Últimas noticias sobre DBV Technologies (NASDAQ:DBVT) Bolsa

DBV Technologies

DBV Technologies SA is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The therapeutic approach is based on epicutaneous immunotherapy or EPIT, its proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. Its main product candidate is Viaskin Peanut for the treatment of peanut-allergic patients.

DBV Technologies S.A. - American Depositary Shares

DBV Technologies SA

DBV TECHNOLOGIES SA by DBV Technologies SA

Half-Year Report on the DBV Technologies Liquidity Contract with ODDO BHF
DBV Technologies (TRQX:<a href="https://www.benzinga.com/stock/DBVp#TRQX">DBVp</a>), a clinical-stage biopharmaceutical company, today issued the Half-Year report on its liquidity contract with ODDO BHF.
Under the liquidity contract between DBV Technologies and ODDO BHF, the following assets appeared on the liquidity account as of December 31, 2024:
<ul>
<li>266,868 DBV Technologies shares,</li>
<li>€ 106,930.51.</li>
</ul>
When the liquidity contract with ODDO BHF was implemented, as of July 1, 2018, the following assets were included in the liquidity account:
<ul>
<li>41,159 DBV Technologies shares,</li>
<li>€ 432,367.25.</li>
</ul>
Over the period from July 1, 2024, to December 31, 2024, the following transactions were executed:
<ul>
<li>1682 buy transactions,</li>
<li>1800 sales transactions.</li>
</ul>
Over this same period, the volumes traded represented:
<ul>
<li>404,081 shares and € 296,390.97 on purchases,</li>
<li>440,957 shares and € 340,906.76 on sales.</li>
</ul>

News

DBVT

DBV Technologies Reports H2 Liquidity Contract Update: 267K Shares, €107K In Account; 1,682 Buy And 1,800 Sales Transactions Covering 404K Shares Purchased, €296K And 441K Shares Sold, €341K

JMP Securities analyst Jonathan Wolleben reiterates DBV Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DBVT#NASDAQ">DBVT</a>) with a Market Outperform and maintains $10 price target.

Price Target

Reiteration

Analyst Ratings

JMP Securities Reiterates Market Outperform on DBV Technologies, Maintains $10 Price Target

WIIM

DBV Technologies shares are trading higher after the company announced 3-year results from its IPITOPE Phase 3 open-label extension study.

<ul>
<li>EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN&#xAE; Peanut patch in toddlers 1 – 3 years through 36 months</li>
<li>68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12</li>
<li>No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE &nbsp;&nbsp;</li>
<li>DBV also announced daily patch wear time data from EPITOPE that is supportive of the Company's proposed labeling approach shared with FDA</li>
<li>DBV to highlight these data in multiple abstract presentations at the Eastern Food Allergy &amp; Comorbidity Conference, January 9-12, in Palm Beach, Florida
<ul>
<li>Company to host investor webcast today at 5:00pm ET</li>
</ul>
</li>
</ul>

Biotech

General

DBV Technologies Announces  3-Year Results from EPITOPE Phase 3 Open-Label Extension Study; Data Provided Support That Continued Treatment With VIASKIN Peanut Showed Improveemntn Through 36 Months Of Treatment Across All Efficacy Parameters

On Wednesday, DBV Technologies SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DBVT#NASDAQ">DBVT</a>) reached a significant milestone with the FDA regarding its Viaskin Peanut patch for <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/g42447895/dbv-confirms-alignment-with-u-s-fda-on-accelerated-approval-pathway-for-the-viaskin-peanut-patch-i" rel="noreferrer noopener">toddlers aged 1–3 years</a>.
The FDA has outlined a clear Accelerated Approval pathway for the therapy, offering a streamlined regulatory process for <a target="_blank" href="https://www.benzinga.com/general/biotech/23/08/33487292/dbv-technologies-advances-peanut-allergy-program-with-fda-support-on-pediatric-studies" rel="noreferrer noopener">peanut allergy treatment</a>.
The FDA confirmed that the Viaskin Peanut patch satisfies the key criteria for Accelerated Approval, including addressing a serious condition and offering a meaningful advantage over existing therapies.
The FDA also acknowledged that efficacy data from DBV's Phase 3 EPITOPE study meets the requirement of an intermediate clinical endpoint reasonably predicting clinical benefits.
The pivotal decision reduces regulatory uncertainty and allows DBV to concentrate on completing essential studies.
To meet FDA requirements for Accelerated Approval, DBV will conduct a post-marketing confirmatory study using the commercial version of the Viaskin Peanut patch.
This study will validate the safety and efficacy of the redesigned patch, which features improvements for ease of use and identification without altering skin contact components. The confirmatory study will include a double-blind, placebo-controlled food challenge and aims to support the Biologic License Application (BLA) for toddlers aged 1–3 years.
The ongoing COMFORT Toddlers trial will complement these efforts.
This Phase 3 study will evaluate safety, adhesion, and efficacy in approximately 480 participants across multiple regions. Data from this study will be crucial in DBV's FDA marketing application submission, expected in the second half of 2026.
DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025.
Price Action: DBVT stock is up 14.90% at $3.78 at the last check on Thursday.
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</ul>

