UPDATE 1-US FDA declines to approve expanded use of Dynavax's hepatitis B vaccine [Yahoo! Finance]
Dynavax Technologies Corporation (DVAX)
Last dynavax technologies corporation earnings: 3/11 04:10 pm
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Source: Yahoo! Finance
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. Shares of the California-based company fell more than 7% in premarket trading. 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. The agency's latest decision will make it harder for the company to implement its plans to expand the total addressable market for its lead commercial asset. (Reporting by Christy Santhosh and Pratik Jain in Bengaluru; Editing by Tasim Zahid and Shilpi Majumdar)
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DVAX
News
- Dynavax to Present at Upcoming Investor ConferencesPR Newswire
- Dynavax Technologies Co. (NASDAQ: DVAX) was downgraded by analysts at StockNews.com from a "buy" rating to a "hold" rating.MarketBeat
- Dynavax Technologies Co. (NASDAQ: DVAX) was upgraded by analysts at StockNews.com from a "hold" rating to a "buy" rating.MarketBeat
- Dynavax Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S. [Yahoo! Finance]Yahoo! Finance
- Dynavax Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S.PR Newswire
DVAX
Earnings
- 5/8/24 - Miss
DVAX
Analyst Actions
- 5/9/24 - HC Wainwright
DVAX
Sec Filings
- 6/3/24 - Form 4
- 5/28/24 - Form 4
- 5/28/24 - Form 4
- DVAX's page on the SEC website