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Benchmark analyst Mark Palmer reiterates Dave (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DAVE#NASDAQ">DAVE</a>) with a Buy and maintains $53 price target.

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DAVE

Benchmark Reiterates Buy on Dave, Maintains $53 Price Target

Earlyworks Co., Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ELWS#NASDAQ">ELWS</a>) ("Earlyworks" or the "Company"), a blockchain solution provider headquartered in Taito-ku, Tokyo which develops its proprietary blockchain technology, Grid Ledger System ("GLS"), has signed a business alliance agreement with CAICA DIGITAL Inc. ("CAICA"), a company headquartered in Minato-ku, Tokyo which develops system solutions for the financial industry and Web3 businesses. Together, the Company and CAICA will provide comprehensive support to businesses engaged in Web3 projects.

ELWS

Earlyworks And CAICA DIGITAL Enter Into Business Alliance Agreement To Support The Expansion Of Web3 Businesses

Nike Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NKE#NYSE">NKE</a>) shares are trading higher by 1.2% to $81.75 Thursday morning after the Federal Reserve cut interest rates by <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40938732/wall-street-ramps-up-interest-rate-cut-bets-after-fed-meeting-the-hard-landing-crow">50 basis points</a>.
Why This Matters: Rate cuts are typically designed to stimulate consumer spending by making credit more affordable, which can boost discretionary spending on items like apparel and footwear. 
Nike's products are consumer discretionary goods, meaning that when consumers have more disposable income (or easier access to credit), they may be more inclined to purchase non-essential items like Nike shoes and sports gear.
With interest rate cuts, Nike as a company also faces lower borrowing costs, improving its overall cost structure. This reduction in financial expenses could increase profitability, making the stock more attractive to investors.
Read Also: <a href="https://www.benzinga.com/news/large-cap/24/09/40938804/gamestop-ceo-ryan-cohen-penalized-nearly-1m-over-wells-fargo-share-acquisition">GameStop CEO Ryan Cohen Penalized Nearly $1M Over Wells Fargo Share Acquisition</a>
What Else: Nike operates in many markets around the world. A more aggressive stance from the Federal Reserve on rate cuts suggests a more supportive macroeconomic environment, which could spur growth not only in the U.S. but also in global markets. 
If central banks worldwide follow a similar easing path, the global consumer base for Nike may increase spending, particularly in emerging markets where credit is becoming more accessible.<a href="https://www.benzinga.com/quote/hood" target="_blank" rel="noreferrer noopener"></a>
Read Also: <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40938732/wall-street-ramps-up-interest-rate-cut-bets-after-fed-meeting-the-hard-landing-crow">Wall Street Ramps Up Interest Rate Cut Bets After Fed Meeting: &#8216;The Hard-Landing Crowd Should Disperse,&#8217; Economist Says</a>
<h2 class="wp-block-heading">Is NKE A Good Stock To Buy?</h2>
When deciding whether to buy a stock, there are some key fundamentals investors may want to consider. One of these factors is revenue growth. Buying a stock is essentially a bet that the business will continue to grow and generate profits in the future.
Nike (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NKE#NYSE">NKE</a>) has reported average annual revenue growth of 8.47% over the past 5 years. .
It's also important to pay attention to valuation when deciding whether to buy a stock. Nike has a forward P/E ratio of 26.18. This means investors are paying $26.18 for each dollar of expected earnings in the future. The average forward P/E ratio of Nike's peers is 17.58.
Other important metrics to look at include a company's profitability, balance sheet, performance relative to a benchmark index and valuation compared to peers. For in-depth analysis tools and important financial data, check out <a href="https://pro.benzinga.com">Benzinga PRO</a>.
NKE has a 52-week high of $123.39 and a 52-week low of $70.75.

What's Going On With Nike Stock?

BMO Capital analyst Tristan Thomas-Martin maintains Thor Industries (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/THO#NYSE">THO</a>) with a Outperform and maintains $120 price target.

BMO Capital Maintains Outperform on Thor Industries, Maintains $120 Price Target

Trading Ideas

GLXG

Galaxy Payroll Group Shares Resume Trade

BMO Capital analyst Keith Bachman maintains HubSpot (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HUBS#NYSE">HUBS</a>) with a Outperform and maintains $570 price target.

