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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.

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'FDA Clears First Blood Test Used In Diagnosing Alzheimer's Disease; New Test Provides Less Invasive Option, Reduces Reliance On Pet Scans And Increases Diagnosis Accessibility' - FDA

In a move that indicates faith in the resurgence of global equities, Lazard Asset Management has transformed its International Equity Advantage mutual fund into<a href="https://www.benzinga.com/etfs"> actively managed ETF</a>, the Lazard International Dynamic Equity Fund (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IEQ#NYSE">IEQ</a>). With this, IEQ joins Lazard&#8217;s theme- and region-based ETF suite that includes the Equity Megatrends ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THMZ#NASDAQ">THMZ</a>), Japanese Equity ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JPY#NASDAQ">JPY</a>), and Next Gen Technologies ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TEKY#NASDAQ">TEKY</a>).
Also Read:<a href="https://www.benzinga.com/etfs/specialty-etfs/25/05/45297474/imtm-etf-tanks-then-soars-why-global-momentum-is-making-a-comeback"> IMTM ETF Tanks, Then Soars: Why Global Momentum Is Making A Comeback</a>
Launched on Monday, IEQ is not starting from zero. It inherits both the history and portfolio DNA of its mutual fund ancestor, now in the slick, low-cost, and tax-efficient wrapper increasingly favored by investors. The ETF launched with $31.1 million in assets and an expense ratio of 0.40%.
IEQ follows the MSCI All Country World ex-US Index (ACWI ex-US) as its benchmark but seeks to outperform it, not merely replicate it. The fund uses a quantitatively oriented process that combines machine intelligence with fundamental research to create a concentrated, high-conviction portfolio of non-U.S. stocks.
The fund&#8217;s strategy resists temptation to lean too heavily in any one direction of investment. Rather, Lazard&#8217;s team regularly assesses companies on the basis of valuation, growth, quality, and the way markets are thinking about them.
Rob Forsyth, Lazard's Global Head of ETFs, sees the &#8220;pendulum swing back toward international equities,&#8221; and investors are taking notice.
Additionally, Lazard Chief Market Strategist Ronald Temple sees a &#8220;world of opportunity&#8221; outside of the U.S., according to Bloomberg.
IEQ's portfolio includes global powerhouses such as TSMC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TSM#NYSE">TSM</a>), Iberdrola (OTCPK: IBDRY), Novartis (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Alibaba (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BABA#NYSE">BABA</a>), and Tencent (OTCPK: TCEHY), offering exposure across key regions and sectors.
As the ETF market starts to sizzle and international shares return to favour with investors, Lazard is betting that an experienced international strategy with a technology-driven twist is precisely what the market needed. IEQ might be a new ticker tape name, but the strategy playbook that underlies it has been rigorously stress-tested through market cycles — and now it&#8217;s taking it global.
Read Next: 
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<li><a href="https://www.benzinga.com/etfs/new-etfs/25/05/45446558/new-innovator-etf-targets-rolling-downside-protection-with-up-to-50-equity-upside">New Innovator ETF Targets Rolling Downside Protection With Up To 50% Equity Upside</a></li>
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Lazard Transforms Mutual Fund Into IEQ ETF Amid Rising Demand For International Stocks

Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced on Wednesday that it will invest at least $20 billion in the <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">U.S. through 2030</a>.
Research and development, plus U.S. manufacturing, will receive the bulk of the spending.
The company also expects higher job creation within the communities where Sanofi and its partners are located, which will help <a href="https://www.benzinga.com/pressreleases/25/05/n45414947/sanofi-to-invest-at-least-20-billion-in-the-us-through-2030-growing-investments-in-science-and-exp" target="_blank" rel="noreferrer noopener">enhance the U.S. supply chain</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44981281/french-drugmaker-sanofi-clocks-20-q1-profit-growth-forecasts-strong-rebound-in-annual-profit" rel="noreferrer noopener">French Drugmaker Sanofi Clocks 20% Q1 Profit Growth, Forecasts Strong Rebound In Annual Profit</a>
Sanofi has 13,000 US-based employees, according to CEO Paul Hudson.
&#8220;Our expected investments in the US will be substantial and will help ensure the production of key medicines in the U.S.,&#8221; he added.
Sanofi also expects to partner with other domestic manufacturers to help ensure the production of medicines in the U.S.  
Earlier in May, U.S. President&nbsp;Donald Trump's&nbsp;signed an executive order to promote prescription drug manufacturing in the U.S., streamlining the path for companies to build new production sites as potential tariffs on&nbsp;<a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">imported medicines loom</a>.
The White House wants facilities to come on board at a faster rate. It <a href="https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" target="_blank" rel="noreferrer noopener">estimates</a> that it can currently take five to 10 years to build new pharmaceutical manufacturing capacity, which it calls "unacceptable from a national-security standpoint.&#8221;
It&#8217;s not just Sanofi. <a href="https://www.benzinga.com/25/05/45234032/fda-expands-surprise-inspections-at-foreign-drug-and-food-facilities-targets-double-standards-in-overseas-manufacturing-oversight" target="_blank" rel="noreferrer noopener">Amid tariff uncertainty</a>, many drug companies are investing to boost production within the U.S.:
<ul class="wp-block-list">
<li>Eli Lilly And Co&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) doubled&nbsp;<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">domestic medicine production</a>.</li>
<li>Thermo Fisher Scientific Inc.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TMO#NYSE">TMO</a>) announced it would invest an additional $2 billion in the U.S. over&nbsp;<a href="https://www.benzinga.com/general/health-care/25/04/44995428/thermo-fisher-doubles-down-on-us-manufacturing-in-2b-expansion-plan" target="_blank" rel="noreferrer noopener">the next four years</a>.</li>
<li>Medtech firm&nbsp;Becton, Dickinson, and Company&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BDX#NYSE">BDX</a>) also announced its intention to invest&nbsp;$2.5 billion&nbsp;in U.S. manufacturing capacity&nbsp;<a href="https://www.benzinga.com/general/health-care/25/05/45140102/potential-tariff-bites-into-becton-dickinson-2025-profit-outlook-company-will-invest-2-5-billion-to-boost-us-manufacturing" target="_blank" rel="noreferrer noopener">over the next 5 years</a>.</li>
<li>Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>)  seeks to nearly double its manufacturing capacity through a new agreement with <a href="https://www.benzinga.com/general/biotech/25/04/44931246/regeneron-partners-with-japan-based-fujifilm-to-bolster-us-manufacturing-capacity-via-3-billion-deal" target="_blank" rel="noreferrer noopener">FUJIFILM Diosynth Biotechnologies</a>.</li>
<li>Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) unveiled a $23 billion investment plan to expand 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-uncertaint" target="_blank" rel="noreferrer noopener">over the next five years</a>.</li>
<li>Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) 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>.</li>
<li>Roche Holdings AG&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>)&nbsp;announced that it will invest $50 billion in the U.S. over&nbsp;<a href="https://www.benzinga.com/topic/pharmaceuticals" target="_blank" rel="noreferrer noopener">the next five years.</a></li>
<li>Bristol-Myers Squibb &amp; Co.'s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>)&nbsp;Christopher Boerner, chair and chief executive officer,&nbsp;<a href="https://www.statnews.com/2025/05/05/bristol-myers-squibb-pharmaceutical-policy-us-trump-administration-innovation-tariffs/?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" target="_blank" rel="noreferrer noopener">shared</a>&nbsp;plans to invest $40 billion in U.S. R&amp;D, technology, and manufacturing over the next five years in an op-ed published by Statnews.</li>
</ul>
Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) is one pharma company that did not highlight investments in new manufacturing plants. The company noted that they already have significant capacity and flexibility to manufacture <a href="https://www.benzinga.com/general/biotech/25/04/45118145/pfizer-ceo-albert-bourla-emphasizes-national-security-in-us-drug-manufacturing" target="_blank" rel="noreferrer noopener">products in the U.S</a>.
Price Action: Sanofi stock is down 1.53% at $49.20 at the last check on Wednesday.
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<li><a href="https://www.benzinga.com/general/biotech/25/05/45407486/novo-nordisk-inks-22-billion-deal-with-septerna-to-develop-oral-weight-loss-and-diabetes-drugs" target="_blank" rel="noreferrer noopener">Novo Nordisk Inks $2.2 Billion Deal With Septerna To Develop Oral Weight Loss And Diabetes Drugs</a></li>
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Sanofi To Navigate Tariff Impact With $20 Billion In Spending Through 2030

