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Valneva SE (VLS.PA)

VLS.PA on Paris Stock Exchange

5.98EUR
23 Nov 2020
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Latest Key Developments (Source: Significant Developments)

Valneva: Positive Initial Results For Second Phase 2 Study Of Lyme Disease Vaccine Candidate
Tuesday, 20 Oct 2020 

Oct 20 (Reuters) - Valneva SE ::ANNOUNCES POSITIVE INITIAL RESULTS FOR SECOND PHASE 2 STUDY OF LYME DISEASE VACCINE CANDIDATE VLA15.VLA15 GENERALLY SAFE ACROSS ALL DOSE AND AGE GROUPS TESTED.IMMUNOGENICITY FURTHER INCREASED IN VLA15-202 COMPARED TO VLA15-201.PHASE 2 STUDY VLA15-202 MET ITS ENDPOINTS.FUNCTIONALITY OF ANTIBODIES WAS DEMONSTRATED ACROSS ALL SEROTYPES USING A SERUM BACTERICIDAL ASSAY.SEROCONVERSION RATES EXCEEDED 90% ACROSS ALL SEROTYPES, INCLUDING IN OLDER ADULTS (50-65 YEARS).  Full Article

Valneva'S Chikungunya Vaccine Candidate Awarded EMA Prime Designation
Friday, 16 Oct 2020 

Oct 16 (Reuters) - Valneva SE ::REG-VALNEVA’S CHIKUNGUNYA VACCINE CANDIDATE AWARDED EMA PRIME DESIGNATION.NEW DESIGNATION FROM EMA COMPLEMENTS FAST TRACK DESIGNATION RECEIVED FROM FDA IN DECEMBER 2018.  Full Article

Valneva Announces Agreement With UK Governement
Monday, 14 Sep 2020 

Sept 14 (Reuters) - VALNEVA SE ::VALNEVA AND DYNAVAX ANNOUNCE COMMERCIAL SUPPLY AGREEMENT FOR INACTIVATED, ADJUVANTED COVID-19 VACCINE.INACTIVATED, ADJUVANTED SARS-COV-2 VACCINE CANDIDATE SCHEDULED TO ENTER FIRST CLINICAL STUDIES IN DECEMBER 2020.EXPECTS VLA2001 TO ENTER CLINICAL STUDIES BY END OF 2020 AND TO POTENTIALLY REACH REGULATORY APPROVAL IN THE SECOND HALF OF 2021.DYNAVAX WILL PROVIDE CPG 1018 TO PRODUCE UP TO 190 MILLION DOSES OVER A FIVE YEAR PERIOD TO SUPPORT VALNEVA’S CONTRACT WITH U.K. GOV.SEPARATELY ANNOUNCED TODAY AN AGREEMENT WITH THE UK GOVERNMENT TO PROVIDE UP TO 190 MILLION DOSES OF VLA2001.DYNAVAX WILL SUPPLY CPG 1018 TO PRODUCE UP TO 100 MILLION DOSES OF VACCINE IN 2021.VALNEVA HAS THE OPTION TO PURCHASE UP TO AN ADDITIONAL 90 MILLION DOSES THROUGH 2025.  Full Article

Valneva Announces IXIARO Supply Contract With US Government Worth Up To $166 Million
Wednesday, 9 Sep 2020 

Sept 9 (Reuters) - Valneva SE ::VALNEVA ANNOUNCES NEW IXIARO® SUPPLY CONTRACT WITH THE US GOVERNMENT WORTH UP TO $166 MILLION.NEW CONTRACT SPANS A TOTAL OF THREE YEARS (ONE BASE YEAR, PLUS TWO OPTION YEARS) WITH A BASE-YEAR VALUE OF $61 MILLION.DELIVERIES FOR BASE-YEAR WILL COMMENCE IN Q4 2020.DOD HAS OPTION TO PURCHASE A TOTAL OF $76 MILLION - $105 MILLION WORTH OF IXIARO(®) ACROSS TWO OPTION YEARS.  Full Article

Valneva Initiates Phase 3 Clinical Study For Chikungunya Vaccine Candidate
Tuesday, 8 Sep 2020 

Sept 8 (Reuters) - VALNEVA SE ::REG-VALNEVA INITIATES PHASE 3 CLINICAL STUDY FOR ITS CHIKUNGUNYA VACCINE CANDIDATE VLA1553.TOTAL DURATION OF STUDY IS EXPECTED TO BE NINE MONTHS AND OUTCOME, IF POSITIVE, SHALL PROVIDE BASIS FOR LICENSURE OF VACCINE..STUDY, CALLED VLA1553-301, IS A DOUBLE-BLINDED, PLACEBO-CONTROLLED, MULTI-CENTER STUDY IN APPROXIMATELY 4,000 HEALTHY ADULTS AGED 18 OR ABOVE, CONDUCTED IN U.S..PARTICIPANTS WILL BE RANDOMIZED INTO TWO STUDY GROUPS TO RECEIVE EITHER VACCINE OR PLACEBO.PRIMARY ENDPOINT WILL BE TO DEMONSTRATE SAFETY AND IMMUNOGENICITY 28 DAYS AFTER A SINGLE-SHOT VACCINATION WITH VLA1553.PARTICIPANTS WILL BE FOLLOWED FOR A TOTAL OF SIX MONTHS.SPONSOR OF FIRST CHIKUNGUNYA VACCINE BIOLOGICS LICENSE APPLICATION (BLA) TO BE APPROVED IN U.S. WILL BE ELIGIBLE TO RECEIVE A PRIORITY REVIEW VOUCHER.  Full Article

