에 대한 최신 뉴스 Nuveen ESG Large-Cap ETF (BATS:NULC)

Technology

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Consumer Cyclical

Industrials

Consumer Defensive

Energy

Basic Materials

Real Estate

Utilities

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Under normal market conditions, the fund invests at least 80% of the sum of its net assets and the amount of any borrowings for investment purposes in component securities of the index. The index selects from the securities included in the MSCI USA Index, which generally consists of large-and mid-capitalization U.S. equity securities that exhibit overall growth style characteristics.

Microsoft Corp

NVIDIA Corporation

Alphabet Inc

Eli Lilly & Co.

Visa Inc

Mastercard Incorporated Class

Coca Cola Co.

International Business Machines Corp.

S&P Global Inc

Walt Disney Co

Nuveen ESG Large-Cap ETF

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Capital One Deal For Discover Clears Justice Department Hurdle

Market analysts say President Donald Trump's newly announced global tariff regime is already reshaping investor sentiment, triggering sharp corrections <a href="https://www.benzinga.com/markets/cryptocurrency/25/04/44625640/anthony-pompliano-praises-trumps-tariffs-as-catalyst-for-crypto-innovation">across risk assets—including crypto. </a>
While digital currencies initially showed some resilience, experts caution that they remain exposed to broader macroeconomic shocks.
Trump's April 2 speech, which introduced a "reciprocal tariff" program with baseline rates starting at 10% and scaling up to 50% by April 9, caused immediate <a href="https://www.benzinga.com/25/04/44622346/trumps-reciprocal-tariff-math-a-masterclass-in-economic-absurdity">volatility in financial markets</a>.
Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) has dipped below $82,000, while U.S. equity futures and global ETFs slid.
Trump described the move as a "Declaration of Economic Independence," aimed at rebalancing global trade dynamics.
According to David Hernandez, a crypto investment specialist at 21Shares, the tariffs removed some ambiguity around U.S. trade policy but raised new concerns. 
"Markets thrive on clarity, and now that the scope is known, we may see institutions buy the dip," he said. "Still, the announcement rattled equities and crypto alike. Bitcoin held above key support at $82,000 but couldn't avoid broader risk-off pressure."
James Toledano, COO at Unity Wallet, observed that crypto wasn't immune to the impact. 
"Bitcoin is down 4.9% on the week, holding around $82,000," he said. "This shows that in the early stages of global instability, digital assets behave more like tech stocks than safe havens."
Also Read: <a href="https://www.benzinga.com/markets/cryptocurrency/25/04/44628685/bitcoin-is-a-realistic-global-reserve-asset-experts-say">Bitcoin Is A Realistic Global Reserve Asset, Experts Say</a>
Toledano added that if the situation escalates into a prolonged economic standoff, crypto could gain renewed appeal. "We're not at safe haven status yet, but if confidence in fiat wavers, Bitcoin might decouple over time."
Javier Rodriguez-Alarcon, Chief Commercial Officer at XBTO, echoed that view, noting the correlation between Bitcoin and traditional markets during moments of high volatility. "Bitcoin still trades like a risk asset during policy shocks. That doesn't negate its long-term potential, but the narrative as a hedge is still maturing."
He added that as digital assets gain wider institutional traction, future dislocations may see crypto react differently. 
For now, however, "the sell-off shows crypto is still subject to the same sentiment-driven dynamics that move traditional finance."
Despite these headwinds, Hernandez noted that institutional inflows into Bitcoin ETFs remained steady, suggesting some investors may view the dip as an entry point. 
"The market reaction underscores Bitcoin's borderless appeal in hedging against geopolitical uncertainty," he said.
With key U.S. trading partners expected to respond in the coming days, including China, South Korea, and Mexico, analysts say further volatility is likely across all asset classes—crypto included.
Read Next: 
<ul>
<li><a href="https://www.benzinga.com/markets/cryptocurrency/25/04/44627407/gold-overtaking-bitcoin-in-inflation-hedge-strategy-jpmorgan-says">Gold Overtaking Bitcoin In Inflation Hedge Strategy, JPMorgan Says</a></li>
</ul>
Image created using artificial intelligence with Midjourney.

