UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
CURRENT REPORT
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| Item 8.01 | Other Events. |
On December 3, 2019, Dynavax Technologies Corporation (the “Company”) announced that it filed with the U.S. Food and Drug Administration a cumulative report on both interim analyses of an ongoing post-marketing study of HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted]. The observational comparative study is assessing the rate of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared to Engerix-B. The event rates reflected in the interim analyses were similar between the two treatment arms. The independent data monitoring committee concurred the analyses showed no evidence of an increase in AMI events in the HEPLISAV-B arm. The study was initiated in August 2018 and is scheduled to continue through November 2020. Final study results will be reported upon study completion.
The interim analyses are based on currently-available data, and the results, related findings and conclusions of the study will not be known until its completion and the receipt and review of the entire study data. Interim results may not be reproduced in the future, and thus should be considered carefully and not relied upon as indicative of future study results. Material adverse differences in final data, compared to interim data, could significantly adversely affect our business and business prospects, including our future HEPLISAV-B business. Certain assumptions, estimations, calculations and conclusions may have been made in connection with the interim analyses of the study data, and others, including regulatory agencies, may not accept or agree with these assumptions, estimations, calculations or conclusions, or may interpret or weigh the importance of data differently, which could impact the actual or perceived value of the study or the Company in general.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dynavax Technologies Corporation | ||||||
| Date: December 3, 2019 |
By: |
/s/ STEVEN N. GERSTEN | ||||
| Steven N. Gersten | ||||||
| Senior Vice President |