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Wednesday, March 22, 2023

Do You Know Why DBV Technologies (DBVT) Stock Jumped 16% After-Hours Monday?

On the most recent check on Monday, DBV Technologies S.A. (NASD: DBVT) was up 15.72% at $1.84. We may then look to recent events to give a more comprehensive knowledge of DBV Technologies as the DBVT stock increased in the absence of fresh news.

How are things going now?

Last week, DBV Technologies (DBVT) released monthly data on the total number of shares and voting rights in the firm as of September 30, 2022. The total number of shares in DBVT with voting rights as of that day was 94,025,441, whereas the total number of shares with voting rights was 93,888,340.

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Management changes at DBVT:

In lieu of Ms. Viviane Monges, who resigned from the Board with effect from October 3, 2022, DBVT recently named Mr. Timothy E. Morris, Independent Director and Member of the Audit Committee of the Board of Directors (“the Board”), as Chairperson of the Board’s Audit Committee.

DBVT further disclosed that Ms. Daniele Guyot-Caparros has been provisionally appointed by the Board as an Independent Director to take Ms. Monges’ place, effective October 3, 2022. After these modifications, the Board now has 10 members.

Since April 2021, Mr. Morris has served on the boards of DBV Technologies and its audit committee. Since August 2020, Mr. Morris has held the positions of Chief Operating Officer and Chief Financial Officer of Humanigen, Inc. He now holds board positions in Humanetics, Aquestive Therapeutics, and Univercells S.A.

Mr. Morris has worked in the financial and accounting fields for 38 years, 25 of those years as the CFO of publicly traded biotechnology firms. Since May 2019, Ms. Monges has been a member of the board and the audit committee for the company. Since March 2021, she has also served as chair of the board’s audit committee.

Clinical trial updates:

Additionally, DBV Technologies gave a clinical update on the VITESSE Phase 3 Trial last month. The U.S. Food and Drug Administration (FDA) provided DBVT with feedback in the form of a partial clinical hold on its Phase 3 VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity, and Efficacy) trial.

The FDA outlines modifications to the VITESSE protocol in the partial clinical hold letter with the goal of using the study to support a future BLA filing. The FDA’s communication outlines the modifications to the design in order to meet the study’s objectives and the total number of trial participants receiving active treatment. These design elements include the statistical analysis of adhesion, the minimum daily wear time, and technical alignments in data classification methods.

What steps had taken DBVT?

The VITESSE research has not yet started the screening or recruiting of volunteers, according to DBV Technologies (DBVT). Any other active DBV clinical investigations are unaffected by the partial clinical hold because it only applies to VITESSE. After speaking with the FDA, DBVT anticipates releasing more updates.

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