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10-K/A - DBV Technologies S.A. (0001613780) (Filer)

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SCHEDULE 13G - DBV Technologies S.A. (0001613780) (Subject)

Châtillon, France, May 15, 2025 Combined General Meeting of June 11, 2025 Procedures for Obtaining Information and Preparatory Documents for the Combined General Meeting DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company (the "Company"), will hold its Combined General Meeting (the "General Meeting") on June 11, 2025, at 02:00 p.m. CEST (08:00 a.m EST) at the Company's headquarters located at IRO Building, 107 Avenue de la République, 92320 Châtillon, France. The preliminary notice (avis de réunion) containing the detailed agenda, draft resolutions as well as instructions to participate and vote for this General Meeting was published in the French "Bulletin des Annon

Information regarding the total number of voting rights and total number of shares of the Company as of April 30, 2025 (Article 223-16 of the General Regulations of the Autorité des Marchés Financiers) Market : NYSE Euronext Paris ISIN Code: FR 0010417345   Date   Total number of shares Total number of voting rights 04/30/2025   136,948,872     Total gross of voting rights: 136,948,872     Total net* of voting rights: 136,762,549   * Net total = total number of voting rights attached to shares – shares without voting rights Attachment PDF Version

Châtillon, France, May 5, 2025 DBV Technologies to Participate in the Citizens JMP Life Sciences Conference DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, today announced Daniel Tassé, Chief Executive Officer, will participate in a fireside chat at the Citizens JMP Life Sciences Conference on Wednesday, May 7, 2025, at 11:00am ET, in New York, NY. A live webcast of the fireside chat can be accessed here, and will also be available on the Events section of the Company's Investors website: https://dbv-technologies.com/investor-overview/events/ A replay will also be available on DBV Technologies' website for 90 days after the event. About DBV TechnologiesDBV Tech

Châtillon, France, April 30, 2025   DBV Technologies Reports First Quarter 2025 Financial Results DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, today reported financial results for the First Quarter of 2025. The quarterly and three months financial statements were approved by the Board of Directors on April 30, 2025. Financial Highlights for the First Quarter Ended March 31, 2025 The Company's interim condensed consolidated financial statements for the three months ended March 31, 2025, are prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP"). Cash and Cash Equivalents Our Condensed Consolidated Financial

Châtillon, France, April 11, 2025 DBV Technologies announces filing of 2024 Annual Report on Form 10-K and Universal Registration Document DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need (the "Company"), today announced: The audited financial statements for the year ended December 31, 2024 were approved by the Board of Directors on April 11, 2025, and present no changes from the unaudited financial statements examined by the Board of Directors on March 23 and published in the Company's press release dated March 24, 2025;The filing, for the year end

Châtillon, France, March 27, 2025 DBV Technologies Announces Financing of up to $306.9 Million (€284.5 Million) to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved DBV secures $125.5 million (€116.3 million) up front and up to $181.4 million (€168.2 million), subject to the full exercise of warrantsDBV sufficiently funded through the expected Biologics License Application (BLA) submission to Food and Drug Administration (FDA) for the Viaskin® peanut patch in children 4 – 7-years-old and commercial launch, if approvedDBV will host an investor conference call on Monday, March 31st at 5:00pm ET (23h00 CET) to discuss the fi

Châtillon, France, March 24, 2025 DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for Biologics License Application (BLA) for Viaskin® Peanut Patch in 4 – 7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, and Reports 2024 Unaudited Financial Results1 COMFORT Children supplemental safety study in children 4 – 7-years-old no longer required FDA confirms safety exposure data generated from VITESSE Phase 3 clinical study and VITESSE Open-Label Extension (OLE) are sufficient to support a Biologics License Application (BLA) for Viaskin peanut patch in children 4 – 7-years-oldVITESSE topline results on-track for the fourth quarter of 2025

Châtillon, France, February 25, 2025 DBV Technologies to Participate in Upcoming AAAAI/WAO Joint Congress DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, today announced that the company will participate in the American Academy of Allergy, Asthma, and Immunology and World Allergy Organization (AAAAI/WAO) Joint Congress, February 28-March 3, 2025, in San Diego, CA. An oral abstract presentation by Dr. David Fleischer, FAAAAI, FACAAI, Professor of Pediatrics at Children's Hospital Colorado, will describe Month 60 (M60), end-of-study efficacy and safety results from PEOPLE (the open-label extension of the 12-month, double-blind placebo-controlled, Phase 3 PEPITES