HUBS

BMO Capital Maintains Outperform on HubSpot, Maintains $570 Price Target

Toronto-Dominion Bank Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TD#NYSE">TD</a>) shares are seeing positive movement Thursday. Here&#8217;s <a href="https://www.benzinga.com/news/24/09/40937551/td-bank-group-president-and-ceo-bharat-masrani-to-retire-april-10-2025-board-names-raymond-chun-as-s">what you need to know.</a>
What To Know: The bank revealed that Bharat Masrani, who has served as CEO for over a decade and spent 38 years at the institution, will retire on April 10 2025. Masrani&#8217;s tenure saw significant milestones but also faced challenges, particularly toward the end of his leadership, as TD dealt with an unraveling $13.4 billion acquisition of First Horizon Corp and investigations into lapses in money-laundering controls at U.S. branches.
In response to these developments, TD Bank Group&#8217;s Board of Directors has named Raymond Chun, currently Group Head of Canadian Personal Banking, as the successor. Chun will step into the role of Chief Operating Officer on November 1 2024, with responsibility for all business lines, before officially taking over as CEO on April 10 2025. This move is part of TD's ongoing efforts to strengthen its leadership and reassure stakeholders during a challenging period for the bank.
What Else: The leadership transition is taking place while the bank grapples with investigations by the U.S. Department of Justice and financial regulators over its handling of money-laundering controls in its American branches—a division that Masrani had previously overseen. The fallout from these issues has led to the departure of several top executives in the bank&#8217;s legal and compliance departments, contributing to uncertainty about the company's direction.
Price Action: TD shares were trading higher by 2.27% at $64.01 according to <a href="https://pro.benzinga.com/dashboard">Benzinga Pro.</a>
<figure class="wp-block-image size-large is-resized"><a href="https://benzinga.slack.com/archives/D072651PB4K/p1722883001180099"><img loading="lazy" decoding="async" width="1024" height="553" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100258/TD-1024x553.png" alt="" class="wp-image-556379" style="width:509px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100258/TD-1024x553.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100258/TD-300x162.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100258/TD-768x415.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100258/TD.png 1072w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></figure>
See Also:
<ul>
<li><a href="https://www.benzinga.com/real-estate/24/09/40939943/elon-musk-mark-zuckerberg-and-jay-z-take-out-mortgages-despite-their-billion-dollar-fortunes-heres-w">Elon Musk, Mark Zuckerberg And Jay-Z Take Out Mortgages Despite Their Billion-Dollar Fortunes – Here&#8217;s Why The Ultra-Wealthy Borrow</a></li>
</ul>
Image via Shutterstock.

Stock Split

Movers

What's Going On With Toronto-Dominion Bank Today?

BMO Capital analyst Brian Pitz maintains Amazon.com (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMZN#NASDAQ">AMZN</a>) with a Outperform and maintains $230 price target.

AMZN

BMO Capital Maintains Outperform on Amazon.com, Maintains $230 Price Target

Cantor Fitzgerald analyst Louise Chen reiterates Roivant Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ROIV#NASDAQ">ROIV</a>) with a Overweight.

ROIV

Cantor Fitzgerald Reiterates Overweight on Roivant Sciences

Galaxy Payroll Group Shares Halted On Circuit Breaker To The Downside, Stock Now Down -36.8%

