Dynavax Technologies

Dynavax Technologies Corp. operates as a biopharmaceutical company, which engages in the discovery, development, and commercialization of novel vaccines and immuno-oncology therapeutics. Its product includes HEPLISAV-B, which prevents infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The company was founded by Lawrence M. Lichtenstein, Dennis A. Carson, and Eyal Raz on August 29, 1996 and is headquartered in Emeryville, CA.

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Dynavax Technologies reports strong Q4 earnings, eyes continued growth

Dynavax Technologies showcased robust financial performance, driven by the success of HEPLISAV-B and CpG 1018 adjuvant. Progress in clinical development and market share growth were notable achievements. Challenges include maintaining market growth amidst competition and regulatory changes, while opportunities exist in expanding product revenue and advancing vaccine programs.

Dynavax reports record revenue growth, eyes market expansion opportunities

Dynavax Technologies showcased robust performance in Q1 2023, driven by record revenue growth and strong financial results.
While facing challenges such as uncertainties and competition, the company's strategic strengths and opportunities position it for continued success.
Management's focus on innovation, market expansion, and financial stability bodes well for future growth and shareholder value.
Overall, Dynavax Technologies remains optimistic about its outlook, supported by a dedicated team and a solid commercialization strategy.

Dynavax reports strong Q2 earnings, eyes growth through innovation

Dynavax Technologies delivered robust financial results in Q2 2023, driven by strong HEPLISAV-B revenue growth and increased market share.
The company's focus on innovation, market expansion, and financial stability positions it well for future growth and strategic opportunities.
While facing challenges in revenue sustainability and competition, Dynavax's strengths in market penetration and product pipeline offer avenues for continued success.
By leveraging opportunities in market expansion, product diversification, and strategic partnerships, Dynavax can further solidify its position in the vaccine and infectious disease spaces.

Dynavax reports record revenue growth and raises full-year guidance

Dynavax Technologies delivered a strong performance in Q3 2023, driven by record HEPLISAV-B revenue and market share gains.
While facing margin pressures from increasing expenses, the company's strategic focus on diversification and innovation bodes well for future growth.
With raised revenue guidance, a robust clinical pipeline, and a solid financial position, Dynavax is poised for continued success and market expansion.

Dynavax Technologies reports record revenue growth and strategic investments

Dynavax Technologies' Q4 2023 earnings call highlighted robust revenue growth, market leadership, and strategic investments in HEPLISAV-B.
The company's financial outlook for 2024, including revenue guidance and expense projections, reflects a balanced approach to growth and profitability.
With a strong cash position, ongoing pipeline developments, and focus on cost management, Dynavax is poised for continued success and market expansion.

Dynavax Technologies reports robust Q1 earnings and growth outlook

Dynavax Technologies delivered solid financial results in Q1 2024, driven by continued growth in HEPLISAV-B net product revenue and a focus on innovation and R&D advancement.
Despite market challenges and expenses, the company's strong cash position, market leadership, and upcoming milestones position it well for sustainable growth and success.
With a clear strategic focus on driving growth, maintaining market share, and advancing its vaccine portfolio, Dynavax is poised for a promising future in the healthcare industry.

Dynavax reports record sales and market share gains in Q2 2024

Dynavax Technologies delivered strong financial performance in Q2 2024, driven by record HEPLISAV-B sales and market share gains.
The company's pipeline progress and robust cash position position it well for future growth and innovation.
While challenges in managing expenses persist, strategic opportunities and a positive outlook for HEPLISAV-B offer avenues for sustained success.
Dynavax's focus on cost management, market expansion, and product development will be key to capitalizing on opportunities and overcoming challenges.

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Valneva SE

European Commission to order 1.25 million doses of Valneva's whole-virus COVID-19 vaccine VLA2001 in 2022

European Commission Approves Purchase Agreement Amendment for Valneva's Inactivated COVID-19 Vaccine

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SHANGHAI, China, June 27, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced new positive clinical data in individuals vaccinated with a third dose of SCB-2019 (CpG 1018/Alum) as a homologous booster against the Omicron variant. A homologous booster dose of SCB-2019 (CpG 1018/Alum) demonstrated a significant, 19-fold increase in neutralizing antibody levels against the Omicron BA.2 variant compared to pre-booster levels among baseline seronegative participants.

