dendreon
Dendreon(DNDN Quote) has yet to resubmit Provenge to the FDA, but regulators already appear to be supportive.
The FDA issued new draft guidance for cancer vaccines last night that validate many of the approaches Dendreon took in the design of its clinical trials and the quality control measures it uses to ensure the potency of the prostate cancer vaccine.
"These are the first FDA statements that acknowledge the validity of Dendreon's regulatory approach for Provenge. The guidance also appears to be almost identical to the approach Dendreon has taken to monitor Provenge activity for quality control," said Deutsche Bank
biotech analyst Robyn Karnauskas. She has a buy rating on Dendreon with a $36 price target.
Dendreon shares rose 7.8% to $28.90 Thursday. The stock has been strong in recent days as investors anticipate the company's analyst meeting on Sept. 24.
