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DBV Technologies SA

DBV Technologies SA (DBVT)

0.71
-0.04
(-5.33%)
Closed September 19 4:00PM
0.71
0.00
(0.00%)
After Hours: 7:59PM

Empower your portfolio: Real-time discussions and actionable trading ideas.

Key stats and details

Current Price
0.71
Bid
0.69
Ask
0.6979
Volume
212,105
0.69 Day's Range 0.745
0.00 52 Week Range 0.00
Market Cap
Previous Close
0.75
Open
0.733601
Last Trade
1
@
0.691
Last Trade Time
Financial Volume
$ 150,520
VWAP
0.709647
Average Volume (3m)
-
Shares Outstanding
96,498,927
Dividend Yield
-
PE Ratio
0.00
Earnings Per Share (EPS)
-
Revenue
15.73M
Net Profit
-72.71M

About DBV Technologies SA

DBV Technologies SA is a biotechnology company that provides therapy for food and pediatric allergy patients. The company focuses on discovering, developing, manufacturing, and commercializing treatments for severe allergies in the United States and other global markets. Its method of delivering bio... DBV Technologies SA is a biotechnology company that provides therapy for food and pediatric allergy patients. The company focuses on discovering, developing, manufacturing, and commercializing treatments for severe allergies in the United States and other global markets. Its method of delivering biologically active compounds to the immune system is through self-administered and non-invasive products. It also explores potential applications of its platform in vaccines and other immune diseases. Show more

Sector
Pharmaceutical Preparations
Industry
Pharmaceutical Preparations
Headquarters
Montrouge, Hauts-de-seine, Fra
Founded
-
DBV Technologies SA is listed in the Pharmaceutical Preparations sector of the NASDAQ with ticker DBVT. The last closing price for DBV Technologies was $0.75. Over the last year, DBV Technologies shares have traded in a share price range of $ 0.00 to $ 0.00.

DBV Technologies currently has 96,498,927 shares outstanding. The market capitalization of DBV Technologies is $72.37 million.

DBVT Latest News

DBV Technologies to Participate in the H.C. Wainwright 26th Annual Global Investment Conference

Châtillon, France, September 4, 2024 DBV Technologies to Participate in the H.C. Wainwright 26th Annual Global Investment Conference DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq...

Information regarding the total number of voting rights and total number of shares of the Company as of July 31, 2024

Information regarding the total number of voting rights and total number of shares of the Company as of July 31, 2024 (Article 223-16 of the General Regulations of the Autorité des Marchés...

DBV Technologies Announces Filing of 2024 Half-Year Report ― Conditions for Accessing or Consulting the Report

Châtillon, France, July 30, 2024 DBV Technologies Announces Filing of 2024 Half-Year Report ― Conditions for Accessing or Consulting the Report DBV Technologies (Euronext: DBV – ISIN:...

DBV Technologies Provides Updates on the Viaskin Peanut Program in Children and Toddlers and Reports Second Quarter and Half-Year 2024 Financial Results

Châtillon, France, July 30, 2024 DBV Technologies Provides Updates on the Viaskin Peanut Program in Children and Toddlers and Reports Second Quarter and Half-Year 2024 Financial Results VITESSE...

DBV Technologies to Report Second Quarter 2024 Financial Results and Business Update on July 30, 2024

Châtillon, France, July 29, 2024 DBV Technologies to Report Second Quarter 2024 Financial Results and Business Update on July 30, 2024 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 –...

Half-Year Report on the DBV Technologies Liquidity Contract with ODDO BHF

AMF Regulated InformationMontrouge, France, July 8, 2024 Half-Year Report on the DBV Technologies Liquidity Contract with ODDO BHF DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq...

DBV Technologies to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference

Châtillon, France, June 5, 2024 DBV Technologies to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock...

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DBVT Discussion

View Posts
Renee Renee 4 months ago
DBVT: effective June 3,2024 a one for 2 reverse split:

https://hedgefollow.com/upcoming-stock-splits.php
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Monksdream Monksdream 7 months ago
DBVT 10Q March 4
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Monksdream Monksdream 11 months ago
DBVT new 52 week low
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Monksdream Monksdream 12 months ago
DBVT under $2
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BostonSportsNut BostonSportsNut 1 year ago
we are BACK!!
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TheFinalCD TheFinalCD 2 years ago
$AIHS WITHDRAWALS REGISTRATION https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170828693
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81vette 81vette 2 years ago
1.6m shares short,better cover your nuts shorties
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subslover subslover 2 years ago
P&D but they are all over NASDAQ and it all depends if we can buy in low and dump for significant profits the same day. Risky? Of course but this is the new NASDAQ CASINO.
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Pedro2004 Pedro2004 2 years ago
I got hooked yesterday on YGMZ
Hit 52-week high of $6.50 yesterday
Now it's trading at $1.55

