DBV Technologies S.A. (DBVT) stock rallied by 23.74% at $1.72 premarket, at the last check on Wednesday. The stock is making gains after experiencing a sharp selloff on news that The Viaskin Peanut patch will have to undergo another costly phase 3 trial before it has a realistic chance of being approved by the FDA. For the same reason, it has also withdrawn an application pending with the European Medicines Agency.
In the previous trading session, the stock saw huge losses, as it slid down to a 52-week low of $1.3510. DBVT closed the session at $1.39 with a loss of 48.52% at 15.4 million shares. At the time of writing the stock was up by $0.32 at a premarket volume of 623.7K shares.
Currently, the clinical-stage biopharmaceutical company DBV Technologies S.A. has a market capitalization of $304.01 million.
What is happening?
On December 20, the company announced the initiation of a new phase 3 trial of its modified Viaskin Peanut patch. The announcement caused the stock to decline to its new 52-week low. The reason for the new trial being taken so negatively was the history of the trial itself. Previously, FDA had refused to approve the Viaskin Peanut patch due to adhesion problems. While DBVT modified the patch, it did not feel the need for a new phase 3 trial. Finally, the company admitted the need for a new phase 3 trial in order to receive approval from the FDA.
DBVT’s Investigational ViaskinTM Peanut
Viaskin Peanut is the company’s investigational product for peanut allergies in the different age groups of people including kids under 3.
According to the updates provided by the company on December 20, the modified Viaskin Peanut (mVP) patch is circular in shape and is almost 50% larger than the current one. Moreover, the new phase 3 study of the patch will also add updates to its IFU (Instructions for Use).
Furthermore, at the end of November, FDA had requested DBVT for further information regarding the allergen uptake/transport comparability of the mVP to the current patch. Hence, the company intends to continue communicating with the FDA before initiating the allergen uptake comparison.
DBVT’s Financial Highlights
On October 26, the company declared its third-quarter financial results for 2021. In the Q3 of 2021, DBVT incurred a net loss of $24.0 million or $0.44 per share.
Moreover, the company ended the quarter with cash and equivalents of $98.2 million.
