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Wire

Celcuity Says Gedatolisib Outperforms Novartis' Alpelisib Plus Fulvestrant in Phase 3 Trial

Celcuity (CELC) said Tuesday that detailed results from the Phase 3 Viktoria-1 trial showed its investigational breast cancer treatment gedatolisib outperformed Novartis' (NVS) alpelisib plus fulvestrant in patients with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer.Celcuity said the gedatolisib plus fulvestrant and palbociclib, or gedatolisib-triplet reduced the risk of disease progression or death by 50% compared with alpelisib plus fulvestrant, and nearly doubled median progression-free survival to 11.1 months from 5.6 months, while gedatolisib plus fulvestrant, or gedatolisib-doublet extended progression-free survival to 11.3 months, with objective response rates of 48.9% and 35.7%, respectively.The gedatolisib triplet and doublet regimens were generally well tolerated, with mostly low-grade treatment-related adverse events, while overall survival data, a key secondary endpoint, showed promising trends but remain immature. Celcuity plans to submit the data to the US Food and Drug Administration as a supplemental new drug application.Shares of Celcuity were down more than 25% in Tuesday trading.Price: $91.65, Change: $-31.31, Percent Change: -25.46%

$CELC$NVS
Wire

Top Midday Stories: NextEra, Dominion to Combine in All-Stock Deal; Big Pharma Firms Denied Certiorari by Supreme Court in Medicare Pricing Case

The Dow Jones Industrial Average, Nasdaq Composite and S&P 500 Index were down in late-morning trading Monday, as Wall Street monitored oil prices and US Treasury yields amid the ongoing conflict in the Middle East.In company news, NextEra Energy (NEE) and Dominion Energy (D) said Monday they have entered into a definitive agreement to combine in an all-stock deal. Under the terms of the transaction, Dominion shareholders will receive a fixed exchange ratio of 0.8138 shares of NextEra for each Dominion share they own at the close of the deal, which is expected in the next 12 to 18 months. NextEra shareholders will own about 74.5% of the combined company, while Dominion shareholders will own the remaining 25.5%. NextEra shares were down 5.5% around midday, while Dominion shares were up 9.6%.The US Supreme Court on Monday denied writ of certiorari petitions by six big pharmaceutical companies seeking to challenge the legality of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act of 2022. AstraZeneca (AZN), Novartis (NVS), Novo Nordisk (NVO), Johnson & Johnson's (JNJ) Janssen Pharmaceuticals, Bristol-Myers Squibb (BMY) and Boehringer Ingelheim Pharmaceuticals all had their petitions denied by the Supreme Court. Shares of AstraZeneca, Novartis, Johnson & Johnson and Bristol-Myers were up 1.1%, 0.8%, 0.4% and 0.5%, respectively, while Novo Nordisk was down 1%.Berkshire Hathaway (BRK.A, BRK.B) disclosed Friday in a regulatory filing that it sold all of its stake in UnitedHealth Group (UNH). Separately, a New York state court judge on Monday prohibited prosecutors from using some evidence found in the backpack of Luigi Mangione, who is standing trial for the murder of UnitedHealth Group's UnitedHealthcare CEO Brian Thompson, CNBC reported. UnitedHealth shares were down 1.5%, while Berkshire's class A and class B shares were up 0.2% and 0.1%, respectively.Citigroup (C) and BlackRock's (BLK) HPS Investment Partners are launching a 15 billion euro ($17.48 billion) private capital program to expand access to private financing for corporate and sponsor-owned borrowers in the Europe, the Middle East and Africa region, the companies said Monday. Citigroup shares were down 0.2%, while BlackRock shares were up 0.5%.Price: $88.24, Change: $-5.13, Percent Change: -5.49%

$AZN$BLK$BMY$BRK.A$BRK.B$C$D$JNJ$NEE$NVO$NVS$UNH
Wire

Big Pharma Firms Denied Certiorari by Supreme Court in Medicare Pricing Case

The US Supreme Court on Monday denied petitions for writs of certiorari filed by six big pharmaceutical companies seeking to challenge the legality of the so-called 'Drug Price Negotiation Program' under the Inflation Reduction Act of 2022.AstraZeneca (AZN), Novartis (NVS), Novo Nordisk (NVO), Johnson & Johnson's (JNJ) Janssen Pharmaceuticals, Bristol Myers Squibb (BMY) and Boehringer Ingelheim Pharmaceuticals all had their petitions denied by the Supreme Court.The companies did not immediately respond to requests for comment from.Price: $183.25, Change: $+1.67, Percent Change: +0.92%

