DVAX Dynavax Technologies Corporation

12.86
-0.29  -2%
Previous Close 13.15
Open 12.81
52 Week Low 4.93
52 Week High 21.39
Market Cap $1,542,584,418
Shares 119,952,132
Float 96,015,826
Enterprise Value $1,386,470,417
Volume 2,380,011
Av. Daily Volume 2,028,916
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Upcoming Catalysts

Drug Stage Catalyst Date
VLA2001-304 + alum and CpG 1018
COVID-19 vaccine
Phase 3
Phase 3
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CpG 1018 adjuvanted Tdap vaccine
Tetanus/Diphtheria/Pertussis Booster Vaccine
Phase 1
Phase 1
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CpG 1018
Shingles vaccine
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Tdap-1018
Tetanus, diphtheria, and acellular pertussis
Phase 1
Phase 1
Phase 1 top-line data due in 1H 2022. Adolescent data due in 2H 2022.
HEPLISAV-B
End Stage Renal Disease on Dialysis undergoing hemodialysis
Phase 1
Phase 1
Phase 1 interim safety data released January 7, 2021 - well tolerated; no safety concerns were observed.
Biological E. vaccine with CpG 1018
COVID-19 vaccine
Phase 3
Phase 3
Phase 3 trial initiated June 2021. Emergency Use Authorization submission due in 2021.
VLA2001-301 + alum and CpG 1018 (COV-COMPARE)
COVID-19 vaccine
Phase 3
Phase 3
Phase 3 top-line data reported that trial met both co-primary endpoints, noted October 18, 2021.
CpG 1018 adjuvant with rF1V vaccine
Recombinant plague vaccine
Phase 2
Phase 2
Phase 2 trial to commence 2022.
S-Trimer COVID-19 Vaccine + CpG 1018 adjuvant plus alum (SPECTRA)
COVID-19 vaccine
Phase 2/3
Phase 2/3
Phase 2/3 interim analysis showed primary and secondary endpoints met. 100% efficacy against severe COVID-19 & hospitalization and 84% efficacy against moderate-to-severe COVID-19 , and 79% efficacy against COVID-19 of any severity caused by the Delta variant, noted September 22, 2021.
Medigen with CpG 1018
COVID-19 vaccine
Phase 1
Phase 1
Phase 2 initiated January 2021.
AZD1419
Asthma
Phase 2a
Phase 2a
Phase 2a trial did not meet primary endpoint - November 29, 2018.
HEPLISAV-B
Hepatitis B
Approved
Approved
CRL February 25, 2013 and November 14, 2016. Advisory Committee Meeting July 28, 2017 voted 21 -1 in favor of recommending approval. Final approval announced November 9, 2017.

Latest News

    • Preliminary laboratory studies demonstrate that three doses of Valneva's inactivated COVID-19 vaccine candidate VLA2001 induced neutralization of the Omicron variant (B.1.1.529 lineage) 
    • 100% of tested serum samples presented neutralizing antibodies against the ancestral virus and Delta variant, and 87% against the Omicron variant

    Saint Herblain (France), January 19, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced results from an initial laboratory study demonstrating that serum antibodies induced by three doses of Valneva's inactivated COVID-19 vaccine candidate, VLA2001, neutralize the Omicron variant.

    Sera from 30 participants in the Phase 1/2 trial VLA2001-201 were used in a pseudovirus assay to…

    • Preliminary laboratory studies demonstrate that three doses of Valneva's inactivated COVID-19 vaccine candidate VLA2001 induced neutralization of the Omicron variant (B.1.1.529 lineage) 

    • 100% of tested serum samples presented neutralizing antibodies against the ancestral virus and Delta variant, and 87% against the Omicron variant

    Saint Herblain (France), January 19, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced results from an initial laboratory study demonstrating that serum antibodies induced by three doses of Valneva's inactivated COVID-19 vaccine candidate, VLA2001, neutralize the Omicron variant.

    Sera from 30 participants in the Phase 1/2 trial VLA2001-201 were used in a pseudovirus assay to analyze neutralization of the ancestral SARS-CoV-2 virus as well as the Delta and Omicron variants.

    All 30 samples (100%) presented neutralizing antibodies against the ancestral virus and Delta variant, and 26 samples (87%) presented neutralizing antibodies against the Omicron variant. The mean fold reduction of neutralization relative to the ancestral virus was 2.7-fold for Delta and 16.7-fold for Omicron.

    Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, "We are extremely pleased with these results, which confirm the potential for broad-spectrum protection of our inactivated, adjuvanted whole virus vaccine and its ability to address currently circulating variants of concern. These results add to earlier findings from our Cov-Compare Phase 3 trial, in which two doses of VLA2001 given as a primary vaccination were shown to induce superior neutralizing antibody levels and a broad T-cell response. We continue to believe that VLA2001 could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can."

