Dynavax(DVAX)
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Dynavax Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S.
Prnewswire· 2024-05-14 12:30
EMERYVILLE, Calif., May 14, 2024 /PRNewswire/ -- 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 ...
Dynavax(DVAX) - 2024 Q1 - Earnings Call Transcript
2024-05-08 23:51
Dynavax Technologies Corporation (NASDAQ:DVAX) Q1 2024 Earnings Conference Call May 8, 2024 4:30 PM ET Company Participants Paul Cox - VP, Investor Relations & Corporate Communications Ryan Spencer - CEO Donn Casale - Chief Commercial Officer Rob Janssen - Chief Medical Officer Rita O'Connor - Interim CFO Conference Call Participants Matthew Phipps - William Blair Paul Choi - Goldman Sachs Ed White - H.C. Wainwright Phil Nadeau - TD Cowen Roy Buchanan - Citizens JMP Operator Welcome to the Dynavax Technolog ...
Dynavax Technologies (DVAX) Reports Q1 Loss, Misses Revenue Estimates
Zacks Investment Research· 2024-05-08 22:21
Dynavax Technologies (DVAX) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.05. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -40%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.01 per share when it actually produced break-even earnings, delivering a surprise of 100%.Over the last four quarters, t ...
Dynavax(DVAX) - 2024 Q1 - Quarterly Report
2024-05-08 20:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-34207 Dynavax Technologies Corporation (Exact name of registrant as specified in its charter) Delaware 33-0728374 (State or o ...
Dynavax(DVAX) - 2024 Q1 - Quarterly Results
2024-05-08 20:05
Exhibit 99.1 Dynavax Reports First Quarter 2024 Financial Results and Provides Business Updates • HEPLISAV-B® vaccine net product revenue grew 10% year-over-year to approximately $48 million in the first quarter of 2024 • Reaffirming full year 2024 HEPLISAV-B net product revenue guidance of $265 - $280 million • Announces U.S. FDA clearance of IND application to initiate Phase 1/2 trial of Z-1018 shingles program • Conference call today at 4:30 p.m. ET/1:30 p.m. PT EMERYVILLE, CA – May 8, 2024 – Dynavax Tec ...
Dynavax Technologies: Still A Believer
Seeking Alpha· 2024-03-24 11:39
Gilnature Shares of vaccine maker Dynavax Technologies Corporation (NASDAQ:DVAX) continue to trade at the lower end of a $12 to $15 range, which they have more or less maintained since mid-June 2023. The company's core asset (HEPISLAV-B) saw FY23 sales improve 69% over FY22 to $213.3 million, making the company cash flow positive despite the loss of revenue from CpG 1018 in Covid-19 vaccines. With three more CpG 1018 vaccine candidates advancing to or posting data from mid-stage trials in 2024 and HEPIS ...
Dynavax to Present at TD Cowen's 44th Annual Health Care Conference
Prnewswire· 2024-02-27 23:54
EMERYVILLE, Calif., Feb. 27, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the Company will present at TD Cowen's 44th Annual Health Care Conference on Monday, March 4 at 10:30 a.m. ET. The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at https://investors.dynavax.com/even ...
Dynavax(DVAX) - 2023 Q4 - Earnings Call Transcript
2024-02-23 00:34
Dynavax Technologies Corporation (NASDAQ:DVAX) Q4 2023 Earnings Conference Call February 22, 2024 4:30 PM ET Company Participants Paul Cox - Vice President, Investor Relations & Corporate Communications Ryan Spencer - Chief Executive Officer Donn Casale - Chief Commercial Officer Rob Janssen - Chief Medical Officer Kelly MacDonald - Chief Financial Officer Conference Call Participants Matthew Phipps - William Blair Jonathan Miller - Evercore ISI Paul Choi - Goldman Sachs Ernesto Rodriguez-Dumont - Cowen Roy ...
Dynavax Technologies (DVAX) Reports Break-Even Earnings for Q4
Zacks Investment Research· 2024-02-22 23:16
Dynavax Technologies (DVAX) reported break-even quarterly earnings per share versus the Zacks Consensus Estimate of a loss of $0.01. This compares to earnings of $0.45 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 100%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.01 per share when it actually produced earnings of $0.10, delivering a surprise of 1,100%.Over the last four quarters ...
Dynavax(DVAX) - 2023 Q4 - Earnings Call Presentation
2024-02-22 22:25
Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about Dynavax's expected financial results and market share as of and for the year and quarter ended December 31, 2023, expectations regarding future growth and market shares, expectations for vaccine markets, the company's strategic priorities, and expectations regarding the timing of IND f ...