最新ニュース Novartis (NYSE:NVS) 株価情報

Novartis

Novartis develops and manufactures innovative drugs. Key areas of drug development include oncology, rare diseases, neuroscience, immunology, respiratory, cardio-metabolic, and established medicines. The company sells its products globally, with the United States comprising close to one third of total revenue.

Novartis AG

NEVADA SUNRISE METALS CRP by NEVADA SUNRISE METALS CORP.

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Novus Holdings Ltd

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Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) reported first-quarter 2025 adjusted earnings per share of $2.28, beating the <a href="https://www.benzinga.com/earnings">street view of $2.10</a>.
Quarterly sales of $13.23 billion marginally outpaced the analyst consensus estimate of $13.12 billion.
Quarterly net sales grew 12% (+15% at constant currency), with volume contributing 15 percentage points to growth.
Heart failure drug Entresto <a href="https://www.novartis.com/sites/novartis_com/files/q1-2025-media-release-en.pdf" target="_blank" rel="noreferrer noopener">sales</a> grew 22% at constant currency to $2.26 billion, driven by demand-led growth in China and Japan, with increased penetration in hypertension.
Cosentyx&nbsp;sales jumped 18% at constant currency to $1.53 billion in the quarter. Sales grew mainly in the US, emerging growth markets, and Europe, driven by recent launches and volume growth in core indications.
Sales of the multiple sclerosis drug&nbsp;Kesimpta&nbsp;reached $899 million, up 43% at constant currency. Novartis said sales grew mainly in the US, emerging growth markets, and Europe, driven by recent launches and volume growth in core indications.
Kisqali sales increased 56% cc to $956 million, including +87% growth in the U.S., with strong momentum from the recently launched early breast cancer indication and continued share gains in metastatic breast cancer.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44761201/novartis-commits-23-billion-to-expand-us-manufacturing-over-five-years-despite-tariffs-uncertainties" rel="noreferrer noopener">Novartis Commits $23 Billion To Expand US Manufacturing Over Five Years, Despite Tariffs Uncertainties</a>.
Core operating income was $5.6 billion, up 23% (+27% at constant currency), mainly driven by higher net sales.
Outlook: For fiscal year 2025, Novartis expects Net sales to grow in the high single digits compared to the mid-to-high single digits <a target="_blank" href="https://www.benzinga.com/general/health-care/25/01/43380284/novartis-q4-earnings-beat-estimates-ceo-dismisses-entresto-patent-expiration-worries" rel="noreferrer noopener">expected earlier</a>.
2025 core operating income is expected to grow in the low double digits, compared to the high single to low double digits forecasted earlier.
"We assume&nbsp;Tasigna,&nbsp;Promacta, and&nbsp;Entresto&nbsp;US generic entry mid-2025 for forecasting purposes," Novartis said in the release.
Reuters cited CEO Vas Narasimhan, who said the company had historically expanded capacity in Europe and other regions to serve the U.S.
&#8220;We now want to ensure that 100% of the demand of our key products in the U.S. is produced in the U.S.,&#8221; Reuters noted, citing Narasimhan in a media call, declining to provide details on volumes.
"Even in this I think complex geopolitical environment, we feel confident we can deliver now this upgraded guidance," Narasimhan <a target="_blank" href="https://www.cnbc.com/2025/04/29/novartis-earning-q1-2025.html" rel="noreferrer noopener">told</a> CNBC's Squawk Box Europe.
Price Action: Novartis stock is up 0.51% at $113.20 at the last check Tuesday.
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Novartis Q1 Earnings Beat Street View, CEO 'Confident' In Delivering Upgraded Guidance