On May 11, 2025, Incyte Corporation (the "Company") and Novartis Pharma AG ("Novartis") entered into a settlement agreement (the "Settlement Agreement") with respect to litigation initiated by Novartis and relating to the duration of royalty payments owed by the Company to Novartis under the Collaboration and License Agreement dated November 24, 2009, as amended, between the Company and Novartis. As of March 31, 2025, the Company had approximately $537.1 million of accrued royalties relating to the dispute with Novartis included in accrued and other current liabilities on the Company's condensed consolidated balance sheet. Under the Settlement Agreement, the Company has agreed to pay to Novartis $280.0 million as the settlement of disputed royalties on net sales of JAKAFI in the United States through December 31, 2024, and the parties agreed to reduce by 50% the royalty rate payable by the Company on future net sales of JAKAFI in the United States beginning January 1, 2025 for a period defined in the Settlement Agreement. The reduced royalty payable for the quarter ended March 31, 2025, is approximately $14.9 million. The difference of $242.2 million between the total accrued royalties and the total amount to be paid by the Company to Novartis as disclosed above will be recorded in the Company's condensed consolidated statement of operations for the quarter ending June 30, 2025.

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Incyte And Novartis Settle Royalty Dispute With $280M Payment And 50% Reduction In Future JAKAFI U.S. Royalties, Resolving Litigation Over 2009 Collaboration Agreement And Releasing $242.2M In Accrued Liabilities

Protagonist Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTGX#NASDAQ">PTGX</a>), in collaboration with Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), released new clinical data from the Phase 3 ICONIC-TOTAL&nbsp;study investigating icotrokinra for <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">scalp and genital psoriasis</a>.
Key findings from the high-impact skin sites cohort:
<ul class="wp-block-list">
<li>At week 16, 57% of patients treated with once daily icotrokinra achieved the study&#8217;s primary endpoint with an Investigator&#8217;s Global Assessment (IGA)&nbsp;b&nbsp;score of 0/1 (clear or almost clear skin) and a ≥2-grade improvement from baseline at Week 16 compared to 6% of <a href="https://www.benzinga.com/pressreleases/25/05/ac45315482/protagonist-announces-icotrokinra-phase-3-data-on-difficult-to-treat-scalp-and-genital-psoriasis-" target="_blank" rel="noreferrer noopener">patients receiving placebo</a>.</li>
<li>66% of patients with scalp psoriasis achieved a scalp-specific Investigator&#8217;s Global Assessment (ss-IGA)&nbsp;c&nbsp;score of 0/1 compared to 11% receiving placebo at 16 weeks.</li>
<li>77% of patients with genital psoriasis achieved a static Physician&#8217;s Global Assessment of Genitalia (sPGA-G)&nbsp;d&nbsp;score of 0/1 at 16 weeks, compared to 21% receiving placebo.</li>
<li>In the smaller subset of patients with hand/foot psoriasis, patients showed a numerically higher rate of skin clearance at Week 16, with 42% achieving a hand and/or foot Physician&#8217;s Global Assessment (hf-PGA)&nbsp;e&nbsp;score of 0/1 compared to 26% receiving placebo.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44737545/johnson-johnson-protagonist-partnered-investigational-psoriasis-oral-pill-shows-75-of-adolescents-achieved-completely-clear-skin" rel="noreferrer noopener">Johnson &amp; Johnson, Protagonist Tout Positive Results For Psoriasis Oral Pill Study</a>
In March, the companies announced topline results from ANTHEM-UC Phase 2b study of icotrokinra (JNJ-2113) in adults with moderately to severely active&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44220449/why-is-protagonist-therapeutics-stock-trading-higher-on-monday" rel="noreferrer noopener">ulcerative colitis (UC)</a>.
The study met its primary endpoint of clinical response&nbsp;in all icotrokinra dose groups evaluated.
Additionally, the study demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/ac44217207/protagonist-reports-positive-top-line-results-from-phase-2b-study-of-icotrokinra-showing-potentia" rel="noreferrer noopener">improvement at Week 12</a>.
The company also shared preclinical characterization of PN-881, the first-in-class oral peptide antagonist blocking the three dimeric forms of IL-17 (AA, AF and FF), at the Society for Investigative Dermatology (SID) Annual Meeting.
PN-881 represents Protagonist&#8217;s next generation of oral peptides for psoriasis. Key takeaways:
<ul class="wp-block-list">
<li>Exhibited nanomolar to picomolar in vitro potency comparable to UCB 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>) Bimzelx (bimekizumab) and superior (70-fold) to Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Consentyx secukinumab.</li>
<li>Showed metabolic stability in several matrices across several species, making it a suitable candidate for oral delivery.</li>
<li>Demonstrated PD-based target engagement in a mouse IL-17 challenge model after oral dosing.</li>
<li>Demonstrated dose-dependent efficacy with significant reduction in skin thickness in a 5-day rat IL-23 induced skin inflammation model after oral dosing.</li>
</ul>
Price Action: PTGX stock is up 1.87% at $44.74 at the last check on Friday.
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Protagonist/Johnson & Johnson Partnered Drug Shows Significant Skin Clearance In Pivotal Psoriasis Study

