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Dynavax Announces FDA Advisory Committee Meeting to Review HEPLISAV-B

Source Link:: http://investors.dynavax.com/releasedetail.cfm?ReleaseID=983286

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Additional Information

Additional Relevant Details The Vaccines and Related Biological Products Advisory Committee (VBRPAC) will review the Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] at its meeting on November 16, 2016. The FDA has indicated it will communicate questions for the VRBPAC to address closer in time to the meeting date. HEPLISAV-B, the company's vaccine candidate for immunization against infection caused by all known subtypes of hepatitis B virus in adults ages 18 years of age and older, is currently under FDA review, with a December 15, 2016 Prescription Drug User Fee Act (PDUFA) action date.

http://investors.dyn...

Additional Relevant Details
The FDA said in its cancellation notice that it needs more time to "review and resolve several outstanding issues," but that it will continue evaluating the drug and will schedule an additional meeting in the future if necessary.

https://www.thestree...

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Catalyst Date

Occurred on:

Sep 02, 2016

Occurred Source:

https://www.thestreet.com/story/13693559/1/dynavax-technologies-dvax-stock-plummets-on-cancelled-fda-meeting.html?source=sa

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Related Keywords Ad-comm, Heplisav-b