U.S. stock futures rose Tuesday morning as investors looked ahead to upcoming earnings reports and awaited greater market clarity throughout the week.
Things haven&#8217;t moved all that much on the trade and tariffs front, with Treasury Secretary Scott Bessent merely stating on Monday that <a href="https://www.benzinga.com/25/04/45038824/treasury-secretary-scott-bessent-says-its-up-to-china-to-de-escalate-trade-tensions-india-to-be-the-first-trade-deal-to-be-signed">it was up to China</a> to &#8220;de-escalate&#8221; trade tensions. Bessent also hinted at a potential trade deal with India, saying that &#8220;it would be one of the first deals we would sign,&#8221; which investors will be watching closely.
This is set to be a packed earnings week for Wall Street, with four of the &#8220;Mag 7&#8243;— Microsoft&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MSFT#NASDAQ">MSFT</a>),&nbsp;Meta&nbsp;Platforms&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/META#NASDAQ">META</a>),&nbsp;Apple&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AAPL#NASDAQ">AAPL</a>),&nbsp;and Amazon&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMZN#NASDAQ">AMZN</a>), set to release their quarterly results over the next couple of days.
On Tuesday, investors will be closely watching the results of several heavy-hitters, such as Visa Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/V#NYSE">V</a>), Coca-Cola Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KO#NYSE">KO</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), AstraZeneca PLC (NASDAQ:&nbsp;AZN), and Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>).
U.S. 10-Year Treasuries are at 4.23%, while the 2-Year Treasuries are at 3.70%. The CME Group's FedWatch&nbsp;<a href="https://www.cmegroup.com/markets/interest-rates/cme-fedwatch-tool.html">tool</a>&nbsp;shows the markets pricing a 91.1% likelihood of interest rates remaining unchanged during the FOMC meeting, the first week of May, marking a decline from Friday last week, at 95.3%, and Monday at 93.1%
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<table>
<tbody>
<tr>
<td class="has-text-align-center" data-align="center">Futures</td>
<td class="has-text-align-center" data-align="center">Change (+/-)</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Dow Jones</td>
<td class="has-text-align-center" data-align="center">0.28%</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">S&amp;P 500</td>
<td class="has-text-align-center" data-align="center">0.20%</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Nasdaq 100</td>
<td class="has-text-align-center" data-align="center">0.21%</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Russell 2000</td>
<td class="has-text-align-center" data-align="center">0.19%</td>
</tr>
</tbody>
</table>
</figure>
The&nbsp;SPDR S&amp;P 500 Trust ETF&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) was up 0.04% on Monday, while the Invesco QQQ Trust (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>), which tracks the Nasdaq-100 Index was down 0.03%, according to <a href="https://pro.benzinga.com/dashboard?_gl=1&#x2A;138z7gr&#x2A;_gcl_au&#x2A;MjA5Njc0MjY1My4xNzQwODM2NTUw&#x2A;_ga&#x2A;R1MxLjEuMTc0NDY0ODA3Mi4yLjAuMTc0NDY0ODA3NS4wLjAuMA..&#x2A;_ga_V7ZK73W7N0&#x2A;MTc0NTgyOTMzMy4xLjEuMTc0NTgyOTYyMy4wLjAuMA..">Benzinga Pro</a> data. 
Cues From Last Session:
Almost all S&amp;P 500 sectors closed in the green on Monday, barring consumer staples and technology. While the index was up just 0.06%, it marked its fifth-straight winning day. There was no economic data released during the day, just a few earnings releases, which were mixed.
Waste Management Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/WM#NYSE">WM</a>), Domino's Pizza Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DPZ#NASDAQ">DPZ</a>), and NXP Semiconductors N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NXPI#NASDAQ">NXPI</a>) were few of the companies that reported Monday, with most of them being a mixed bag, with hits and misses across consensus estimates.
See Also: <a href="https://www.benzinga.com/25/04/45057906/palantirs-defense-moat-ex-employee-reveals-how-pltr-could-dominate-ai-defenseamid-pricing-puzzles-and-competitive-pressures" target="_blank" rel="noreferrer noopener">Fortress Palantir: Former Insider Explains How PLTR Could Conquer The AI-Defense Battlefield Despite Pricing Puzzles And Competition</a>
As of Monday, the Nasdaq 100 is down 12.6% from its high of 22,222.61 points, the S&amp;P 500 is down 10% from 6147.43 points, and the Dow Jones Industrial Average is down 10.75% from 45,073.63 points.
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<table>
<tbody>
<tr>
<td class="has-text-align-center" data-align="center">Index</td>
<td class="has-text-align-center" data-align="center">Performance (+/-)</td>
<td class="has-text-align-center" data-align="center">Value</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Nasdaq Composite</td>
<td class="has-text-align-center" data-align="center">-0.09%</td>
<td class="has-text-align-center" data-align="center">17,366.13</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">S&amp;P 500</td>
<td class="has-text-align-center" data-align="center">0.06%</td>
<td class="has-text-align-center" data-align="center">5,528.75</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Dow Jones</td>
<td class="has-text-align-center" data-align="center">0.28%</td>
<td class="has-text-align-center" data-align="center">40,227.59</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Russell 2000</td>
<td class="has-text-align-center" data-align="center">0.41%</td>
<td class="has-text-align-center" data-align="center">1,965.55</td>
</tr>
</tbody>
</table>
</figure>
Insights From Analysts:
According to analysts at Charles Schwab (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SCHW#NYSE">SCHW</a>), the <a href="https://www.schwab.com/learn/story/weekly-traders-outlook">outlook for the week</a> is being described as &#8220;Volatile,&#8221; given the several mega-cap earnings that are scheduled to be released this week, alongside volatility-inducing economic data, such as the Monthly Jobs Report, Jobless Claims, and more.
Trader and mentor at UIFCA, Eric Daniel, has posted on X that the markets are approaching the perfect volatility storm, in part due to the reasons stated above, alongside the Federal Reserve FOMC meeting on the 6th and 7th of May. 
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">Market approaching the perfect volatility storm: Fed meeting Big tech earnings Jobs report Friday Pre-market action suggests caution. My approach: Reduced position sizes, defined risk strategies, patience for premium opportunities. Discipline &gt; Prediction this week.
&mdash; Eric Daniel (@EricDaniel_NYC) <a href="https://twitter.com/EricDaniel_NYC/status/1916692599714304068?ref_src=twsrc%5Etfw">April 28, 2025</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
Upcoming Economic Data:
Here&#8217;s what investors will be monitoring on Tuesday,
<ul>
<li>The Advanced U.S. trade balance in goods, Advanced retail inventories, and the Advanced wholesale inventories for March will be out by 8:30 AM ET. </li>
<li>The S&amp;P Case-Shiller home price index (20 cities) for February will be out by 9 AM ET. </li>
<li>The Consumer Confidence Report for April and the Job Openings Report for March will be out by 10 AM ET.</li>
</ul>
Stocks In Focus:
<ul>
<li>Visa Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/V#NYSE">V</a>) shares are up 0.41% in pre-market trade, with the company set to release its earnings after markets close on Tuesday. Analyst consensus estimates stand at $9.5 billion in revenue, and $2.68 per share earnings. </li>
<li>Coca-Cola Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KO#NYSE">KO</a>) is down 0.06% in pre-market trade, as investors wait for the company&#8217;s first quarter results, scheduled to be released before the opening bell. Analysts expect the company to post $0.72 per share in earnings, from $11.2 billion in revenue. </li>
<li>AstraZeneca PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NYSE">AZN</a>) is down 2.57% in pre-market trade. The company just released its earnings, with a miss on top-line estimates, but a beat at the bottom. </li>
<li>Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) is up 0.13% in pre-market trade, with the company set to announce its quarter results before markets open. Analysts expect $0.68 per share in earnings, from $14.1 billion in revenue. </li>
<li>Honeywell International Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HON#NASDAQ">HON</a>) is scheduled to release its quarterly results before markets open, with analysts expecting $2.21 earnings, on $9.6 billion in revenue. The stock is up 0.63% in pre-market trade.</li>
</ul>
Commodities, Gold And Global Equity Markets:
Crude oil futures continue to decline, down 1.10% during the early New York session, trading at $61.37 per barrel. Gold Spot U.S. Dollar is down 0.66%, trading at $3,313 per ounce, down from record high levels of $3.400 per ounce this time last week.
The U.S. Dollar Index (DXY) is up 0.26%, trading at 99.26 against a basket of other currencies.
Asian markets are up on Tuesday, with the Nikkei, Kospi, and the Nifty 50, all in the green, barring the Chinese benchmarks that continue to decline. Australia&#8217;s ASX 200 is up, while New Zealand&#8217;s NZX 50 is down during the day.
Read Next:
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</ul>
Photo courtesy: Frontpage / Shutterstock.com