Health Care

Movers

Trading Ideas

DBV Aligns With FDA On Accelerated Approval For Viaskin Peanut Patch In Younger Kids

DBC Technologies shares are trading higher after the company announced alignment with the FDA on an accelerated approval pathway for the Viaskin peanut patch in toddlers one to three years old.

ADBE: -11% &#x7C; <a href="https://www.benzinga.com//node/42448063">Adobe shares are trading lower following mixed guidance.</a>
&nbsp;
DBVT: 76% &#x7C; <a href="https://www.benzinga.com//node/42448378">DBC Technologies shares are trading higher after the company announced alignment with the FDA on an accelerated approval pathway for the Viaskin peanut patch in toddlers one to three years old.</a>
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ADBE

ZENA

Market-Moving News for December 12th

U.S. stock futures declined on Thursday in premarket hours after hitting fresh highs on Wednesday. The futures of all the four major indices were trading lower.
November inflation data was in line with analyst expectations, shooting up the probability of a further 25 basis point rate cut in December rose to 98.6% versus 58.75% probability a month ago, according to <a href="https://www.cmegroup.com/markets/interest-rates/cme-fedwatch-tool.html">CME Group&#8217;s FedWatch tool</a>. Federal Reserve officials are currently in a quiet period ahead of their December meeting.
Traders now await the producer price index data, which will be released later today. The 10-year and two-year Treasury notes yielded 4.30% and 4.18%, respectively
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<table>
<tbody>
<tr>
<td>Futures</td>
<td>Change (+/-)</td>
</tr>
<tr>
<td>Nasdaq 100</td>
<td>-0.24%</td>
</tr>
<tr>
<td>S&amp;P 500</td>
<td>-0.16%</td>
</tr>
<tr>
<td>Dow Jones</td>
<td>-0.19%</td>
</tr>
<tr>
<td>Russell 2000</td>
<td>-0.18%</td>
</tr>
</tbody>
</table>
</figure>
In premarket trading on Wednesday, the SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) was down 0.12% to $606.71 and the Invesco QQQ Trust ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>) declined 0.20% to $528.87, according to <a href="https://www.benzinga.com/pro/">Benzinga Pro data</a>.
Cues From The Last Session
The Consumer Price Index (CPI) for November climbed 2.7% year-over-year, aligning with expectations. 1 Core inflation, excluding volatile food and energy costs, held steady at 3.3%.  
The Magnificent Seven's combined <a href="https://www.benzinga.com/economics/macro-economic-events/24/12/42445451/nasdaq-100-rallies-to-record-highs-magnificent-7-market-cap-tops-17-trillion-bitcoin-soars-to-100000-whats-driving-markets-wednesday">market cap hits $18.2 trillion,</a> with five giants reaching all-time highs on Wednesday. The Roundhill Magnificent Seven ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MAGS#NASDAQ">MAGS</a>), a closely watched benchmark for the group&#8217;s market performance, surged 3.03% on Wednesday, setting a new all-time high.
The Roundhill Magnificent Seven ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MAGS#NASDAQ">MAGS</a>) surged 3.03%, its best performance since early November. 
The broader market also participated in the rally. The S&amp;P 500 climbed 0.82%, nearing its all-time high. Small-cap stocks added 0.48%, while the Dow Jones Industrial Average ended 0.22% lower.
<figure class="wp-block-table"> 
<table>
<tbody>
<tr>
<td>Index</td>
<td>Performance (+/-)</td>
<td>Value</td>
</tr>
<tr>
<td>Nasdaq Composite</td>
<td>1.77%</td>
<td>20,034.90</td>
</tr>
<tr>
<td>S&amp;P 500</td>
<td>0.82%</td>
<td>6,084.19</td>
</tr>
<tr>
<td>Dow Jones</td>
<td>-0.22%</td>
<td>44,148.56</td>
</tr>
<tr>
<td>Russell 2000</td>
<td>0.48%</td>
<td>2,394.16</td>
</tr>
</tbody>
</table>
</figure>
See Also: <a href="https://www.benzinga.com/economics/macro-economic-events/24/12/42445451/nasdaq-100-rallies-to-record-highs-magnificent-7-market-cap-tops-17-trillion-bitcoin-soars-to-100000-whats-driving-markets-wednesday">Nasdaq 100 Rallies To Record Highs, Magnificent 7 Market Cap Tops $17 Trillion, Bitcoin Soars To $100,000: What&#8217;s Driving Markets Wednesday?</a>
Insights From Analysts
Despite the S&amp;P 500 Index nearing record highs on Wednesday, its breadth was skewed in the favour of the bears.
&#8220;117 stocks in the S&amp;P 500 made a new monthly low yesterday, the most since 139 on Halloween. 211 made a 10-day low, most since Sept 6,&#8221; said Ryan Detrick, the chief market strategist at Carson Group.
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<div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">117 stocks in the S&amp;P 500 made a new monthly low yesterday, the most since 139 on Halloween. 211 made a 10-day low, most since Sept 6. Not end of world stuff, but clearly some deterioration under the surface taking place.
&mdash; Ryan Detrick, CMT (@RyanDetrick) <a href="https://twitter.com/RyanDetrick/status/1866927212479590411?ref_src=twsrc%5Etfw">December 11, 2024</a></blockquote>
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The breadth has been skewed for the last seven days. &#8220;Since 2010, only happened two other times. Aug &#8217;11 and Dec &#8217;18. Small sample size yes, but not the worst times for bulls going forward,&#8221; added Detrick.
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<div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">7 consecutive days there have been more decliners than advancers on the S&amp;P 500. Since 2010, only happened two other times. Aug &#39;11 and Dec &#39;18. Small sample size yes, but not the worst times for bulls going forward.