AMF Regulated InformationChâtillon, France, January 13, 2025 Half-Year Report on the DBV Technologies Liquidity Contract with ODDO BHF DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, today issued the Half-Year report on its liquidity contract with ODDO BHF. Under the liquidity contract between DBV Technologies and ODDO BHF, the following assets appeared on the liquidity account as of December 31, 2024: 266,868 DBV Technologies shares,€ 106,930.51. When the liquidity contract with ODDO BHF was implemented, as of July 1, 2018, the following assets were included in the liquidity account: 41,159 DBV Technologies shares,€ 432,367.25. Over the period from July 1,

Châtillon, France, January 8th, 2025 DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months 68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE    DBV also announced daily patch wear time data from EPITOPE that is supportive of the Company's proposed labeling approach shared with FD

Montrouge, France, May 7, 2024 DBV Technologies Reports First Quarter 2024 Financial Results and Business Update VITESSE enrollment on track to screen last patient by Q3 2024Appointment of Robert Pietrusko, PharmD to Chief Regulatory OfficerQ1 2024 closes with a cash balance of $101.5 million DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the first quarter 2024. The quarterly financial statements were approved by the Board of Directors on May 7, 2024. Recent

Montrouge, France, October 16, 2023 DBV Technologies Announces Appointment of Virginie Boucinha as Chief Financial Officer DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the appointment of Virginie Boucinha as its Chief Financial Officer, effective November 6, 2023. An experienced financial and operations executive, Virginie will report directly to Daniel Tassé, Chief Executive Officer, and serve as a member of the Executive Committee. "I am pleased to welcome Virginie to the DBV Executive Committee to lead our global financial organization," said Daniel Tassé, Chief Executive Officer, DBV Tech

Montrouge, France, October 3, 2022 DBV Technologies Announces Appointment of New Chair of its Audit Committee and Appointment of Daniele Guyot-Caparros to Board of Directors DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that Mr. Timothy E. Morris, Independent Director and Member of the Audit Committee of the Board of Directors ("the Board"), was appointed as Chairperson of the Board's Audit Committee in replacement of Ms. Viviane Monges, who resigned from the Board effective October 3, 2022. DBV also announced the Board's provisional appointment of Ms. Daniele Guyot-Caparros as Independent Director to fill Ms. Monges' vacancy, effective October

Appoints Timothy E. Morris, a veteran biotech executive with over 35 years of experience in executive and financial leadership, to Board of DirectorsNames Kenneth Truitt, M.D., with over 25 years of clinical and regulatory experience across biotechnology and large pharmaceutical companies, as Chief Medical Officer Reports inducement grant to Dr. Truitt under Nasdaq Listing Rule 5635(c)(4) WARREN, N.J., Aug. 10, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today the appointments of Timothy E. Mo

GARDEN CITY, N.Y., Aug. 20, 2021 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ:XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced the appointment of Douglas Larson as Chief Financial Officer, succeeding Douglas Beck effective September 1, 2021. Mr. Beck will remain a consultant to the Company and is expected to work closely with Mr. Larson and the Beyond Air leadership team to ensure a seamless transition of CFO responsibilities. Dougl

Montrouge, France, May 19, 2021 DBV Technologies Announces Results of its 2021 Ordinary and Extraordinary General Meeting and the Appointment of Dr. Adora Ndu, Pharm.D., J.D., and Dr. Ravi Madduri Rao, M.D., Ph.D., as Members of its Board of Directors DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today held its Ordinary and Extraordinary General Meeting. DBV Technologies' General Meeting was chaired by Michel de Rosen, Chairman of DBV Technologies' Board of Directors, in a closed virtual session without the physical presence of shareholders or any other person authorized to attend, at DBV Technologies' registered office. The Company's shareholders approved all

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Goldman resumed coverage of DBV Technologies with a rating of Sell and set a new price target of $7.25

Societe Generale upgraded DBV Technologies from Hold to Buy

Goldman downgraded DBV Technologies from Neutral to Sell

Goldman downgraded DBV Technologies from Buy to Neutral and set a new price target of $1.50 from $6.00 previously

JMP Securities reiterated coverage of DBV Technologies with a rating of Market Outperform and set a new price target of $5.00 from $8.00 previously

HC Wainwright & Co. reiterated coverage of DBV Technologies with a rating of Buy and set a new price target of $10.00 from $14.00 previously

