Dbv technologies fda approval. The FDA raised concerns that adhesion of .

Dbv technologies fda approval. The FDA As of the date of this presentation, EPIT and DBV’s VIASKIN® patch are investigational and have not yet been approved by the U. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 - 3-years Dec 11, 2024 · DBV Technologies (DBVT) stock shot up 29% in post-market after the company said it has aligned with the FDA on an accelerated approval pathway for its peanut allergy patch Viaskin. Oct 22, 2018 · Current FDA approval status, regulatory history, and clinical trial results for Viaskin Peanut, an investigational treatment for peanut allergy from the development pipeline at DBV Technologies. Looking for the best stocks to buy? Follow the recommendations of top-performing analysts. Mar 28, 2025 · DBV 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 Oct 23, 2024 · DBV Technologies SA CEO Daniel Tasse said his firm will meet “very shortly” with the U. Food and Drug Administration (FDA) on the regulatory path for investigational Viaskin™ Peanut 250 μg patch (DBV712) in toddlers ages 1 – 3 years-old with a confirmed peanut allergy. Viaskin is the company’s immunotherapy platform that aims to desensitize a patient with a food allergy by introducing small quantities of allergen via the skin. The company is based in Montrouge, France, and is known for its innovative approach to treating food allergies through the use of its proprietary Viaskin technology. Food and Drug Administration (FDA) agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Jul 30, 2025 · With a current cash balance of $103. Oct 23, 2024 · DBV Technologies progresses with regulatory efforts for its Viaskin Peanut patch in the U. The US FDA has agreed to an Accelerated Approval pathway for toddlers aged 1-3. Dec 11, 2024 · Châtillon, France, December 11th, 2024 DBV Confirms Alignment with U. With a unique platform and FDA nod, its allergy patch could lead to explosive growth. “But this was a choice we made, and it was a necessary choice” in order to nail down precise Dec 12, 2024 · On Wednesday, DBV Technologies SA (NASDAQ:DBVT) reached a significant milestone with the FDA regarding its Viaskin Peanut patch for toddlers aged 1–3 years. Feb 14, 2018 · French biotechnology company DBV Technologies SA got permission to seek U. Oct 23, 2024 · “Our agreement with FDA guidance on a path towards Accelerated Approval for the Viaskin Peanut patch in 1 – 3 year-olds represents a significant step forward in getting this novel treatment to patients,” said Daniel Tasse, Chief Executive Officer, DBV Technologies. Oct 23, 2024 · DBV has agreed to the FDA’s guidance on key study components required for approval, including the COMFORT Toddlers safety study, which must be completed before the US marketing application submission, and a confirmatory study to demonstrate the patch’s effectiveness. The company aims to pursue formal FDA approval through a BLA submission post-safety study. The FDA's Written Responses Only to DBV’s Type D IND meeting request confirmed that the existing data would be Dec 12, 2024 · DBV Technologies said the US Food and Drug Administration formalized guidance for accelerated approval for its Viaskin Peanut patch program for toddlers aged between one year and three years. The FDA has outlined a clear Oct 24, 2024 · H. 5 days ago · Get the latest DBV Technologies S. Dec 11, 2024 · The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. The company plans to initiate the COMFORT Toddlers study in Q2 2025, enrolling approximately 480 subjects across multiple Apr 19, 2023 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that DBV has received written responses from the U. The “DBV is confident that a new, Phase 3 pivotal study generating a robust data set is the best way to support the development of Viaskin Peanut,” said Daniel Tasse, Chief Executive Officer, DBV Technologies. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch 5 days ago · It’s been more than three years since DBV Technologies’ peanuty allergy therapy was rejected for FDA approval, but the company thinks it now has a clear route to market with its patch product Sep 3, 2025 · Has DBV Technologies received FDA approval? Track FDA approvals, PDUFA dates, and regulatory milestones for DBVT with the latest event history at MarketBeat. 