Dynavax makes 52- Week high after FDA Removes Clinical Hold on HEPLISAVTM Phase 3 Hepatitis B Vaccine
September 10, 2009 10:14 AM
Shares of Dynavax Technologies Corporation (NASDAQ: DVAX) soared $1.05 or 60.57% to $2.80 on volume of 15.76 million shares more than 15.50X than its daily total average volume on the news 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.
As a result of the FDA’s decision, 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.
Also earlier in the morning trade the stock touched a new 52 – week high at $3.35.
