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DBV・テクノロジーズ

DBV.PA

現在値

9.00EUR

変化

-0.02(-0.22%)

出来高

118,307

本日のレンジ

8.98

 - 

9.22

52週レンジ

2.35

 - 

18.27

∙ 約20分前の相場を表示しています。

適時開示

DBV Technologies Provides Update On Investigational Viaskin Peanut

Jan 14 (Reuters) - DBV Technologies SA <DBV.PA>::DBV TECHNOLOGIES PROVIDES UPDATE ON INVESTIGATIONAL VIASKIN™ PEANUT FOR CHILDREN AGES 4-11 YEARS.DBV TECHNOLOGIES SA - RECEIPT OF WRITTEN RESPONSES FROM FDA TO QUESTIONS PROVIDED IN TYPE A MEETING REQUEST COMPANY SUBMITTED IN OCTOBER 2020.DBV TECHNOLOGIES SA - FDA HAS REQUESTED AN ASSESSMENT COMPARING UPTAKE OF ALLERGEN BETWEEN PATCHES IN PEANUT ALLERGIC CHILDREN AGES 4-11.DBV TECHNOLOGIES - FDA RECOMMENDED CONDUCTING A 6-MONTH, SAFETY AND ADHESION TRIAL TO ASSESS MODIFIED VIASKIN PEANUT PATCH IN INTENDED PATIENT POPULATION.DBV TECHNOLOGIES SA - PLANS TO INITIATE SELECTION OF MODIFIED PROTOTYPE PATCHES IN Q1 OF 2021.DBV TECHNOLOGIES - WILL SUBMIT PROTOCOL FOR SAFETY & ADHESION TRIAL IN CHILDREN WITH PEANUT ALLERGY TO FDA FOR REVIEW AND COMMENTS IN Q2 OF 2021.DBV TECHNOLOGIES SA - BELIEVES THAT FEEDBACK RECEIVED FROM FDA PROVIDES A WELL-DEFINED REGULATORY PATH FORWARD.

DBV Plans To Cut Over 200 Jobs

Jan 7 (Reuters) - DBV Technologies SA <DBV.PA>::DBV TECHNOLOGIES ANNOUNCES CHANGE IN U.S. REPORTING STATUS AND FINAL APPROVAL OF GLOBAL RESTRUCTURING PROCESS.QUALIFIES AS A U.S. DOMESTIC ISSUER RATHER THAN A FOREIGN PRIVATE ISSUER IN UNITED STATES..AS OF JANUARY 1, 2021, DBV TECHNOLOGIES IS SUBJECT TO U.S. SEC AND OTHER RULES, REGULATIONS APPLICABLE TO U.S. DOMESTIC ISSUERS.PROCESS IMPLEMENTING EMPLOYMENT SAFEGUARD PLAN IN FRANCE HAS BEEN APPROVED..DBV EXPECTS ALL HEAD-COUNT REDUCTIONS TO BE COMPLETED BY END OF Q1 OF 2021.FULL IMPLEMENTATION OF RESTRUCTURING PLAN WILL RESULT IN A REDUCTION OF MORE THAN 200 JOBS.DBV TECHNOLOGIES EXPECTS CONTINUED DECELERATION IN ITS AVERAGE MONTHLY CASH BURN THROUGH SECOND HALF OF 2021.EXPECTS FULL IMPLEMENTATION OF ORGANIZATION-WIDE COST REDUCTION MEASURES TO BE COMPLETED BY SECOND HALF OF 2021.DBV EXPECTS THESE COST-REDUCTION EFFORTS TO SIGNIFICANTLY EXTEND COMPANY'S CASH RUNWAY TO H2 OF 2022.