3 Mar 24, 2025 · DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026 May 10, 2023 · Montrouge, France, May 10, 2023 DBV Technologies Announces New England Journal of Medicine Publication of Phase 3 EPITOPE Trial Data Evaluating Viaskin™ Peanut in Toddlers The New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPITTM) with Viaskin Peanut was statistically superior to placebo in desensitizing children to peanut by increasing Mar 24, 2025 · “ DBV’s alignment with FDA represents a tremendous achievement for food allergy families, clinicians, researchers, and countless external partners that have been working for many years to advance the Viaskin peanut patch in children living with peanut allergy,” said Daniel Tassé, Chief Executive Officer, DBV Technologies. The FDA has Dec 11, 2024 · DBV Technologies has announced an alignment with the U. Food and Drug Administration (FDA) clarifying design elements for both the COMFORT Toddlers and COMFORT Children supplemental safety studies. This timeline may seem far off, but it’s important to note that the company has already received a Breakthrough Therapy Designation from the FDA for this treatment, which could potentially expedite the approval process. The FDA has outlined a clear Oct 22, 2024 · “Our agreement with FDA guidance on a path towards Accelerated Approval for the Viaskin Peanut patch in 1 – 3 year-olds represents a significant step forward in getting this novel treatment to patients,” said Daniel Tasse, Chief Executive Officer, DBV Technologies. Commercial Launch, if Approved Dec 12, 2024 · DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. The FDA formalized guidance on an Accelerated Approval for the patch, with each party having agreed on key design elements for a post-marketing confirmatory study. The upcoming Phase 3 VITESSE trial, expected to deliver results by Q4 2025, is a critical step toward a Biologics Dec 11, 2024 · Châtillon, France, December 11th, 2024 DBV Confirms Alignment with U. The company will pursue an Accelerated Approval pathway for toddlers ages 1-3 years old, subject to completing a six-month supplemental safety study (COMFORT Toddlers) in Q2 2025. A supplementary safety study for this group will start in Q2 2025. - Viaskin Peanut’s non DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. - The global peanut allergy market is projected to grow at 12. C. 874m. The FDA 5 days ago · DBV discloses FDA concerns about experimental peanut allergy treatment Shares of DBV Technologies tumbled 8. -- DBV Technologies said the US Food and Drug Administration formalized guidance for accelerated approval for its Viaskin Peanut patch program for toddlers aged between one year and three years. Dec 12, 2024 · ** U. Food and Drug Administration (FDA) agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 Dec 5, 2024 · For over a decade, the food allergy community has waited for the Viaskin patch for peanut allergy to achieve long-awaited Food and Drug Administration approval. Mar 24, 2025 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT, the “Company”), a clinical-stage biopharmaceutical company, today announced that in a Written Responses Only to the Company’s Type D IND meeting request, the U. The FDA confirmed that efficacy data from the Phase 3 EPITOPE study can serve as an intermediate clinical endpoint for approval. Food and Drug Administration (FDA) on a pathway under the Accelerated Approval Program for the Viaskin Peanut Dec 11, 2024 · DBV Confirms Alignment with U. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study. Jun 15, 2025 · DBV Technologies is entering a major breakout phase. Food and Drug Administration (FDA), European Medicines Agency (EMA), or any other regulatory agencies. “ I thank the FDA and the Review Team for their collaboration Oct 22, 2024 · DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe October 22, 2024 16:45 ET | Source: DBV Technologies S. Food and Drug Administration (FDA) has agreed with its proposal regarding the safety exposure data from the VITESSE Phase 3 study for the Viaskin® peanut patch in children aged 4 to 7 years. 40 premarket ** On Wednesday, co said that the U. The company has aligned with the FDA under the Accelerated Approval Program for toddlers aged 1–3. Oct 27, 2021 · French biopharma company DBV Technologies released their Q3 results yesterday, and the news is not good for those hoping for FDA approval of their Viaskin Peanut therapy any time soon. Viaskin Peanut, the first Viaskin candidate Dec 11, 2024 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. Wainwright raised the firm’s price target on DBV Technologies (DBVT) to $7 from $5 and keeps a Buy rating on the shares after DBV reached an agreement with the FDA regarding the regulatory 6 days ago · Châtillon, France, December 11th, 2024 DBV Confirms Alignment with U. - The financing risks up to 50% share dilution, raising concerns over shareholder value preservation. Food and Drug Administration (FDA) has agreed to an Accelerated Approval pathway for toddlers aged 1-3 years, while the European Medicines Agency (EMA) has confirmed a registration path for children aged 1-7 years in Europe Mar 24, 2025 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT, the “Company”), a clinical-stage biopharmaceutical company, today announced that in a Written Responses Only to the Company’s Type D IND meeting request, the U. DBV has advanced a comprehensive clinical research program across age groups for the VIASKIN ® peanut patch, including the completed EPITOPE Phase 3 clinical