Galmed Pharmaceuticals Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GLMD#NASDAQ">GLMD</a>) shares are surging Thursday after the company&nbsp;announced plans to broaden its drug development activities <a href="https://www.benzinga.com/pressreleases/24/09/n40935244/galmed-announces-an-expansion-of-its-activities-to-cancer-and-major-cardiometabolic-diseases">over the next two years</a>.
What Happened: Galmed announced that it plans to expand its drug development activities by adding two additional programs.
One program aims to identify novel Aramchol-based drug combinations to overcome resistance to standard-of-care oncological treatments for patients with advanced colorectal and hepatic cancers. The other program is expected to help discover new methods to allow the development of a novel Aramchol-based drug combination targeting cardiac fibrosis.
The clinical-stage biopharmaceutical company said it&nbsp;plans to release new data from in-vitro and ex-vivo studies on the aforementioned programs during the&nbsp;fourth quarter.
&#8220;The conditions Galmed plans to focus upon in the coming years are major public health problems impacting millions of people worldwide and posing huge financial burden on health providers,&#8221; said Allen Baharaff, president and CEO of Galmed Pharmaceuticals.
&#8220;SCD1 is a key enzyme that critically regulates many physiological processes, thereby promoting the progression of cardiovascular, cancer and neurodegenerative diseases. We are leveraging on two decades of development of the most clinically advanced SCD1 inhibitor (Aramchol) to date as we broaden our drug development activities.&#8221;
Check This Out: <a href="https://www.benzinga.com/trading-ideas/long-ideas/24/09/40939795/1-8m-bet-on-singular-genomics-check-out-these-3-stocks-executives-are-buying">$1.8M Bet On Singular Genomics? Check Out These 3 Stocks Executives Are Buying</a>
Galmed Pharmaceuticals is a very low-float stock with approximately 625,000 shares available for public trading, per&nbsp;<a href="http://pro.benzinga.com/" target="_blank" rel="noreferrer noopener">Benzinga Pro</a>.&nbsp;The company also had a market cap of less than $4.5 million as of Wednesday's close.&nbsp;Low-float, micro-cap stocks can be extremely volatile, which may help explain some of Thursday's surge.
Galmed&#8217;s average session volume over a 100-day period is approximately 1.711 million. Thursday&#8217;s trading volume has already crossed 16 million at the time of writing, according to <a href="http://pro.benzinga.com">Benzinga Pro</a>.
GLMD Price Action: <a href="http://benzinga.com/quote/glmd">Galmed shares</a> were up 53.6% at $10.60 at the time of publication, according to <a href="http://pro.benzinga.com">Benzinga Pro</a>.
Photo: 3844328 from Pixabay.

GLMD

Galmed Pharmaceuticals Stock Is Soaring Thursday: Here's Why

Cantor Fitzgerald analyst Louise Chen reiterates Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) with a Overweight and maintains $215 price target.

Cantor Fitzgerald Reiterates Overweight on Johnson & Johnson, Maintains $215 Price Target

Vivos Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VVOS#NASDAQ">VVOS</a>) shares are trading lower by 26.1% to $3.05 during Thursday&#8217;s session after the company announced a $4.3 million registered offering of 1.36 million shares of common stock at <a href="https://www.benzinga.com/pressreleases/24/09/g40935188/vivos-therapeutics-announces-pricing-of-4-3-million-registered-direct-offering-of-common-stock-pri">$3.15 per share</a>.
The direct offering is expected to close on September 20, pending standard closing conditions, and will generate approximately $4.3 million in gross proceeds. H.C. Wainwright &amp; Co. is the exclusive placement agent for the offering. 
Vivos says the company plans to use the net proceeds for working capital and general corporate purposes. Additionally, no stock purchase warrants are included in the offering.
Read Also: <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40937291/bank-stocks-hit-inflection-point-after-feds-50-basis-point-cut-analyst-reveal-top-p">Bank Stocks Hit Inflection Point After Fed&#8217;s 50 Basis Point Cut, Analyst Reveals Top Picks</a>
<h2 class="wp-block-heading">Is VVOS A Good Stock To Buy?</h2>
An investor can make a few decisions when deciding whether a stock is a good buy. In addition to valuation metrics and price action which you can find on Benzinga's quote pages &#8211; like <a href="https://www.benzinga.com/quote/VVOS">Vivos Therapeutics</a>&#8216;s page for example &#8211; there are factors like whether or not a company pays a dividend or buys a large portion of its stock each quarter.
These are known as capital allocation programs. Vivos Therapeutics does not pay a dividend, but obviously has a few ways it can return value to shareholders. Feel free to search Benzinga's <a href="https://www.benzinga.com/calendars/dividends">dividend calendar</a> for the next company that is due to pay a dividend and determine what kind of yield you can earn for holding a share of the company.
For example, if you're looking to earn an annualized return of 23.1%, you'll need to buy a share of North American Finl 15 by the Sep. 30, 2024. Once done, you can expect to receive a nominal payout of $0.11 on Oct. 10, 2024.
Buyback programs are obviously different and highly variable. A company can approve a buyback program and purchase shares as it sees fit over the course of time in which the buyback was authorized. Looking through the latest news on <a href="https://www.benzinga.com/quote/VVOS">Vivos Therapeutics</a> will often yield whether or not the company has approved a buyback program recently. Buyback programs usually serve as a support for share prices, serving as a backstop for demand.
According to data from&nbsp;<a href="https://benzinga.grsm.io/register174">Benzinga Pro</a>, VVOS has a 52-week high of $48.79 and a 52-week low of $1.91.

VVOS

Why Vivos Therapeutics (VVOS) Stock Is Down 25% Today

BMO Capital analyst John McNulty reiterates Avery Dennison (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AVY#NYSE">AVY</a>) with a Outperform and lowers the price target from $254 to $252.

