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21st Austria weekly - Valneva (07/01/2020)

12.01.2020

Valneva: Austrian Frensch biotech company Valneva SE announced that an End Of Phase 2 (EOP2) meeting has been scheduled with the U.S. Food and Drug Administration (FDA) on February 24, 2020 for its single-shot chikungunya vaccine candidate, VLA1553. The Company plans to present its plan for Phase 3 clinical studies and licensure. VLA1553 has been awarded Fast Track designation by the FDA and may be eligible for a Priority Review Voucher. Wolfgang Bender, chief medical officer of Valneva, commented: “We are extremely pleased that the FDA has accepted our proposal for an EOP2 meeting. Subject to the outcome we may commence Phase 3 clinical trials within a few months. We are strongly committed to advancing VLA1553, currently the only chikungunya vaccine candidate in clinical development showing fully sustained titers one year after a single vaccination, through the accelerated approval.”
Valneva: weekly performance: 9.29%

(From the 21st Austria weekly https://www.boerse-social.com/21staustria (07/01/2020)


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21st Austria weekly - Valneva (07/01/2020)


12.01.2020, 1019 Zeichen



Valneva: Austrian Frensch biotech company Valneva SE announced that an End Of Phase 2 (EOP2) meeting has been scheduled with the U.S. Food and Drug Administration (FDA) on February 24, 2020 for its single-shot chikungunya vaccine candidate, VLA1553. The Company plans to present its plan for Phase 3 clinical studies and licensure. VLA1553 has been awarded Fast Track designation by the FDA and may be eligible for a Priority Review Voucher. Wolfgang Bender, chief medical officer of Valneva, commented: “We are extremely pleased that the FDA has accepted our proposal for an EOP2 meeting. Subject to the outcome we may commence Phase 3 clinical trials within a few months. We are strongly committed to advancing VLA1553, currently the only chikungunya vaccine candidate in clinical development showing fully sustained titers one year after a single vaccination, through the accelerated approval.”
Valneva: weekly performance: 9.29%

(From the 21st Austria weekly https://www.boerse-social.com/21staustria (07/01/2020)



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