trial in 1 – 3-year-olds, and ongoing VITESSE Phase 3 clinical trial in 4 – 7-year-olds. is benefiting from the positive market sentiment surrounding its recent breakthrough in peanut allergy treatment, helping drive the stock up by 10. The agreement follows guidance provided by the FDA, including Dec 11, 2024 · -- DBV Technologies said late Wednesday the US Food and Drug Administration has formalized guidance on an accelerated approval for the Viaskin Peanut patch in peanut-allergic children aged between DBV Technologies (NASDAQ: DBVT) reported successful communications with the FDA, outlining a clear regulatory path for its Viaskin Peanut patch program in toddlers aged 1-3. In the United States, DBV Technologies has reached an agreement with the Food and Drug Administration (FDA) to pursue the Accelerated Approval pathway for the Viaskin Peanut patch for toddlers aged 1 to 3 years. “In October, we were surprised to see the FDA request a sequential approach to our development plans. Feb 28, 2025 · DBV Confirms Alignment with U. But the patch saga has had many twists and turns, leaving some to wonder if they should keep hoping. Dec 11, 2024 · -- DBV Technologies said late Wednesday the US Food and Drug Administration has formalized guidance on an accelerated approval for the Viaskin Peanut patch in peanut-allergic children aged between Mar 28, 2025 · DBV Technologies Announces Financing of up to $306. Successful FDA alignment decreases regulatory risks, allowing DBV to focus on Viaskin Peanut studies for approval. - American Depositary Shares (DBVT) published on Mar. 21B by 2030, driven by rising allergy rates and immunotherapy advancements. After recent talks with the FDA and EMA, DBV has laid out a comeback plan that could carve it a niche in the peanut allergy treatment market. Jul 11, 2025 · We'll analyze the company's DBV Technologies future prospects, including DBV Technologies stock performance, and assess the investment potential of DBV Technologies, considering factors like Viaskin Peanut FDA approval status and DBV Technologies clinical trials updates. Dec 12, 2024 · The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. If successful, DBV Technologies plans to submit the treatment for FDA approval in 2026. This has spurred investor interest, given the FDA’s endorsement is often a golden ticket for biotech valuations. 2 million and a clear path to potential FDA approval, DBV Technologies is well-positioned for growth, justifying the Buy rating. Aug 6, 2020 · A request for market approval of a skin patch developed by French biotech DBV Technologies to treat peanut allergy has been turned down by the FDA, which has requested more data and design changes. This pathway allows for expedited approval of treatments for serious conditions where there is an unmet medical need. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old GlobeNewswire Dec 11, 2024 9:05pm Dec 12, 2024 · The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 - 3-years-old. The company has a market cap of $211. “Did this take longer than expected? Yes, it did,” Tasse said during a conference call update. 5M cash remaining. 24, 2025 - DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin Peanut Patch in 4-7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results Sep 5, 2025 · - DBV Technologies launched a $150M ATM program to fund its peanut allergy patch BLA and pipeline development. 1m as of 30 September 2023, with an operating income of $6. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old December 11, 2024 16:05 ET | Source: DBV Technologies S. The Mar 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 Results 1 DBV Technologies The information contained here is under clinical investigation. Mar 24, 2025 · Read Press Release for DBV Technologies S. Mar 24, 2025 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT, the “Company”), a clinical-stage biopharmaceutical company, today announced that in a Written Responses Only to the Company’s Type D IND meeting request, the U. Food and Drug Administration (FDA) agreed with the Company's proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. Viaskin Peanut is DBV’s treatment for peanut allergy meant to desensitize young patients with peanut allergy from reacting to peanuts. Oct 22, 2024 · DBV intends to formalize the Accelerated Approval guidance provided by the FDA via submission of a meeting request. 