DBV’s Viaskin™ Peanut (DBV712) is currently being tested through various stages for the treatment of children suffering from peanut allergies.
Shares of DBV Technologies (DBVT) are trading with a bullish momentum after the stock surged as high as 80% in the premarket. The stock soared after the company announced that it has obtained validation by the European Medicines Agency (EMA) for its Marketing Authorization Application (MAA) for its investigational product Viaskin™ Peanut (DBV712).
DBVT stock began trading at $2.53 compared to the previous close of $1.43. As we write this at 12;11 P.M. EDT, DBVT was trading at $2 up by 39%. The stock had a high trading volume of almost 56 million.
The clinical-stage biopharmaceutical company announced the approval of the application of Viaskin, a couple of days after DBV reported its cash and cash equivalents of €189.1 million and the number of outstanding shares was 54,927,187 ordinary shares as of September 30, 2020.
DBV Technologies stock has spiked today followed by a massive development of its investigational product Viaskin that will treat patients with Peanut allergy. The company has a comprehensive clinical research program in place for Viaskin Peanut.
The company is currently conducting two Phase 3 long-term studies in children ages 4 to 11 along with a Phase 3 trial in patients of 1 to 3 years of age. DBV’s Viaskin Peanut has already obtained Fast Track and Breakthrough Therapy designation from the FDA for the treatment in children.
In August 2020, the company received a Complete Response Letter (CRL) from the FDA for its Biologics License Application (BLA) for investigational Viaskin™ Peanut. DBV is currently in the process to engage with the FDA for discussion on the regulatory path forward.
After the validation of the MAA, the company has almost reached the stage where it can begin the formal review process for the investigational non-invasive, once-daily epicutaneous patch for treating peanut allergies patients of ages between 4 and 11 years.
Peanut allergy is one of the most common food allergies and can be harmful causing fatal allergic reactions, including anaphylaxis.
The Committee for Medicinal Products for Human Use (CHMP) at EMA will review the application in detail and provide a recommendation to the European Commission (EC) following the MAA validation. The CHMP committee will address the EC on whether to grant DBV Technologies a marketing authorization across Europe.
Once the company attains the marketing approval, DBV Technologies (DBVT) will initiate its commercialization campaign in European countries. The company anticipates the questionary response from the EMA almost four months post-validation.