BMO Capital Reiterates Outperform on Avery Dennison, Lowers Price Target to $252

BMO Capital analyst Tim Casey maintains Rogers Communications (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RCI#NYSE">RCI</a>) with a Outperform and raises the price target from $67 to $70.

BMO Capital Maintains Outperform on Rogers Communications, Raises Price Target to $70

Mobileye Global Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MBLY#NASDAQ">MBLY</a>) stock was trading higher Thursday after Intel Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INTC#NASDAQ">INTC</a>) said it does not plan to divest its majority interest <a href="https://www.intc.com/news-events/press-releases/detail/1711/statement-regarding-mobileye" target="_blank" rel="noreferrer noopener">in the company</a>. U.S. Fed rate cut also had a bearing on the <a href="http://U.S. Federal Reserve" target="_blank" rel="noreferrer noopener">stock price movement</a>.
Intel made the statement after winning a multi-year, multi-billion-dollar U.S. chipmaking deal from existing customer Amazon.com Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMZN#NASDAQ">AMZN</a>) cloud unit and <a href="https://www.benzinga.com/news/24/09/40897994/whats-going-on-with-intel-stock-on-tuesday" target="_blank" rel="noreferrer noopener">U.S. semiconductor grant</a>.
Intel also won up to&nbsp;$3 billion in CHIPS and Science Act funding, in addition to the $8.5 billion in grants and $11 billion in loans the struggling chipmaker previously won under the act.
Also Read: <a href="https://www.benzinga.com/news/24/09/40888884/intel-missed-out-on-playstation-6-chip-deal-to-amd-report" target="_blank" rel="noreferrer noopener">Intel Missed Out on PlayStation 6 Chip Deal to AMD: Report</a>
<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="750" height="650" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19084609/newplot-15.png" alt="" class="wp-image-556163" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19084609/newplot-15.png 750w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19084609/newplot-15-300x260.png 300w" sizes="(max-width: 750px) 100vw, 750px" /></figure>
Intel stock is down 43% in the last 12 months as its foundry unit failed to capitalize on the AI shift.
Prior reports indicated Intel&#8217;s plans to divest up to 88% of its stake in the <a href="https://www.benzinga.com/m-a/24/09/40747080/intel-eyes-mobileye-stake-sale-amid-pressure-stock-slides" target="_blank" rel="noreferrer noopener">Israeli autonomous driving company</a>.
Mobileye Global stock is down 70% in the last 12 months as it slashed revenue guidance after posting a topline decline in the second quarter. The company also flagged impending challenges due to China's weak demand. 
It expects fiscal 2024 revenue of $1.60 billion–$1.68 billion below the $1.87 billion analyst estimate.
Price Action: MBLY stock is up 14.4% at $13.28 at last check Thursday.
Also Read:
<ul>
<li><a href="https://www.benzinga.com/m-a/24/09/40926078/nvidia-considers-165m-octoai-acquisition-aims-to-strengthen-ai-and-cloud-dominance" target="_blank" rel="noreferrer noopener">Nvidia Considers $165M OctoAI Acquisition, Aims to Strengthen AI and Cloud Dominance</a></li>
</ul>
Photo courtesy of Mobileye.

Asset Sales

Tech

INTC

MBLY

What's Going On With Autonomous Driving Stock Mobileye Thursday?