    Valneva is continuing to provide data to the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency, and the National Health Regulatory Authority in Bahrain (NHRA) as part of the rolling submissions process for initial approval of VLA2001. The Company continues to expect to complete these submissions in time to receive potential regulatory approvals in the first quarter of 2022.1

    Valneva announced in November 2021 that the European Commission signed an agreement for the Company to supply up to 60 million doses of VLA2001 over two years – including 24.3 million doses in 20222. Delivery of the vaccine in Europe is currently expected to begin in April 2022, subject to approval by the EMA. Valneva also announced in December 2021 that it had signed an agreement to supply one million doses of VLA2001 to the Kingdom of Bahrain, with deliveries planned in the first quarter of 2022 subject to approval from the Bahraini NHRA.3

    About Valneva's Cross-Neutralization Laboratory Studies

    Neutralization of the currently circulating variants of concern, Delta and Omicron, induced by vaccination with VLA2001 was tested using a pseudovirus neutralization assay. The tested sera were collected from participants in Valneva's Phase 1/2 trial, VLA2001-201, two to four weeks after receiving a booster dose of VLA2001. The booster dose had been administered seven to eight months after the second dose of the priming schedule.

    To assess neutralization, pseudoviruses expressing the spike (S) protein from either the ancestral SARS-CoV-2 virus, the Delta variant, or the Omicron variant were pre-incubated with serial dilutions of individual serum samples and then used to infect target cells. Neutralization was calculated from the reduction of infection efficiency at different serum dilutions compared to a no serum control. The assays and analyses were performed by the German Primate Center (Deutsches Primatenzentrum).4

    About VLA2001

    VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (NASDAQ:DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001's manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).

    About Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

    Media & Investor Contacts

    Laëtitia Bachelot-Fontaine

    VP Global Communications & European Investor Relations

    M +33 (0)6 4516 7099

            
     



    Joshua Drumm, Ph.D.

    VP Global Investor Relations

    M +001 917 815 4520

    Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials of VLA2001 and with respect to possible regulatory approval of VLA2001. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.


    1 Valneva Confirms Clinical Trial and Regulatory Submission Timelines for its Inactivated COVID-19 Vaccine Candidate VLA2001

    2 Valneva Signs Purchase Agreement with European Commission for its Inactivated COVID-19 Vaccine VLA2001

    3 Valneva Signs Advance Purchase Agreement with Bahrain for Inactivated COVID-19 Vaccine VLA2001

    4 For further details of the method, please see Hoffmann et al, Cell 2021 Apr 29; 184(9):2384-2393.

     

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  1. EMERYVILLE, Calif., Jan. 10, 2022 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a commercial stage biopharmaceutical company focused on developing and commercializing innovative vaccines, today outlined its strategic priorities for 2022, and announced the newest candidate in its clinical development portfolio – a herpes zoster virus (shingles) vaccine candidate.

    "The transformative increase in value we saw in 2021 resulted from the strategic realignment of our company to focus on vaccines, driving growth in HEPLISAV-B® and advancing our CpG 1018® adjuvant supply strategy with a diverse portfolio of COVID-19 vaccine developers," said Ryan Spencer, Chief Executive Officer of Dynavax. "We anticipate continued product revenue growth in 2022 which will further enable investment in our clinical pipeline leveraging our proven adjuvant technology and help fuel our vision to build a leading vaccine company."

    Strategic Priorities to Drive Long-term Growth

    Dynavax anticipates continued profitability in 2022 driven by its CpG 1018 adjuvant supply business for COVID-19 vaccines and increasing HEPLISAV-B sales. To help achieve its long-term growth strategy, the Company's strategic priorities for 2022 include:

    Maximize Growth of HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

    • Recently upgraded recommendations from the CDC's Advisory Committee on Immunization Practices advise that all adults aged 19-59 be vaccinated against Hepatitis-B, creating a significantly expanded market opportunity which the company estimates to be $800 million in the U.S. by 2027. The Company believes that HEPLISAV-B is well-positioned to secure majority market share.
    • With a proven clinical profile and strong commercial execution, the Company expects further market share gains and revenue growth in 2022.

    Expand CpG 1018 Adjuvant Supply Business for COVID-19 Vaccines

    • Recent Phase 3 clinical data from partnered programs consistently demonstrated the value of CpG 1018 adjuvant across multiple vaccine platforms.
    • Additional regulatory authorization for partners' COVID-19 vaccines anticipated in the first half of 2022.
    • Dynavax continues to expand manufacturing capacity to meet our partners' needs for adjuvant in 2022 and beyond.

