DBV Technologies S.A. (NASDAQ: DBVT) kicked off Monday trading session with a strong performance as it stocks rocketed 72.03% after the company revealed that the European Medicines Agency (EMA) has approved its Marketing Authorization Application (MAA) for its investigational product ViaskinTM Peanut (DBV712).
The verification of the Marketing Authorization Application (MAA) enables the company to commence the formal review process for the investigational non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.
After the approval of MAA, the committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) will review the application. After the review process committee will give suggestions to the European Commission (EC) on whether to give a marketing authorization. DBV Technologies revealed that it anticipates that it will receive the first set of questions from the EMA approximately 120 days post-validation.
DBV Technologies S.A. (NASDAQ: DBVT) shares were trading up 69.23% at $2.42 at the time of writing on Monday. DBV Technologies S.A. (DBVT) share price went from a low point around $1.35 to briefly over $13.49 in the past 52 weeks. It has moved up 79.26% from its 522-weeks low and moved down -82.06% from its 52-weeks low. DBVT market cap has remained high, hitting $156.78 Million at the time of writing.
Earlier in August, DBV Technologies S.A. has earlier disclosed that it had got a Complete Response Letter (CRL) from the U.S Food and Drug Administration (FDA) for its Biologics License Application (BLA) for investigational Viaskin Peanut.
Previously, DBV Technologies has shared the cash and cash equivalents and the number of outstanding shares as of September 30, 2020. It has reported the cash and cash equivalent of €189.1 million as compared to €225.9 million as of June 30, 2020. It has revealed that its average monthly cash burn reduced in the third quarter of 2020 as compared to the second quarter of 2020, excluding the expenses related to the ongoing global restructuring plan of the company.