Monday, June 10, 2013

Dynavax's hepatitis B vaccine delayed as FDA seeks more data

(Reuters) - Dynavax Technologies Corp said the U.S. Food and Drug Administration asked for additional safety data on its experimental hepatitis B vaccine potentially delaying its approval and sending its shares down as much as 30 percent.

Analysts said the company will be required to conduct an additional trial on Heplisav - Dynavax's most advanced clinical candidate.

Cowen and Co analyst Phil Nadeau said the outcome of Dynavax' meeting with the FDA was disappointing.

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