Societe Generale upgraded DBV Technologies from Hold to Buy

Societe Generale downgraded DBV Technologies from Hold to Sell

Châtillon, France, January 8th, 2025 DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months 68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE    DBV also announced daily patch wear time data from EPITOPE that is supportive of the Company's proposed labeling approach shared with FD

Châtillon, France, December 11th, 2024 DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study on-track to initiate in 2Q 2025Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026 FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-oldCompany to host investor webcast today at 5:00pm ET DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, tod

Châtillon, France, October 22, 2024 DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old BLA submission under Accelerated Approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in Q2 2025VITESSE Phase 3 study evaluating the Viaskin Peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; Topline results on track for 4Q 2025  European Medicines Agency (EMA) scientific advice confirms registration path for a Marketing Authorization Application (MAA) with the modified Viaskin peanut patch for a 1 – 7

Châtillon, France, July 30, 2024 DBV Technologies Provides Updates on the Viaskin Peanut Program in Children and Toddlers and Reports Second Quarter and Half-Year 2024 Financial Results VITESSE enrollment in peanut allergic 4-7-year-olds is on-track and recruitment is expected to be complete by end of Q3 2024 DBV submitted a labeling proposal, informed by the EPITOPE efficacy data, to the Food and Drug Administration (FDA) to address the FDA's protocol queries regarding patch wear-time in COMFORT ToddlersDBV closes Q2 2024 with a cash balance of $66.2 million; due to cost-saving measures, the Company's cash runway is extended into Q1 2025 DBV Technologies (Euronext: DBV – ISIN: FR0010417

Châtillon, France, July 29, 2024 DBV Technologies to Report Second Quarter 2024 Financial Results and Business Update on July 30, 2024 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Tuesday, July 30th, at 5:30 p.m. ET to review its second quarter 2024 financial results and provide a business update. Interested participants may access this call via the below teleconferencing numbers and asking to join the DBV Technologies call: United States: +1-877-346-6112International: +1-848-280-6350 A live webcast of the call will be a

Montrouge, France, March 7, 2024 DBV Technologies Reports Full Year 2023 Financial Results and Business Update Advanced Viaskin™ Peanut clinical development programs in peanut-allergic toddlers (1 through 3 years old) and children (4 through 7 years old)Strengthened executive leadership team in preparation for BLA submissionReported cash and cash equivalents of $141 million DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the full year 2023. The audit procedure

Montrouge, France, March 4, 2024 DBV Technologies to Report Full Year 2023 Financial Results and Business Update on March 7, 2024 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatments for food allergies, today announced the Company will host a conference call and live audio webcast on Thursday, March 7th, at 5:00 p.m. ET to review full year 2023 financial results and provide a business update. Interested participants may access this call via the below teleconferencing numbers and reference the DBV Technologies call: United States: 1-844-481-2866International: 1-412-317-1859 A live webcast of th

Montrouge, France, November 9, 2023 DBV Technologies Announces 2-Year Results from Ongoing Phase 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin™ Peanut in Toddlers Viaskin Peanut showed improvement between months 12 and 24 of treatment across all efficacy parameters. Notably, 81.3% of subjects who completed the oral food challenge reached an eliciting dose of ≥1,000 mg after 24 months of treatment.55.9% of subjects completed the oral food challenge at a cumulative dose of 3,444 mg without meeting stopping criteria.Among treatment-arm subjects from EPITOPE, there were no treatment-related anaphylactic or serious treatment-related adverse events in the second year of active

Montrouge, France, October 31, 2023 DBV Technologies Receives Requested Feedback from FDA on Protocol Design Elements for COMFORT Safety Studies and Reports Third Quarter 2023 Financial Results DBV has received written feedback from the U.S. Food and Drug Administration (FDA) clarifying design elements for both the COMFORT Toddlers and COMFORT Children supplemental safety studies.Both supplemental safety studies will have harmonized, simplified protocol language on how the product should be used.  The COMFORT Toddlers study will apply the same eligibility criteria as EPITOPE, DBV's successful Phase 3 efficacy study in toddlers 1-3 years.DBV will submit the final protocol for COMFORT Toddl

Montrouge, France, October 27, 2023 DBV Technologies to Report Third Quarter 2023 Financial Results and Business Update DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Tuesday, October 31st, at 5:00 p.m. ET to review third quarter 2023 financial results and provide a business update. Interested participants may access this call via the below teleconferencing numbers and asking to join the DBV Technologies call: United States: 1-844-481-2866International: 1-412-317-1859 A live webcast of the call will be available on the In