Dynavax Technologies (DVAX) Up Sharply On Hepatitis News
Dynavax Technologies (DVAX) said that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease. HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.
Dynavax expects to initiate a Phase 3 trial in chronic kidney disease patients in the near-term. Dynavax also plans to initiate a Phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010.
Shares are 86% higher at $3.18 and hit a 52-week high of $3.35, up from a period low of $.15.
DVAX revenue for the second quarter 2009 were $15.9 million, compared to $10.0 million reported for the second quarter in 2008. The net income of $4.1 million, or $0.10 per share, reported for the second quarter 2009 improved from the net loss of $6.1 million, or $0.15 per share, for the same period in 2008. At the end of the quarter, the company had $53 million in cash and has a market cap of $127 million.
Douglas A. McIntyre
