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News Breaks | | | | February 27, 2013 | | 09:25 EDT |  | DVAX | Dynavax discloses departure of CFO Christine Larson
Dynavax disclosed in a regulatory filing last night that Christine Larson departed as the company's VP and Chief Financial Officer, effective on February 28. Jennifer Lew, Dynavax's VP, Finance and Principal Accounting Officer, has assumed Larson's responsibilities, the company said. | |
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News For DVAX From The Last 14 Days Check below for free stories on DVAX the last two weeks. |
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| June 10, 2013 | | 16:39 EDT |  | DVAX | On The Fly: Closing Wrap
 Subscribe for More Information | | | 12:11 EDT | | DVAX | On The Fly: Midday Wrap
Stocks on Wall Street were higher at midday after S&P raised its outlook on the U.S. economy, Chinese data disappointed and Japanese stocks rallied. Stocks began the session higher but the averages turned mixed within minutes and passed back and forth across the flatline in the early minutes of the trading day. The averages made a definitive move higher about an hour into trading and have remained in positive territory since. ECONOMIC EVENTS: In the U.S., ratings agency Standard & Poor's upgraded its outlook for the U.S. economy to stable from negative, pointing to the strengthening economy and the dollar's status as the world's "key reserve currency" as contributors to its decision. In Asia, Chinese exports posted their lowest growth in almost a year in May, while inflation, growth in bank lending and investment came in below expectations. Also, factory output and retail sales grew at a pace that was similar to previous months. However, in Japan, the Nikkei index rallied nearly 5% after the nation's gross domestic product expanded by an annualized 4.1% in the first quarter, which was stronger than the prior 3.5% growth estimate. COMPANY NEWS: Apple (AAPL) advanced over 1% ahead of the start of its Worldwide Developers Conference, which kicks off with a keynote address from CEO Tim Cook scheduled for 1 pm ET. An updated mobile iOS, a new version of its desktop operating system and new MacBooks have all been rumored to debut, but the most discussed potential announcement is Apple’s "iRadio" Pandora (P) competitor. Pandora shares were down almost 3% as the event approached... Facebook (FB) shares rallied 5% after research analysts at Stifel and JPMorgan both issued positive notes to investors about the social network company. MAJOR MOVERS: Among the notable gainers was Canadian Solar (CSIQ), which rose 7% after announcing a $300M deal for solar power plant construction. Among the noteworthy losers were Dynavax (DVAX), which dropped 34% after reporting feedback from an FDA meeting regarding its investigational adult hepatitis B vaccine, and Titan International (TWI), which fell over 8% following downgrades by at least three firms. INDICES: Near noon, the Dow was up 25.89, or 0.17%, to 15,274.01; the Nasdaq was up 14.18, or 0.41%, to 3,483.40; and the S&P 500 was up 3.76, or 0.23%, to 1,647.14. | | | 09:28 EDT | | DVAX | On The Fly: Pre-market Movers
HIGHER: Monsanto (MON), up 3.5% after Monsanto following upgrade at Macquarie, comments from Morgan Stanley on implications of potential approval of product in China... Facebook (FB), up 3.1% following upgrade at Stifel, JPMorgan reiterating its Overweight rating on shares... Apricus Biosciences (APRI), up 14% after announcing European approval for ED drug Vitaros... McDonalds (MCD), up 1.8% after May global comp sales rose 2.6%. LOWER: Tesla (TSLA), down 3.2% following cautious mention over weekend in Barron's magazine... Titan International (TWI), down 5.8% following downgrades by at least three firms... Dynavax (DVAX), down 29% after reporting feedback from FDA meeting regarding Heplisav. | | | 06:09 EDT |  | DVAX | Dynavax to host conference call
Conference call to discuss feedback from FDA meeting regarding HEPLISAV Biologic License Application will be held on June 10 at 9 am. Webcast Link | | | 06:05 EDT | | DVAX | Dynavax reports feedback from FDA meeting regarding Heplisav
Dynavax reported that it concluded a meeting with the FDA regarding its Biologic License Application for HEPLISAV, an investigational adult hepatitis B vaccine. The meeting with FDA resulted in the following messages: The safety database does indeed need additional subjects; VRBPAC's strong endorsement of HEPLISAV's demonstrated immunogenicity was acknowledged; Analyzing the benefit/risk of HEPLISAV's use in discrete patient populations did not fundamentally address the shortfall in the safety database. It was concluded that to do so would unnecessarily restrict the patient population that could benefit from HEPLISAV's approval; The additional safety data collected would facilitate review for an indication in adults 18-70 years of age. Dynavax will meet with the FDA shortly to discuss the protocol for collecting the additional safety data, which is expected to be incorporated into the existing BLA. The company also continues to work on the questions raised by the FDA in the Complete Response Letter regarding the manufacturing and testing of HEPLISAV. | |
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