Coverage of Bitcoin, Etherum, Ripple and all the latest digital currencies.

Cryptocurrency

$BTC

Bitcoin As Trump Tariff Safe Haven? Not Yet, But 'Might Decouple Over Time,' Expert Says

Dutch advanced chipmaking equipment supplier ASML Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ASML#NASDAQ">ASML</a>) plans to quintuple its Japan-based maintenance staff for the machines in the next few years, Nikkei <a target="_blank" href="https://asia.nikkei.com/Business/Tech/Semiconductors/ASML-to-quintuple-advanced-EUV-chip-tools-staff-in-Japan" rel="noreferrer noopener">reported</a> Tuesday.
ASML manufactures extreme ultraviolet (EUV) lithography equipment for making advanced technology chips.
In December, Rapidus became the first Japanese chipmaker to receive EUV machines.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/02/43945751/huawei-boosts-ai-chip-production-despite-taiwan-semi-and-asml-ban-aims-to-challenge-nvidia-in-china" rel="noreferrer noopener">Huawei Boosts AI Chip Production Despite Taiwan Semi And ASML Ban, Aims to Challenge Nvidia In China</a>
Japan continues bolstering its advanced semiconductor technology position, as in the U.S., Europe, and China.
Japanese multinational investment holding company Softbank Group Corp (OTC:<a class="ticker" href="https://www.benzinga.com/stock/SFTBY#OTC">SFTBY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/SFTBF#OTC">SFTBF</a>) is <a target="_blank" href="https://www.benzinga.com/media/25/04/44589685/softbank-weighs-165-billion-loan-that-could-back-openais-40-billion-raise-report" rel="noreferrer noopener">weighing a loan</a> of up to $16.5 billion to finance its&nbsp;U.S. artificial intelligence ambitions. The loan may help SoftBank lead a $40 billion&nbsp;funding round&nbsp;in OpenAI. The move values the ChatGPT parent&nbsp;at $300 billion.
Contract chipmaker Taiwan Semiconductor Manufacturing Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TSM#NYSE">TSM</a>) is expanding globally with <a target="_blank" href="https://www.benzinga.com/government/regulations/25/01/42843001/taiwan-semiconductor-ramps-up-production-in-japan-us-and-germany-to-diversify-away-from-china" rel="noreferrer noopener">plants in the U.S., Japan, and Germany</a>.
Meanwhile, ASML continues to gain traction, which is backed by the higher demand for semiconductor chips.
In March, ASML and imec forged a <a target="_blank" href="https://www.benzinga.com/markets/eurozone/25/03/44253751/asml-boosts-ai-chip-rd-in-europe-amid-us-sanctions-china-slowdown-and-subsidy-uncertainty" rel="noreferrer noopener">five-year deal</a> complemented by funding made available by the Chips Joint Undertaking, the Flemish government, and&nbsp;the Dutch government to boost semiconductor R&amp;D and sustainable innovation with EU and government backing to develop sub-2nm chips and advance AI-ready semiconductor solutions.
ASML Holding stock has plunged 34% in the last 12 months. The company disclosed in its&nbsp;annual report that the U.S. semiconductor sanctions on China hurt 2024 demand, with China making up 36% of its sales.
ASML customers slashed capital spending amid U.S. chip restrictions, impacting AI and semiconductor growth. Additionally, reports indicated President Donald Trump&#8217;s plans to scrap&nbsp;the U.S. CHIPS Act.
The EUV lithography market size was worth $10.09 billion in 2023 and is <a target="_blank" href="https://www.globenewswire.com/news-release/2025/03/21/3047088/0/en/Extreme-Ultraviolet-EUV-Lithography-Market-to-Hit-USD-35-70-billion-by-2032-Driven-by-Rising-Demand-for-Advanced-Semiconductor-Manufacturing-SNS-Insider.html" rel="noreferrer noopener">expected to reach</a> $35.70 Billion by 2032 and grow at a CAGR of 15.1% over the forecast period 2024-2032.
The growth potential reflects technological advancements, increasing semiconductor complexity, and the demand for smaller, more powerful chips. Industries like AI, high-performance computing, 5G, and IoT.
Price Action:&nbsp;ASML stock is down 4.55% at $638.55 at the last check on Thursday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/25/02/43938789/intel-deploys-asmls-advanced-euv-machines-aims-to-challenge-taiwan-semiconductors-lead" target="_blank" rel="noreferrer noopener">Intel Deploys ASML&#8217;s Advanced EUV Machines, Aims to Challenge Taiwan Semiconductor&#8217;s Lead</a></li>
</ul>
Photo via Shutterstock

