- The stock price of DBV Technologies (DBVT) fell by over 12% intraday today. This is why.
The stock price of DBV Technologies (DBVT) fell by over 12% intraday today.
Why: DBV Technologies – a clinical-stage biopharmaceutical company – announced that it received feedback from the U.S. Food and Drug Administration (FDA) in the form of a partial clinical hold on its VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase 3 clinical study.
In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol with the intent for the trial to support a future BLA submission. And within the FDA’s communication, the modifications address design elements, including the statistical analysis of adhesion, minimum daily wear time, and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment.
DBV has not yet begun the screening or recruitment of subjects in the VITESSE study. And the partial clinical hold is specific to VITESSE and does not impact any other ongoing DBV clinical studies. The Company expects to provide additional updates following consultation with the FDA.
VITESSE is known as a Phase 3, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin™ Peanut 250 µg patch in peanut-allergic children ages 4 to 7 years.
“We are grateful for the FDA’s additional feedback reflecting careful attention to DBV’s VITESSE study. We are pleased that the comments to the protocol are specific, clear and arrived prior to enrollment. We look forward to upcoming discussions with key FDA personnel.”
— Daniel Tassé, Chief Executive Officer of DBV Technologies