Bulls are stampeding across Wall Street on Thursday in the wake of the Federal Reserve&#8217;s decision to cut interest rates for the first time<a href="https://www.benzinga.com/economics/macro-economic-events/24/09/40926026/federal-reserve-delivers-bold-0-5-rate-cut-signals-further-easing-ahead"> in over four years</a>.
The central bank&#8217;s bold move, a 50-basis-point cut, caught analysts off guard and sent the U.S. stock market to fresh record highs at the opening of Thursday&#8217;s session.
The S&amp;P 500 soared to a new all-time high, reaching 5,700 points. Similarly, the Dow Jones Industrial Average climbed to an unprecedented 42,000 points.
In the first 30 minutes of trading, the S&amp;P 500 and Dow Jones rose by 1.4% and 1%, respectively. The Nasdaq 100 climbed 1.5%, although the Russell 2000, representing small-cap stocks, outperformed with a surge of over 2%.
The market rally was primarily driven by the Magnificent Seven: Microsoft Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MSFT#NYSE">MSFT</a>), Apple Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AAPL#NASDAQ">AAPL</a>), NVIDIA Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>), Alphabet Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOG#NASDAQ">GOOG</a>) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOGL#NASDAQ">GOOGL</a>), Amazon Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMZN#NASDAQ">AMZN</a>), Meta Platforms Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/META#NASDAQ">META</a>) and Tesla, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>). Each of the Magnificent Seven are recording daily gains ranging from 1.5% to 4.5%, solidly in positive territory.
<h3 class="wp-block-heading">Chart: S&amp;P 500 Hits Record Highs</h3>
<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="447" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100943/image-155-1024x447.png" alt="" class="wp-image-556397" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100943/image-155-1024x447.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100943/image-155-300x131.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100943/image-155-768x336.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100943/image-155-1536x671.png 1536w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/19100943/image-155.png 1920w" sizes="(max-width: 1024px) 100vw, 1024px" /><figcaption class="wp-element-caption">Image: <a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent091924&amp;t=be2bearmibe3na1">Benzinga Pro</a></figcaption></figure>
<h3 class="wp-block-heading">Strong Labor Market Eases Slowdown Fears, Analysts Boost Rate-Cut Wagers</h3>
Thursday&#8217;s economic data further boosted investor confidence. Weekly jobless claims came in well below expectations, suggesting a lower-than-expected trend of rising unemployment. 
Continuing jobless claims also dropped more than expected, hinting at a potential absorption of long-term unemployed individuals into the job market. 
This data alleviated concerns about rising unemployment and provided a more optimistic outlook for the economy.
Wall Street analysts quickly adjusted their expectations following the Federal Reserve&#8217;s rate cut. There is now growing anticipation of additional rate cuts, diverging from the cautious tone expressed in the Fed&#8217;s September &#8220;dot plot&#8221; and Chair Jerome Powell&#8216;s remarks during the press conference.
Notably, Goldman Sachs economist Jan Hatzius revised his forecast from expecting a 25-basis-point cut at every other meeting to predicting a rate cut at every meeting. He even left the door open for a back-to-back 50-basis-point reduction in November.
<h3 class="wp-block-heading">Thursday&#8217;s 5 Top-Performing S&amp;P 500 Stocks</h3>
Among the S&amp;P 500, the top five performers as of 10 a.m. ET were:
<figure class="wp-block-table is-style-stripes"> 
<table>
<tbody>
<tr>
<td>Name</td>
<td>1-day Return</td>
</tr>
<tr>
<td>Darden Restaurants, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DRI#NASDAQ">DRI</a>) </td>
<td>7.46</td>
</tr>
<tr>
<td>Airbnb, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABNB#NASDAQ">ABNB</a>)</td>
<td>5.27</td>
</tr>
<tr>
<td>Cadence Design Systems, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDNS#NASDAQ">CDNS</a>)</td>
<td>4.40</td>
</tr>
<tr>
<td>Lam Research Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LCRX#NASDAQ">LCRX</a>)</td>
<td>4.34</td>
</tr>
<tr>
<td>NVIDIA Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>)</td>
<td>4.33</td>
</tr>
</tbody>
</table>
</figure>
<h3 class="wp-block-heading">Thursday&#8217;s 5 Top-Performing Dow Jones Industrial Average Stocks</h3>
Among the Dow Jone, the top five performers were:
<figure class="wp-block-table is-style-stripes"> 
<table>
<tbody>
<tr>
<td>Name</td>
<td>1-day Return</td>
</tr>
<tr>
<td>Apple Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AAPL#NASDAQ">AAPL</a>)</td>
<td>3.02</td>
</tr>
<tr>
<td>Salesforce, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRM#NASDAQ">CRM</a>)</td>
<td>3.01</td>
</tr>
<tr>
<td>The Goldman Sachs Group, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GS#NYSE">GS</a>)</td>
<td>2.80</td>
</tr>
<tr>
<td>Caterpillar Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CAT#NYSE">CAT</a>)</td>
<td>2.71</td>
</tr>
<tr>
<td>American Express Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AXP#NYSE">AXP</a>)</td>
<td>2.67</td>
</tr>
</tbody>
</table>
</figure>
Read Next:
<ul>
<li><a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40938732/wall-street-ramps-up-interest-rate-cut-bets-after-fed-meeting-the-hard-landing-crow">Wall Street Ramps Up Interest Rate Cut Bets After Fed Meeting: &#8216;The Hard-Landing Crowd Should Disperse,&#8217; Economist Says</a></li>
</ul>
Photo via Shutterstock.