I have a rule to never buy-into a China company.
I didn't follow my rule and I lost 35% yesterday.
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81vette 81vette 2 years ago
i hope shorts get their nuts squeezed off,lol
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81vette 81vette 2 years ago
lots of scanner buy signals>Strong Volume Gainers,Bullish MACD Crossovers,Parabolic SAR Buy Signals,Gap Ups,Filled Black Candles,Elder Bar Turned Green
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subslover subslover 2 years ago
Yup. The NASDAQ has many P&D's.
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Pedro2004 Pedro2004 2 years ago
Thanks...
I think it's another pump PR.
But I'll keep this on the radar.
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81vette 81vette 2 years ago
nice ss,big moves in past
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81vette 81vette 2 years ago
lots of ppl with nut allergies,could see nice pop
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subslover subslover 2 years ago
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial
December 23 2022 - 01:30AM
GlobeNewswire Inc.
Alert
Print
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Montrouge, France, December 23, 2022

DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial

DBV expects to initiate patient screening in Q1 2023 with the last patient screened by 1H 2024 and topline results anticipated in 1H 2025
Company reiterates that cash on-hand is sufficient to fund operations through VITESSE topline data
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the Company’s VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase 3 clinical trial that will evaluate the modified Viaskin™ Peanut 250 µg patch (DBV712) in peanut-allergic children ages 4 to 7 years. The updated protocol will be submitted to study sites for subsequent Institutional Review Boards (IRB)/Ethics Committees (EC) approval.

In the Partial Clinical Hold (PCH) letter, the FDA requested changes to certain elements of the VITESSE protocol with the intent for the trial to support a Biologics License Application (BLA). The FDA communication contained four protocol modifications: the redefinition of the minimal daily wear time, the addition of a statistical test for the patch adhesion assessment, the reclassification of certain adverse events (AEs) to adverse events of special interest (AESIs) and an increase in the number of trial participants on active treatment.

Key design elements of VITESSE such as inclusion criteria, primary efficacy endpoint, responder criteria, efficacy assessment methodology and safety endpoints were not impacted by the PCH letter and have not changed.

“We are pleased that the FDA has lifted the partial clinical hold on the VITESSE study and anticipate initiating patient screening in Q1 2023,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “I am proud of our team for continuing to advance important pre-study activities these last several weeks so that we are prepared to act quickly to re-launch VITESSE following today’s announcement.”

Following receipt of the PCH letter, DBV and the FDA discussed how VITESSE protocol modifications could best support the Agency’s review of a potential BLA for Viaskin Peanut as a peanut allergy treatment.

In lifting the PCH, the FDA confirmed DBV satisfactorily addressed all clinical hold issues identified in the PCH letter. The FDA stated that DBV may proceed with VITESSE with the following changes included in the revised protocol:

The updated VITESSE Instructions for Use (IFU) will direct caregivers to apply one patch at approximately the same time each day, following removal of the previous day’s patch. The updated IFU now outlines that Viaskin Peanut 250 µg is to be worn for as close to a full day as possible (i.e., 24 hours) with a minimum daily wear time of 20 hours each day.
Patch adhesion will be assessed in VITESSE to affirm the modified Viaskin Peanut patch performs adequately, which aligns with existing regulatory requirements for patch-based therapies. In post-PCH discussions, DBV and the FDA agreed a statistical test of adhesion will be included in the VITESSE statistical analysis plan and further considered patch adhesion data collection and interpretation in the context of the novel nature of the Viaskin patch platform.
Four AEs will be classified as AESIs. These AEs – which include AEs leading to inhaled or systemic corticosteroid or epinephrine use, systemic allergic reactions, and Grade 4 local application site (skin) reactions – were collected and assessed in all previous Viaskin Peanut trials and included in the previous VITESSE protocol. Only the classification of these AEs has changed.
DBV plans to initiate a separate safety study in approximately 275 additional subjects, randomized 3:1 active versus placebo. The additional safety data generated by this six-month study will supplement the safety data generated by the VITESSE trial, resulting in a safety database comprised of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut. The protocol design of the safety study will be submitted to the FDA and is expected to be similar to the REALISE (REAL Life Use and Safety of EPIT) safety study that DBV previously conducted with Viaskin Peanut in children ages 4 to 11 years.
The Company does not expect the additional safety study to have an impact on the Company’s cash runway guidance as DBV had included a provision for a possible supplemental safety trial in its cash runway assumptions. The Company reiterates that cash on-hand is sufficient to fund operations through VITESSE topline data.

