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  • 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.