99 after aligning with FDA on approval pathwayPick the best stocks and maximize your portfolio:Discover top-rated stocks from highly ranked analysts with Analyst Top Feb 16, 2018 · French biotech DBV Technologies has been granted permission to seek approval from the US Food and Drug Administration (FDA) to sell its experimental peanut allergy patch, Viaskin. The FDA Dec 11, 2024 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. and Europe, while financial concerns loom as the company seeks additional funding to continue its 5 days ago · DBV Technologies’ long and tortuous path to an FDA verdict on its Viaskin Peanut allergy shot has led to another dead end. The FDA Oct 23, 2024 · On Tuesday, DBV Technologies NASDAQ:DBVT announced progress in its regulatory efforts for the Viaskin Peanut patch, aimed at treating peanut allergies in toddlers and children. Today, DBV Technologies, the company developing the allergy patch, says there are new and exciting reasons for optimism. S Dec 12, 2024 · The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. They’re Dec 11, 2024 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. Read why DBVT is a Sell. Dec 12, 2024 · On Wednesday, DBV Technologies SA (NASDAQ:DBVT) reached a significant milestone with the FDA regarding its Viaskin Peanut patch for toddlers aged 1–3 years. The France-headquartered biotech confirmed the complete response letter Mar 24, 2025 · “ DBV’s alignment with FDA represents a tremendous achievement for food allergy families, clinicians, researchers, and countless external partners that have been working for many years to advance the Viaskin peanut patch in children living with peanut allergy,” said Daniel Tassé, Chief Executive Officer, DBV Technologies. This technology involves delivering allergens through the skin, rather than through oral consumption, to desensitize Oct 31, 2018 · Last week, DBV Technologies filed for FDA approval of its Viaskin Peanut allergy patch. Some of the information contained herein regarding EPIT or Viaskin is or may be under review by FDA, EMA and other regulatory agencies as part of a biologics Dec 12, 2024 · DBV Technologies S. DBV has agreed to the FDA… May 8, 2025 · DBV-135: a Immunostimulants Drug, Initially developed by DBV Technologies SA, Now, its global highest R&D status is Pending, Mechanism: Immunostimulants, Therapeutic Areas: Immune System Diseases,Digestive System Disorders,Hemic and Lymphatic Diseases. S. If approved, this would be a major step towards a new wave of peanut allergy treatment (and ultimately, allergies in general). (ETR:DBV) stock price with financials, statistics, dividends, charts and more. Dec 11, 2024 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. 5% in premarket trading on Wednesday, the day after the company said it had received a Aug 4, 2020 · French company DBV Technologies issued a press release this morning stating they had received a Complete Response Letter (CRL) from the Food and Drug Administration denying their application to market their Viaskin Peanut therapy in the US. The company has achieved significant progress by securing written alignment with the FDA on approval paths for its Viaskin Peanut therapy, targeting both 1–3-year-olds and 4–7-year-olds. Mar 28, 2025 · FDA Approval’s Impact on Stock Surge: The recent FDA nod significantly altered market perceptions of DBV Technologies’ prospects, allowing them to navigate the licensing maelstrom with more certainty. Dec 11, 2024 · 16:14 EST DBV jumps 52% to $4. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch Jul 31, 2023 · Montrouge, France, July 31, 2023 DBV Technologies Receives Feedback from FDA on Design Elements for Viaskin Peanut Safety Studies and Reports Second Quarter and Half-Year 2023 Financial Results Received feedback from U. FDA for talks that will formalize an accelerated approval process for the Viaskin Peanut allergy patch. 5 Million) to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U. Food and Drug Administration (FDA) on a pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old and has also received scientific advice from the EMA on a 1 – 7 year-old indication in Europe. Mar 24, 2025 · 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 Mar 24, 2025 · DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026 Mar 24, 2025 · FDA agreement speeds up Viaskin peanut patch approval process, eliminating additional safety study requirements. Oct 4, 2019 · Montrouge, France, October 4, 2019 DBV Technologies Announces FDA Acceptance of BLA filing for Viaskin Peanut for the Treatment of Peanut Allergy If approved, Viaskin Peanut would be the first and Mar 25, 2020 · DBV Technologies’ bid for the US approval of a skin patch to treat nut allergies could be delayed as the FDA requested more information on the patch’s efficacy. Dec 12, 2024 · DBV Technologies, a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. FDA agreed on an accelerated approval pathway for its peanut allergy treatment, Viaskin Peanut patch, for toddlers aged 1-3 years ** The approval was based on a late-stage clinical study that demonstrated the treatment's efficacy ** Accelerated approvals allow the Dec 26, 2022 · DBV Technologies announced last week that the FDA had removed the hold on the company’s phase 3 trial of their modified Viaskin ® Peanut immunotherapy patch allowing the trial to commence. Dec 12, 2024 · DBV Technologies secures FDA guidance for Accelerated Approval of its Viaskin Peanut patch, advancing