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Tag: DBVT Stock

  • DBV Technologies (DBVT) Stock Climbs Following Strategic Equity Raise

    DBV Technologies (DBVT) Stock Climbs Following Strategic Equity Raise

    The stock market saw a spectacular increase in DBV Technologies S.A. (NASDAQ: DBVT) shares, which as of the latest check were up 60.34% to $6.27. Following the company’s announcement of a sizable funding deal intended to support its development plans, the stock value increased significantly.

    The Multi-Million Finance Plan

    DBV Technologies has negotiated a $306.9 million (€284.5 million) finance deal. At closure, DBVT anticipates gross proceeds of $125.5 million (€116.3 million). Additionally, if all related warrants are exercised, subject to certain restrictions, a total of up to $181.4 million (€168.2 million) might be raised.

    The accomplishment of the primary outcome in the current VITESSE Phase 3 research is a crucial catalyst for warrant acceleration. The majority of the recently obtained money will go toward general business operations and working capital.

    They will also be used to advance the Viaskin Peanut program, draft and submit a possible Biologics License Application (BLA), and, subject to regulatory approval, help with the possible commercial launch of Viaskin Peanut in the United States.

    However, it is anticipated that the financing structure will dilute current shareholders by 22.4%; if all warrants are exercised, the maximum possible dilution on a non-diluted basis may reach 73.7%.

    Key Investors Behind the Transaction

    Several well-known institutional investors supported the fundraising round, including Yiheng Capital, Bpifrance Participations, Octagon Capital, Vivo Capital, Janus Henderson Investors, Surveyor Capital (a Citadel subsidiary), MPM BioImpact, and Adage Capital Management LP. Together with other healthcare-focused funds, these investors have shown confidence in DBV Technologies’ potential for long-term success.

    Moving Forward with Commercialization and FDA Submission

    The investment comes after DBV Technologies recently partnered with the FDA to harmonize safety exposure data for a BLA filing for its Viaskin Peanut patch for kids ages 4–7. With this funding, the business may move more quickly toward becoming a commercial entity, finishing out the required research and being ready to submit to the government.

    The funds will also help DBVT get ready for the possible introduction of Viaskin Peanut in toddlers ages 1-3 and kids ages 4-6, subject to FDA clearance. The funding agreement strengthens DBV Technologies’ strategic positioning and dedication to treating pediatric peanut allergy with cutting-edge therapeutic approaches as it advances.

  • After-Market Gains For DBV Technologies (DBVT) Stock

    After-Market Gains For DBV Technologies (DBVT) Stock

    DBV Technologies S.A. (NASDAQ: DBVT) shares jumped 27.36% to $4.19 on the US stock charts during Wednesday’s after-hours trade. The cause for that spike in DBVT stock price was the disclosure of significant regulatory advancements with the U.S. Food and Drug Administration (FDA) concerning their Viaskin Peanut patch product.

    Faster Approval Process

    Successful written and verbal interactions with the FDA resulted in a clearly defined regulatory process for the Viaskin Peanut patch, which is intended for children ages one to three, according to Defined DBV Technologies (DBVT). The FDA agreed with DBVT on the essential components of a post-marketing confirmatory study design and issued official guidelines in favor of the product’s Accelerated Approval.

    This progress significantly reduces regulatory uncertainty and allows DBV Technologies to focus on completing studies to support two Biologics License Applications (BLAs) for distinct age groups and a Marketing Authorization Application (MAA) in Europe.

    Efficacy Data Validated for Accelerated Approval

    The FDA confirmed that efficacy data from DBV Technologies’ Phase 3 EPITOPE study could serve as an intermediate clinical endpoint, satisfying the criteria for Accelerated Approval.

    The regulatory body acknowledged that the data is “reasonably likely to predict clinical benefit,” meeting one of the three qualifying criteria for Accelerated Approval, which also includes addressing a serious condition and providing meaningful advantages over available therapies. This confirmation marks a pivotal step toward the commercialization of the Viaskin Peanut patch.

    Preparations for Commercialization

    DBV Technologies has implemented changes to improve the patch’s usability and production efficiency in anticipation of commercialization. These modifications, such as simplifying application for caregivers and enhancing product identification, do not alter the patch’s interaction with patients. Additionally, adjustments to the manufacturing process and location have been made to scale up production volume, ensuring readiness for broader market distribution.

