Welcome to our dedicated page for Dynavax Technolo news (Ticker: DVAX), a resource for investors and traders seeking the latest updates and insights on Dynavax Technolo stock.
Dynavax Technologies Corporation (Nasdaq: DVAX) is a prominent clinical-stage biopharmaceutical firm dedicated to developing innovative vaccines targeting infectious and inflammatory diseases, as well as cancer. With its headquarters in Emeryville, California, the company is renowned for leveraging the body's innate and adaptive immune responses through its proprietary Toll-like Receptor Immune Modulation Platform technology.
Core Products and Clinical Pipeline:
- HEPLISAV-B®: Approved in the U.S., EU, and Great Britain, HEPLISAV-B is the first and only adult hepatitis B vaccine that allows series completion with just two doses in one month. It continues to show strong market expansion and revenue growth.
- CpG 1018® Adjuvant: An essential component in multiple adjuvanted COVID-19 vaccines, this adjuvant enhances the immune response.
- Shingles Vaccine Program (Z-1018): In development for preventing shingles in adults aged 50 and older, promising robust immune responses.
- Tdap Vaccine Program (Tdap-1018): Focused on active booster immunization against tetanus, diphtheria, and pertussis.
- Plague Vaccine Program (DV2-PLG-01): In Phase 2 clinical trials, this program is fully funded by the U.S. Department of Defense.
Recent Achievements and Financial Highlights:
- Dynavax reported record revenue growth for HEPLISAV-B in 2023, capturing significant market share in the adult hepatitis B vaccine sector.
- As of December 31, 2023, the company had cash, cash equivalents, and marketable securities worth $742.3 million, underpinning its strong financial foundation.
- For the first quarter of 2024, Dynavax's net loss was reduced compared to the same period in 2023, due to improved operational efficiencies and strategic market initiatives.
Strategic Partnerships:
Collaborations with global biopharmaceutical companies, including AstraZeneca in Europe, further strengthen Dynavax's market position and broaden its product reach.
For detailed financial information and ongoing updates, investors can access the company's Events & Presentations page on their official website.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for HEPLISAV-B, recommending marketing authorization for this hepatitis B vaccine in adults 18 and older. The recommendation is based on favorable safety and immunogenicity data from three Phase 3 trials. If approved by the European Commission in early 2021, HEPLISAV-B will enhance patient compliance with its two-dose regimen, addressing significant challenges in hepatitis B vaccination.
Clover Biopharmaceuticals has reported positive Phase 1 clinical trial results for its COVID-19 S-Trimer vaccine candidates, demonstrating strong immune responses and a favorable safety profile in 150 participants. Both GSK and Dynavax adjuvants showed 100% seroconversion for neutralizing antibodies in adult groups. The vaccine's stability allows for storage at refrigeration temperatures, facilitating global distribution. Clover plans to begin Phase 2/3 efficacy studies in December 2020 and initiate a pivotal trial with Dynavax in early 2021, aiming to produce over one billion doses annually.
Dynavax Technologies Corporation (NASDAQ: DVAX) will have CEO Ryan Spencer participate in a virtual fireside chat at the 3rd Annual Evercore Virtual ISI HealthCONx Conference on December 3, 2020, at 10:05 a.m. E.T. The event will be accessible via the company's website under the 'Events & Presentations' section. A replay will be available for 30 days post-event. Dynavax is developing innovative vaccines, including its first commercial product, HEPLISAV-B, aimed at preventing hepatitis B infections in adults.
Biological E. Limited, in partnership with Dynavax Technologies and Baylor College of Medicine, has initiated a Phase I/II clinical trial for its COVID-19 subunit vaccine candidate in India, receiving approval from the Drugs Controller General of India. The trial will involve approximately 360 healthy participants aged 18 to 65, evaluating the vaccine's safety and immunogenicity using an antigen from BCM Ventures and Dynavax's adjuvant CpG 1018. Results are anticipated by February 2021, marking a significant step in addressing the COVID-19 pandemic with a safe and affordable vaccine.
Dynavax Technologies Corporation (Nasdaq: DVAX) reported third-quarter 2020 results, with HEPLISAV-B product revenue at $11.6 million, a rise from $10.2 million in 2019. The company highlighted a rebound in the adult hepatitis B vaccine market, achieving a 23% market share. Agreements with Valneva could yield $130 to $230 million in 2021 for its adjuvant, CpG 1018. Research and development expenses decreased to $8.5 million, while SG&A expenses rose to $21.5 million. Net income was $4.4 million, influenced by a $21.2 million gain in warrant liability.
Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical firm focusing on vaccine development, announced that CEO Ryan Spencer will present at the Stifel 2020 Virtual Healthcare Conference on November 16 at 3:30 p.m. E.T. Investors can access the live audio webcast via the 'Events & Presentations' section on the company's website. A replay will be available for 30 days after the event. Dynavax's HEPLISAV-B® vaccine is approved for preventing hepatitis B in adults and is advancing its CpG 1018 vaccine adjuvant through various collaborations.
Dynavax Technologies Corporation (Nasdaq: DVAX) will report its third quarter 2020 financial results on November 5, 2020, after U.S. markets close. A conference call with live audio webcast is scheduled at 4:30 p.m. ET. The company is known for developing novel vaccines, including HEPLISAV-B®, a hepatitis B vaccine. Further developments include collaborations on adjuvanted vaccines targeting COVID-19 and influenza. For detailed information, visit www.dynavax.com.
Dynavax Technologies (DVAX) announced that Medigen Vaccine Biologics Corporation (MVC) received a Taiwan government subsidy of NT$ 472 million (US$ 16.4 million) for initiating a Phase 1 clinical trial of a COVID-19 vaccine. The trial, which started in early October, aims to evaluate the safety and immunogenicity of MVC's vaccine combined with Dynavax's CpG 1018 adjuvant. The study involves around 45 healthy participants, receiving two doses 28 days apart, demonstrating the potential for enhanced immune response against COVID-19.
Dynavax Technologies Corporation (NASDAQ: DVAX) announced the appointment of Peter R. Paradiso, Ph.D., to its Board of Directors on September 24, 2020. With over 30 years of expertise in vaccine strategic planning, Paradiso is set to provide valuable guidance as the company expands its vaccine portfolio, particularly focusing on HEPLISAV-B and CpG 1018. Concurrently, Michael Ostrach, CFO and CBO, has announced his retirement planned for 2021. Dynavax will seek a successor while Ostrach continues until March 31, 2021, to ensure a smooth transition.
Valneva SE and Dynavax Technologies Corporation have formed a commercial partnership for the supply of Dynavax's CpG 1018 adjuvant to be used in Valneva's COVID-19 vaccine candidate, VLA2001. The UK government has agreed to purchase up to 190 million doses of VLA2001 over five years. Dynavax will supply the adjuvant necessary for 100 million doses in 2021, with an option for an additional 90 million doses by 2025. VLA2001 is expected to enter clinical studies by the end of 2020 and aims for regulatory approval in the second half of 2021.
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