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Tag: DBV Technologies S.A

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.

December 12, 2024
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.

March 15, 2022
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 Viaskin^TMPeanut

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.

December 22, 2021
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 Viaskin^TM 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.

November 2, 2020
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.

November 2, 2020