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DBV Technologies S.A.: DBV Technologies Provides Update on Investigational Viaskin Peanut for Children Ages 4-11 Years DBV Technologies Provides Update on Investigational Viaskin Peanut for Children Ages 4-11 Years DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the receipt of written responses from the U.S Food and Drug Administration (FDA) to questions provided in the Type A meeting request the Company submitted in October 2020. The Type A meeting request was submitted following the Company s receipt of a Complete Response Letter (CRL) in connection with its Biologics License Application (BLA) for Viaskin Peanut (DBV712), an investigational, non-invasive, once-daily epicutaneous patch to treat peanut allergy in children ages 4 to 11 years. ....
Montrouge, France, January 7, 2021 DBV Technologies Announces Change in U.S. Reporting Status and Final Approval of Global Restructuring Process DBV Technologies S.A. (Euronext: DBV - ISIN: FR0010417345 ....
DBV Technologies Announces Change in U.S. Reporting Status and Final Approval of Global Restructuring Process Montrouge, France, January 7, 2021 DBV Technologies Announces Change in U.S. Reporting Status and Final Approval of Global Restructuring Process DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that it has determined that it now qualifies as a U.S. domestic issuer rather than a foreign private issuer in the United States. As of January 1, 2021, DBV Technologies is subject to U.S. Securities and Exchange Commission (SEC) and other rules and regulations applicable to U.S. domestic issuers, in addition to applicable French and EU regulations. DBV will be required to file with the SEC periodic reports (including current reports on Form 8-K and quarterly reports on Form 10-Q) and registration statements on U.S. domestic issuer forms. Pursuant to SEC rules, the ....