&mdash; Ryan Detrick, CMT (@RyanDetrick) <a href="https://twitter.com/RyanDetrick/status/1866929220540305836?ref_src=twsrc%5Etfw">December 11, 2024</a></blockquote>
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Talking about balancing growth amid policy shifts, Andrew Pease, the chief investment strategist at Russell Investments said, &#8220;Tax cuts and deregulation could provide a meaningful growth boost, particularly to domestic and cyclical sectors.&#8221;
&#8220;Given lower valuations and improving sentiment, we are more positive on U.S. small-cap equity than we have been in prior years. Large-cap dominance in both earnings and price appreciation will require a catalyst to shift returns in the small-cap direction,&#8221; he added.
Apart from small-caps, Pease in his note said that &#8220;growth managers targeting high-growth cyclical sectors like software, while value managers identify mergers and acquisitions potential in financials and healthcare. Core managers are balancing cyclical exposure and managing risks in rate-sensitive sectors.&#8221;
Citing rich valuations, Alex Chaloff, the chief investment officer at Bernstein Private Wealth Management said that they are still pro-equities.
&#8220;We&#8217;re optimistic on equities, think that valuations are a little bit rich in a pocket of the market, but there are some opportunities. In bonds, you can clip the coupon even if rates move higher from here, which we don&#8217;t think is our base case,&#8221; he said.
See Also: <a href="https://www.benzinga.com/24/12/42453807/spacex-hits-350-billion-valuation-in-insider-share-sale-ceo-elon-musk-says-no-investors-wanted-to-sell-shares">SpaceX Hits $350 Billion Valuation In Insider Share Sale: CEO Elon Musk Says &#8216;No Investors Wanted To Sell Shares&#8217;</a>
Upcoming Economic Data
This week&#8217;s remaining economic calendar with essential data releases that will help investors shape their future plans and strategies.
<ul>
<li>On Thursday, initial jobless claims data till Dec. 7 and the core and headline producer price index for November will be released at 8:30 a.m. ET.</li>
<li>On Friday, the import price index data will be released at 8:30 a.m. ET.</li>
</ul>
Stocks In Focus:
<ul>
<li>Macy's, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/M#NYSE">M</a>) was down 1.03% as its net sales decreased 2.4%. Sales growth at Macy's First 50 locations, Bloomingdale's, and Bluemercury was offset primarily by weakness in Macy's non-First 50 locations, digital channels, and cold weather categories.</li>
<li>Nordson Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NDSN#NASDAQ">NDSN</a>) fell by 5.43% as the company revenue guidance for the fiscal year 2025 was below analyst expectations.</li>
<li>Adobe Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADBE#NASDAQ">ADBE</a>) declined by 9.99% after its earnings beat estimates but the revenue guidance for the first quarter missed the mark.</li>
<li>Ciena Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CIEN#NYSE">CIEN</a>) was up 1.08% in the premarket as it is slated to report quarterly earnings before the bell. Wall Street expects it to report quarterly earnings of 66 cents per share on revenue of $1.10 billion.</li>
<li>DBV Technologies SA &#8211; ADR (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DBVT#NASDAQ">DBVT</a>) rose by 32.83% after the company announced alignment with the FDA on an accelerated approval pathway for the Viaskin peanut patch in toddlers one to three years old.</li>
<li>Amplitech Group Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPG#NASDAQ">AMPG</a>) gained 39.90% after the company priced its $2.2 million registered direct offering of 1.35 million shares at $1.60 per share.</li>
<li>Nuburu Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BURU#NYSE">BURU</a>) was up 22.62% after the company addressed NYSE compliance violations over 4.6 million share issuance.</li>
<li>Trump Media &amp; Technology Group Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DJT#NASDAQ">DJT</a>) is in focus as President-elect Donald Trump <a href="https://www.benzinga.com/general/social-media/24/12/42454492/djt-stock-in-focus-as-trump-set-to-ring-nyse-bell-today-heres-why-president-elect-once-threatened-to-shift-trump-media-from-nasdaq">is set to ring </a>the New York Stock Exchange opening bell Thursday.</li>
</ul>
Commodities, Bonds And Global Equity Markets:
Crude oil futures were largely unchanged in the early New York session and rose 0.03% to hover around $70.31 per barrel.
The gold spot index fell by 0.37% to $2,746.59 per ounce. The Dollar Index was down 0.12% to 106.581 level.
Asian markets were mixed on Thursday as Australia&#8217;s ASX 200 and India&#8217;s S&amp;P BSE Sensex declined. While, Hong Kong&#8217;s Hang Seng, China&#8217;s CSI 300, Japan&#8217;s Nikkei 225, and South Korea&#8217;s Kospi Index advanced. Most European markets advanced.
Read Next:
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<li><a href="https://www.benzinga.com/24/12/42454495/microsoft-expects-800-million-impairment-charge-due-to-gms-cruise-exit-but-analysts-say-its-a-step-in-the-right-direction-for-automaker">Microsoft Expects $800 Million Impairment Charge Due To GM&#8217;s Cruise Exit, Analyst Says It&#8217;s A &#8216;Step In The Right Direction&#8217; For Automaker</a></li>
</ul>
Image Via Shutterstock