DBV Technologies Announces Validation Of Marketing Authorization Application For Viaskin Peanut By EMA

Nov 2 (Reuters) - DBV TECHNOLOGIES SA <DBV.PA>::ANNOUNCES FILING AND VALIDATION OF MARKETING AUTHORIZATION APPLICATION FOR VIASKIN™ PEANUT BY EUROPEAN MEDICINES AGENCY.DBV EXPECTS TO RECEIVE FIRST SET OF QUESTIONS FROM EMA APPROXIMATELY 120 DAYS POST-VALIDATION.VALIDATION CONFIRMS THAT SUBMISSION IS SUFFICIENTLY COMPLETE TO BEGIN FORMAL REVIEW PROCESS FOR INVESTIGATIONAL NON-INVASIVE, ONCE-DAILY EPICUTANEOUS PATCH TO TREAT PEANUT ALLERGIES IN CHILDREN AGES 4 TO 11 YEARS.FOLLOWING MAA VALIDATION, EMA'S COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE WILL PROVIDE RECOMMENDATION TO EC ON WHETHER TO GRANT MARKETING AUTHORIZATION.

DBV Technologies End-Sept Cash, Cash Equivalents At EUR 189.1 Mln

Oct 30 (Reuters) - DBV Technologies SA <DBV.PA>::CASH AND CASH EQUIVALENTS AS OF SEPTEMBER 30, 2020, WERE EUR 189.1 MILLION, COMPARED TO EUR 225.9 MILLION AS OF JUNE 30, 2020.COMPANY EXPECTS FULL IMPLEMENTATION OF ORGANIZATION-WIDE COST REDUCTION MEASURES TO BE COMPLETED BY SECOND HALF OF 2021.ONCE MEASURES IMPLEMENTED BY H2 OF 2021, IT FORECASTS IT WILL HAVE REDUCED ITS AVERAGE MONTHLY CASH BURN BY 40-50% AS COMPARED TO H1 2020.

Dbv Technologies Appoints Sebastien Robitaille To Replace Ramzi Benamar As CFO

Sept 9 (Reuters) - DBV Technologies SA <DBV.PA>::DBV TECHNOLOGIES ANNOUNCES LEADERSHIP CHANGES.RAMZI BENAMAR, CHIEF FINANCIAL OFFICER, AND KEVIN TRAPP, CHIEF COMMERCIAL OFFICER, WILL BE LEAVING COMPANY AS OF OCTOBER 2, 2020.SÉBASTIEN ROBITAILLE HAS BEEN APPOINTED AS CHIEF FINANCIAL OFFICER EFFECTIVE OCTOBER 2, 2020..

DBV Technologies Receives Response From FDA For Viaskin Peanut BLA

Aug 4 (Reuters) - DBV Technologies SA <DBV.PA>::DBV TECHNOLOGIES RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR VIASKIN PEANUT BLA IN CHILDREN AGES 4-11 YEARS.RESPONSE LETTER INDICATES THAT FDA CANNOT APPROVE APPLICATION IN ITS PRESENT FORM.FDA HAS IDENTIFIED CONCERNS REGARDING IMPACT OF PATCH-SITE ADHESION ON EFFICACY AND INDICATED NEED FOR PATCH MODIFICATIONS, AND SUBSEQUENTLY A NEW HUMAN FACTOR STUDY.FDA HAS ALSO INDICATED THAT SUPPLEMENTARY CLINICAL DATA WOULD NEED TO BE GENERATED TO SUPPORT MODIFIED PATCH.AGENCY DID NOT RAISE ANY SAFETY CONCERNS RELATED TO VIASKIN PEANUT.DBV INTENDS TO REQUEST A MEETING WITH FDA TO DISCUSS FDA'S COMMENTS AS WELL AS REQUIREMENTS FOR ADDITIONAL CLINICAL DATA THAT MAY BE NEEDED TO SUPPORT BLA RESUBMISSION.