Asia

Tech

Media

ASML

SFTBF

SFTBY

Chip Equipment Maker ASML To Boost Japan Workforce 5x Amid Global Race For Advanced Semiconductor Tech

OTIS

Live On CNBC: Josh Brown Buys OTIS

KinderCare Learning Companies Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KLC#NYSE">KLC</a>) is under fire Thursday following a <a href="https://thebearcave.substack.com/p/problems-at-kindercare-learning-companies">new report</a> from The Bear Cave, which alleges safety failures, regulatory concerns and a deteriorating reputation at the nation's <a href="https://www.benzinga.com/quote/KLC">largest private childcare provider</a>.
What Happened: The Bear Cave released a short report on KinderCare Thursday, alleging the company is plagued by operational failures that could threaten its stock performance.
"Recent investigations reveal alarming safety incidents, including children left unsupervised, instances of abuse and regulatory violations that raise serious concerns about KinderCare's ability to operate responsibly," the short seller said.
Benzinga has reached out to KinderCare Learnings Companies for comment on the report.
Read Also: <a href="https://www.benzinga.com/trading-ideas/technicals/25/04/44629335/apple-stock-slammed-by-trump-tariffs-is-a-death-cross-next">Apple Stock Slammed By Trump Tariffs: Is A Death Cross Next?</a>
KinderCare operates roughly 1,500 childcare centers across 41 states and relies heavily on government funding. The company went public in 2022, positioning itself as a leader in early childhood education.
The Bear Cave&#8217;s report cites troubling incidents, including a <a href="https://www.jsonline.com/story/communities/south/2024/11/20/cudahy-woman-pleads-guilty-in-oak-creek-kindercare-cocaine-case/76434101007/">case</a> where an 11-month-old tested positive for cocaine at a KinderCare center in Wisconsin. Other reports detail children <a href="https://wcti12.com/news/local/teachers-on-leave-after-toddler-wanders-onto-busy-road-from-daycare">escaping</a> facilities, being <a href="https://www.nbcnews.com/news/us-news/florida-mom-finds-toddler-locked-day-care-workers-left-day-rcna16918">locked</a> inside after closing hours and experiencing mistreatment by staff.
&#8220;In sum, The Bear Cave believes KinderCare is a broken business that harms the children and families it claims to help,&#8221; the short seller said.
The Bear Cave reported that KinderCare has faced repeated scrutiny from regulatory agencies. The short seller believes growing concerns could impact its ability to secure funding and expand operations.
The short seller also highlighted online complaints from parents and former employees, with some alleging understaffing, inadequate training and neglect.
KLC Price Action: <a href="http://benzinga.com/quote/klc">KinderCare shares</a> are falling by 10.8 % during Thursday&#8217;s session, trading at $11.40 at the time of publication. According to data from <a href="https://benzinga.grsm.io/register174">Benzinga Pro</a>, KinderCare has a 52-week high of $29.89 and a 52-week low of $10.91 after making new lows for the year in Thursday&#8217;s session.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/news/global/25/04/44628368/trumps-tariffs-prompt-china-to-vow-countermeasures-experts-see-retaliation-likely" target="_blank" rel="noreferrer noopener">Trump's Tariffs Prompt China To Vow ‘Countermeasures': Experts See Retaliation Likely</a></li>
</ul>
Photo: <a href="https://www.shutterstock.com/g/lordn">Lordn</a>/Shutterstock.