The U.S. Food and Drug Administration (FDA) announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">American consumers and patients</a>.
This change builds upon the agency&#8217;s Office of Inspection and Investigations&#8217; Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.&nbsp;
&#8220;For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning,&#8221; said FDA Commissioner Martin Makary. &nbsp;
On Tuesday, the FDA <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities?utm_medium=email&amp;utm_source=govdelivery" rel="noreferrer noopener">said</a> it plans to review and improve its foreign inspection program to ensure it meets the highest standards for oversight. Part of this effort includes making it clear that FDA inspectors should not accept travel-related perks like hotel stays or transportation from the companies they inspect.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/05/45225204/iqvia-beats-q1-earnings-expectations-despite-sector-uncertainty-company-navigating-market-conditions-effectively-says-ceo" rel="noreferrer noopener">IQVIA Beats Q1 Earnings Expectations Despite Sector Uncertainty, Company Navigating Market Conditions &#8216;Effectively&#8217; Says CEO</a>
The FDA conducts about 12,000 inspections annually in the U.S. and 3,000 in other countries. While U.S. companies often get surprise inspections, foreign companies usually receive advanced notice, giving them time to prepare and potentially hide problems.
Still, foreign inspections often reveal serious issues, more than twice as often as domestic ones.
In the U.S., inspections are usually unannounced unless specific programs require advance notice to ensure staff and records are available.
Even then, companies can&#8217;t pick the date or time. The FDA says foreign companies shouldn&#8217;t have that option either.
By shifting to more surprise inspections abroad, the FDA aims to better protect American consumers by catching dishonest practices, like falsifying records or hiding violations, before they cause harm.
The agency can take action against any company that tries to delay, block, or refuse an unannounced inspection.
The update follows President&nbsp;Donald Trump&#8217;s signed executive order on Monday to promote prescription drug manufacturing in the U.S., streamlining the path for companies to build new production sites as potential tariffs on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">imported medicines loom</a>.
The order directs the FDA to reduce the amount of time it takes to approve manufacturing plants in the U.S. by eliminating unnecessary requirements, streamlining reviews, and working with domestic drugmakers to &#8220;provide early support before facilities come online,&#8221; <a target="_blank" href="https://www.whitehouse.gov/fact-sheets/2025/05/fact-sheet-president-donald-j-trump-announces-actions-to-reduce-regulatory-barriers-to-domestic-pharmaceutical-manufacturing/" rel="noreferrer noopener">according</a> to&nbsp;a White House fact sheet.
It also directs the agency to raise inspection fees for foreign manufacturing plants, improve the enforcement of active-ingredient source reporting by overseas producers, and consider publicly listing facilities that don&#8217;t comply.
The White House <a target="_blank" href="https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/" rel="noreferrer noopener">estimates</a> that it can currently take five to ten years to build new pharmaceutical manufacturing capacity, which it calls &#8220;unacceptable from a national-security standpoint.&#8221;
<a target="_blank" href="https://www.benzinga.com/markets/25/02/43906811/trump-reportedly-warns-big-pharma-move-manufacturing-to-us-or-face-tariffs" rel="noreferrer noopener">Amid tariff uncertainty</a>, many companies have disclosed a wave of investments in recent months to boost production in the U.S.
<ul>
<li>Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) doubled <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">domestic medicine production</a>.</li>
<li>Thermo Fisher Scientific Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TMO#NYSE">TMO</a>) announced it would invest an additional $2 billion in the U.S. over <a href="https://www.benzinga.com/general/health-care/25/04/44995428/thermo-fisher-doubles-down-on-us-manufacturing-in-2b-expansion-plan" target="_blank" rel="noreferrer noopener">the next four years</a>.</li>
<li>Medtech firm Becton, Dickinson, and Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BDX#NYSE">BDX</a>) also announced its intention to invest $2.5 billion in U.S. manufacturing capacity <a href="https://www.benzinga.com/general/health-care/25/05/45140102/potential-tariff-bites-into-becton-dickinson-2025-profit-outlook-company-will-invest-2-5-billion-to-boost-us-manufacturing" target="_blank" rel="noreferrer noopener">over the next 5 years</a>.</li>
<li>Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) did not highlight investments in new manufacturing plants; it noted that they already have significant capacity and flexibility to manufacture <a href="https://www.benzinga.com/general/biotech/25/04/45118145/pfizer-ceo-albert-bourla-emphasizes-national-security-in-us-drug-manufacturing" target="_blank" rel="noreferrer noopener">their products in the U.S</a>.</li>
<li>Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) seeks to nearly double its manufacturing capacity through a new agreement with <a href="https://www.benzinga.com/general/biotech/25/04/44931246/regeneron-partners-with-japan-based-fujifilm-to-bolster-us-manufacturing-capacity-via-3-billion-deal" target="_blank" rel="noreferrer noopener">FUJIFILM Diosynth Biotechnologies</a>.</li>
<li>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-uncertaint" target="_blank" rel="noreferrer noopener">over the next five years</a>.</li>
<li>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>.</li>
<li>Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) announced that it will invest $50 billion in the U.S. over <a href="https://www.benzinga.com/topic/pharmaceuticals" target="_blank" rel="noreferrer noopener">the next five years.</a></li>
<li>Most recently, Bristol-Myers Squibb &amp; Co.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Christopher Boerner, chair and chief executive officer, <a href="https://www.statnews.com/2025/05/05/bristol-myers-squibb-pharmaceutical-policy-us-trump-administration-innovation-tariffs/" target="_blank" rel="noreferrer noopener">shared</a> plans to invest $40 billion in U.S. R&amp;D, technology, and manufacturing over the next five years in an op-ed published by Stat this week.</li>
</ul>
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</ul>
Photo by Tada Images via Shutterstock