    Drive Innovation Through Clinical Pipeline Expansion and Discovery

    • Topline data is expected in the first half of 2022 from the Company's ongoing Tdap-1018 phase 1 clinical trial evaluating the safety, tolerability, and immunogenicity in adults with adolescent data expected in the second half of 2022.
    • Topline data from a phase 1 clinical trial evaluating the safety, tolerability, and immunogenicity of the Company's investigational shingles vaccine candidate adjuvanted with CpG 1018 is expected by the end of 2022.
    • In collaboration with, and fully funded by, the U.S. Department of Defense, the company will conduct a phase 2 clinical trial for a plague vaccine adjuvanted with CpG 1018 which is anticipated to initiate in the second half of 2022.
    • Further advancement of product candidates with CpG 1018 adjuvant through pre-clinical and clinical collaborations and additional discovery efforts, including ongoing partnership with Mount Sinai investigating universal and seasonal influenza.

    CpG 1018 Adjuvanted Shingles (Herpes Zoster) Vaccine Candidate Enters the Clinic

    Shingles is an extremely painful consequence of the reactivation of a latent varicella zoster virus infection, with attacks leading to potential complications including chronic pain. The current shingles vaccine market is approximately $2 billion and expected to grow over time.

    "Our CpG 1018 adjuvant has an established tolerability profile demonstrated in a wide range of clinical trials and real-world, commercial use," commented Rob Janssen, Chief Medical Officer of Dynavax. "We therefore believe it is the ideal adjuvant to maintain high levels of efficacy with significantly less reactogenicity resulting in an improved shingles vaccine."

    CpG 1018 adjuvant has demonstrated its ability to enhance the immune response without excessive reactogenicity in both HEPLISAV-B and multiple COVID-19 clinical trials. Importantly, CpG 1018 has shown the ability to generate high levels of CD4+ t-cells which have been demonstrated to be key cell types in controlling latent VZV infection to avoid reactivation leading to shingles. The global phase 1 study is designed to evaluate safety, tolerability and immunogenicity of the vaccine candidate which is comprised of glycoprotein E (gE) plus CpG 1018 adjuvant. Data from this trial is expected to be available by the end of 2022.

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, plague, Tdap, seasonal influenza and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    Forward-Looking Statements

    This press release contains "forward-looking" statements, including statements regarding expected or anticipated financial performance, including market share, revenue and profitability, potential U.S. market for hepatitis vaccines, establishing CpG 1018 as a leading adjuvant, the development and potential approval of vaccines containing CpG 1018 by us or by our collaborators, potential market size and future sales of CpG 1018 or HEPLISAV-B or other product candidates, the timing of initiation and completion of clinical studies and the publication of results, the timing of our collaborators seeking conditional, emergency use or full authorization of COVID-19 vaccines containing CpG 1018 adjuvant, our ability to scale manufacturing capacity, our efforts to develop an improved pertussis and shingles vaccine, our collaboration partners' efforts to develop and commercialize a vaccine for COVID-19, entering into strategic relationships and expected results of such relationships and the potential for CpG 1018 to accelerate development and large scale manufacturing of COVID-19 or other vaccines. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that HEPLISAV-B may not become the standard of care adult hepatitis B vaccine in the U.S., risks related to whether and when prescribers and other key decision-makers at potential purchasing entities will make the decision to switch to HEPLISAV-B, and the timing and quantity of actual purchases, risks related to the timing and impact of the ACIP universal hepatitis B recommendation, risks related to the timing of completion and results of current clinical studies conducted by us or our collaborators, risks that our collaborators will not obtain approval of their vaccine candidates, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018 adjuvant, and whether use of CpG 1018 will prove to be beneficial in these vaccines, risks related to whether, when and the quantity of CpG 1018 actually purchased by vaccine companies, risks related to the use of contract manufacturers to timely supply CpG 1018 and financial commitments made to them, as well as other risks detailed in the "Risk Factors" and "Management's Discussion of Financial Condition and Results of Operations" sections of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2021 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. 

    Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.

    Contacts:

    Nicole Arndt, Investor Relations



    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-highlights-2022-priorities-and-announces-initiation-of-phase-1-clinical-trial-for-its-shingles-vaccine-candidate-301457026.html

    SOURCE Dynavax Technologies

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  2. EMERYVILLE, Calif., Jan. 7, 2022 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX) today reported that it has granted nonstatutory stock options to purchase an aggregate of 94,000 shares of Dynavax common stock and restricted stock units (RSUs) covering an aggregate of 2,500 shares of Dynavax common stock as inducements to 5 newly-hired employees in connection with commencement of employment with the Company.

