1. Saint-Herblain (France), May 16, 2022Valneva 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.

    The APA provides the EC with a right to terminate the APA if VLA2001 had not received a marketing authorization from the European Medicines Agency ("EMA") by April 30, 2022. Based on the terms of the APA, Valneva has 30 days from May 13, 2022 to obtain a marketing authorization or propose an acceptable remediation plan.

    The Company will work with the EC and the participating EC member states to agree to a remediation plan and to make VLA2001 available…

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  2. Saint Herblain (France), May 16, 2022Valneva SE (NASDAQ:VALN, PARIS:VLA), a specialty vaccine company, today announced that the United Arab Emirates (UAE) granted emergency use authorization for Valneva's inactivated, adjuvanted COVID-19 vaccine, VLA2001.

    Thomas Lingelbach, Chief Executive Officer of Valneva, commented, "We are extremely pleased with this new authorization and would like to thank the UAE for their trust and confidence. As the only dual-adjuvanted, whole-virus inactivated COVID-19 vaccine approved by the UAE Ministry of Health and Prevention, VLA2001 could offer an alternative vaccine solution to people across the Emirates. This is our second approval in the Gulf countries, and we are hoping that further approvals of VLA2001…

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  3. NEW YORK, May 12, 2022 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P MidCap 400 and S&P SmallCap 600:

    • Dynavax Technologies Corp. (NASD: DVAX) will replace Bottomline Technologies Inc. (NASD: EPAY) in the S&P SmallCap 600 effective prior to the opening of trading on Tuesday, May 17. Thoma Bravo LP is acquiring Bottomline Technologies in a deal expected to be completed on May 13.
    • S&P SmallCap 600 constituent Independence Realty Trust Inc. (NYSE:IRT) will replace Mimecast Ltd. (NASD: MIME) in the S&P MidCap 400, and Alpha and Omega Semiconductor Ltd. (NASD: AOSL) will replace Mimecast in the S&P SmallCap 600 effective prior to the opening of trading on Thursday, May 19. Permira Holdings Ltd. is acquiring Mimecast…
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    • 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. PT

    EMERYVILLE, Calif., May 5, 2022 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today reported financial results and provided business updates for the three months ending March

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