Government

Regulations

FDA Expands Surprise Inspections At Foreign Drug And Food Facilities, Targets Double Standards In Overseas Manufacturing Oversight

BioNTech SE&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>)&nbsp;on Monday reported a first-quarter per-share loss of $1.82 (1.73 euros), up from 1.31 euros reported a year ago compared to beating <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">the consensus of $2.02</a>.
The COVID-19 vaccine maker reported sales of $192.23 million (182 million euros), compared to 187 million euros, beating&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/g45190192/biontech-announces-first-quarter-2025-financial-results-and-corporate-update" rel="noreferrer noopener">the consensus of $177.40 million</a>.
Revenues during the first quarter of 2025 were mainly driven by revenues derived from BioNTech&#8217;s COVID-19 vaccine collaboration.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44535393/european-patent-office-rules-vaccine-developer-curevacs-amended-patent-valid-stock-jumps" rel="noreferrer noopener">European Patent Office Rules Vaccine Developer CureVac&#8217;s Amended Patent Valid, Stock Jumps</a>
&#8220;Our revenues for the first quarter reflect the seasonal demand for COVID-19 vaccines and are in line with our expectations,&#8221;&nbsp;said Jens Holstein, CFO of BioNTech. &#8220;BioNTech&#8217;s robust financial position empowers us to pursue our strategic goal of evolving into a leading biotech company with multiple oncology products by 2030.&#8221;
Cost of sales was 83.8&nbsp;million euros compared to 59.1&nbsp;million&nbsp;a year ago, mainly due to a positive impact of an inventory revaluation in the first quarter of 2024.
Research and development expenses were 525.6&nbsp;million euros compared to 507.5&nbsp;million euros a year ago. The increase was mainly driven by progressing late-stage clinical studies for candidates in BioNTech&#8217;s ADC and antibody portfolio.
Cash and cash equivalents plus security investments&nbsp;as of March&nbsp;31, 2025, reached 15.85 billion euros.
<h2 class="wp-block-heading">CFO Appointment</h2>
BioNTech appointed Ramón Zapata-Gomez to the Management Board on Monday as Chief Financial Officer, effective July 1, 2025. He will join BioNTech from Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) global biomedical research organization, where he has been serving as CFO since 2022. Ramón Zapata will succeed Jens Holstein, who, as previously planned and announced, will retire at the end of his term <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/g45189869/biontech-announces-appointment-of-ram-n-zapata-to-management-board-as-chief-financial-officer" rel="noreferrer noopener">on June 30, 2025</a>.
<h2 class="wp-block-heading">Guidance For 2025</h2>
BioNTech <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44220746/pfizers-covid-19-shot-partner-biontech-reports-q4-profit-but-2025-guidance-falls-short-on-expectations" rel="noreferrer noopener">reaffirmed its fiscal year 2025</a> guidance of 1.7 billion-2.2 billion euros compared to the consensus of 2.08 billion euros and revenue phasing similar to 2024, primarily concentrated in the last three to four months, driving the full-year revenue figure. The revenue guidance assumes:
<ul>
<li>Relatively stable vaccination rates, pricing levels, and market share compared to 2024.</li>
<li>Estimated inventory write-downs and other charges by BioNTech&#8217;s collaboration partner Pfizer Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) that negatively influence BioNTech&#8217;s revenues.</li>
<li>Anticipated revenues from a pandemic preparedness contract with the German government.</li>
<li>Anticipated revenues from the BioNTech Group service businesses.</li>
<li>Potential changes to the law or governmental policy, including tariffs, public health policy, and evolving public sentiment worldwide, could further negatively impact our anticipated revenues and expenses.</li>
</ul>
BioNTech expects to focus investments on R&amp;D and scaling the business for late-stage development and commercial readiness in oncology while remaining cost-disciplined.
As part of BioNTech&#8217;s strategy, the Company may continue to evaluate appropriate corporate development opportunities to drive sustainable long-term growth and create future value.
Price Action: BNTX stock is down 3.65% at $101.11 at the last check Monday.
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</ul>
Photo Marcus Krauss via Shutterstock