$AZN$BMY$JNJ$NVO$NVS
Wire

Big Pharma Firms Denied Certiorari by Supreme Court in Medicare Pricing Case

Big Pharma Firms Denied Certiorari by Supreme Court in Medicare Pricing Case

$AZN$BMY$JNJ$NVO$NVS
Wire

Novartis Starts Construction on Texas Cancer Therapy Manufacturing Facility

Novartis (NVS) said Thursday it started construction on a new radioligand therapy manufacturing facility in Denton, Texas, as part of the company's broader $23 billion US investment plan.The company said the Texas facility will become its fifth radioligand therapy manufacturing site in the US and is expected to begin operations in 2028, supporting production of personalized cancer therapies.The company said the project is part of its plan to expand US manufacturing and research operations over five years.Price: $145.47, Change: $-2.89, Percent Change: -1.95%

$NVS
Wire

Novartis Gains Canada Nod for Fabhalta in Rare Kidney Disease

Novartis (NVS) said Health Canada has approved Fabhalta for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.C3G is a rare, long-term kidney disease caused by an overactive immune pathway. This leads to a buildup of protein in the kidneys, causing inflammation, damage and, over time, loss of kidney function.The approval was backed by Phase III data showing a statistically significant reduction in proteinuria at six months, with sustained benefits through one year.Fabhalta (iptacopan) is an oral drug that blocks a key part of the immune system (Factor B), helping reduce the harmful activity that drives C3G and protects the kidneys.Price: $146.84, Change: $-1.01, Percent Change: -0.68%

$NVS
Sectors

Sector Update: Health Care Stocks Edge Higher Late Afternoon

Health care stocks edged up late Tuesday afternoon, with the NYSE Health Care Index fractionally higher and the State Street Health Care Select Sector SPDR ETF (XLV) up 0.2%.The iShares Biotechnology ETF (IBB) declined 0.6%.In sector news, the US Food and Drug Administration plans to pilot an approach this summer that will use AI to accelerate clinical trials of new medicines by automating data collection and submission, The Wall Street Journal reported Tuesday, citing an interview with Jeremy Walsh, the FDA's chief AI officer.In corporate news, Axogen (AXGN) shares jumped past 6% after it reported Tuesday a swing to Q1 adjusted EPS from a a loss a year earlier following a surge in revenue.Pfizer (PFE) said Tuesday it entered into settlement agreements with three generic drug manufacturers regarding lawsuits filed in the US District Court for the District of Delaware for patent infringement related to Vyndamax, a cardiomyopathy transthyretin-mediated amyloidosis treatment. Pfizer shares were down 1.7%.Eli Lilly (LLY) has entered into a strategic partnership with Profluent to develop AI-designed recombinases for genetic medicines, Profluent said Tuesday. Lilly shares rose 0.6%.Novartis (NVS) reported Q1 core earnings Tuesday of $1.99 per share, down from $2.28 a year earlier. Analysts polled by FactSet expected $2.19. Net sales for the quarter ended March 31 were $13.11 billion, down from $13.23 billion a year earlier. For 2026, the company said it continues to expect a low-single-digit core operating income decline. Novartis shares were up 0.3%.

$AXGN$LLY$NVS$PFE
Sectors

Sector Update: Health Care Stocks Edge Higher Tuesday Afternoon

Health care stocks edged up Tuesday afternoon, with the NYSE Health Care Index and the State Street Health Care Select Sector SPDR ETF (XLV) each adding 0.2%.The iShares Biotechnology ETF (IBB) shed 0.6%.In corporate news, Pfizer (PFE) said Tuesday it entered into settlement agreements with three generic drug manufacturers regarding lawsuits filed in the US District Court for the District of Delaware for patent infringement related to Vyndamax, a cardiomyopathy transthyretin-mediated amyloidosis treatment. Pfizer shares were down 0.8%.Eli Lilly (LLY) has entered into a strategic partnership with Profluent to develop AI-designed recombinases for genetic medicines, Profluent said Tuesday. Lilly shares decreased 0.2%.Novartis (NVS) reported Q1 core earnings Tuesday of $1.99 per share, down from $2.28 a year earlier. Analysts polled by FactSet expected $2.19. Net sales for the quarter ended March 31 were $13.11 billion, down from $13.23 billion a year earlier. For 2026, the company said it continues to expect a low-single-digit core operating income decline. Novartis shares were fractionally lower.