“Following a very productive dialogue with the FDA, we have incorporated the Agency’s modifications to VITESSE into the study protocol and look forward to initiating patient treatments,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “I am confident that the VITESSE study, when completed, will add to the growing body of evidence demonstrating the ability of our novel drug-device immunotherapy platform, Viaskin Peanut, to address significant unmet needs among peanut-allergic children and their families.”

DBV anticipates initiating VITESSE patient screening in the first quarter of 2023 with the last patient screened in 1H 2024 and topline results anticipated in 1H 2025.

About VITESSE
The VITESSE trial will enroll 600 subjects, randomized 2:1 active versus placebo. The study will involve approximately 80 trial sites across the United States, Canada, Australia and Europe. Dr. David Fleischer, Children’s Hospital Colorado, will act as the principal investigator.

The primary efficacy endpoint is the percentage of treatment responders in the active versus placebo arms at Month 12. The primary efficacy analysis includes the success criterion of a lower bound of the confidence interval of the difference in responder rates between active and placebo groups being greater than or equal to 15%.

A treatment responder is defined as either a subject with a baseline eliciting dose (ED) ≤30 mg who reaches an ED ≥300 mg of peanut protein at Month 12, or a subject with a baseline ED = 100 mg who reaches an ED ≥600 mg of peanut protein at Month 12. A double-blind, placebo-controlled food challenge (DBPCFC) will be administered at baseline and Month 12 to determine a subject’s ED at both timepoints.

During the screening period, subjects will undergo an initial visit with assessment for eligibility according to peanut skin prick test (SPT) and serum peanut IgE. Those meeting these criteria will proceed to a DBPCFC to confirm their peanut allergy and establish an entry peanut ED. The entry DBPCFC will be 1 mg peanut protein, and will escalate up to a highest single dose of 100 mg peanut protein. Subjects who react with an ED at or below the dose of 100 mg peanut protein are considered eligible. At Month 12, a post-treatment DBPCFC will be performed, with a starting dose of 3 mg peanut protein, escalating to a highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, 1,000 mg. Secondary efficacy endpoints include changes in Cumulative Reactive Dose, ED and severity of allergic reaction at Month 12 food challenge.
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Pedro2004 Pedro2004 2 years ago
Damn. This was running to $4.00 -- until some assh### Insider dumped their shares.
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ErnieBilco ErnieBilco 2 years ago
Here we go - never really doubted it.
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honest dave honest dave 3 years ago
Rewards outweigh the risks here imo. DBVT recent news is very positive to me. The recent dump is from the "I want it NOW" and "can't wait" crowd. Patience will win the day.
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ErnieBilco ErnieBilco 3 years ago
I had to buy the news. From what I read they seem to have a path forward on a much needed treatment for peanut allergy peeps.

Didn't do a deep dive just dipped me toes in the water.
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stocksrising stocksrising 3 years ago
Will these upcoming conferences move the needle ? Perhaps further advancement of final stage(s) for approval ?
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ClayTrader ClayTrader 4 years ago
* * $DBVT Video Chart 01-15-2021 * *

Link to Video - click here to watch the technical chart video

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stocksrising stocksrising 4 years ago
Where are you sweet pee? CT
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ClayTrader ClayTrader 4 years ago
* * $DBVT Video Chart 11-03-2020 * *

Link to Video - click here to watch the technical chart video

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ClayTrader ClayTrader 4 years ago
* * $DBVT Video Chart 11-02-2020 * *

Link to Video - click here to watch the technical chart video

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doogdilinger doogdilinger 4 years ago
Nice call Boston kudos!
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doogdilinger doogdilinger 4 years ago
Significant dol vol pm here
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doogdilinger doogdilinger 4 years ago
About time we had some pm action jackson plays flowing again, glty as always GC!
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Golden Cross Golden Cross 4 years ago
Yep, she has life...
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doogdilinger doogdilinger 4 years ago
DBVT wakin' Golden
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Golden Cross Golden Cross 4 years ago
DBV Technologies Announces Filing and Validation of Marketing Autho...
Montrouge, France, November 2, 2020DBV Technologies Announces Filing and Validation of Marketing Authorization Application for Viaskin™ Peanut by European Medicines Agency DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: $DBVT ), a clinical-stage bioph...
https://finance.yahoo.com/news/dbv-technologies-announces-filing-validation-063000296.html
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ClayTrader ClayTrader 5 years ago
* * $DBVT Video Chart 01-30-2020 * *

Link to Video - click here to watch the technical chart video

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BostonSportsNut BostonSportsNut 5 years ago
GREAT news just out.