Earnings

Guidance

Management

BNTX

BioNTech Appoints Novartis Executive As Finance Chief, Reaffirms 2025 Outlook Focusing on Oncology Expansion

Humana Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HUM#NYSE">HUM</a>) on Wednesday posted a first-quarter adjusted EPS of $11.58, up from $7.23 a year ago,&nbsp;beating the <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $10.07</a>.
Humana sales increased from $29.6 billion to $32.11 billion, slightly missing the <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/b45093637/humana-reports-first-quarter-2025-financial-results-affirms-full-year-2025-adjusted-financial-guid" rel="noreferrer noopener">consensus of $32.22 billion</a>.
The revenue was driven by higher per-member Medicare and state-based contract premiums. The Medicare increase was primarily driven by an increased direct subsidy due to the Inflation Reduction Act (IRA) and membership growth in the company&#8217;s stand-alone PDP and state-based contracts businesses.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/04/44927473/despite-medicaid-pressure-elevance-health-delivers-strong-q1-performance-reiterates-profit-outlook" rel="noreferrer noopener">Despite Medicaid Pressure, Elevance Health Delivers Strong Q1 Performance, Reiterates Profit Outlook</a>
Humana&nbsp;ended the first quarter with 14.84 million in total medical membership, down from 16.35 million in December 2024 and 16.17 million in March 2024. Individual Medicare Advantage membership&nbsp;<a target="_blank" href="https://humana.gcs-web.com/static-files/ef339ddf-83f9-4333-8f2d-4f97fe1e4bcb" rel="noreferrer noopener">reached</a> 5.22 million, down from 5.55 million a year ago.
1Q25 Insurance segment benefit ratio of 87.4% aligns with the previously disclosed expectation of approximately 87.5%.
In its prepared remarks, the company <a target="_blank" href="https://humana.gcs-web.com/static-files/04e1ec5b-ef37-44fc-bf21-0b5d2d6ac304" rel="noreferrer noopener">said</a>, &#8220;We are pleased with a solid start to 2025. Our first quarter Insurance segment benefit ratio of 87.4% reflects medical cost trends that developed in line with our expectations.&#8221;
The company states, &#8220;We remain committed to achieving an individual Medicare Advantage (MA) pretax margin of &#8216;at least 3%&#8217; over time and remain confident in our expectation that our 2025 MA pricing will drive the intended underlying margin improvement.&#8221;
Guidance: Humana expects 2025 GAAP sales of $126 billion-$128 billion versus the <a target="_blank" href="https://www.benzinga.com/25/02/43621782/insurance-giant-humanas-q4-earnings-at-par-with-estimates-2025-profit-outlook-falls-below-street-view" rel="noreferrer noopener">consensus of $126.21 billion</a>.
Sales guidance includes insurance segment sales of $121 billion—$123 billion and center-well segment sales of $20.5 billion—$21.5 billion.
The company said CenterWell Pharmacy was selected as the fulfillment pharmacy for NovoCare Pharmacy, operated by Novo Nordisk A/S&#8217; (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) weight loss medication for cash-pay customers.
The insurer expects an annual membership decline of approximately 550,000 for individual Medicare Advantage, including the company&#8217;s decision to exit certain unprofitable plans and counties. Group Medicare Advantage will remain relatively flat, and Medicare stand-alone PDP growth will be approximately 200,000.
Humana reaffirms the 2025 adjusted EPS outlook of $16.25 versus the consensus of $16.35.
For 2025, Humana expects its insurance segment&#8217;s benefit ratio guidance of approximately 90.1-90.5%.
The company added, &#8220;Looking ahead, the 2026 final MA rate notice better reflects the medical cost trend environment and should enable greater stability within the industry as it serves the 34 million seniors who rely on the MA program.&#8221;
Price Action: HUM stock is down 0.80% at $257.28 at the last check on Wednesday.
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</ul>
Photo by T. Schneider via Shutterstock

