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) recently announced the grant of nonstatutory stock options for 7,500 shares of common stock to a new employee. The options, awarded on February 1, 2021, have an exercise price of $10.27 per share, reflecting the closing stock price on the grant date. These options vest over three years, starting with one-third vesting after one year. This move aligns with Nasdaq Listing Rule 5635(c)(4) and supports the company's strategy to attract talent as it advances its vaccine development initiatives.
Dynavax Technologies Corporation (Nasdaq: DVAX) and Serum Institute of India (SIIPL) announced the initiation of a Phase 1 clinical trial for an improved Tdap booster vaccine candidate, adjuvanted with CpG 1018. The trial aims to address the challenges associated with current acellular pertussis vaccines, which have seen a rise in pertussis cases in industrialized nations. The clinical trial will evaluate safety and immunogenicity in healthy volunteers aged 10 to 22. Results are anticipated by Q4 2021, with Dynavax holding exclusive commercialization rights globally, excluding India.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced that the UK Government ordered an additional 40 million doses of Valneva's SARS-CoV-2 vaccine candidate, VLA2001. This triggers the reservation of Dynavax's adjuvant, CpG 1018, for production support. Dynavax expects to generate up to $230 million in revenue from this deal in 2021, contingent on successful material delivery. This partnership aims to enhance vaccine development, following a prior agreement for up to 190 million doses over five years.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced a partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to supply its CpG 1018 adjuvant for COVID-19 vaccines. CEPI will provide up to $99 million in funding through a forgivable loan to support the manufacturing of CpG 1018. This agreement aims to enhance vaccine efficacy and ensure equitable access globally. The stockpiled adjuvant will be available for CEPI grantees, with reimbursement obligations tied to sales. This collaboration underscores CpG 1018's potential role in addressing the pandemic.
Clover Biopharmaceuticals and Dynavax Technologies (DVAX) announced plans to initiate a global Phase 2/3 efficacy trial for the S-Trimer COVID-19 vaccine candidate in the first half of 2021. This trial, supported by CEPI, aims for interim efficacy results mid-2021. Clover's vaccine showed promising results in Phase 1, generating high neutralizing antibodies with a favorable safety profile. Clover aims to produce up to 1 billion doses annually. The partnership with GSK evaluating an adjuvant has been discontinued, but both companies remain committed to combating the pandemic.
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.
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