Dynavax Technologies Corporation (NASDAQ:DVAX): Closing price $2.01
On Monday, Dynavax said that it has received a Complete Response Letter from the FDA regarding its Biologic License Application for Heplisav, its investigational adult hepatitis B vaccine. The agency specified that the indication in adults 18-70 years of age cannot be approved without further study of safety in this broad age group, and also continues to express concern that novel adjuvants could cause rare autoimmune events. However, the FDA indicated its willingness to continue talks regarding a more restricted use of Heplisav.
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