Valneva H1 Net Loss Widens To 25.6 Million Euros
Tuesday, 4 Aug 2020 

Aug 4 (Reuters) - Valneva SE ::VALNEVA REPORTS H1 RESULTS MARKED BY MAJOR CORPORATE ACHIEVEMENTS AND STRONG CASH POSITION.UNPRECEDENTED PARTNERING DEAL SIGNED WITH PFIZER FOR LYME DISEASE VACCINE.BINDING PRELIMINARY AGREEMENT NOW IN PLACE WITH UK GOVERNMENT TO PROVIDE INITIAL FUNDING FOR MANUFACTURING EXPANSION OF SARS-COV-2 VACCINE.AGREEMENT IN PRINCIPLE TO SUPPLY UP TO 100 MILLION DOSES TO UK GOVERNMENT.POSITIVE INITIAL RESULTS FOR PHASE 2 STUDY OF LYME DISEASE VACCINE VLA15.POSITIVE END-OF-PHASE 2 CHIKUNGUNYA MEETING WITH THE U.S. FDA.MARKETING AND DISTRIBUTION PARTNERSHIP WITH BAVARIAN NORDIC.$85 MILLION FINANCING ARRANGEMENT WITH LEADING US HEALTHCARE FUNDS.STRONG CASH POSITION OF €200 MILLION AT END OF JUNE 2020.TOTAL REVENUES OF €47.9 MILLION IN H1 2020 COMPARED TO €54.5 MILLION IN H1 2019.H1 EBITDA LOSS OF €17.2 MILLION COMPARED TO AN EBITDA PROFIT OF €2.4 MILLION IN H1 2019.VALNEVA FY 2020 TOTAL REVENUE GUIDANCE CONFIRMED WITH MAJOR EBITDA IMPROVEMENT COMPARED TO ORIGINAL GUIDANCE.FORECASTS TOTAL 2020 REVENUES OF €120 MILLION TO €140 MILLION, BROADLY IN LINE WITH ITS ORIGINAL GUIDANCE.NOW ESTIMATES EBITDA OF BETWEEN ZERO AND NEGATIVE €10 MILLION IN 2020 (COMPARED TO ORIGINAL GUIDANCE OF UP TO €35 MILLION NEGATIVE EBITDA).IN VALNEVA GENERATED A NET LOSS AMOUNTING TO €25.6 MILLION COMPARED TO A NET LOSS OF €2.4 MILLION IN THE FIRST HALF OF 2019.  Full Article

Valneva Partners With Batavia Biosciences For Polio Vaccine
Monday, 15 Jun 2020 

June 15 (Reuters) - VALNEVA SE ::BATAVIA BIOSCIENCES AND VALNEVA COLLABORATE TO ACCELERATE DEVELOPMENT OF LOW-COST INACTIVATED POLIO VACCINE.VALNEVA WILL RECEIVE AN UPFRONT PAYMENT AND MONTHLY SERVICE FEES.TO MANUFACTURE SIPV VACCINE FOR CLINICAL TRIAL PURPOSES IN ITS STATE-OF--ART GMP POLIO MANUFACTURING FACILITY OPERATED UNDER GAPIII POLIO CONTAINMENT.BATAVIA WILL REMAIN RESPONSIBLE FOR RELEASE AND SUPPLY OF GMP VACCINE TO DCVMS.  Full Article

Valneva Announces FDA Approval Of Ixiaro Shelf Life Extension To 36 Months
Sunday, 8 Mar 2020 

March 8 (Reuters) - Valneva SE ::VALNEVA ANNOUNCES FDA APPROVAL OF IXIARO® SHELF LIFE EXTENSION TO 36 MONTHS; NEW US MILITARY RFP ISSUED.US DEPARTMENT OF DEFENSE ("DOD") HAS ISSUED A REQUEST FOR PROPOSAL ("RFP") FOR JAPANESE ENCEPHALITIS VACCINE.WILL RESPOND TO THIS RFP EXPEDITIOUSLY AND, IF SUCCESSFUL, EXPECTS TO ENTER INTO A NEW SUPPLY CONTRACT DURING FIRST HALF OF 2020.  Full Article

Valneva Confirms Delisting From Vienna Stock Exchange
Thursday, 19 Sep 2019 

Sept 19 (Reuters) - VALNEVA SE ::VALNEVA CONFIRMS DELISTING FROM THE VIENNA STOCK EXCHANGE.VALNEVA SHARES WILL BE AUTOMATICALLY TRANSFERRED TO EURONEXT PARIS.VALNEVA’S LISTING ON EURONEXT PARIS REMAINS UNCHANGED.  Full Article

Valneva Initiates Second Phase 2 Study For VLA15
Monday, 1 Jul 2019 

July 1 (Reuters) - Valneva SE ::REG-VALNEVA INITIATES SECOND PHASE 2 STUDY FOR ITS LYME DISEASE VACCINE CANDIDATE VLA15.PHASE 2 DURATION IS EXPECTED TO BE APPROXIMATELY TWO YEARS WITH INITIAL DATA (PRIMARY ENDPOINT) EXPECTED MID-2020.OVERALL PHASE 2 OBJECTIVES FOR VLA15 ARE TO DETERMINE OPTIMAL DOSAGE LEVEL AND VACCINATION SCHEDULE FOR USE IN PHASE 3 PIVOTAL FIELD EFFICACY STUDIES, BASED ON IMMUNOGENICITY AND SAFETY DATA.  Full Article

Valneva to supply up to 190 million doses of COVID-19 vaccine to UK

French vaccine maker Valneva said on Monday it would supply the UK with up to 190 million doses of its coronavirus vaccine candidate, VLA2001, over a five-year period.