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.
Dynavax Technologies (Nasdaq: DVAX) announced that the U.S. FDA has issued a Complete Response Letter (CRL) regarding its supplemental Biologics License Application (sBLA) for a four-dose HEPLISAV-B vaccine regimen for adults on hemodialysis. The CRL cited insufficient data to fully evaluate the effectiveness and safety of the regimen, due to the destruction of data source documents and an inadequate sample size in the HBV-24 study. This decision does not impact the current approved indications for HEPLISAV-B in the U.S., EU, and Great Britain, nor the European Commission's approval of the four-dose regimen for hemodialysis patients. Dynavax plans to meet with the FDA to explore options for providing additional data.
Dynavax reported $48 million in HEPLISAV-B vaccine net product revenue, a 10% increase year-over-year in Q1 2024. The company reaffirmed its full-year revenue guidance and FDA clearance to initiate Phase 1/2 trial of Z-1018 shingles program. Dynavax continues to evaluate strategic growth opportunities while focusing on expanding its hepatitis B vaccine market share.
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