Short Sellers

Short Ideas

Short Seller Slams KinderCare Over Safety Failures, Stock Hits New 52-Week Low

WIIM

ACDC

CGBS

CIVI

EQNR

FANG

SHEL

Shares of energy companies are trading lower as markets react to President Trump's announcement of sweeping tariffs.

Truist Securities analyst William Stein maintains Tesla (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) with a Hold and lowers the price target from $373 to $280.

Price Target

Analyst Ratings

TSLA

Truist Securities Maintains Hold on Tesla, Lowers Price Target to $280

TIVC

Tivic Health Shares resume Trading

Tivic Health Shares Halted On Circuit Breaker To Downside; Stock Up 53.9%

Genius Group Ltd (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/GNS#AMEX">GNS</a>) shares are trading lower on Thursday following news that the company is being compelled <a href="https://www.benzinga.com/pressreleases/25/04/g44625455/genius-group-blocked-from-raising-funds-and-buying-bitcoin-by-new-york-court" target="_blank" rel="noreferrer noopener">to sell its Bitcoin treasury.</a>
The move comes after a court ruling in the U.S. District Court Southern District of New York, which blocked Genius from selling shares, raising funds and using investor money to purchase Bitcoin.
This injunction was granted as part of a larger legal battle with Fatbrain AI, part of Lzg International Inc (OTC:<a class="ticker" href="https://www.benzinga.com/stock/LZGI#OTC">LZGI</a>), where Genius had initiated arbitration to terminate its asset purchase agreement with the company.
The court&#8217;s decision is based on fraud allegations against LZGI executives Michael Moe and Peter Ritz, who have been accused of defrauding shareholders.
Also Read: <a target="_blank" href="https://www.benzinga.com/top-stories/25/04/44627817/retaliation-odds-spike-after-trumps-heavy-tariffs-sending-country-etfs-tumbling" rel="noreferrer noopener">Retaliation Odds Spike After Trump&#8217;s Heavy Tariffs, Sending Country ETFs Tumbling</a>
Genius filed motions and presented evidence of what it claims is a scheme to extort money from the company through the legal process.
As a result, Genius&#8217;s ability to finance its operations and issue share compensation to employees has been blocked, forcing the company to consider drastic measures.
In response, Genius is actively appealing the injunction, while restructuring its operations, including downsizing and halting marketing and investment activities.
The company has been forced to sell some of its Bitcoin holdings to sustain operations, reducing its treasury from 440 Bitcoin to 430 Bitcoin.
Despite the challenges, CEO Roger James Hamilton remains committed to fighting fraud and market manipulation and intends to protect shareholders&#8217; interests.
The ongoing restrictions, however, pose a serious risk to the company's future operations, with Genius&#8217; stock price falling 53% since the temporary restraining order was imposed.
GNS Price Action: Genius shares are trading lower by 11.88% to 22 cents at publication Thursday.
Read Now:
<ul>
<li><a href="https://www.benzinga.com/25/04/44624245/tariffs-to-plug-the-hole-for-income-tax-cuts-to-come-economists-predict-what-more-could-be-expected" target="_blank" rel="noreferrer noopener">Trump Tariffs To ‘Plug The Hole' For Income Tax Cuts To Come: Economists Predict What More Could Be Expected</a></li>
</ul>
Photo: Courtesy Genius Group

Markets

General

LZGI

What's Going On With Genius Group Stock Today?

CART

CASY

CELH

CHEF

COST

HNST

PFGC

USFD

Shares of companies within the broader consumer staples sector are trading lower as markets react to President Trump's announcement of sweeping tariffs.

