Key Developments: Dynavax Technologies Corp (DVAX.PH)
2.48USD
20 May 2013
$-0.04 (-1.59%)
$2.52
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Latest Key Developments (Source: Significant Developments)
Dynavax Technologies Corp Announces Management Changes
Dynavax Technologies Corp announced that the Company's Board Of Directors has appointed Eddie Gray Chief Executive Officer and a member of Dynavax's board, effective May 1, 2013. Mr. Gray will succeed Dino Dina, M.D., Chief Executive Officer. Dr. Dina will remain a consultant to the Company for a transition period and plans to continue serving as a member of the Dynavax board. The Company also indicated that Tyler Martin, M.D., President, is departing from Dynavax on May 31, 2013 and plans to remain a consultant for a transition period. Full Article
Dynavax Technologies Corp Announces Departure Of CFO-Form 8-K
Dynavax Technologies Corp reported in its Form 8-K that on February 20, 2013, Christine R. Larson departed Dynavax as its Vice President and Chief Financial Officer (CFO), effective on February 28, 2013. Jennifer Lew, Dynavax's Vice President, Finance and Principal Accounting Officer, has assumed Ms. Larson's responsibilities. Full Article
Dynavax Technologies Corp Receives FDA Complete Response Letter On HEPLISAV Biologic License Application
Dynavax Technologies Corp announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its Biologic License Application (BLA) for HEPLISAV, an investigational adult hepatitis B vaccine. In the CRL, the FDA specified that the indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group. The FDA also continues to express concern that adjuvants may cause rare autoimmune events. However, the Agency indicated its willingness to continue discussions regarding a more restricted use of HEPLISAV. Dynavax plans to discuss the CRL with the FDA to identify the most expeditious path to approval for HEPLISAV, particularly in adults who may receive the greatest benefit from HEPLISAV. Furthermore, the FDA requested additional data from Dynavax's process validation program and clarifying information on the manufacturing controls and facilities related to the assurance of the quality of the commercial product. Dynavax believes it can provide the information but the exact timeframe for its response cannot be determined until it has met with the Agency. Dynavax plans to meet with the FDA to discuss the steps necessary for potential approval of HEPLISAV and currently believes the meeting can take place within 6 weeks. Following its meeting with the FDA, Dynavax will provide updates as appropriate. Full Article
Dynavax Technologies Corp Announces Marketing Authorization Application For Heplisav Accepted For Review By European Medicines Agency
Dynavax Technologies Corp announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease. Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review by the EMA. Full Article
Dynavax Technologies Corp Appoints Christine Larson As Chief Financial Officer
Dynavax Technologies Corp announced the appointment of Christine Larson to the position of Vice President and Chief Financial Officer, a newly created position. Full Article
Dynavax Technologies Corp Announces FDA Acceptance of HEPLISAV BLA
Dynavax Technologies Corp announced that the Food and Drug Administration (FDA) has accepted for review the U.S. Biologics License Application (BLA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age. Full Article
Dynavax Technologies Corporation Prices Public Offering Of Common Stock
Dynavax Technologies Corporation announced the pricing of an underwritten public offering of 17,500,000 shares of its common stock, offered at a price to the public of $4.25 per share. The gross proceeds to Dynavax from this offering are expected to be approximately $74.4 million, before deducting underwriting discounts and commissions and other offering expenses payable by Dynavax. Dynavax has granted the underwriters a 30-day option to purchase up to an aggregate of 2,625,000 additional shares of common stock to cover over-allotments, if any. All of the shares in the offering are to be sold by Dynavax. The offering is expected to close on or about May 14, 2012, subject to customary closing conditions. Dynavax expects to use the net proceeds from the offering primarily to fund activities in preparation for the anticipated commercial launch of HEPLISAV(TM), subject to receipt of regulatory approval, including the manufacture of commercial supply, to fund the marketing, sales and medical affairs infrastructure and personnel, including the hiring of a field sales force, and to commercialize HEPLISAV in the United States, if approved by the U.S. Food and Drug Administration, as well as for other general corporate purposes. J.P. Morgan Securities LLC is acting as sole book-running manager for the offering. Cowen and Company, LLC is acting as co-manager. Full Article
Dynavax Technologies Corporation Proposes Public Offering of Common Stock
Dynavax Technologies Corporation announced that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering. Dynavax also expects to grant the underwriters a 30-day option to purchase additional shares of its common stock to cover over-allotments, if any. All of the shares in the offering are being offered by Dynavax. J.P. Morgan Securities LLC is acting as sole book-running manager for the offering. Cowen and Company, LLC is acting as co-manager. Full Article
Dynavax Technologies Corporation Announces Phase 3 Data On HEPLISAV In Adults Aged 40-70 Published In VACCINE
Dynavax Technologies Corporation announced that results of an early Phase 3 trial (HBV-04) of HEPLISAV investigational hepatitis B vaccine were published online in the journal VACCINE. The article concludes that HEPLISAV was well-tolerated and demonstrated superior and more durable seroprotection earlier than the licensed comparator hepatitis B vaccine. The article, entitled "Demonstration of Safety and Enhanced Seroprotection Against Hepatitis B with Investigational HBsAg-1018 ISS Vaccine Compared to a Licensed Hepatitis B Vaccine" by first author Benjamin Sablan, describes the results from a Phase 3 clinical trial of HEPLISAV conducted in Asia. The trial compared the safety and immunogenicity of HEPLISAV with Engerix-B® in 412 adults 40-70 years of age. The seroprotection rate at one month after the second dose in the HEPLISAV group was 97% versus 24% in the Engerix-B group (p < 0.0001). At one month after the third dose, the seroprotection rates were 100% for HEPLISAV and 73% for Engerix-B (p < 0.0001). Seroprotection rates at one year after the first dose were 100% for HEPLISAV and 69% for Engerix-B (p < 0.0001). HEPLISAV is an investigational adult hepatitis B vaccine. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a Toll-like Receptor 9 agonist to enhance the immune response. Full Article
Dynavax Technologies Corporation Announces Exercise In Full Of Overallotment Option And Completion Of Public Offering Of Common Stock
Dynavax Technologies Corporation announced the completion of a public offering of 27,600,000 shares of its common stock, including 3,600,000 shares sold pursuant to the full exercise of an overallotment option previously granted to the underwriters. All of the shares were offered by Dynavax at a price to the public of $2.50 per share. 160,000 shares were purchased by the Chairman of Dynavax's Board of Directors. The net proceeds to Dynavax from this offering were approximately $64.5 million, after deducting the underwriting discount and other estimated offering expenses payable by Dynavax. Dynavax anticipates using the net proceeds from the offering primarily to fund activities in connection with the anticipated approval and commercial launch of HEPLISAV, and for other general corporate purposes, including working capital. Cowen and Company, LLC acted as sole book-running manager for the offering and William Blair & Company, L.L.C. acted as co-manager. Full Article
Dynavax may have to repitch hepatitis B vaccine for smaller market
- Dynavax Technologies Inc may need to repitch its hepatitis B vaccine for a smaller patient population, after U.S. health regulators declined to approve the vaccine for adults - an estimated $700 million global market.
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