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US Stock Futures Edge Higher Tuesday: Expert Warns Of 'Perfect Volatility Storm' With Major Earnings And Economic Data Due This Week

With U.S. stock futures trading slightly higher this morning on Tuesday, some of the stocks that may grab investor focus today are as follows:
<ul>
<li>Wall Street expects General Motors Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GM#NYSE">GM</a>) to report quarterly earnings at $2.66 per share on revenue of $43.21 billion before the opening bell, according to data from <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a>. GM shares gained 0.3% to $47.39 in after-hours trading.</li>
<li>Analysts are expecting The Coca-Cola Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KO#NYSE">KO</a>) to post quarterly earnings at 72 cents per share on revenue of $11.17 billion. The company will release earnings before the markets open. Coca-Cola shares fell 0.1% to $71.70 in after-hours trading.</li>
<li>Sanmina Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SANM#NASDAQ">SANM</a>) posted upbeat results for its second quarter, but issued weak forecast for the third quarter. The company said it sees third-quarter adjusted earnings of $1.35 to $1.45 per share, versus market estimates of $1.53 per share. It also expects sales of $1.925 billion to $2.025 billion for the current quarter, versus market projections of $2.06 billion. Sanmina shares dipped 7.1% to $75.02 in the after-hours trading session.</li>
</ul>
Check out our <a href="https://www.benzinga.com/premarket/">premarket coverage here</a>
<ul>
<li>Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) posted better-than-expected earnings for its first quarter and increased its guidance for 2025. Novartis shares rose 0.02% to $112.65 in the after-hours trading session.</li>
<li>Analysts expect Starbucks Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SBUX#NASDAQ">SBUX</a>) to post quarterly earnings at 48 cents per share on revenue of $8.83 billion after the closing bell. Starbucks shares gained 0.3% to $84.18 in the after-hours trading session.</li>
</ul>
Check This Out: 
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<li><a href="https://www.benzinga.com/25/04/45038052/top-2-industrials-stocks-that-may-fall-off-a-cliff-this-quarter">Top 2 Industrials Stocks That May Fall Off A Cliff This Quarter</a> </li>
</ul>
Photo via Shutterstock

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SBUX

General Motors, Coca-Cola And 3 Stocks To Watch Heading Into Tuesday

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FICO

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FRST

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HLMN

HOUS

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INCY

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KNSA

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Laboratory Corporation Of America Holdings

LOGI

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Earnings Scheduled For April 29, 2025

2025 outlook Barring unforeseen events; growth vs. prior year in cc Net sales Expected to grow high single-digit Core operating income Expected to grow low

Novartis Raises 2025 Outlook: Sales Now Seen Up High Single Digits (Prior Mid-To-High Single), Core Income Up Low Double Digits (Prior High Single To Low Double)

Novartis (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) reported quarterly earnings of $2.28 per share which beat the analyst consensus estimate of $2.10 by 8.57 percent. This is a 26.67 percent increase over earnings of $1.80 per share from the same period last year. The company reported quarterly sales of $13.23 billion which beat the analyst consensus estimate of $13.12 billion by 0.85 percent. This is a 11.87 percent increase over sales of $11.83 billion the same period last year.

Earnings Beats

Novartis Q1 Adj. EPS $2.28 Beats $2.10 Estimate, Sales $13.23B Beat $13.12B Estimate

Novartis (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) will release its quarterly earnings report on Tuesday, 2025-04-29. Here's a brief overview for investors ahead of the announcement.
Analysts anticipate Novartis to report an earnings per share (EPS) of $2.08.
The market awaits Novartis's announcement, with hopes high for news of surpassing estimates and providing upbeat guidance for the next quarter.
It's important for new investors to understand that guidance can be a significant driver of stock prices.
<h3>Overview of Past Earnings</h3>
The company's EPS beat by $0.19 in the last quarter, leading to a 0.0% drop in the share price on the following day.
Here's a look at Novartis's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q4 2024</th>
<th>Q3 2024</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>1.79</td>
<td>1.96</td>
<td>1.86</td>
<td>1.69</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>1.98</td>
<td>2.06</td>
<td>1.97</td>
<td>1.80</td>
</tr>
<tr>
<td>Price Change %</td>
<td>-0.0%</td>
<td>-1.0%</td>
<td>-1.0%</td>
<td>1.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2025/1745848950_0.png" alt="eps graph" />
<h3>Novartis Share Price Analysis</h3>
Shares of Novartis were trading at $112.14 as of April 25. Over the last 52-week period, shares are up 15.69%. Given that these returns are generally positive, long-term shareholders are likely bullish going into this earnings release. 
<a href="https://www.benzinga.com/quote/NVS/earnings">To track all earnings releases for Novartis visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Earnings Preview For Novartis