Equities

Market Summary

Movers & Shakers

Economics

Federal Reserve

Pre-Market Outlook

Markets

AMPG

BURU

CIEN

MAGS

NDSN

Wall Street Poised To Open Lower A Day After Nasdaq's Record Close Above 20,000: Expert Flags 'Deterioration Under The Surface' As 117 S&P 500 Stocks Hit New Monthly Lows

Shares of DBV Technologies S.A. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DBVT#NASDAQ">DBVT</a>) rose sharply in the pre-market trading after the company announced alignment with the FDA on an accelerated approval pathway for the Viaskin peanut patch in toddlers <a href="https://www.benzinga.com/quote/DBVT">one to three years old</a>.
DBV Technologies shares jumped 36.9% to $4.60 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>Palisade Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PALI#NASDAQ">PALI</a>) gained 125% to $3.15 in pre-market trading.</li>
<li>AmpliTech Group, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMPG#NASDAQ">AMPG</a>) gained 38.3% to $2.67 in pre-market trading after the company priced its $2.2 million registered direct offering of 1.35 million shares at $1.60 per share.</li>
<li>Wheeler Real Estate Investment Trust, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WHLR#NASDAQ">WHLR</a>) gained 35.2% to $6.05 in pre-market trading after dipping 16% on Wednesday.</li>
<li>Nuburu, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BURU#NASDAQ">BURU</a>) gained 27.5% to $0.3162 in pre-market trading after the company addressed NYSE compliance violations over 4.6 million share issuance.</li>
<li>Coeptis Therapeutics Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COEP#NASDAQ">COEP</a>) gained 19.2% to $0.22 in pre-market trading after gaining around 4% on Wednesday.</li>
<li>SRM Entertainment, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRM#NASDAQ">SRM</a>) rose 15.8% to $0.8599 in pre-market trading after falling 6% on Wednesday.</li>
<li>Rezolve AI Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RZLV#NASDAQ">RZLV</a>) gained 12.5% to $2.24 in pre-market trading after gaining over 3% on Wednesday.</li>
<li>Charles &amp; Colvard, Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CTHR#NASDAQ">CTHR</a>) climbed 12% to $1.78 in pre-market trading after the company announced it received an interim award in Wolfspeed arbitration which led to reduced damages.</li>
<li>Absci Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABSI#NASDAQ">ABSI</a>) gained 10.5% to $4.84 in pre-market trading following a 9% gain on Wednesday.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>Avinger, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVGR#NASDAQ">AVGR</a>) shares tumbled 50% to $0.4200 in pre-market trading.</li>
<li>Sacks Parente Golf, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SPGC#NASDAQ">SPGC</a>) declined 43.3% to $0.7938 in pre-market trading after declining 7% on Wednesday.</li>
<li>BriaCell Therapeutics Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCTX#NASDAQ">BCTX</a>) shares fell 33.4% to $0.7310 in pre-market trading after the company announced the pricing of $5.5 million public offering.</li>
<li>Samfine Creation Holdings Group Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SFHG#NASDAQ">SFHG</a>) fell 20.8% to $2.42 in pre-market trading after dipping 85% on Wednesday.</li>
<li>Primis Financial Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FRST#NASDAQ">FRST</a>) dipped 20.1% to $10.01 in pre-market trading.</li>
<li>TFF Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TFFP#NASDAQ">TFFP</a>) shares fell 15.2% to $0.1379 in pre-market trading after dipping 46% on Wednesday.</li>
<li>NewGenIvf Group Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NIVF#NASDAQ">NIVF</a>) fell 14% to $0.3103 in pre-market trading. The company recently announced it entered a binding term sheet regarding the proposed reverse merger with Wellness Investment.</li>
<li>New Era Helium, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NEHC#NASDAQ">NEHC</a>) shares dipped 13.5% to $4.50 in pre-market trading after declining 9% on Wednesday.</li>
<li>Contineum Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CTNM#NASDAQ">CTNM</a>) fell 12.3% to $12.50 in pre-market trading.</li>
<li>Adobe Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADBE#NASDAQ">ADBE</a>) fell 10% to $495.00 in today's pre-market trading. Adobe posted better-than-expected earnings and sales results for its fourth quarter. The company said it expects first-quarter revenue to be in the range of $5.63 billion to $5.68 billion versus estimates of $5.73 billion. The company anticipates first-quarter adjusted earnings of $4.95 to $5 per share versus estimates of $4.95 per share.</li>
</ul>
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Why DBV Technologies Shares Are Trading Higher By Around 37%; Here Are 20 Stocks Moving Premarket

DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin&#xAE; Peanut Patch in Toddlers 1 – 3 Years-Old
<ul>
<li>DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis</li>
<li>COMFORT Toddlers study on-track to initiate in 2Q 2025</li>
<li>Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026</li>
<li>FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-old</li>
<li>Company to host investor webcast today at 5:00pm ET &nbsp;</li>
</ul>
DBV Technologies (TRQX:<a href="https://www.benzinga.com/stock/DBVp#TRQX">DBVp</a>), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U.S. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study.

DBV Confirms Alignment With U.S. FDA On Accelerated Approval Pathway For The Viaskin Peanut Patch In Toddlers 1–3 Years-Old; Company To Host Investor Webcast Today At 5:00pm ET

Trading Halt: Halt status updated at 8:55:00 AM ET: Quotation Resumption: News and Resumption Times

Trading Halt: Halted at 7:50:00 p.m. ET - Trading Halt: Halt News Pending

Stock Split

DBV Technologies Plans To Change Ratio From 1 ADS to 1 Ordinary Share To 1 ADS To 5 Ordinary Shares

DBV Technologies shares are trading higher after HC Wainwright & Co. maintained a Buy rating on the stock and raised its price target from $5 to $7.

