DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old
DBV Technologies S.A. - American Depositary Shares (DBVT)
US:NASDAQ Investor Relations:
dbv-technologies.com/en/investor-relations
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Source: GlobeNewswire
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 (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.S. 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-o
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News
- DBV Technologies S.A. (NASDAQ: DBVT) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- DBV Technologies S.A. (NASDAQ: DBVT) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- DBV Technologies S.A. (NASDAQ: DBVT) had its "market outperform" rating re-affirmed by analysts at JMP Securities. They now have a $10.00 price target on the stock.MarketBeat
- DBV Technologies S.A. (NASDAQ: DBVT) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Information regarding the total number of voting rights and total number of shares of the Company as of November 30, 2024GlobeNewswire
DBVT
Earnings
- 11/6/24 - Beat
DBVT
Sec Filings
- 12/18/24 - Form 8-K
- 12/16/24 - Form 8-K
- 12/11/24 - Form 8-K
- DBVT's page on the SEC website