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) announced on Tuesday that it will invest $50 billion in the U.S. over <a href="https://www.benzinga.com/topic/pharmaceuticals">the next five years.</a>
These investments further strengthen Roche's already significant U.S. footprint, which includes 13 manufacturing and 15 R&amp;D sites across the Pharmaceutical and Diagnostics Divisions.
The investment is expected to <a href="https://www.roche.com/media/releases/med-cor-2025-04-22" target="_blank" rel="noreferrer noopener">create</a> over 12,000 new jobs, including nearly 6,500 construction jobs and 1,000 jobs at new and expanded facilities.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44724763/pharma-industry-faces-jitters-as-trump-hints-at-historic-tariffs-bofa-outlines-probable-timeline" rel="noreferrer noopener">Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline</a>
As part of this investment, Roche will increase its footprint of more than 25,000 employees in 24 sites across eight U.S. states. The investment will include: 
<ul>
<li>Expanded and upgraded US manufacturing and distribution capabilities for its innovative medicines and diagnostics portfolio in Kentucky, Indiana, New Jersey, Oregon, and California.</li>
<li>Gene therapy manufacturing facility in Pennsylvania.</li>
<li>A new 900,000-square-foot manufacturing center to support Roche's expanding portfolio of <a href="https://www.benzinga.com/general/biotech/25/04/44791986/whats-going-on-with-viking-therapeutics-structure-therapeutics-stock-on-monday" target="_blank" rel="noreferrer noopener">next-generation weight loss medicines</a>. The company says the location will be announced.</li>
<li>A new manufacturing facility for continuous glucose monitoring in Indiana.</li>
<li>A new R&amp;D center in Massachusetts for conducting artificial intelligence research and as a hub for new cardiovascular, renal, and metabolism R&amp;D efforts.</li>
<li>Significant expansion and upgrading of existing pharmaceuticals and diagnostics R&amp;D centers in Arizona, Indiana, and California.</li>
</ul>
Once all new and expanded manufacturing capacity comes online, Roche will export more medicines from the U.S. than it imports. The company says its diagnostics division already has an export surplus from the U.S. to other countries.
Earlier this month, Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) unveiled a sweeping $23 billion investment plan to expand its manufacturing and research infrastructure in the U.S. <a href="https://www.benzinga.com/general/biotech/25/04/44761201/novartis-commits-23-billion-to-expand-us-manufacturing-over-five-years-despite-tariffs-uncertainties" target="_blank" rel="noreferrer noopener">over the next five years</a>.
The move is part of a broader strategy to ensure that all key Novartis medicines for U.S. patients are produced domestically.
Earlier this year, Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) announced its plans to invest more than <a href="https://www.benzinga.com/markets/equities/25/03/44433978/johnson-johnson-to-invest-55-billion-in-us-to-boost-manufacturing-drug-discovery" target="_blank" rel="noreferrer noopener">$55 billion in the U.S. over the next four years</a>, while Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) plans to double its U.S. drug manufacturing spending from $23 billion to <a href="https://www.benzinga.com/general/biotech/25/02/43982604/eli-lilly-doubles-capital-spending-on-us-drug-manufacturing-with-50-billion-target" target="_blank" rel="noreferrer noopener">$50 billion within five years</a>.
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Photo: Gorodenkoff/Shutterstock

RHHBY

Roche Plans $50 Billion US Investment Over 5 Years With 12,000 New Jobs

U.S. stock futures rose Monday night even as Wall Street had a rough start to the week, amid growing concerns regarding the Federal Reserve&#8217;s independence, and President Donald Trump&#8217;s <a href="https://benzinga.com/markets/equities/25/04/44902537/selling-on-threat-to-powell-dollar-stocks-and-bonds-fall-gold-and-yen-rise">repeated attacks</a> on Fed Chair Jerome Powell for not cutting interest rates.
The S&amp;P 500 futures are up 0.47%, at 5,209, followed by Nasdaq futures at 18,010, up 0.51%, and the Dow Jones futures at 38,500, an increase of 0.45%. This comes despite the sharp selloff during the regular session on Monday morning.
See More: <a href="https://www.benzinga.com/25/04/44913967/trumps-bowling-ball-tale-bounces-back-japan-refutes-presidents-car-safety-test-claims">Trump&#8217;s Bowling Ball Tale Bounces Back, Japan Refutes President&#8217;s Car Safety Test Claims</a>
It&#8217;s another volatile start for Japan&#8217;s benchmark Nikkei 225. After opening down by 0.50%, the index mounted a recovery, before slipping back into the red, trading down by 109 points, or 0.32%, at the time of writing. 
This is attributed to the strengthening Yen, which reached a 7-month high against the U.S. Dollar on Monday, weighing on Japan&#8217;s export-reliant industries, according <a href="https://tradingeconomics.com/japan/stock-market">to</a> TradingEconomics data.
The U.S. Dollar Index (DXY) hit a fresh three-year low of 97.923 on Monday, a level it last saw in 2022. It, however, recovered in the latter half of the day and is now back above the 98 level. It currently trades at 98.47, up 0.16%.
Investors will be closely watching several large-cap stocks that are set to report their earnings today. This includes Tesla Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>), SAP SE (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SAP#NYSE">SAP</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Verizon Communications Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VZ#NYSE">VZ</a>), and Lockheed Martin Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LMT#NYSE">LMT</a>), among several others.
Photo Courtesy: tadamichi on Shutterstock.com
Read More: <a href="https://www.benzinga.com/news/earnings/25/04/44913389/rtx-lockheed-martin-northrup-grumman-report-earnings-tuesday-what-to-watch">RTX, Lockheed Martin, Northrup Grumman Report Earnings Tuesday: What To Watch</a>

TSLA

S&P 500, Nasdaq Futures Rise After Stocks Dip Amid Trump's Jabs At Powell, Strong Yen Gives Nikkei A Volatile Start

WIIM

Novartis shares are trading higher after the company announced it will commit $23 billion to expand US manufacturing over the next 5 years.

Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) on Thursday unveiled a sweeping $23 billion investment plan to expand its manufacturing and research infrastructure in the U.S. <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">over the next five years</a>.
The move is part of a broader strategy to ensure that all key Novartis medicines for U.S. patients are produced domestically.
As part of the initiative, Novartis will build seven new facilities — four focused on manufacturing and two dedicated to radioligand therapy (RLT) — and expand three existing RLT production sites.
Also Read: <a target="_blank" href="https://www.benzinga.com/markets/25/04/44751289/pharma-industry-faces-jitters-as-trump-hints-at-historic-tariffs-bofa-outlines-probable-timeline" rel="noreferrer noopener">Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline</a>
These efforts are expected to generate nearly 1,000 new jobs at Novartis and support around 4,000 additional roles.
The move comes after U.S. President Donald Trump on Tuesday disclosed plans for a &#8220;major tariff&#8221; on&nbsp;<a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">foreign pharmaceuticals</a>.
On Wednesday, President Donald Trump announced a 90-day pause on tariffs for countries that have not retaliated against U.S. trade measures.
&#8220;As a Swiss-based company with a significant presence in the U.S., these investments will enable us to fully bring our supply chain and key technology platforms into the U.S. to support our strong U.S. growth outlook. These investments also reflect the pro-innovation policy and regulatory environment in the U.S. that supports our ability to find the next medical breakthroughs for patients,&#8221; <a href="https://www.novartis.com/us-en/news/media-releases/novartis-plans-expand-its-us-based-manufacturing-and-rd-footprint-total-investment-23b-over-next-5-years" target="_blank" rel="noreferrer noopener">said</a> Vas Narasimhan, CEO of Novartis. &#8220;We are prepared for shifts in the external environment and fully confident in our 2025 guidance, mid- to long-term sales growth outlook, and 2027 core margin guidance of 40%+.&#8221;
The investment includes a newly planned&nbsp;$1.1 billion&nbsp;research hub in&nbsp;San Diego, a research facility for scientific infrastructure and drug discovery.
The new complex, expected to open between 2028 and 2029, will serve as the epicenter of the Novartis West Coast Biomedical Research presence, complementing existing hubs in Cambridge, Massachusetts, and Basel, Switzerland.
In addition, the company will be expanding RLT manufacturing with new facilities in&nbsp;Florida&nbsp;and&nbsp;Texas.
To support growing demand for RLTs in the U.S., Novartis has expanded production capabilities in Millburn, New Jersey, and a state-of-the-art facility in Indianapolis, Indiana, and is building a third US RLT manufacturing facility in Carlsbad, California.
The total investment in Novartis&#8217; U.S. operations is expected to be nearly $50 billion over the next five years.
Earlier this year, Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) announced its plans to invest more than <a href="https://www.benzinga.com/markets/equities/25/03/44433978/johnson-johnson-to-invest-55-billion-in-us-to-boost-manufacturing-drug-discovery" target="_blank" rel="noreferrer noopener">$55 billion in the U.S. over the next four years</a>, while Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) announced to double its U.S. drug manufacturing spending from $23 billion to <a href="https://www.benzinga.com/general/biotech/25/02/43982604/eli-lilly-doubles-capital-spending-on-us-drug-manufacturing-with-50-billion-target" target="_blank" rel="noreferrer noopener">$50 billion within five years</a>.
A Wedbush analyst said on Tuesday that building a factory in the U.S. <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">takes four to five years</a>. The analyst explains that high labor costs and other expenses in the U.S. don't align with how modern supply chains are designed to operate.
NVS Price Action: Novartis stock is up 2.33% at $103.40 during the premarket session at publication Friday.
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Photo: Highly trained specialists on the production line of Novartis&#8217; radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana, courtesy Novartis.

Novartis Commits $23 Billion To Expand US Manufacturing Over Five Years, Despite Tariffs Uncertainties

<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-plans-invest-23-billion-us-plants-trump-renews-drug-tariff-threats-2025-04-10/#:~:text=April%2010%20(Reuters)%20%2D%20Swiss,duties%20from%20the%20Trump%20administration.">https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-plans-invest-23-billion-us-plants-trump-renews-drug-tariff-threats-2025-04-10/#:~:text=April%2010%20(Reuters)%20%2D%20Swiss,duties%20from%20the%20Trump%20administration.</a>
&nbsp;

'Novartis Plans To Spend $23B To Build And Expand 10 U.S. Facilities; The New Sites And Extensions Will Be Built Over Five Years And Are Expected To Create More Than 4,000 Jobs; New Facilities Include 6 Manufacturing Plants And A Research And Development Site' - Reuters News