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li>Baird raised ServiceNow, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NOW#NYSE">NOW</a>) price target from $900 to $975. Baird analyst Rob Oliver maintained an Outperform rating. ServiceNow shares closed at $907.68 on Wednesday. <a href="https://www.benzinga.com/quote/NOW/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Keybanc raised the price target for Rocket Lab USA, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RKLB#NASDAQ">RKLB</a>) from $11 to $12. Keybanc analyst Michael Leshock maintained an Overweight rating. Rocket Lab shares closed at $10.91 on Wednesday. <a href="https://www.benzinga.com/quote/RKLB/analyst-ratings">See how other analysts view this stock.</a></li>
<li>Piper Sandler cut the price target for Synopsys, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNPS#NASDAQ">SNPS</a>) from $687 to $670. Piper Sandler analyst Clarke Jeffries maintained an Overweight rating. Synopsys shares closed at $493.41 on Wednesday. <a href="https://www.benzinga.com/quote/SNPS/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>HC Wainwright &amp; Co. raised DBV Technologies S.A. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DBVT#NASDAQ">DBVT</a>) price target from $5 to $7. HC Wainwright &amp; Co. analyst Andrew Fein maintained a Buy rating. DBV Technologies shares settled at $0.6801 on Wednesday. <a href="https://www.benzinga.com/quote/DBVT/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Needham boosted Teledyne Technologies Incorporated (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TDY#NYSE">TDY</a>) price target from $482 to $528. Needham analyst James Ricchiuti maintained a Buy rating. Teledyne Technologies shares closed at $470.09 on Wednesday. <a href="https://www.benzinga.com/quote/TDY/analyst-ratings">See how other analysts view this stock.</a></li>
<li>JP Morgan cut NextEra Energy Partners, LP (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NEP#NYSE">NEP</a>) price target from $25 to $22. JP Morgan analyst Mark Strouse upgraded the stock from Underweight to Neutral. NextEra Energy shares closed at $21.01 on Wednesday. <a href="https://www.benzinga.com/quote/MSFT/analyst-ratings">See </a><a href="https://www.benzinga.com/quote/NEP/analyst-ratings">how </a><a href="https://www.benzinga.com/quote/MSFT/analyst-ratings">other analysts view this stock</a>.</li>
<li>BMO Capital cut the price target for CoStar Group, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CSGP#NASDAQ">CSGP</a>) from $78 to $75. BMO Capital analyst Jeffrey Silber maintained a Market Perform rating. CoStar shares settled at $72.82 on Wednesday. <a href="https://www.benzinga.com/quote/CSGP/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>B of A Securities raised Amphenol Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/APH#NYSE">APH</a>) price target from $70 to $74. B of A Securities analyst Wamsi Mohan maintained a Neutral rating. Amphenol shares closed at $68.47 on Wednesday. <a href="https://www.benzinga.com/quote/APH/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>B of A Securities raised the price target for Tesla, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) from $255 to $265. B of A Securities analyst John Murphy maintained a Buy rating. Tesla shares closed at $213.65 on Wednesday. <a href="https://www.benzinga.com/quote/TSLA/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Stephens &amp; Co. boosted East West Bancorp, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EWBC#NASDAQ">EWBC</a>) price target from $91 to $104. Stephens &amp; Co. analyst Andrew Terrell maintained an Overweight rating. East West Bancorp shares closed at $95.63 on Wednesday. <a href="https://www.benzinga.com/quote/EWBC/analyst-ratings">See how other analysts view this stock</a>.</li>
</ul>
Read More:
<ul>
<li> <a href="https://www.benzinga.com/trading-ideas/long-ideas/24/10/41512422/top-3-tech-stocks-youll-regret-missing-in-q4">Top 3 Tech Stocks You&#8217;ll Regret Missing In Q4</a></li>
</ul>

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Tesla To Rally More Than 24%? Here Are 10 Top Analyst Forecasts For Thursday

<h3>Gainers</h3>
<ul>
<li>Tevogen Bio Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TVGN#NASDAQ">TVGN</a>) shares increased by 27.4% to $3.16 during Thursday's pre-market session. The company's market cap stands at $539.2 million. </li>
<li>CNS Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNSP#NASDAQ">CNSP</a>) shares moved upwards by 24.11% to $0.17. The market value of their outstanding shares is at $5.6 million. </li>
<li>DBV Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DBVT#NASDAQ">DBVT</a>) stock rose 21.51% to $0.83. The market value of their outstanding shares is at $79.4 million. </li>
<li>MediciNova (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNOV#NASDAQ">MNOV</a>) stock moved upwards by 19.65% to $2.07. The company's market cap stands at $101.5 million. </li>
<li>Qualigen Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QLGN#NASDAQ">QLGN</a>) shares increased by 17.24% to $0.2. The market value of their outstanding shares is at $5.5 million. </li>
<li>BioVie (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIVI#NASDAQ">BIVI</a>) stock rose 14.78% to $2.95. The company's market cap stands at $23.5 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Conduit Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDT#NASDAQ">CDT</a>) shares declined by 16.8% to $0.11 during Thursday's pre-market session. The market value of their outstanding shares is at $10.8 million. </li>
<li>Genprex (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GNPX#NASDAQ">GNPX</a>) stock decreased by 13.59% to $2.29. The company's market cap stands at $5.9 million. </li>
<li>Ensysce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ENSC#NASDAQ">ENSC</a>) stock declined by 13.56% to $0.35. The market value of their outstanding shares is at $4.8 million. </li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>) stock declined by 12.27% to $0.93. The company's market cap stands at $1.8 million. </li>
<li>ENDRA Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NDRA#NASDAQ">NDRA</a>) shares declined by 12.13% to $0.29. The market value of their outstanding shares is at $5.2 million. </li>
<li>Anitra (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/AZTR#AMEX">AZTR</a>) stock decreased by 9.18% to $0.52. The company's market cap stands at $3.9 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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Qualigen Therapeutics, Inc. - Common Stock

