Shares of clinical-stage biopharmaceutical company, DBV Technologies S.A. (DBVT) are surging more than 35% Friday morning after the company updated on Viaskin Peanut.<\/p>\n
Viaskin Peanut is the company’s investigational, epicutaneous patch to treat peanut allergy in children of age between 4 to 11 years.<\/p>\n
DBV said it has received written responses from the FDA to questions provided in the Type A meeting request the Company had submitted in October 2020. <\/p>\n
The Type A meeting request was submitted following the Company’s receipt of a Complete Response Letter in connection with its Biologics License Application (BLA) for Viaskin Peanut.<\/p>\n
“DBV believes that the feedback received from the FDA provides a well-defined regulatory path forward. In exchanges with the FDA, DBV proposed potential
resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications,” the company said.<\/p>\n
The FDA agreed with DBV’s position that a modified Viaskin Peanut patch should
not be considered as a new product entity provided the occlusion chamber of the
current Viaskin Peanut patch and the peanut protein dose of 250 \u00b5g remains unchanged and performs in the same way it has performed previously, the company added.<\/p>\n
DBV plans to initiate the selection of modified prototype patches in the first quarter of 2021. Additionally, DBV will submit the protocol for the safety and adhesion trial Montrouge, France, January 14, 2021 in children with peanut allergy to FDA for review and comments in the second quarter of 2021 before initiating the trial.<\/p>\n
DBVT, currently at $5.09, has been trading in the range of $1.35- $13.02 in the last one year. <\/p>\n