U.S.&nbsp;President Donald Trump, on Tuesday, disclosed plans for a "major tariff" on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">foreign pharmaceuticals</a>.
"We're&nbsp;going to be announcing very&nbsp;shortly a major tariff on&nbsp;pharmaceuticals… when they hear that&nbsp;they will leave China, they&nbsp;will leave other places because… most of their product&nbsp;is sold here," Trump expressed at&nbsp;a National Republican <a target="_blank" href="https://www.benzinga.com/25/04/44708204/trump-hints-at-major-tariff-on-imported-pharmaceuticals-us-pharma-stocks-tumble-in-wednesday-pre-market" rel="noreferrer noopener">Congressional Committee&nbsp;dinner</a>.
He also told reporters on board his Air Force One plane that "pharma" tariffs would arrive "at a level that you haven't really seen before," saying these would be announced "in the near future," BBC <a target="_blank" href="https://www.bbc.com/news/articles/cedyylj1v32o" rel="noreferrer noopener">report</a> added.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">Trump Tariff Strategy Creates ‘Self-Inflicted Market Debacle': Analyst</a>
When President Trump announced tariffs last week, he excluded pharmaceuticals from the new tariffs, likely a relief for the industry under pressure following his prior comments suggesting a 25% tariff&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44652075/us-tariffs-spare-drugmakers-but-threaten-diabetes-device-industry" rel="noreferrer noopener">on pharmaceutical imports</a>.&nbsp;
On Wednesday, in a surprise announcement from President Donald Trump, a 90-day pause on tariffs for countries that have not retaliated <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">against U.S. trade measures.</a>
The news ignited a broad risk-on rally, catapulting major indices to multi-month highs and sending volatility plunging.
Trump's latest Truth Social post slammed China for showing "a lack of respect" and declared an immediate 125% tariff hike on Chinese goods.
"At some point, hopefully in the near future, China will realize that the days of ripping off the U.S.A. and other Countries is no longer sustainable or acceptable," he said.
He praised the over 75 countries that, in his words, "have not, at my strong suggestion, retaliated in any way, shape, or form."
As a reward, those countries would benefit from a temporary 10% reciprocal tariff and a 90-day pause on additional duties.
The biopharma industry has historically been shielded from tariffs, including during Trump's first term.
Although Trump didn't provide many details, his remarks have unsettled buyers, especially those who depend on medicines from India. India provides nearly half of all generic drugs used in the U.S., helping cut billions from healthcare costs.
The U.S. is a major market, buying about a third of India's $13 billion in yearly drug exports.
Indian drug companies warn that if tariffs are added, they'd have to raise prices—which could increase healthcare costs in the U.S.
Even though some companies like Cipla and Dr. Reddy's Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) have factories in the U.S., most say it's too expensive to move production for low-profit generic drugs.
BofA Securities analyst says if the Trump administration plans to impose tariffs on the pharmaceutical industry, it would likely do so through a "Section 232 investigation" under the Trade Expansion Act of 1962 to determine whether importing certain goods threatens national security.
The typical timeline for a Section 232 investigation is about a year. If the same timeline applied here, tariffs on drug imports likely wouldn't take effect until late in the year—at the earliest.
It's unclear whether the Section 232 investigation into the drug industry is about to start, but based on recent comments from the administration, it seems possible. However, launching an investigation doesn't guarantee that tariffs will follow.
As the first quarter 2025 earnings season starts soon, analyst Tim Anderson says it will be worth watching whether companies discuss potential tariffs during earnings calls.
That said, any actual earnings impact likely wouldn't show up until sometime after 2025, which could leave investors with more questions than answers.
Wedbush analyst Daniel Ives <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">on Tuesday wrote</a> that "saying we can just make this in the USA" understates how complex the supply chain in Asia really is—and how electronics, chips, semiconductors, hardware, and smartphones have been built for U.S. consumers over the past 30 years."
Shares of major drugmakers such as Gilead Sciences&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Eli Lilly&nbsp;And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), AstraZeneca&nbsp;Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Roche&nbsp;Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi&nbsp;SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Novartis&nbsp;AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Argenx&nbsp;SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>), UCB&nbsp;SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>), Novo Nordisk&nbsp;A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), Regeneron Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) fell on Wednesday, only reverse course later after the 90-day tariff pause.
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Photo by MargJohnsonVA via Shutterstock

Government

Analyst Ratings

Movers

Trading Ideas

ARGX

GILD

REGN

UCBJF

UCBJY

Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline

With U.S. President Donald Trump&#8217;s <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">tariffs</a>, HC Wainwright analyst writes that investors are looking for companies with macroeconomic moats that protect against tariff exposure and regulatory uncertainty.
Legend Biotech Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LEGN#NASDAQ">LEGN</a>) has no material exposure to tariffs, the analyst stated.
The cell therapy company&#8217;s lead product, Carvykti, is a one-time treatment for relapsed or refractory&nbsp;multiple myeloma, which it develops and markets with collaborator Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>).
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/41093953/johnson-johnson-legend-biotech-partnered-blood-cancer-drug-extends-overall-survival" rel="noreferrer noopener">Johnson &amp; Johnson/ Legend Biotech Partnered Blood Cancer Drug Extends Overall Survival, Support Use In Previously Treated Patients</a>
Analyst Mitchell Kapoor notes that Legend manufactures in the U.S. for 100% of the commercial Carvykti patients in the U.S. and Europe.
In the first quarter of 2025, the company initiated commercial production of Carvykti&nbsp;at a Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) production facility under the master manufacturing and supply agreement among <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44242720/legend-biotech-reports-fourth-quarter-and-full-year-2024-results-and-recent-highlights" rel="noreferrer noopener">Legend, Janssen, and Novartis</a>.
Analyst Kapoor adds that Legend does not have to import materials for CAR-T manufacturing and thus has no material exposure to tariffs or transfer pricing.
&#8220;Legend has no tariff exposure, creating an attractive opportunity to own shares in unpredictable macroeconomic times,&#8221; HC Wainwright highlights. The analyst reiterates the Buy rating, with a <a target="_blank" href="https://www.benzinga.com/quote/LEGN/analyst-ratings" rel="noreferrer noopener">price target of $75</a>.
While Legend Biotech has several drugs in development, analyst Kapoor writes the biggest factor driving its stock is how well Carvykti performs as an earlier treatment for multiple myeloma.
The analyst is confident that Carvykti will be widely adopted in earlier lines of treatment, as the data show it&#8217;s among the best available options. &#8220;Thus, we see LEGN as considerably insulated from the regulatory risks plaguing the biotech space, and we view this as a compelling time to own the stock,&#8221; says HC Wainwright analyst.
Carvykti remains very favorably positioned compared to competitors, citing robust efficacy (particularly durability) data in the fourth- and second-line treatments, leaving little room for improvement.
HC Wainwright writes that the drug is far ahead of competitors, as it is already approved for second-line Relapsed/refractory multiple myeloma (RRMM). New therapies usually start by getting approved for use in patients who have already tried other treatments. Over time, they can receive additional approvals to be used earlier in the treatment process.
Price Action: LEGN stock is up 1.86% at $30.81 at the last check Tuesday.
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Price Target

