Sirius Capital
Biotech, portfolio strategy, long/short equity, small-mid cap

How Do Recent Developments In The Approval Process For Heplisav-B By Dynavax Affect The Chances For A Positive PDUFA?

Inroduction Dynavax (NASDAQ:DVAX) is developing Heplisav-B, a new vaccine for HBV (Hepatitis B virus) prevention. This vaccine utilizes a novel mechanism for stimulating the immune system which will allow the vaccine to protect from infection after two vaccinations, 4 weeks apart. This is a simpler vaccination regime than that of the standard-of-care vaccines like Engerix-B by GlaxoSmithKline (NYSE:GSK) that require 3 vaccinations with the last being 6 months after the first. We reviewed this drug development program in an SA article last August while we were anticipating results of a large scale trial with 8,000 patients that was designed to remove doubts about the safety of the treatment. The company was also reviewed recently by Bhavneesh ...
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