Humana Does Not Alter 2025 Outlook Despite Sales Miss And Medicare Membership Decline

Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) agreed to acquire Regulus Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGLS#NASDAQ">RGLS</a>) on Wednesday for an initial payment of $7.00 per share in <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">cash or $0.8 billion</a>.
The upfront cash portion of the consideration represents a premium of 274% to Regulus&#8217; 60-day volume-weighted average stock price and 108% to Regulus&#8217; closing <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/n45095629/regulus-therapeutics-enters-into-agreement-to-be-acquired-by-novartis-ag" rel="noreferrer noopener">price on&nbsp;April 29, 2025</a>.
Regulus is a clinical-stage biopharmaceutical company developing microRNA therapeutics for severe renal disease and autosomal dominant polycystic kidney disease (ADPKD).
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/45075714/novartis-q1-earnings-beat-street-view-ceo-confident-to-deliver-upgraded-2025-guidance" rel="noreferrer noopener">Novartis Q1 Earnings Beat Street View, CEO &#8216;Confident&#8217; In Delivering Upgraded Guidance</a>
The lead asset for ADPKD, farabursen, is a novel, next-generation oligonucleotide targeting miR-17 that recently completed a Phase 1b multiple-ascending dose clinical trial.
In addition, Regulus shareholders will receive a contingent value right (CVR) providing for payment of&nbsp;$7.00&nbsp;per share, contingent upon the achievement of a milestone regarding the regulatory approval of Regulus&#8217; lead product candidate, farabursen.
If the milestone is achieved, total consideration, including the CVR, would be approximately&nbsp;$1.7 billion.
The transaction is expected to close in the second half of 2025. Regulus will continue to operate as a separate and independent company.
In March, Regulus Therapeutics released topline results from all patients in the fourth cohort in its Phase&nbsp;1b&nbsp;MAD study of farabursen <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44519887/regulus-therapeutics-stock-shoots-higher-after-positive-results-from-investigational-drug-for-rare-type-of-kidney-disease" rel="noreferrer noopener">(RGLS8429) for ADPKD</a>.
Cohort 4 data highlights:
<ul>
<li>Increases in urinary PC1 and PC2 levels were similar to cohort 3 and reached a similar level of statistical significance compared to placebo (PC1 p=0.026; PC2 p=0.014).</li>
<li>The mean htTKV growth rate over 4 months was 0.05%, while placebo subjects in the trial experienced a mean growth rate of 2.58%.</li>
<li>Changes in htTKV were highly correlated with changes in renal cyst volume, suggesting farabursen directly impacts disease progression by limiting abnormal cyst growth.</li>
</ul>
Novartis strengthened its kidney disease portfolio after the U.S. Food and Drug Administration (FDA) granted accelerated approval for&nbsp;Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44631273/novartis-secures-third-fda-approval-for-its-kidney-disease-portfolio-in-one-year" rel="noreferrer noopener">rapid disease progression</a>.
This is Novartis' third U.S. approval for its kidney disease portfolio in the last year. Fabhalta&nbsp;was granted FDA approval in&nbsp;<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>&nbsp;and accelerated approval in&nbsp;<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>.
Price Action: RGLS stock is up 132.9% at $7.85 during the premarket session at the last check Wednesday.
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Photo: Shutterstock