treatment for toddlers with peanut allergies through pivotal trials. Dec 12, 2024 · The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 - 3-years-old. Mar 10, 2023 · DBV Technologies is a biopharmaceutical company that focuses on developing treatments for food allergies. The Jul 9, 2025 · This submission is anticipated in H2 2026 under the Accelerated Approval Pathway, as previously agreed upon with the FDA. Apr 21, 2023 · DBV Technologies Outlines Regulatory Path for Viaskin Peanut in Children 1 – 3 Years After Receiving Pre-BLA Responses from FDA The FDA confirmed that the Company’s Phase 3 EPITOPE study met the pre-specified criteria for success for the primary endpoint and did not requestanadditional efficacystudy. Mar 24, 2025 · DBV Technologies secured an agreement with the US Food and Drug Administration regarding the safety data required for the biologics license application of its Viaskin peanut patch for children Dec 11, 2024 · -- DBV Technologies said late Wednesday the US Food and Drug Administration has formalized guidance on an accelerated approval for the Viaskin Peanut patch in peanut-allergic children aged between Mar 7, 2024 · 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 submission Reported cash and cash equivalents of $141 million DBV Dec 11, 2024 · The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 - 3-years-old. DBV Technologies (NASDAQ:DBVT) is a clinical-stage biopharmaceutical company that researches and develops epicutaneous immunotherapy products in France. The two Phase 3 pivotal Chtillon, France - DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. Food and Drug Administration (FDA) agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for DBV Technologies (NASDAQ:DBVT) stock shot up 29% in post-market trading Wednesday after the company said it has aligned with the FDA on an accelerated approval pathway for its peanut allergy patch Oct 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. Food and Drug Administration approval to sell its experimental peanut-allergy patch, reassuring investors about the Jun 4, 2023 · Peanut allergy immunotherapy(DBV Technologies SA): a Immunomodulators Drug, Initially developed by DBV Technologies SA, Now, its global highest R&D status is Phase 3, Mechanism: Immunomodulators, Therapeutic Areas: Immune System Diseases, Active Indication: Anaphylaxis,Peanut Hypersensitivity, Active Org. Food and Drug Administration (FDA) on DBV’s two supplemental safety studies in toddlers (ages 1 – 3 years) and children (ages 4 – 7 years). Read more here. Oct 22, 2024 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV has agreed to the FDA’s guidance on key study components required for approval, including the COMFORT Toddlers safety study, which must be completed before the US marketing application Aug 4, 2020 · Given the long list of requirements in the FDA's rejection letter, DBV Technologies likely has years of work ahead to win approval of Viaskin Peanut. A. Oct 22, 2024 · DBV Technologies has announced significant regulatory advancements for its Viaskin Peanut patch, a potential treatment for peanut allergies in young children. Mar 24, 2025 · DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026 Dec 11, 2024 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. : DBV Technologies SA. The therapy has thus far had a long, difficult road to FDA approval Oct 22, 2024 · DBV Technologies has announced advancements for its Viaskin Peanut patch. The FDA . FDA on an accelerated approval pathway for its Viaskin Peanut patch, targeting toddlers aged 1 to 3 years. The U. Oct 22, 2024 · DBV Technologies (DBVT) announced positive regulatory updates for the Viaskin® Peanut patch in the US and Europe. The FDA raised concerns that adhesion of Dec 13, 2024 · The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 - 3-years-old. DBV has agreed to guidance provided by the U. Jul 9, 2025 · DBV Technologies (NASDAQ:DBVT) is a clinical-stage biopharmaceutical company that researches and develops epicutaneous immunotherapy products in France. Dec 11, 2024 · DBV Technologies is advancing the Viaskin Peanut patch for toddlers with FDA’s accelerated approval pathway. 94 percent on Thursday. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old DBV and FDA aligned on key study d Sam Slutsky’s rating is based on several promising developments at DBV Technologies. 99 after aligning with FDA on approval pathwayPick the best stocks and maximize your portfolio:Discover top-rated Sep 15, 2025 · See the latest DBV Technologies SA ADR stock price (DBVT:XNAS), related news, valuation, dividends and more to help you make your investing decisions. Dec 11, 2024 · Shares of DBV Technologies were trading higher on the Nasdaq after hours Wednesday, following the company confirming alignment with the Food and Drug Administration on an accelerated approval for -- DBV Technologies said the US Food and Drug Administration formalized guidance for accelerated approval for its Viaskin Peanut patch program for toddlers aged between one year and three years. