dynavax technologies corp (DVAX) Key Developments
Dynavax Technologies Corporation Announces Resignation of J. Tyler Martin from Board of Directors
Nov 27 13
Dynavax Technologies Corporation announced that J. Tyler Martin, M.D. plans to resign from the Board of Directors, effective at the end of the year. Dr. Martin, a director of the company since 2010, decided to resign to devote more time to his other professional responsibilities. Dr. Martin is Founder and Chief Executive Officer of Great Plains Biotechnology.
Dynavax Technologies Corporation Announces Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2013
Nov 7 13
Dynavax Technologies Corporation announced unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2013. For the quarter, the company reported total revenues of $2,927,000 compared with $2,874,000 for the same period a year ago. Loss from operations was $15,568,000 compared with $17,097,000 for the same period a year ago. Net loss was $15,675,000 or $0.09 per basic and diluted share compared with $17,791,000 or $0.10 per basic and diluted share for the same period a year ago.
For the six months, the company reported total revenues of $8,404,000 compared with $7,908,000 for the same period a year ago. Loss from operations was $53,496,000 compared with $47,594,000 for the same period a year ago. Net loss was $53,664,000 or $0.29 per basic and diluted share compared with $49,406,000 or $0.30 per basic and diluted share for the same period a year ago.
Dynavax Seeks Acquisitions
Oct 25 13
Dynavax Technologies Corporation (NasdaqCM:DVAX) is seeking acquisitions. Dynavax Technologies Corporation has completed a follow-on equity offering in the amount of $85.54 million. Dynavax may use a portion of the net proceeds from Dynavax concurrent Series B Preferred Stock offering to in-license invest in or acquire businesses, technologies, product candidates or other intellectual property that Dynavax believe are complementary to Dynavax, although Dynavax have no current plans, commitments or agreements to do so as of the date of this prospectus supplement.
Dynavax Technologies Corporation - Special Call
Oct 16 13
To consider HEPLISAV(TM) regulatory path
Dynavax Technologies Corporation Reports on HEPLISAV(TM) Regulatory Path
Oct 16 13
Dynavax Technologies Corporation announced the design of its next large-scale clinical study of HEPLISAV, its investigational adult hepatitis B vaccine, following discussions with the U.S. Food and Drug Administration. The planned study, HBV-23, is intended to provide a sufficiently-sized safety database for the Agency to complete its review of Dynavax's Biologics License Application (BLA). It will be an 8,000 subject, Phase 3, observer-blinded, randomized, active-controlled, multicenter trial of the safety and immunogenicity of HEPLISAV compared with Engerix-B(R) in adults 18 to 70 years of age. The primary objectives of HBV-23 will be: to evaluate the overall safety of HEPLISAV with respect to clinically significant adverse events; and to demonstrate the noninferiority of the peak seroprotection rate (SPR) induced by HEPLISAV to Engerix-B in subjects with type 2 diabetes mellitus. HBV-23 will include 5,500 HEPLISAV subjects and 2,500 Engerix-B subjects, randomized 2:1 and stratified by age and diabetes diagnosis. HEPLISAV subjects will receive two doses at 0 and 1 month, while Engerix-B subjects will receive three doses at 0, 1 and 6 months. All HEPLISAV subjects will be evaluated for safety for one year following the second dose and all potential autoimmune events will be adjudicated by a Safety Evaluation and Adjudication Committee. Immunogenicity assessments will be conducted in a subset of subjects, including those with type 2 diabetes. Dynavax intends to initiate this study in the first quarter of 2014 and conclude subject visits by the end of 2015 and estimates the external costs of the study to be in the range of $50 million-$55 million. Dynavax's Marketing Authorization Application for HEPLISAV remains on file in Europe. The Company is currently preparing its response to the European Medicines Agency's (EMA) 120-Day List of Questions to be submitted in the fourth quarter of 2013, following which the EMA will provide Dynavax its 180-Day List of Outstanding Issues expected in the first quarter 2014. The 120-Day response will incorporate the target population for HEPLISAV and size of the safety database, and will address Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)-related items, including questions arising from a recent EMA GCP inspection. Dynavax will continue to work through the European regulatory review process to determine the appropriate next steps, corrective actions, and possible post-approval commitments. The Company anticipates that some of these matters will need to be resolved following issuance of the 180-Day List of Outstanding Issues, which when received, will enable Dynavax to provide further clarification on HEPLISAV's potential path forward in Europe.