Welcome to our dedicated page for Dynavax Technologies Corporation news (Ticker: DVAX), a resource for investors and traders seeking the latest updates and insights on Dynavax Technologies Corporation 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.
Medigen Vaccine Biologics Corporation and Dynavax Technologies Corporation announced the dosing of the first participant in the Phase 2 clinical trial for MVC-COV1901, a COVID-19 vaccine candidate. The trial, which aims to enroll 3,700 healthy participants aged 20 and above, will assess the safety and immunogenicity of the vaccine, which is a subunit vaccine using recombinant S-2P antigen and CpG 1018 adjuvant. Preliminary Phase 1 data indicated a good safety profile and promising immunogenicity. The trial's approval by Taiwan FDA marks a significant step forward in addressing COVID-19.
Dynavax Technologies Corporation (Nasdaq: DVAX) has appointed Kelly MacDonald as Senior Vice President and Chief Financial Officer, effective March 1, 2021. Her predecessor, Michael Ostrach, is retiring after 14 years but will remain as an advisor. MacDonald brings extensive experience from Ironwood Pharmaceuticals, where she was Chief Accounting Officer. She holds an MBA and is a Certified Public Accountant. This leadership change is expected to support Dynavax's strategic growth in developing vaccines for infectious diseases.
Dynavax Technologies Corporation (Nasdaq: DVAX) reported positive final immunogenicity and interim safety results from a clinical trial of its hepatitis B vaccine, HEPLISAV-B, in patients undergoing hemodialysis. The study included 119 patients, achieving a seroprotection rate of 89.3% with no safety concerns noted. The trial suggests HEPLISAV-B can offer a 4-dose regimen, potentially requiring fewer doses than the current standard of care. Full safety results are anticipated by the end of 2021.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced that CEO Ryan Spencer will present at the H.C. Wainwright Virtual BioConnect 2021 Conference from January 11-14, 2021. The on-demand presentation will start on January 11 at 6:00 a.m. E.T., accessible via the company's website. Dynavax focuses on developing and commercializing vaccines, with its first product, HEPLISAV-B®, approved in the U.S. for hepatitis B prevention in adults. The company is also advancing vaccine adjuvants for COVID-19 and other diseases.
On December 23, 2020, Serum Institute of India (SIIPL) and Dynavax Technologies Corporation (Nasdaq: DVAX) announced the dosing of the first participants in their Phase 1/2 clinical trial for a COVID-19 vaccine. The trial evaluates SIIPL's vaccine candidate, using Dynavax's CpG 1018 adjuvant, aiming to boost the immune response. The Phase 1 part will enroll 39 volunteers, leading to up to 216 subjects in Phase 2. SIIPL aims to leverage its manufacturing capabilities for affordable global vaccine supply amidst the pandemic.
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.
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