Previous close | 11.11 |
Open | 0.00 |
Bid | 0.00 x N/A |
Ask | 0.00 x N/A |
Day's range | 0.00 - 0.00 |
52-week range | |
Volume | |
Avg. volume | 1,118 |
Market cap | 2.419M |
Beta (5Y monthly) | 1.30 |
PE ratio (TTM) | 0.15 |
EPS (TTM) | 0.75 |
Earnings date | 01 Aug 2024 - 05 Aug 2024 |
Forward dividend & yield | N/A (N/A) |
Ex-dividend date | N/A |
1y target est | N/A |
Dynavax Technologies said on Tuesday the U.S. Food and Drug Administration (FDA) has declined to approve the expanded use of its hepatitis B vaccine in patients undergoing hemodialysis, citing insufficient safety and effectiveness data. The FDA, in its so-called "complete response letter", stated that the data was insufficient as a third-party clinical trial site operator had destroyed data source documents for about half of the subjects enrolled in the vaccine's trial, according to the company. Dynavax's vaccine, Heplisav-B, was first approved by the FDA in 2017, having been rejected twice before in 2013 and 2016 over unresolved safety concerns.
Dynavax Technologies Corporation (Nasdaq: DVAX) today provided a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of effectiveness
Dynavax Technologies Corporation ( NASDAQ:DVAX ) just released its latest first-quarter report and things are not...