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Tag: NASDAQ: DBVT

  • Why DBV Technologies (NASDAQ: DBVT) Is Skyrocketing Today?

    Why DBV Technologies (NASDAQ: DBVT) Is Skyrocketing Today?

    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.

  • Stocks to Watch As Volatility Triggers a Rally Pre-Market

    Stocks to Watch As Volatility Triggers a Rally Pre-Market

    U.S equities are on the rise pre-market, reflecting the positive price movements that have been recorded in Europe today. All the major indices are up with the S&P 500 up by 1.64%, the Dow by 1.88%, and the NASDAQ by 1.48% at the time of writing. The gains are a reflection of investors trading the volatility that has characterized the markets over the last couple of weeks. Last week the markets dropped hard creating some buying opportunities for investors in the short-term. At the same time, there is a lot that the markets have a lot to look forward to this week that could generate even more volatility for traders. One of the big events that are expected this week is the U.S election. There is also the upcoming monetary policy decision by the FOMC. Expectations of positive news from the FOMC could play a much bigger role in the price action this week than the election. That’s because the election results are expected to take some time before they are announced. According to a JP Morgan analyst, the expectation is that the election-related volatility will subside in a few months, and fundamentals will take the course as the key drivers of growth. In today’s largely bullish market, there are some stocks that are performing much better than the overall market. Some of the pre-market top gainers that could extend gains all through the day are as below:

    DBV Technologies S.A [NASDAQ: DBVT]

    DBV Technologies S.A. is a top performer this morning and is up by over 80% pre-market. This follows the company’s announcement of a filing and validation of marketing application for Viaskin™ by the European Medicines Agency.  The validation means that the company can start a review of the investigational non-invasive treatment for peanut allergies in people between 4 to 11 years.

    BioLineRX Ltd [NASDAQ: BLBX]

    BioLineRX Ltd is a top gainer this morning and is up by over 15% pre-market, adding to the gains it recorded last week. This comes after the company announced that it had positive results from its phase 3 trial for BL-8040 in cancer treatment. The news has created excitement around the stock and could see it keep gaining all through the day.

    Insignia Systems Inc [NASDAQ: ISIG]

    Insignia Systems Inc is a top performer this morning and is up by over 46%. This is largely a momentum-driven move and is in tandem with the overall market. It comes days after the company announced a donation of 100k meals to Feeding America.