Clover's COVID-19 Vaccine Candidate Demonstrates Strong Cross-Neutralization Against Omicron as a Homologous Booster

VLA2001 becomes the first COVID-19 vaccine to receive a standard marketing authorization in Europe

Valneva Receives Marketing Authorization in Europe for Inactivated Whole-Virus COVID-19 Vaccine VLA2001

Its partner's coronavirus vaccine comes one important step closer to approval in Europe.

Why Dynavax Crushed the Market on Thursday

Saint Herblain (France ), June 23 , 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization in Europe for Valneva's inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use as primary vaccination in people from 18 to 50 years of age.

Valneva Receives Positive CHMP Opinion for Marketing Authorization of its Inactivated COVID-19 Vaccine Candidate in Europe

Saint- Herb lain (France ) , June 15 , 202 2 – Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has entered into a settlement agreement with the Government of the United Kingdom (“HMG”) in relation to the termination of the supply agreement for Valneva's COVID-19 vaccine candidate, VLA2001.

Valneva Announces Settlement Agreement with the UK Government

-- Study to evaluate SCB-2019 (CpG 1018/Alum) as a heterologous booster in individuals previously vaccinated with CoronaVac™  ( Sinovac Inactivated Vaccine ), Comirnaty ® ( Pfizer mRNA Vaccine ), and Vaxzevria ® ( AstraZeneca Viral Vector Vaccine ) -- -- Safety & immunogenicity data expected for key 3 rd dose booster groups (CoronaVac™  and Comirnaty ® ) in Q3-2022 and the 4 th dose booster group (CoronaVac™ ) in Q4-2022 --

Clover Doses First Participants in Phase 3 Trial Evaluating SCB-2019 as a Heterologous COVID-19 Booster Following Prior Vaccination with Inactivated, mRNA or Viral Vector Vaccines

Saint-Herb lain (France ) , June 1 0 , 2 02 2 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today provides an update on its European inactivated whole-virus COVID-19 vaccine candidate VLA2001. Following receipt of the European Commission (EC)'s notice of intent to terminate the Advance Purchase Agreement (APA)1, Valneva proposed a remediation plan, which is now subject to further discussion within the EC and among the participating member states.

Valneva Provides Update on European Inactivated, Whole-Virus COVID-19 Vaccine Program VLA2001

EMERYVILLE, Calif. , May 25, 2022 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that Ryan Spencer , Chief Executive Officer and Kelly MacDonald , Chief Financial Officer, will participate in a fireside chat during the William Blair 42nd Annual Growth Stock Conference in Chicago, Illinois on Monday June 6, 2022 at 4:40 p.m.

Dynavax to Present at the William Blair 42nd Annual Growth Stock Conference

DVAX will do well as long as the coronavirus vaccine demand exists. While the urgency is somewhat abated, an evolving endemic situation may continue to need CpG 1018.

Dynavax: Evolving Endemic Situation Adds To Its Risk

Dynavax (DVAX) gains as the EMA accepts partner Valneva's MAA for COVID-19 vaccine.

Dynavax (DVAX) Up as EMA Accepts Valneva's COVID-19 Vaccine MAA

One of its vaccine partners had some encouraging regulatory news to report.

Why Dynavax Stock Blasted 16% Higher Today

The company earns an Emergency Use Authorization from a well-off Middle Eastern country.

Why Dynavax Stock Won on a Losing Monday for the Market

EMERYVILLE, Calif. , May 16, 2022 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that Ryan Spencer , Chief Executive Officer, will present at the H.C.

Dynavax to Present at the H.C. Wainwright Global Investment Conference

Saint-Herb lain (France ) , May 16 , 2 02 2 – Valneva SE, a specialty vaccine company, today announced that it has received a notice from the European Commission (“EC”) of intent to terminate the advance purchase agreement (“APA”) for Valneva's inactivated whole-virus COVID-19 vaccine candidate VLA2001.