    The stock options were granted on January 4, 2022 at an exercise price of $13.40 per share, which is equal to the closing price of Dynavax common stock on the date of grant. Each stock option granted has a 7-year term and vests over three years, with one-third of the shares underlying the option vesting on the one-year anniversary of the grant date, and the remaining shares vesting 1/36 per month in equal installments, subject to continued service with Dynavax through the applicable vesting dates. The RSUs vest one-third per year on each anniversary of the grant date, subject to continued service with Dynavax. The options and the RSUs were granted as  material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of a stock option agreement covering the grant and Dynavax' 2021 Inducement Award Plan, which was adopted January 9, 2021 and provides for the granting of stock options to new employees.

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, plague, Tdap, and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    Contacts:

    Nicole Arndt, Investor Relations and Corporate Communications



    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-reports-inducement-grants-under-nasdaq-listing-rule-5635c4-301456432.html

    SOURCE Dynavax Technologies

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  3. Saint Herblain (France), January 6, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today confirms the previously communicated timelines of its clinical trials and regulatory submissions for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    As announced in December 20211, the Company commenced rolling submissions for initial approval of VLA2001 with the European Medicines Agency, the UK MHRA and the Bahraini NHRA, and is continuing to work closely with those authorities to complete their review process following its positive Phase 3 trial results2. Valneva continues to expect potential regulatory approvals in the first quarter of 20221.

    The Company also announced positive homologous booster results…

    Saint Herblain (France), January 6, 2022 – Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today confirms the previously communicated timelines of its clinical trials and regulatory submissions for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

    As announced in December 20211, the Company commenced rolling submissions for initial approval of VLA2001 with the European Medicines Agency, the UK MHRA and the Bahraini NHRA, and is continuing to work closely with those authorities to complete their review process following its positive Phase 3 trial results2. Valneva continues to expect potential regulatory approvals in the first quarter of 20221.

    The Company also announced positive homologous booster results at the end of December 20213. The data showed an excellent immune response after a third dose of VLA2001 administered seven to eight months after the second dose of primary vaccination. Valneva is also evaluating the sera from the boosted participants for cross-neutralization against Variants of Concern, including Omicron. In parallel, the Company is preparing to launch a dedicated heterologous booster trial, which will evaluate a VLA2001 booster shot provided at least six months after primary vaccination with licensed COVID-19 vaccines or following natural COVID-19 infection.

    VLA2001 is also being evaluated in elderly and adolescent volunteers. The Company expects to report topline data for the elderly trial in the coming weeks.

    Thomas Lingelbach, Chief Executive Officer of Valneva, commented, "In recent weeks, we have been receiving even more messages every day from people around the world who would like to be vaccinated with an inactivated vaccine and want to know more about VLA2001. We continue to believe that our inactivated vaccine candidate could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can. We look forward to sharing further data in due course."

    Valneva announced in November 2021 that the European Commission signed an agreement for the Company to supply up to 60 million doses of VLA2001 over two years – including 24.3 million doses in 20224. Delivery of the vaccine is currently expected to begin in April 2022, subject to approval by the EMA.

    About VLA2001

    VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva's established Vero-cell platform, leveraging the manufacturing technology for Valneva's licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (NASDAQ:DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001's manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).

    About Valneva SE

    Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

    Media & Investor Contacts

    Laëtitia Bachelot-Fontaine

    VP Global Communications & European Investor Relations

    M +33 (0)6 4516 7099

            
     



    Joshua Drumm, Ph.D.

    VP Global Investor Relations

    M +001 917 815 4520

    Forward-Looking Statements

    This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials for VLA2001. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.


    1 Valneva Confirms Initiation of Rolling Review with EMA and Provides Updates on its COVID-19 Vaccine Program VLA2001

    2 Valneva Reports Positive Phase 3 Results for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

    3 Valneva Announces Positive Homologous Booster Data for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

    4 Valneva Signs Purchase Agreement with European Commission for its Inactivated COVID-19 Vaccine VLA2001

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  4. EMERYVILLE, Calif., Jan. 5, 2022 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced that Ryan Spencer, Chief Executive Officer, will present at the H.C. Wainwright Virtual BioConnect 2022 Conference being held January 10-13, 2022.

    The on demand presentation will be available, beginning Monday, January 10, 2022 at 7:00 a.m. E.T. and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at http://investors.dynavax.com/events-presentations.

    About Dynavax

    Dynavax is a commercial stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the U.S. and the European Union for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax is also advancing CpG 1018 adjuvant as a premier vaccine adjuvant through research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, plague, Tdap, seasonal influenza and universal influenza. For more information, visit www.dynavax.com and follow the company on LinkedIn.

    Contacts:

    Nicole Arndt

     

    510-665-7264

    Derek Cole, President

    Investor Relations Advisory Solutions

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/dynavax-to-present-at-the-hc-wainwright-virtual-bioconnect-2022-conference-301454785.html

    SOURCE Dynavax Technologies

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