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12 Health Care Stocks Moving In Thursday's Pre-Market Session

<h3>Gainers</h3>
<ul>
<li>Tevogen Bio Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TVGN#NASDAQ">TVGN</a>) stock rose 28.6% to $3.19 during Thursday's pre-market session. The company's market cap stands at $544.3 million. </li>
<li>CNS Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNSP#NASDAQ">CNSP</a>) shares moved upwards by 24.04% to $0.17. The company's market cap stands at $5.6 million. </li>
<li>DBV Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DBVT#NASDAQ">DBVT</a>) stock rose 22.17% to $0.83. The company's market cap stands at $79.9 million. </li>
<li>MediciNova (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNOV#NASDAQ">MNOV</a>) shares moved upwards by 19.65% to $2.07. The company's market cap stands at $101.5 million. </li>
<li>Qualigen Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QLGN#NASDAQ">QLGN</a>) stock rose 14.82% to $0.2. The company's market cap stands at $5.3 million. </li>
<li>BioVie (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIVI#NASDAQ">BIVI</a>) stock moved upwards by 14.78% to $2.95. The market value of their outstanding shares is at $23.5 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Conduit Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDT#NASDAQ">CDT</a>) shares declined by 16.9% to $0.11 during Thursday's pre-market session. The company's market cap stands at $10.8 million. </li>
<li>Genprex (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GNPX#NASDAQ">GNPX</a>) shares decreased by 13.97% to $2.28. The market value of their outstanding shares is at $5.9 million. </li>
<li>Ensysce Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ENSC#NASDAQ">ENSC</a>) stock fell 13.24% to $0.35. The market value of their outstanding shares is at $4.8 million. </li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>) stock declined by 12.27% to $0.93. The market value of their outstanding shares is at $1.8 million. </li>
<li>ENDRA Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NDRA#NASDAQ">NDRA</a>) shares decreased by 12.13% to $0.29. The market value of their outstanding shares is at $5.2 million. </li>
<li>Anitra (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/AZTR#AMEX">AZTR</a>) stock decreased by 9.18% to $0.52. The company's market cap stands at $3.9 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Shares of Tesla, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) rose sharply in today's pre-market trading after the company reported stronger-than-expected <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/10/41509528/tesla-bull-gary-black-praises-ev-giants-clean-beat-in-q3-as-auto-margins-blow-past-">earnings for its third quarter</a>.
The automaker reported third-quarter earnings per share of 72 cents, beating a Street consensus estimate of 58 cents per share.
Tesla shares jumped 10.8% to $236.82 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>CCSC Technology International Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CCTG#NASDAQ">CCTG</a>) rose 122% to $3.8800 in pre-market trading after gaining around 4% on Wednesday.</li>
<li>Mobile-health Network Solutions (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNDR#NASDAQ">MNDR</a>) gained 46.1% to $0.7449 in pre-market trading as the company posted FY24 results.</li>
<li>Qualigen Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QLGN#NASDAQ">QLGN</a>) shares rose 37.4% to $0.2390 in pre-market trading.</li>