Valneva Receives Notice of European Commission's Intent to Terminate COVID-19 Vaccine Purchase Agreement

Dynavax Technologies Corp (NASDAQ:DVAX ) Q1 2022 Earnings Conference Call May 5, 2022 4:30 PM ET Company Participants Nicole Arndt - Senior Manager, IR Ryan Spencer - CEO & Director Donn Casale - SVP, Commercial Robert Janssen - Chief Medical Officer and SVP, Clinical Development, Medical & Regulatory Affairs Kelly MacDonald - SVP & CFO Conference Call Participants Ernie Rodriguez - Cowen and Company Matthew Phipps - William Blair & Company Robert Palermo - Goldman Sachs Group Operator Good day, ladies and gentlemen, and welcome to the Dynavax Technologies First Quarter 2022 Financial Results. As a reminder, this conference call is being recorded.

Dynavax Technologies Corp (DVAX) CEO Ryan Spencer on Q1 2022 Results - Earnings Call Transcript

Dynavax Technologies (DVAX) delivered earnings and revenue surprises of -8.33% and 3.20%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?

Dynavax Technologies (DVAX) Misses Q1 Earnings and Revenue Estimates

First quarter 2022 total revenue of $114.0 million, up 37% from $83.3 million for Q1 2021 HEPLISAV-B® vaccine net product revenue of $20.8 million, up 151% from $8.3 million for Q1 2021 CpG 1018® adjuvant net product revenue of $91.5 million, up 23% from $74.6 million for Q1 2021 Guidance reiterated for 2022 CpG 1018 revenue, operating expenses, and other costs On track for a second consecutive year of profitability Conference call today at 4:30 p.m. ET/1:30 p.m.

Dynavax Reports First Quarter 2022 Financial Results

-- Bivalent candidate (Prototype + Omicron) demonstrates broad neutralization against Omicron and all VoCs in both primary vaccination and booster settings in preclinical study -- -- Potential to pursue licensure pathway based on immuno-bridging to prototype vaccine candidate SCB-2019 (CpG 1018/Alum) which utilizes the validated Trimer-Tag™ technology platform --

Clover's Bivalent COVID-19 Vaccine Candidate Demonstrates Broad Neutralization Against Omicron and Other Variants of Concern

Saint-Herb lain (France) , May 4, 2 02 2 – Valneva SE, a specialty vaccine company, today announced the initiation of a heterologous booster trial of its inactivated whole-virus COVID-19 vaccine candidate VLA2001. The VLA2001-307 trial will be the Company's first clinical trial to provide booster data following primary vaccination with an mRNA vaccine or natural COVID-19 infection. Data, if positive, could support potential use as heterologous booster, subject to applicable regulatory recommendations and approvals.

Valneva Initiates Heterologous Booster Trial of Inactivated, COVID-19 Vaccine Candidate

EMERYVILLE, Calif. , April 21, 2022 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company focused on developing and commercializing innovative vaccines, will report first quarter 2022 financial results on Thursday, May 5, 2022, after the U.S. financial markets close.

Dynavax to Report First Quarter 2022 Financial Results and Host Conference Call on May 5, 2022

--94% cumulative protective effect against COVID-19 in previously-infected individuals that subsequently received Clover's COVID-19 vaccine candidate-- --First and only COVID-19 vaccine candidate to demonstrate significantly reduced risk of COVID-19 of any severity in previously-infected individuals in a randomized efficacy clinical trial--

Clover's Efficacy Data in Previously-Infected Individuals is Published in Lancet Infectious Disease

SHANGHAI, China, April 19, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced additional positive data from two ongoing studies evaluating SCB-2019 (CpG 1018/Alum), which demonstrated durable protection through approximately six months following primary vaccination and robust immune responses in neutralizing Omicron and other variants of concern after a booster dose in an expanded data set involving over 100 participants. These data were announced as part of a larger presentation, Clover's adjuvanted protein-based vaccine: efficacy against SARS-CoV-2 variants and duration of protection, delivered on April 18th at the World Vaccine Congress Washington 2022.

Clover Presents Updated Durability and Booster Data for COVID-19 Vaccine Candidate at World Vaccine Congress Washington 2022

SHANGHAI, China, April 12, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced that Igor Smolenov, Senior Vice President, Global Clinical Development, will deliver a presentation at the World Vaccine Congress Washington 2022. The presentation will include data on SCB-2019 (CpG 1018/Alum), Clover's adjuvanted protein-based COVID-19 vaccine candidate.

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