Reuters: Regulatory News: FDA asks for more safety data on Dynavax's hepatitis B vaccine

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FDA asks for more safety data on Dynavax's hepatitis B vaccine Jun 10th 2013, 11:02 June 10 | Mon Jun 10, 2013 7:02am EDT June 10 (Reuters) - Dynavax Technologies Corp said the U.S. Food and Drug Administration asked for additional safety data on its experimental hepatitis B vaccine, Heplisav. The company's shares fell 6 percent to $2.31 in premarket trading. They closed at $2.47 on the Nasdaq on Friday. Dynavax said it will meet with the FDA shortly to discuss the protocol for collecting additional safety data, which it expects to include in the current approval application. Heplisav, Dynavax's most advanced clinical candidate, was denied approval by the FDA in February, saying the safety data provided by the company was insufficient to support an approval. The FDA said Dynavax's safety database needed additional subjects, the company said on Monday. The company said it was also working on the questions raised by the FDA regarding the manufacturing and testing of Heplisav.

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