<li>CNS Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNSP#NASDAQ">CNSP</a>) shares surged 36.2% to $0.1920 in pre-market trading after declining around 10% on Wednesday. CNS Pharmaceuticals announced the pricing of $3 million registered direct offering of common stock priced at-the-market under Nasdaq rules.</li>
<li>Twin Vee Powercats Co. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VEEE#NASDAQ">VEEE</a>) rose 35.9% to $0.5874 in pre-market trading after gaining 16% on Wednesday.</li>
<li>DBV Technologies S.A. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DBVT#NASDAQ">DBVT</a>) shares jumped 21% to $0.8226 in pre-market trading. HC Wainwright &amp; Co. analyst Andrew Fein maintained DBV Technologies with a Buy rating and raised the price target from $5 to $7.</li>
<li>Seadrill Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SDRL#NYSE">SDRL</a>) shares rose 13.1% to $39.78 in pre-market trading. Seadrill will report its third quarter results on Tuesday, Nov. 12 after the closing bell.</li>
<li>Inhibikase Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IKT#NASDAQ">IKT</a>) climbed 11.1% to $2.70 in pre-market trading after jumping 15% on Wednesday.</li>
<li>Garrett Motion Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GTX#NASDAQ">GTX</a>) gained 8.3% to $8.65 in pre-market trading.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>SaverOne 2014 Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SVRE#NASDAQ">SVRE</a>) shares dipped 25.9% to $0.1079 in pre-market trading after surging 12% on Wednesday.</li>
<li>Gold Resource Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GORO#NYSE">GORO</a>) shares fell 25.8% to $0.3670 in pre-market trading after the company reported preliminary third-quarter and year-to-date results.</li>
<li>Osisko Development Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ODV#NYSE">ODV</a>) fell 18.6% to $2.05 in today's pre-market trading. Osisko Development announced a $50 million marketed private placement of 27,778,000 unit at $1.80/unit.</li>
<li>Zapata Computing Holdings Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZPTA#NASDAQ">ZPTA</a>) fell 17.2% to $0.0750 in pre-market trading after jumping 43% on Wednesday.</li>
<li>KWESST Micro Systems Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KWE#NASDAQ">KWE</a>) fell 16.3% to $2.09 in pre-market trading after jumping 112% on Wednesday.</li>
<li>Orangekloud Technology Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ORKT#NASDAQ">ORKT</a>) shares fell 15.1% to $6.46 in pre-market trading.</li>
<li>ICON Public Limited Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ICLR#NASDAQ">ICLR</a>) declined 16.3% to $235.13 in pre-market trading following worse-than-expected third-quarter financial results.</li>
<li>La Rosa Holdings Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LRHC#NASDAQ">LRHC</a>) shares declined 15.9% to $0.9501 in pre-market trading after gaining over 130% on Wednesday. La Rosa Holdings reported preliminary 9-month revenue growth of 120% year over year.</li>
<li>Carrier Global Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CARR#NYSE">CARR</a>) shares declined 9.9% to $72.00 in pre-market trading following worse-than-expected third-quarter revenues.</li>
<li>International Business Machines Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IBM#NYSE">IBM</a>) shares fell 5% to $221.28 following a third-quarter revenue miss.</li>
</ul>
Now Read This: 
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<li><a href="https://www.benzinga.com/news/earnings/24/10/41508985/dow-records-worst-session-in-over-a-month-apple-nvidia-drag-nasdaq-down-fear-index-remains-in-greed">Dow Records Worst Session In Over A Month, Apple, Nvidia Drag Nasdaq Down: Fear Index Remains In &#8216;Greed&#8217; Zone</a></li>
</ul>