DBV Technologies H1 Net Loss Widens To EUR 86.5 Mln

July 31 (Reuters) - DBV TECHNOLOGIES SA <DBV.PA>::DBV TECHNOLOGIES REPORTS FIRST HALF 2020 FINANCIAL RESULTS.CASH POSITION: CASH AND CASH EQUIVALENTS AS OF JUNE 30, 2020 WERE EUR 225.9 MILLION, COMPARED TO EUR 172.0 MILLION AS OF DECEMBER 31, 2019.NET LOSS: NET LOSS WAS EUR (86.5) MILLION FOR FIRST HALF 2020, COMPARED TO EUR (79.8) MILLION FOR FIRST HALF 2019.OPERATING INCOME WAS €7.6 MILLION FOR THE FIRST HALF 2020.COMPARED TO €7.1 MILLION FOR THE FIRST HALF 2019.

Dbv Technologies: EPITOPE Phase III trial in toddlers ongoing; treatment benefit observed in Part A analysis

June 26 (Reuters) - DBV Technologies SA <DBV.PA>::REG-DBV TECHNOLOGIES PROVIDES OPERATIONAL AND BUSINESS UPDATE.EPITOPE PHASE III TRIAL IN TODDLERS AGES 1-3 YEARS ONGOING; TREATMENT BENEFIT OBSERVED IN PART A ANALYSIS.COMPANY TO IMMEDIATELY INITIATE RESTRUCTURING PLAN TO EXTEND CASH RUNWAY WHILE AWAITING FDA CLARITY.BLA REVIEW OF VIASKIN PEANUT FOR TREATMENT OF PEANUT ALLERGY IN CHILDREN AGES 4-11 YEARS ONGOING.ALL ONGOING CLINICAL TRIALS WILL CONTINUE AS PLANNED; HOWEVER, ENROLLMENT TIMELINES HAVE BEEN IMPACTED BY COVID-19.PLANS TO FOCUS ON VIASKIN PEANUT AND SCALE DOWN OTHER CLINICAL PROGRAMS AND PRE-CLINICAL SPEND..COMPANY ANTICIPATES PROVIDING AN UPDATE REGARDING SAMPLE SIZE AND EXPECTATIONS FOR COMPLETION OF ENROLLMENT OF PART B IN SECOND HALF OF 2020.EXPECTS THAT ITS CURRENT BALANCE OF CASH AND CASH EQUIVALENTS OF EUR 262.4 MILLION AT END OF Q1 WILL BE SUFFICIENT TO FUND OPERATIONS SIGNIFICANTLY BEYOND PRIOR GUIDANCE OF Q1 OF 2021.FOLLOWING FEEDBACK FROM FDA ON VIASKIN PEANUT BLA REVIEW, COMPANY WILL PROVIDE UPDATED FINANCIAL GUIDANCE.

DBV Technologies Cash And Cash Equivalents As of March 31 Up At EUR 262.4 Mln

April 30 (Reuters) - :AS OF MARCH 31, 2020, CASH AND CASH EQUIVALENTS EUR 262.4 MILLION VERSUS EUR 172.0 MILLION AS OF DEC 31, 2019.

DBV Technologies Provides Update On Viaskin Peanut BLA For Children Ages 4-11 Years

March 16 (Reuters) - DBV Technologies SA <DBV.PA>::DBV TECHNOLOGIES PROVIDES UPDATE ON VIASKIN PEANUT BLA FOR CHILDREN AGES 4-11 YEARS.DBV TECHNOLOGIES SA - HAS RECEIVED NO ADDITIONAL INFORMATION REGARDING TIMELINE OF BLA REVIEW.DBV TECHNOLOGIES SA - TO COMPANY'S KNOWLEDGE, TARGET ACTION DATE OF AUGUST 5, 2020 REMAINS UNCHANGED.DBV TECHNOLOGIES - U.S. FDA HAS INFORMED THAT DURING REVIEW OF BLA FOR INVESTIGATIONAL VIASKIK PEANUT, HAS IDENTIFIED QUESTIONS REGARDING EFFICACY.DBV TECHNOLOGIES SA - ALLERGENIC PRODUCTS ADVISORY COMMITTEE MEETING TO DISCUSS BLA WILL NO LONGER TAKE PLACE AS PREVIOUSLY SCHEDULED ON MAY 15, 2020.

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