U.S. stocks traded lower midway through trading, with the Nasdaq Composite dipping more than 800 points on Thursday.
The Dow traded down 3.07% to 40,929.87 while the NASDAQ fell 4.83% to 16,750.33. The S&amp;P 500 also fell, dropping, 3.73% to 5,459.39.
Check This Out: <a href="https://www.benzinga.com/analyst-ratings/price-target/25/04/44625270/top-3-tech-and-telecom-stocks-youll-regret-missing-this-month">Top 3 Tech And Telecom Stocks You&#8217;ll Regret Missing This Month</a>
Leading and Lagging Sectors Consumer staples shares rose by 0.4% on Thursday.
In trading on Thursday, energy shares tumbled by 5.6%.
Top Headline
The ISM services PMI dipped to 50.8 in March versus a reading of 53.5 in February, and down from market estimates of 53.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Lamb Weston Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LW#NYSE">LW</a>) shares shot up 10% to $59.60 after the company reported better-than-expected third-quarter financial results and issued FY25 sales guidance above estimates.</li>
<li>Shares of NewGenIvf Group Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NIVF#NASDAQ">NIVF</a>)got a boost, surging 95% to $1.15 after the company announced it secured $5.2 million in funding to drive international expansion.</li>
<li>The Goodyear Tire &amp; Rubber Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GT#NASDAQ">GT</a>) shares were also up, gaining 12% to $10.19.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Aldeyra Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALDX#NASDAQ">ALDX</a>) shares dropped 76% to $1.2750 after the company received a response letter from the FDA for the Reproxalap new drug application for the treatment of signs and symptoms of dry eye disease.</li>
<li>Shares of RH (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RH#NYSE">RH</a>) were down 41% to $147.59 after the company reported weaker-than-expected fourth-quarter financial results.</li>
<li>Wayfair Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/W#NYSE">W</a>) was down, falling 22% to $26.30. Shares of specialty retailers in the furniture and home goods space traded lower following disappointing earnings from RH.</li>
</ul>
Commodities In commodity news, oil traded down 7.1% to $66.64 while gold traded down 1.8% at $3,110.80.
Silver traded down 7.1% to $32.205 on Thursday, while copper fell 3.4% to $4.8705.
Euro zone
European shares were lower today. The eurozone's STOXX 600 fell 2.19%, Germany's DAX 40 dipped 2.11% and France's CAC 40 fell 2.93%. Spain's IBEX 35 Index fell 1.32%, while London's FTSE 100 fell 1.30%.
Asia Pacific Markets
Asian markets closed lower on Thursday, with Japan's Nikkei 225 dipping 2.77%, China's Shanghai Composite Index falling 0.24%, Hong Kong's Hang Seng Index falling 1.52% and India's BSE Sensex falling 0.42%.
Economics
<ul>
<li>U.S. initial jobless claims fell by 6,000 to 219,000 in the week ending March 29, compared to market estimates of 225,000.</li>
<li>The U.S. trade deficit shrank to $122.7 billion in February compared to $130.7 billion in the previous month and versus market estimates of a $123.5 billion gap.</li>
<li>The S&amp;P Global services PMI was revised higher to 54.4 in March compared to a preliminary reading of 54.3.</li>
<li>The S&amp;P Global composite PMI climbed to 53.5 in March versus 51.6 in the previous month.</li>
<li>The ISM services PMI dipped to 50.8 in March versus a reading of 53.5 in February, and down from market estimates of 53.</li>
</ul>
Now Read This:
<ul>
<li> <a href="https://www.benzinga.com/news/earnings/25/04/44622367/acuity-rh-and-3-stocks-to-watch-heading-into-thursday">Acuity, RH And 3 Stocks To Watch Heading Into Thursday</a> </li>
</ul>
Photo via Shutterstock

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Intraday Update

ALDX

NIVF

Crude Oil Dips 7%; ISM Services PMI Falls In March

Macro Economic Events

Econ #s

Economics

Canada PM Carney Says: He May Speak With Trump Again But Nothing Scheduled

PAAS

Shares of precious metals stocks are trading lower as markets react to President Trump's announcement of sweeping tariffs.