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Why Tesla Shares Are Trading Higher By Around 11%; Here Are 20 Stocks Moving Premarket

There's a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on DBV Technologies SA – American (DBVT – Research Repo...

Wall Street Analysts Are Bullish on Top Healthcare Picks

DBV Technologies (DBVT) announced the successful outcome of recent written and oral communication with the FDA that provides a regulatory pathway f...

DBV Technologies announces FDA alignment on Viaskin Peanut patch program pathway

16:14 EST DBV jumps 52% to $4.99 after aligning with FDA on approval pathway Published first on TheFly – the ultimate source for real-time, market-...

DBV jumps 52% to $4.99 after aligning with FDA on approval pathway

DBV Technologies SA – American ( ($DBVT) ) has issued an announcement. DBV Technologies has announced an alignment with the U.S. FDA on an accelera...

DBV Technologies Aligns with FDA for Viaskin Peanut Approval

DBV stock rallies post-market on FDA Viaskin update

The latest announcement is out from DBV Technologies SA – American ( ($DBVT) ). DBV Technologies Inc., a subsidiary of DBV Technologies S.A., has a...

DBV Technologies Amends Executive Severance Agreements

DBV Technologies (DBVT) announced twenty-four month results from its Open-Label Extension Study of EPITOPE. The data provide support that continued...

DBV Technologies announces three-year results from EPITOPE trial

DBV Technologies SA – American ( ($DBVT) ) has shared an update. DBV Technologies announced positive results from the EPITOPE Phase 3 Open-Label Ex...

DBV Technologies Reports Positive Phase 3 Study Results

Analyst Jonathan Wolleben from JMP Securities reiterated a Buy rating on DBV Technologies SA – American (DBVT – Research Report) and keeping the pr...

Positive Outlook on Viaskin Peanut Treatment Drives Buy Rating for DBV Technologies

Kepler Capital analyst Justine Telliez maintained a Buy rating on DBV Technologies (0QAJ – Research Report) on January 9 and set a price target of ...

Kepler Capital  Sticks to Their Buy Rating for DBV Technologies (0QAJ)

AORT

Press Releases

DBV Technologies to Participate in Upcoming ACAAI 2024 Congress

DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe

French Biotech Stock Soars On Regulatory Updates

Healthcare and Biotech Stocks to Watch: MODD, CRDL, DBVT, VRAX

DBV Technologies Reports Third Quarter 2024 Financial Results

DBV Technologies Announces Plan to Implement ADS Ratio Change

Information regarding the total number of voting rights and   total number of shares of the Company as of November 30, 2024

DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old

DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study

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