FDA advisory panel backs Heplisav-B
The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 12 to 1 that the safety data for Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]) support licensure for immunization against hepatitis B infection in adults 18 years of age and older.
This would suggest that US immunotherapy specialist Dynavax Technologies’ (Nasdaq: DVAX) Heplisav-B could at last gain US marketing approval from the FDA, which has put obstacles in the way for the product’s registration since 2013, including a second Complete Response letter in November 2016.
Dynavax’ shares rocketed 80% to $16.55 in after-hours trading on Friday following the positive news coming out of the advisory panel meeting.
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