Analyst Color

Equities

Large Cap

Macro Economic Events

Broad U.S. Equity ETFs

Small Cap

Econ #s

Economics

Federal Reserve

Markets

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AAPL

ABNB

CDNS

GOOG

GOOGL

LCRX

MSFT

NVDA

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S&P 500, Dow Jones Hit Record Highs: Magnificent 7 Add $400 Billion After Fed's Historic Interest Rate Cut

Thursday,&nbsp;the FDA declined to approve Vanda Pharmaceuticals Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>)&nbsp;New Drug Application (NDA) of tradipitant for symptoms in gastroparesis, providing Vanda with a <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/n40935243/fda-declines-to-approve-vandas-marketing-application-for-tradipitant-in-gastroparesis" rel="noreferrer noopener">Complete Response Letter (CRL)</a>.
Gastroparesis (means&nbsp;paralysis of the stomach) is&nbsp;a condition that slows down the stomach&#8217;s ability to empty its contents.
It is associated with severe nausea, vomiting, and difficulty finishing a normal meal.
Also Read: <a target="_blank" href="https://www.benzinga.com/markets/equities/24/06/39530573/whats-going-on-with-vanda-pharmaceuticals-shares-today" rel="noreferrer noopener">What&#8217;s Going On With Vanda Pharmaceuticals Shares Today?</a>
The FDA has approved no effective treatment in over 40 years.
Vanda&#8217;s tradipitant application included evidence from two placebo-controlled studies, the results of which were published in peer-reviewed journals.
The&nbsp;CRL was conclusory in nature. It generally disregarded the evidence provided and instead suggested that Vanda conduct additional studies with a design and duration inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of the disorder.&nbsp;
Furthermore, the FDA&#8217;s action was delayed by more than 185 days and failed to satisfy the Food Drug and Cosmetic Act (FDCA) requirements.
The FDCA requires that the FDA review a new drug application and provide either an approval or an opportunity for a hearing within 180 days of submission. In this case, the FDA failed to do either.
Despite the FDA&#8217;s disappointing action,&nbsp;Vanda believes that the tradipitant application has met the substantial evidence of efficacy standard and has a favorable benefit-risk profile for gastroparesis patients.&nbsp;
While Vanda has repeatedly requested that the FDA convene an expert advisory committee to review the application and advise the Commissioner on its approvability, the FDA has refused to do so.
The company added that several patients currently treated with tradipitant have filed a Citizen Petition urging the FDA to approve tradipitant for gastroparesis.
Vanda will continue to pursue the marketing authorization for tradipitant and support the expanded access program.
Vanda plans to submit a separate NDA for tradipitant to prevent vomiting in motion sickness later this year.
Price Action: VNDA stock is down 7.68% at $4.57 at the last check on Thursday.
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VNDA

FDA Strikes Off Vanda Pharmaceuticals' Tradipitant For Stomach Paralysis, Asks For Additional Studies

New offering allows employers with self-funded medical plans to manage the risk of high medical claim payouts
Prudential Financial, Inc. ((<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;,%20url=https%3A%2F%2Fwww.prudential.com%2Fabout&amp;,%20esheet=54124569&amp;,%20newsitemid=20240919373614&amp;,%20lan=en-US&amp;,%20anchor=NYSE%3A+PRU&amp;,%20index=1&amp;,%20NYSE:%3Ca%20class=">PRU</a>) has introduced a <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fprudential.scene7.com%2Fis%2Fcontent%2Fprudential%2F1081799_MedicalStopLoss_Video&amp;esheet=54124569&amp;newsitemid=20240919373614&amp;lan=en-US&amp;anchor=Stop+Loss+Insurance+product&amp;index=2&amp;md5=d31b07d257288220c647ba0a7590e606">Stop Loss Insurance product</a> aimed at helping protect companies with self-funded employee medical plans against catastrophic medical claim payouts.
With Stop Loss Insurance, employers can set a cap on their potential employee healthcare spend and transfer some of the claims volatility to The Prudential Insurance Company of America.

Prudential Financial Introduces Stop Loss Insurance, New Offering Allows Employers With Self-Funded Medical Plans To Manage The Risk Of High Medical Claim Payouts

Cantor Fitzgerald analyst Sarah James maintains Progyny (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PGNY#NASDAQ">PGNY</a>) with a Overweight and lowers the price target from $37 to $25.

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