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.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/general/biotech/25/04/44614171/uks-health-agency-endorses-pfizers-blood-cancer-combo-therapy-as-first-for-untreated-hodgkin-lymphoma-patients" target="_blank" rel="noreferrer noopener">UK&#8217;s Health Agency Endorses Pfizer&#8217;s Blood Cancer Combo Therapy As First For Untreated Hodgkin Lymphoma Patients</a></li>
</ul>
Photo by Taljat David via Shutterstock

Biotech

Health Care

Novartis Secures Third FDA Approval For Its Kidney Disease Portfolio In One Year

The <a href="https://www.benzinga.com/topic/u-s-food-and-drug-administration">U.S. Food and Drug Administration</a> (FDA) on Thursday granted orphan drug designation to Sanofi SA&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) rilzabrutinib.
The treatment is an investigational, novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor, for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">IgG4-related disease (IgG4-RD)</a>.
The FDA grants orphan drug designation to investigational therapies that address rare medical diseases or conditions that affect fewer than 200,000 people in the US.
Rilzabrutinib is <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-03-05-00-00-3054815" rel="noreferrer noopener">currently</a> under regulatory review in the US, the EU, and China for its potential use in immune thrombocytopenia (ITP).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44440233/pharmaceutical-firms-say-uk-investment-is-unlikely-unless-payment-levy-is-adressed" rel="noreferrer noopener">Pharmaceutical Firms Say UK Investment Is &#8216;Unlikely&#8217; Unless Payment Levy Is Addressed</a>
The target action date for the FDA regulatory decision on ITP, which was granted fast-track designation, is Aug. 29.
Rilzabrutinib also received orphan drug designation for ITP in the US, EU, and Japan.
Results from a phase 2b study on wAIHA&nbsp;presented at ASH 2024 demonstrated that treatment with rilzabrutinib showed clinically meaningful outcomes on response rate and disease markers.
In IgG4-RD patients, results from a phase 2a study showed treatment with rilzabrutinib for 52 weeks led to reduction in disease flare, other disease markers, and glucocorticoid sparing.
The safety profile of rilzabrutinib in both studies was consistent with previous studies.
Last week, the FDA approved&nbsp;Sanofi&#8217;s Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without&nbsp;<a target="_blank" href="https://www.benzinga.com/25/03/44560065/fda-approves-sanofis-hemophilia-drug" rel="noreferrer noopener">factor VIII or IX inhibitors</a>.
The&nbsp;<a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-03-28-20-07-38-3051637" rel="noreferrer noopener">approval</a>&nbsp;is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates.
Price Action: Sanofi&#8217;s stock is up 3.54% at $55.86 during the premarket session at the last check Thursday.
Read Next:
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<li><a href="https://www.benzinga.com/25/04/44613863/biomarin-seeks-label-expansion-for-palynziq-after-positive-phase-3-results-in-adolescent-patients" target="_blank" rel="noreferrer noopener">BioMarin Seeks Label Expansion For Palynziq After Positive Phase 3 Results In Adolescent Patients</a></li>
</ul>
Image: Shutterstock

Large Cap

Why Is French Pharma Giant Sanofi Stock Trading Higher On Thursday?

ASPI

CENX

FEAM

MATV

MEOH

MERC

PACK

TECK

VALE

Shares of companies within the broader materials sector are trading lower as markets react to President Trump's announcement of sweeping tariffs.

Canada PM Carney Says: Call With Trump Helped Canada Avoid Reciprocal Tariffs

TD Securities analyst Craig Hutchison maintains Trilogy Metals (TSX:<a class="ticker" href="https://www.benzinga.com/stock/TMQ#TSX">TMQ</a>) with a Hold and raises the price target from C$2 to C$2.25.

TSX:TMQ

TD Securities Maintains Hold on Trilogy Metals, Raises Price Target to C$2.25

<a href="https://investor.gm.com/news-releases/news-release-details/gm-reports-strong-q1-china-growth-evs-and-hybrids" title="https://investor.gm.com/news-releases/news-release-details/gm-reports-strong-q1-china-growth-evs-and-hybrids">https://investor.gm.com/news-releases/news-release-details/gm-reports-strong-q1-china-growth-evs-and-hybrids</a>

General Motors And Its Joint Ventures Announces It Delivered More Than 442,000 Units In China In Q1 2025

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