LEGN

Cell Therapy Maker Legend Biotech Is An 'Attractive Opportunity' Due To No Material Tariff Exposure: Analyst

This whale alert can help traders discover the next big trading opportunities.
Whales are entities with large sums of money and we track their transactions here at Benzinga on our options activity scanner.
Traders often look for circumstances when the market estimation of an option diverges away from its normal worth. Abnormal amounts of trading activity could push option prices to hyperbolic or underperforming levels. 
Here's the list of options activity happening in today's session: 
<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>TLRY</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>01/16/26</td>
<td>$2.00</td>
<td>$609.6K</td>
<td>25.5K</td>
<td>4.0K</td>
</tr>
<tr>
<td>CVS</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>05/16/25</td>
<td>$65.00</td>
<td>$26.4K</td>
<td>3.7K</td>
<td>1.0K</td>
</tr>
<tr>
<td>NVS</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>07/18/25</td>
<td>$105.00</td>
<td>$35.7K</td>
<td>681</td>
<td>156</td>
</tr>
</tbody>
</table>

<h2>Explanation</h2>
These itemized elaborations have been created using the accompanying table. 
• Regarding TLRY (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TLRY#NASDAQ">TLRY</a>), we observe a put option sweep with bullish sentiment. It expires in 283 day(s) on January 16, 2026. Parties traded 4000 contract(s) at a $2.00 strike. This particular put needed to be split into 3 different trades to become filled. The total cost received by the writing party (or parties) was $609.6K, with a price of $152.0 per contract. There were 25574 open contracts at this strike prior to today, and today 4001 contract(s) were bought and sold. 
• For CVS (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>), we notice a put option sweep that happens to be bearish, expiring in 38 day(s) on May 16, 2025. This event was a transfer of 90 contract(s) at a $65.00 strike. This particular put needed to be split into 16 different trades to become filled. The total cost received by the writing party (or parties) was $26.4K, with a price of $294.0 per contract. There were 3731 open contracts at this strike prior to today, and today 1028 contract(s) were bought and sold. 
• Regarding NVS (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), we observe a put option sweep with bearish sentiment. It expires in 101 day(s) on July 18, 2025. Parties traded 55 contract(s) at a $105.00 strike. This particular put needed to be split into 4 different trades to become filled. The total cost received by the writing party (or parties) was $35.7K, with a price of $650.0 per contract. There were 681 open contracts at this strike prior to today, and today 156 contract(s) were bought and sold. 
Options Alert Terminology 
 - Call Contracts: The right to buy shares as indicated in the contract. 
 - Put Contracts: The right to sell shares as indicated in the contract. 
 - Expiration Date: When the contract expires. One must act on the contract by this date if one wants to use it. 
 - Premium/Option Price: The price of the contract. 
For more information, visit our <a href="https://pro.benzinga.com/blog/how-to-understand-option-alerts/">Guide to Understanding Options Alerts</a> or read <a href="https://www.benzinga.com/markets/options">more about unusual options activity</a>. 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Options

TLRY

3 Health Care Stocks Whale Activity In Today's Session

The U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval for Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">rapid disease progression</a>.
Vanrafia is a once-daily, non-steroidal, oral treatment that can be added to supportive care, including a renin-angiotensin system inhibitor with or without a sodium-glucose co-<a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/n44619827/novartis-receives-fda-accelerated-approval-for-vanrafia-atrasentan-the-first-and-only-selective-en" rel="noreferrer noopener">transporter-2 inhibitor</a>.
Vanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase 3 ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44592342/apellis-pharmaceuticals-rare-kidney-disease-drug-under-fda-review-seeks-to-compete-novartis-recently-approved-drug" rel="noreferrer noopener">FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals</a>
It has not been established whether Vanrafia slows kidney function decline in patients with IgAN.
The continued approval of Vanrafia may be contingent upon verifying clinical benefit from the ongoing Phase 3 ALIGN study evaluating whether Vanrafia slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline at week 136.
The eGFR data are expected in 2026 and are intended to support traditional FDA approval.
In the ongoing Phase 3 ALIGN study, patients receiving Vanrafia in combination with a RAS inhibitor achieved clinically meaningful and statistically significant proteinuria reduction of 36.1% compared to placebo, with results seen as early as week 6 and sustained through week 36.
A similar treatment effect of Vanrafia was seen in an additional group of patients treated with both an RAS inhibitor and an SGLT2 inhibitor (37.4% reduction in UPCR vs. placebo).
The ALIGN study showed that Vanrafia has a favorable safety profile consistent with previously reported data.
This is Novartis&#8217;s third U.S. approval for its kidney disease portfolio in the last year. Fabhalta&nbsp;was granted FDA approval in <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44544720/fda-oks-novartis-prostate-cancer-treatment-triples-eligible-patient-pool" rel="noreferrer noopener">C3 glomerulopathy in&nbsp;March 2025</a> and accelerated approval in <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40254535/fda-approves-expanded-use-of-novartis-rare-disease-drug-fabhalta-for-kidney-disease" rel="noreferrer noopener">IgAN in&nbsp;August 2024</a>.
Fabhalta is also being studied in rare kidney diseases, including atypical hemolytic uremic syndrome, immune complex membranoproliferative glomerulonephritis, and lupus nephritis.
An investigational subcutaneously administered anti-APRIL monoclonal antibody, zigakibart, is currently in Phase 3 development in IgAN, with results expected in 2026.
Price Action: NVS stock is up 2.16% at $113.17 at the last check Thursday.
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Novartis Secures Third FDA Approval For Its Kidney Disease Portfolio In One Year

<ul>
<li>Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program1</li>
<li>Phase III data showed Vanrafia achieved proteinuria reduction of 36.1% (P&lt;0.0001) vs. placebo with improvements seen at Week 6 and sustained through Week 36 and favorable safety1,2</li>
<li>IgAN is a progressive, rare kidney disease; up to 50% of patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis3-9</li>
<li>With third FDA approval in under 1 year across its renal portfolio, Novartis is uniquely positioned to lead a transformation in kidney care</li>
</ul>

