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Valneva SE (VLS.PA)

VLS.PA on Paris Stock Exchange

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Latest Key Developments (Source: Significant Developments)

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 Reports Successful Outcome of Phase 2 Run-In for VLA15
Wednesday, 12 Jun 2019 

June 12 (Reuters) - VALNEVA SE ::ANNOUNCED PROGRESS OF ITS ONGOING PHASE 2 STUDY FOR ITS LEADING, UNIQUE LYME DISEASE VACCINE CANDIDATE, VLA15.BASED ON DSMB CLEARANCE, TWO LEAD DOSAGE LEVELS HAVE BEEN SELECTED FOR ONGOING PHASE 2 CLINICAL DEVELOPMENT.PRELIMINARY PHASE 2 RESULTS (PRIMARY ENDPOINT) ARE ANTICIPATED - AS PREVIOUSLY ANNOUNCED - MID-2020.VACCINE CANDIDATE HAS A FAVORABLE SAFETY PROFILE AND WAS IMMUNOGENIC IN ALL DOSES AND FORMULATIONS TESTED.AS PART OF VLA15-201 RUN-IN PHASE, 120 SUBJECTS RECEIVED ONE OF THREE ALUM ADJUVANTED DOSE LEVELS OF VLA15 (90ΜG, HIGH DOSE FROM PHASE 1, 135ΜG OR 180ΜG) OR PLACEBO..DSMB HAS REVIEWED SAFETY DATA FROM THOSE SUBJECTS AND HAS CLEARED 135ΜG AND 180ΜG DOSAGE LEVELS FOR FURTHER INVESTIGATION IN MAIN STUDY PHASE..COMPANY EXPECTS THIS STUDY TO COMMENCE IN Q3 OF THIS YEAR.STARTED PREPARATIONS TO INITIATE A FURTHER PHASE 2 STUDY (VLA15-202) TO EVALUATE AN ALTERNATIVE IMMUNIZATION SCHEDULE.  Full Article

Valneva Sees 2019 Total Revenues In Range Of EUR 125-135 Million
Wednesday, 16 Jan 2019 

Jan 16 (Reuters) - VALNEVA SE ::REG-VALNEVA CONFIRMS FY 2018 GUIDANCE AND PROVIDES INITIAL PRODUCT SALES REVENUE GUIDANCE FOR 2019.CONFIRMED THAT IT EXPECTS 2018 PRODUCT SALES REVENUES TO REACH BETWEEN EUR 100 MILLION AND EUR 105 MILLION.2018 PRODUCT SALES GROWTH IS PRIMARILY BEING DRIVEN BY INCREASING IXIARO(® )SALES.IN 2019, COMPANY PROJECTS THAT PRODUCT SALES REVENUES WILL GROW TO BETWEEN EUR 115 MILLION TO EUR 125 MILLION WHILE OTHER REVENUES SHOULD REMAIN AT SIMILAR LEVELS TO 2018.IN 2019 TOTAL REVENUES WILL BE IN RANGE OF EUR 125 MILLION TO EUR 135 MILLION.  Full Article

Valneva Intends To Delist From Vienna Stock Exchange
Monday, 7 Jan 2019 

Jan 7 (Reuters) - VALNEVA SE ::REG-VALNEVA ANNOUNCES ITS INTENTION TO DELIST FROM THE VIENNA STOCK EXCHANGE.TRADING WILL BE CENTRALIZED ON EURONEXT PARIS.  Full Article

Valneva Reports Phase 1 Results For Chikungunya Vaccine
Monday, 7 Jan 2019 

Jan 7 (Reuters) - VALNEVA SE ::VALNEVA REPORTS POSITIVE PHASE 1 INTERIM RESULTS FOR ITS CHIKUNGUNYA VACCINE CANDIDATE.100% SEROCONVERSION RATE ACHIEVED AT DAY 28 AFTER A SINGLE-SHOT VACCINATION IN A POOLED ANALYSIS OF ALL DOSE GROUPS.NO SERIOUS ADVERSE EVENTS OR ADVERSE EVENTS OF SPECIAL INTEREST WERE REPORTED UP TO DAY 28.  Full Article

Valneva Initiates Phase 2 Clinical Development For Its Lyme Disease Vaccine Candidate
Monday, 17 Dec 2018 

Dec 17 (Reuters) - VALNEVA SE ::VALNEVA INITIATES PHASE 2 CLINICAL DEVELOPMENT FOR ITS LYME DISEASE VACCINE CANDIDATE.PHASE 2 DURATION IS EXPECTED TO BE APPROXIMATELY TWO YEARS WITH INTERIM DATA (PRIMARY ENDPOINT) EXPECTED MID-2020.PHASE 2 DEVELOPMENT WILL INCLUDE THE EVALUATION OF THE HIGHEST DOSE OF VLA15 TESTED IN PHASE 1 IN ADDITION TO TWO HIGHER DOSES.PHASE 2 OBJECTIVE FOR VLA15 IS TO DETERMINE THE OPTIMAL DOSAGE LEVEL AND SCHEDULE FOR USE IN PHASE 3 PIVOTAL FIELD EFFICACY STUDIES.  Full Article

Valneva Receives Positive Feedback From EMA On Its Further Development For VLA15
Thursday, 25 Oct 2018 

Oct 25 (Reuters) - VALNEVA SE ::VALNEVA RECEIVES POSITIVE FEEDBACK FROM EMA ON ITS FURTHER DEVELOPMENT FOR LYME DISEASE VACCINE VLA15.THE COMPANY CONFIRMS IT EXPECTS TO ENTER PHASE 2 CLINICAL DEVELOPMENT AT THE END OF 2018..  Full Article

Valneva Receives Positive Feedback From EMA On Development Of Vaccine VLA15
Thursday, 25 Oct 2018 

Oct 25 (Reuters) - VALNEVA SE ::RECEIVES POSITIVE FEEDBACK FROM EMA ON ITS FURTHER DEVELOPMENT FOR LYME DISEASE VACCINE VLA15.  Full Article

Valneva Announces FDA Approval Of Accelerated IXIARO Vaccination Schedule
Friday, 5 Oct 2018 

Oct 5 (Reuters) - VALNEVA SE ::VALNEVA ANNOUNCES FDA APPROVAL OF ACCELERATED IXIARO VACCINATION SCHEDULE.FDA APPROVED ALTERNATE IXIARO IMMUNIZATION SCHEDULE OF 2 DOSES ADMINISTERED 7 DAYS APART FOR ADULT TRAVELERS AGED 18-65 YRS OLD.  Full Article

Oddo BHF Says Valneva Placement Priced At 3.75 Euros
Thursday, 27 Sep 2018 

Sept 27 (Reuters) - ODDO BHF::VALNEVA PLACEMENT : SIZE INCREASED FROM 40M€ TO 50M€ THANKS TO VERY STRONG TRACTION, ESPECIALLY FROM USA .VALNEVA PLACEMENT : PRICING SET AT 3.75€ REPRESENTING 2.6% DISCOUNT VERSUS 3 DAYS VWAP.  Full Article

BRIEF-Valneva Announces Mutual Agreement With GSK To End Strategic Alliance Agreement

* VALNEVA ANNOUNCES MUTUAL AGREEMENT WITH GSK TO END STRATEGIC ALLIANCE AGREEMENT; REGAINS CONTROL OF RESEARCH AND DEVELOPMENT