    Strategic Focus on Global Approvals

    With a clearer regulatory pathway, DBV Technologies is poised to advance its Viaskin Peanut programs for both toddlers and older children, addressing unmet needs in allergen immunotherapy. This milestone underscores DBVT’s commitment to innovation and its readiness to bring transformative solutions to market.

  • Participation at Healthcare Conference: DBV Technologies S.A. (DBVT) Stock Recovered in Tuesday’s Premarket.

    Participation at Healthcare Conference: DBV Technologies S.A. (DBVT) Stock Recovered in Tuesday’s Premarket.

    DBV Technologies S.A. (DBVT) is producing an exclusive technology platform known as Viaskin, having a wide range of applications in immunotherapeutics and based on EPIT. It belongs to a new class of non-invasive candidate products. The safe transformation of food allergic patients’ care is the goal of the company.

    DBVT stock price during the regular trading on March 14, 2022, declined 1.45% to be $1.36. Its price soared by 5.15% at the last check of the premarket session of March 15, 2022.

    DBVT: Events and Happenings

    On March 14, 2022, DBVT reported its CMO will present at the Oppenheimer’s 32nd Annual Healthcare Conference was held on March 17, 2022.

    DBVT: Key Financials

    DBVT released its full fiscal year 2021 financials on March 3, 2022, for the year ended December 31, 2021. Some significant features are shared here.

    Revenue

    Revenues in fiscal 2021 were $5.7 million against $11.2 million in fiscal 2020. The company observed an increase of $5.56 million in its revenue YoY.

    EPS

    FY 2021 net loss basic and diluted per share was $97.8 million or $1.78 compared to $159.5 million or $2.95 for the comparable year 2020. The company’s EPS nose-dived YoY. Also, its EPS remained in line with the expectations.

    On February 22, 2022, DBVT updated on the participation of its management at the Annual Scientific Meeting of the American Academy of Allergy, Asthma, and Immunology on February 24-28. On February 14, 2022, DBVT announced the presentation of its CEO at the 11th Annual SVB Leerink Global Healthcare Conference on February 18. On January 21, 2022, DBVT issued its half-yearly statement of its liquidity agreement with ODDO BHF.

    Conclusion

    DBVT stock plunged deep in the last six months by 73%. Its current stock position is good as the company announced its Executive management’s participation at the Oppenheimer’s Healthcare Conference, hence its stock price surged in the premarket. For the first quarter of 2022, the company’s expectation of revenue is $1.28 million and -$0.40 EPS.

  • DBV Technologies S.A. (DBVT) stock plunged in the pre-market. Here’s why

    DBV Technologies S.A. (DBVT) stock plunged in the pre-market. Here’s why

    The stock of DBV Technologies S.A. (DBVT) lost 20.00% in the pre-market to $1.40 after releasing the fiscal performance for FY2021. DBVT stock closed the regular trading session at $1.75, gaining 34.62% from the previous day’s trading session. The stock kept moving between $1.44 and $1.75. DBV Technologies also filed form 8-K with the SEC on 3 March 2022.

    DBV Technologies SA is a biopharmaceutical firm known for creating “Viaskin” innovation. It regulates the allergens or antigens to unblemished skin while keeping away from any movement to the blood. The company has a market cap of $96.14 million with 54.94 million pending shares. DBVT has its headquarter in Mont rouge, France.

    DBVT’s key financials

    On 3 March 2022, DBV Technologies released the fiscal performance for FY2021. The firm’s sales for FY21 reduced by 49.3% to $5.7 million in 2021 from $11.2 million in 2020. DBVT had the expense from the operation of $104.3 million in 2021 versus $170.1 million in 2020. This marks a contraction of 38.6% in the expenses from operations. Moreover, the firm reported a total loss of $97.8 million in 2021 against $159.5 million in 2020. The total loss declined by 38.6%. Also, the loss of $1.78 per stock in 2021 is compared to the loss of $2.95 per stock in 2020. The loss per stock also declined by 39.6%. Moreover, as of December 31, 2021, DBVT had total assets worth $146.7 million of which cash and cash equivalents were $77.3 million.

    CEO Remarks

    The CEO of DBVT, Daniel Tasse, commented that starting the new Phase 3 preliminary with the mVP is their main concern. They are satisfied with the continuous discussions with FDA. He further added that they expect this financial position will give DBV an adequate chance to acquire an alliance with FDA on the convention for the mVP essential preliminary.

    Further, Mr. Tasse concluded that they expect to understand the maximum capacity of the Viaskin innovation for patients and families.

  • DBV Technologies S.A. (DBVT) stock making a comeback after heavy losses

    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.

  • 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.