Reported Earlier, Novartis Gains FDA Accelerated Approval For Vanrafia, The First Selective ETA Receptor Antagonist For Proteinuria Reduction In IgA Nephropathy

The U.S. Food and Drug Administration (FDA) on Tuesday accepted and granted Priority Review designation to Apellis Pharmaceuticals, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APLS#NASDAQ">APLS</a>) supplemental New Drug Application (sNDA) for Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative <a href="https://www.benzinga.com/general/health-care">glomerulonephritis (IC-MPGN)</a>.
C3G and primary IC-MPGN are rare kidney diseases. Excessive C3c deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. The diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/03/44383078/jp-morgan-cut-apellis-price-forecasts-cites-longer-peak-sales-timing-for-syfovre" target="_blank" rel="noreferrer noopener">JPMorgan Cut Apellis&#8217; Price Forecasts, Cites Longer Peak Sales Timing For Syfovre</a>
The Prescription Drug User Fee Act (PDUFA) target action <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g44581423/apellis-announces-fda-acceptance-and-priority-review-of-the-supplemental-new-drug-application-for-" rel="noreferrer noopener">date is July 28, 2025</a>.
The supplemental application submission supported by Phase 3 VALIANT results at Week 26:
<ul>
<li>Proteinuria reduction:&nbsp;The study met its primary endpoint, demonstrating a statistically significant 68% (p&lt;0.0001) proteinuria reduction in Empaveli-treated patients compared to placebo.</li>
<li>Stabilization of kidney function:&nbsp;Empaveli-treated patients achieved stabilization of kidney function (nominal p=0.03) as measured by eGFR.</li>
<li>Reduction of C3c staining:&nbsp;A substantial proportion of Empaveli-treated patients achieved a reduction in C3c staining intensity (nominal p&lt;0.0001).&nbsp;71% of Empaveli-treated patients showed complete clearance of C3c staining compared to placebo.</li>
</ul>
Empaveli showed favorable safety and tolerability, which is consistent with its established profile.
William Blair writes, &#8220;We believe the recent approval of Fabhalta (iptacopan) for the treatment of adults with C3G bodes well for an approval of Empaveli given it demonstrated what we believe is best-in-class data and did so in a broader population that included adolescents, patients with IC-MPGN, and post-transplant patients, which should support a broader label and larger addressable market.&#8221;
In March, the FDA approved Novartis AG&#8217;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) oral Fabhalta&nbsp;(iptacopan) for adults with C3 glomerulopathy (C3G) to reduce proteinuria (protein in the urine), making it the first and only treatment&nbsp;<a target="_blank" href="https://www.benzinga.com/25/03/44439352/fda-approves-expanded-use-of-novartis-rare-disease-drug-as-only-treatment-for-rare-type-of-kidney-disease" rel="noreferrer noopener">approved for this condition</a>.
Price Action: APLS stock is up 8.05% at $23.63&nbsp;at the last check Tuesday.
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Image: Shutterstock

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FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals

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The U.S. Food and Drug Administration (FDA) on Friday approved Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Pluvicto for <a href="https://www.benzinga.com/topic/fda-0">prostate cancer patients</a>.
The <a href="https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer" target="_blank" rel="noreferrer noopener">expanded</a> indication, which approximately triples the number of patients eligible to receive Pluvicto, is based on the Phase 3 PSMAfore trial results.
The patients have prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) and have been treated with an androgen receptor pathway inhibitor (ARPI) therapy.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44439352/fda-approves-expanded-use-of-novartis-rare-disease-drug-as-only-treatment-for-rare-type-of-kidney-disease" rel="noreferrer noopener">FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease</a>
In the study, Pluvicto (lutetium Lu 177 vipivotide tetraxetan) reduced the risk of radiographic progression or death by 59% compared to a change in ARPI in patients with PSMA-positive mCRPC after treatment with ARPI therapy.
At an updated exploratory analysis, Pluvicto more than doubled median radiographic progression-free survival (11.6 months vs. 5.6 months).
In PSMAfore, the final overall survival (OS) analysis numerically favored Pluvicto, with a hazard ratio of 0.91, but was not statistically significant.
The OS analysis was confounded by the high rate of patients who crossed over from the control arm to Pluvicto (60.3%). When adjusted for crossover, the OS hazard ratio was 0.59.
Additional findings from the PSMAfore study showed Pluvicto demonstrated a consistent and favorable safety profile.
In March 2022, the FDA approved Pluvicto for adult patients with advanced PSMA-positive mCRPC that has spread to <a target="_blank" href="https://www.benzinga.com/general/biotech/22/03/26274467/fda-approves-novartis-pluvicto-as-first-targeted-radioligand-therapy-for-prostate-cancer" rel="noreferrer noopener">other body parts (metastatic)</a>.
These patients have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).
Novartis is investigating Pluvicto in earlier stages of the disease, including metastatic hormone-sensitive prostate cancer (PSMAddition) and oligometastatic prostate cancer (PSMA-DC).
Price Action: NVS stock is up 0.81% at $112.30 at the last check Friday.
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FDA OKs Novartis Prostate Cancer Treatment, Triples Eligible Patient Pool

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GeminiBio Appoints Mike Stella to Board

Novartis data presentations at AAAAI and AAD underscore commitment to advancing treatment of hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU)

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) - the first and only treatment approved in C3 glomerulopathy (C3G)

The Radoff-JEC Group Nominates Three Highly Qualified Candidates for Election to the Atea Pharmaceuticals Board of Directors

Global Radiotherapy Market Expected to Reach $9.62 Billion By 2030 Realizing Growth Due to Technological Advancements

Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN)

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