Look back at pharma news in week to Nov 18

20 November 2016

Dynavax common stock plunged last Monday after receiving a complete response letter from the FDA regarding its approval application for Heplisav-B hepatitis vaccine.

Bhavneesh Sharma of Premium Research, writing on Seeking Alpha, says he believes the vaccine could still be approved by the US Food and Drug Administration, despite at least six-nine months of delay. The approval application also is under consideration in the European Union.

Dynavax' other products, like SD-101 (immuno-oncology), continue to show promise. AstraZeneca plans to start a Phase II trial of DV1179 in asthma later this year. A more restricted label, for example, in diabetes may be approved by the FDA. We calculated the fair value for the common stock at $16 with a 50% market penetration in diabetes patients in the US.

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