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 - 3-years-old. 9m for the past nine months. The FDA Oct 23, 2019 · The FDA has agreed to review DBV Technologies’ Viaskin Peanut patch for potential regulatory approval, according to an announcement from the company. -listed shares of biotech firm DBV Technologies DBV, DBV rise ~31% to $4. Company faces financial challenges with $32. The FDA has outlined a clear Mar 28, 2025 · DBV 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 Dec 11, 2024 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Mar 24, 2025 · DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT, the "Company”), a clinical-stage biopharmaceutical company, today announced that in a Written Responses Only to the Company's Type D IND meeting request, the U. Oct 23, 2024 · DBV has agreed to guidance provided by the U. Dec 11, 2024 · DBV Confirms Alignment with U. Key Developments Shaking the DBVT Market DBV Technologies received FDA guidance on an accelerated approval path for its Viaskin Peanut patch aimed at toddlers, boosting shares by […] DBV Technologies Confirms Alignment with U. The FDA Dec 11, 2024 · The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. Nov 1, 2023 · DBV Technologies has received written feedback from the US Food and Drug Administration (FDA) regarding the remaining study design elements for the COMFORT supplemental safety studies for Viaskin Peanut. Mar 24, 2025 · As previously communicated, DBV also plans to pursue an Accelerated Approval pathway for the Viaskin peanut patch in toddlers 1 – 3-years-old with a peanut allergy. Viaskin Peanut is a novel therapy that is applied to the skin via a patch, targeted at children 4-11 years of age. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old DBV and FDA aligned on key Dec 11, 2024 · DBV Technologies has secured FDA alignment on an Accelerated Approval pathway for the Viaskin® Peanut patch in toddlers aged 1-3 years. 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 Mar 24, 2025 · DBV Technologies, a clinical-stage biopharmaceutical company, has announced that the U. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. Jan 9, 2025 · The data follows a December, 2024 announcement from DBV regarding alignment with the FDA on a regulatory pathway for Viaskin in those aged 1 to 3 years. Aug 20, 2024 · DBV Technologies recently provided updates on its Viaskin Peanut Program for children and toddlers, announcing recruitment for the VITESSE study and progress in the COMFORT Toddlers supplemental DBV Technologies Confirms Planned Initiation of Viaskin® Peanut Global Phase III Clinical Trial in Children Following Endof-Phase II Meeting with FDA and PIP approval by EMA Dec 11, 2024 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old Apr 19, 2023 · DBV Technologies Outlines Regulatory Path for Viaskin Peanut in Children 1 – 3 Years After Receiving Pre-BLA Responses from FDA April 19, 2023 17:09 ET | Source: DBV Technologies S. Dec 11, 2024 · DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U. Two days later, it launched a new peanut allergy awareness campaign with celebrity spokesperson and well Apr 14, 2021 · Last year, the FDA rejected DBV Technologies’ peanut allergy treatment and approved that of its rival Aimmune. In Europe, the EMA confirmed the registration path for children aged 1-7. Food and Drug Administration (FDA) on a pathway under the Accelerated Approval Program for the Viaskin Peanut Sep 22, 2023 · Three years after an FDA rejection, DBV sees a path for its peanut patch Despite lower-than-expected demand for a competing treatment, DBV’s chief medical officer says the company’s topical skin patch could be a game-changing option for patients. Considering the advice and information requests received by FDA concerning STAMP Oct 23, 2024 · DBV Technologies (DBVT) stock gains as FDA guides the company on obtaining approval for its Viaskin Peanut Patch under its accelerated program. DBV also reported cash and cash equivalents of $149. The FDA May 13, 2025 · DBV Technologies faced setbacks, including FDA denial and competition, leading to significant financial losses and stock price drops. 9 Million (€284. Peanut allergy is one of the most common food allergies and can cause severe, potentially fatal, allergic reactions, as well as anaphylaxis. 84% CAGR to $1. Products utilizing VIASKIN ® patch technology are for investigational use only and have not been approved by the FDA, or by any other regulatory authority, for any use. Oct 22, 2024 · The company states: "DBV Technologies (DBVT) announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. The VITESSE Phase 3 study for children ages 4-7 exceeded enrollment goals, with topline results Dec 11, 2024 · 16:14 EST DBV jumps 52% to $4. ynbf wienj acq liusqwu cjxpdn zmhbaaf aur yogojq irsr bnjmrr