RGLS

Novartis To Buy US Kidney Drug Developer Regulus Therapeutics For Around $800 Million

Regulus Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGLS#NASDAQ">RGLS</a>), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that it has entered into an agreement and plan of merger with Novartis AG ("Novartis") and an indirectly wholly owned subsidiary of Novartis, pursuant to which Novartis will acquire Regulus for an initial payment of $7.00 per share in cash at closing, or $0.8 billion. The upfront cash portion of the consideration represents a premium of 274 percent to Regulus' 60-day volume-weighted average stock price and 108 percent to Regulus' closing price on April 29, 2025. In addition, Regulus shareholders will receive a contingent value right (CVR) providing for payment of $7.00 per share, contingent upon the achievement of a milestone with respect to regulatory approval of Regulus' lead product candidate, farabursen. Total consideration including the CVR, if the milestone is achieved, would be approximately $1.7 billion. The transaction has been unanimously approved by the Boards of Directors of both companies.
Completion of the transaction is expected in the second half of 2025, subject to the satisfaction or waiver of customary closing conditions, including the tender of shares representing at least a majority of the total number of Regulus' outstanding shares, and other customary closing conditions and regulatory clearance. Until that time, Regulus will continue to operate as a separate and independent company.
&nbsp;

Novartis To Buy Regulus Therapeutics For $7.00/Shr In Cash, With Potential To Receive Addl $7.00/Shr In Cash Through Contingent Value Right, For Total Equity Value Of Up To About $1.7B

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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Image: Shutterstock

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%
<figure class="wp-block-table"> 
<table>
<tbody>
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<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>
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<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>
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<td class="has-text-align-center" data-align="center">Nasdaq 100</td>
<td class="has-text-align-center" data-align="center">0.21%</td>
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<td class="has-text-align-center" data-align="center">Russell 2000</td>
<td class="has-text-align-center" data-align="center">0.19%</td>
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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.
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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.
<figure class="wp-block-table"> 
<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. 
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
<div class="wp-block-embed__wrapper">
<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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<li><a href="https://www.benzinga.com/media/25/04/45058018/trumps-145-china-tariffs-spark-seller-backlash-as-amazon-prime-day-2025-faces-pullouts-and-discount-cuts-report" target="_blank" rel="noreferrer noopener">Trump's 145% China Tariffs Spark Seller Backlash As Amazon Prime Day 2025 Faces Pullouts And Discount Cuts: Report</a></li>
</ul>
Photo courtesy: Frontpage / Shutterstock.com

Analyst Color

Equities

Economics

Markets

AAPL

ABBV

AMZN

MSFT

NXPI

SCHW

WELL

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: 
<ul>
<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

SANM

SBUX

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

ACGL

AEYE

AMSF

APAM

ARCB

ARCC

ASTE

ASTL

ATRC

BBIO

BBVA

BGFV

BKNG

BRSP

CECO

CHCT

CLVT

CSGP

CVLT

DHIL

ENSG

ENVA

ESRT

ETWO

EXLS

FELE

FFIC

FIBK

FICO

FOUR

FRSH

FRST

FSLR

FYBR

HLMN

HOUS

HRZN

HSBC

HURN

ILPT

INTZ

JAKK

JBGS

JBLU

KNSA

LFUS

LGIH

Laboratory Corporation Of America Holdings

LOGI

LXFR

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>.
Read Next:
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<li><a href="https://www.benzinga.com/news/asset-sales/25/04/44929060/boeing-finalizes-10-55-billion-deal-to-divest-jeppesen-and-foreflight-assets" target="_blank" rel="noreferrer noopener">Boeing Finalizes $10.55 Billion Deal To Divest Jeppesen And ForeFlight Assets</a></li>
</ul>
Photo: Gorodenkoff/Shutterstock

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.

Press Releases

Ratio Enters License and Collaboration Agreement with Novartis for SSTR2-targeting Radiotherapeutic Candidate

PTC Therapeutics Enters into a Global License and Collaboration Agreement with Novartis for PTC518 Huntington's Disease Program

Promising Data for Treating Gastrointestinal Cancer Leading to Hopeful Advancements for Pancreatic & Anal Cancers

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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