UNITED STATES
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FORM
CURRENT REPORT
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Item 8.01 Other Events
On December 23, 2022, DBV Technologies S.A. (the “Company”) issued a press release announcing that on December 22, 2022 the Company received feedback from the U.S. Food and Drug Administration (“FDA”) that the partial clinical hold, which had been placed on the new Phase 3 pivotal study for modified Viaskin Peanut - VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) (“VITESSE”) as of September 21, 2022, had been lifted as of December 22, 2022. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the timing of receipt of additional details for the clinical hold of the VITESSE study from the FDA. The forward-looking statements included in this Current Report on Form 8-K are subject to a number of risks, uncertainties and assumptions, including, without limitation, the expected timing of review by governmental authorities. These statements are based only on facts currently known by the Company and speak only as of the date of this Current Report on Form 8-K. As a result, you are cautioned not to rely on these forward-looking statements and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated December 23, 2022 | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: December 23, 2022 | DBV TECHNOLOGIES S.A. | |||||
| By: | /s/ Sébastien Robitaille | |||||
| Name: Sébastien Robitaille | ||||||
| Title: Chief Financial Officer | ||||||