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Noticias de DBVT
Eventos de DBVT
DBV Technologies Submits BLA for Viaskin Peanut Patch to FDA
DBV Technologies announced that the company has submitted a Biologics License Application to the U.S. FDA for the Viaskin Peanut Patch in children with peanut allergy aged 4 through 7 years. DBV has requested Priority Review of the BLA. The FDA previously granted Breakthrough Therapy Designation to the Viaskin Peanut Patch.
DBV Technologies Issues New Shares Raising Approximately $50M
DBV Technologies announced that, pursuant to the company's At-The-Market Program established on September 1, 2025 and included in a new registration statement and accompanying prospectus filed on July 27, it has agreed to issue and sell new ordinary shares in the form of American Depositary Shares, for total gross proceeds to the company of approximately $50M, before deducting sales agent commissions and offering expenses payable by the company, to RA Capital Management, L.P through Citizens JMP Securities acting as sales agent. Each ADS represents the right to receive five ordinary shares of the company.
DBV Technologies Files $150M Securities Registration Statement
DBV Technologies announced that it has filed a new automatically effective shelf registration statement with the SEC, which includes a base prospectus and a sales agreement prospectus supplement refreshing the company's previously established at-the-market offering program by filing a prospectus supplement for sales of up to $150M of American Depositary Shares. The company intends to use the net proceeds of any offering of securities primarily for activities associated with manufacturing expansion, our BLAs in ages 4 through 7 and 1 through 3, launch preparation of Viaskin Peanut in ages 4-7, if approved, development of its product candidates, and for working capital and other general corporate purposes. Accordingly, The company will have significant discretion in the use of any net proceeds.
DBV Technologies CEO Reports Progress Towards Commercialization in 2026
"2026 is an important year for DBV as we continue to prepare to become a commercial company, if approved. I'm happy to report that we have made meaningful progress towards that goal in the first half of the year," said Daniel Tasse, CEO of DBV Technologies. "Recently, we shared the regulatory progress we've made through collaborative engagement with the FDA. We have also made judicious investments in launch readiness, while we continue to execute clinical studies that we expect will add further understanding to the potentially transformative value of the VIASKIN Peanut Patch."
DBV Technologies Updates on Viaskin Peanut Patch BLA Submission Progress
DBV Technologies provided an update on the biologics license application, or BLA, submission seeking marketing approval of the Viaskin Peanut Patch in children aged four through seven years. Over recent weeks, DBV has had ongoing detailed and iterative engagement with the FDA with the objective of ensuring a review of the company's upcoming BLA for children aged four through seven years. DBV and the FDA have collaborated through meetings, information exchanges, and filings for the Viaskin Peanut Patch investigational new drug application, or IND. Through this process and based on its review, DBV received input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. The FDA has not requested additional data. The company will take the required time to incorporate that feedback and now anticipates filing of the BLA to occur in the third quarter of 2026.
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