DVAX Jan 2025 13.000 call
| Previous Close | 0.8000 |
| Open | 0.8000 |
| Bid | 0.6500 |
| Ask | 0.9000 |
| Strike | 13.00 |
| Expire Date | 2025-01-17 |
| Day's Range | 0.8000 - 0.8000 |
| Contract Range | N/A |
| Volume | |
| Open Interest | 7 |
- Reuters
UPDATE 1-US FDA declines to approve expanded use of Dynavax's hepatitis B vaccine
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.
PR NewswireDynavax Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S.
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
Simply Wall St.Analysts Are Updating Their Dynavax Technologies Corporation (NASDAQ:DVAX) Estimates After Its First-Quarter Results
Dynavax Technologies Corporation ( NASDAQ:DVAX ) just released its latest first-quarter report and things are not...