$DBVT 34 sec ago: DBV Tech up 23% after hours on positive long-term Viaskin data: DBV Technologies announces positive long-term results from the open-label extension study) of its Phase 3 clinical trial, PEPITES,.. newsfilter.io/articles/dbv-...
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BostonSportsNut BostonSportsNut 5 years ago
On the move tonight, since recenbt dilution stock moving from high 6s, to mid 10s tonight, news coming soon? Or just Baker Brothers buying in large creating momentum?
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BostonSportsNut BostonSportsNut 5 years ago

DBV Technologies Submits Biologics License Application to U.S. Food and Drug Administration for Viaskin Peanut for the Treatment of Peanut Allergy
PRESS RELEASE GlobeNewswire
Aug. 7, 2019, 04:05 PM
Montrouge, France, August 7, 2019

DBV Technologies Submits Biologics License Application to U.S. Food and Drug Administration for Viaskin Peanut for the Treatment of Peanut Allergy

DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years. Viaskin Peanut is the Company’s lead product candidate based on epicutaneous immunotherapy (EPIT®). Viaskin is the Company’s proprietary, investigational platform that is designed to leverage the skin to activate the immune system and induce desensitization to allergens.

This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December 2018, when DBV voluntarily withdrew its prior BLA submission for Viaskin Peanut. The FDA did not cite concerns related to the clinical module of the BLA for Viaskin Peanut in December 2018.

“This is an important milestone for DBV, as we are one step closer towards potentially bringing Viaskin Peanut to patients.I want to thank the team for their dedication in working to address the FDA’s findings over the past few months. Everyone at DBV is highly committed to potentially addressing the significant unmet medical need facing peanut-allergic patients,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “We would also like to thank our investigators, clinical trial sites, as well as the children living with peanut allergy and their families for all of their help in the development of Viaskin Peanut. We look forward to working with the FDA throughout its review process.”

Viaskin Peanut received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively. The BLA for Viaskin Peanut is supported by a global development program comprised of eight clinical trials including, two Phase I studies, four Phase II studies and two Phase III studies. The two double-blind placebo-controlled Phase III trials, PEPITES and REALISE, studied patients aged 4 to 11 years for 12 months and 6 months, respectively, and were included in the submission. Additionally, supportive long-term data from the Company’s open-label Phase II program were also included in the submission.
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BostonSportsNut BostonSportsNut 5 years ago
Bla submitted
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BostonSportsNut BostonSportsNut 5 years ago
Shyster
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ClayTrader ClayTrader 5 years ago
* * $DBVT Video Chart 07-05-2019 * *

Link to Video - click here to watch the technical chart video

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BostonSportsNut BostonSportsNut 5 years ago
JfC just go away
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Golden Cross Golden Cross 5 years ago
$DBVT daily chart: Nice pop today!

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ClayTrader ClayTrader 5 years ago
* * $DBVT Video Chart 04-04-2019 * *

Link to Video - click here to watch the technical chart video

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BostonSportsNut BostonSportsNut 6 years ago
Massive overreaction yes, still time to buy it up cheap, wont stay here for long.
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BostonSportsNut BostonSportsNut 6 years ago
Hope springs eternal......steady slow climb, re submission happening sooner than expected, 8.75 and climbing
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retireat40 retireat40 6 years ago
Yes...the issues all surround manufacturing and QC issues. No concerns whatsoever with efficacy. Massive overreaction to the news.
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jdlamont jdlamont 6 years ago
anyone hear the cc? Earlier they said the snafu had to do with questions about the manufacturing,
That is not that hard a fix. Surprised it doesn't;t get up to 9 in a couple of days.
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ClayTrader ClayTrader 6 years ago
* * $DBVT Video Chart 12-20-18 * *

Link to Video - click here to watch the technical chart video

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~MulaGreen~ ~MulaGreen~ 6 years ago
DBVT 1.1M Block Buy X $4.14 around @ 14:07:09 Expect a great recovery over 5+
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retireat40 retireat40 6 years ago
Wow...getting crushed. Now at $4.60 from $14 yesterday.
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retireat40 retireat40 6 years ago
They submitted and now have withdrawn submittal. $5.18 PM trading.
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ALERTS100%to10000%GAIN ALERTS100%to10000%GAIN 6 years ago
DBVT~~5.25 now,,62%% down
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