$LLY$NVS$PFE
Sectors

Sector Update: Health Care

Health care stocks edged up Tuesday afternoon, with the NYSE Health Care Index and the State Street Health Care Select Sector SPDR ETF (XLV) each fractionally higher.The iShares Biotechnology ETF (IBB) shed 0.8%.In corporate news, Novartis (NVS) reported Q1 core earnings Tuesday of $1.99 per share, down from $2.28 a year earlier. Analysts polled by FactSet expected $2.19. Net sales for the quarter ended March 31 were $13.11 billion, down from $13.23 billion a year earlier. For 2026, the company said it continues to expect a low-single-digit core operating income decline. Novartis shares were fractionally lower.

$NVS
Sectors

Sector Update: Health Care Stocks Mixed Pre-Bell Tuesday

Health care stocks were mixed premarket Tuesday, with the State Street Health Care Select Sector SPDR ETF (XLV) gaining by 0.6% and the iShares Biotechnology ETF (IBB) retreating marginally by 0.01%.Novartis (NVS) shares retreated less than 1% pre-bell after the company reported lower Q1 core earnings and net sales.Axogen (AXGN) stock was up more than 9% premarket after the company reported it swung to Q1 adjusted earnings as revenue increased.Zimmer Biomet (ZBH) stock was down more than 6% premarket after closing the prior session with a 1.5% gain. The company reported higher Q1 financial results and said its chief financial officer, Suketu Upadhyay, is leaving the company.

$AXGN$IBB$NVS$XLV$ZBH
Asia Markets

US Equity Futures Mostly Lower Pre-Bell Amid Continued Middle East Standoff, AI Spending Concerns

US equity futures were mostly lower pre-bell Tuesday as the US-Iran standoff continues with no end in sight, while concerns about heavy spending on data centers were brought into focus amid reports of OpenAI's missed targets.Dow Jones Industrial Average futures were 0.1% higher, S&P 500 futures were down 0.8%, and Nasdaq futures were 1.4% lower.President Donald Trump was unhappy with Iran's latest proposal to end the Middle East conflict, Reuters reported, citing a US official. Iran had proposed to reopen the Strait of Hormuz by deferring nuclear talks to a later date, while Trump wants nuclear issues dealt with from the outset.Microsoft-backed (MSFT) OpenAI recently missed internal targets for new users and revenue, raising concerns among company leaders about being able to support its massive spending on data centers, according to a Wall Street Journal report that cited sources familiar with the matter.Traders digested the latest round of earnings. Coca-Cola (KO) reported higher Q1 adjusted earnings and revenue, while Novartis (NVS) posted a decline in Q1 core earnings and net sales.Oil prices were higher, with front-month global benchmark North Sea Brent crude up 2.5% at $104.21 per barrel and US West Texas Intermediate crude 3.6% higher at $99.84 per barrel.The February S&P Case-Shiller home price index, scheduled for release at 9 am ET, is expected to show a 0.2% gain following a similar increase in the preceding month, according to estimates compiled by Bloomberg.The April consumer confidence index, due at 10 am ET, is projected to fall to 89.0 from 91.8.In other world markets, Japan's Nikkei closed 1% lower, Hong Kong's Hang Seng ended 1% lower, and China's Shanghai Composite finished 0.2% lower. Meanwhile, the UK's FTSE 100 was down 0.1%, and Germany's DAX index was 0.5% lower in Europe's early afternoon session.In equities, Microsoft, which is OpenAI's biggest investor, and Oracle (ORCL), which relies on the ChatGPT creator for its cloud computing plans, saw their shares decline 1.3% and 7.6%, respectively. Novartis stock was down 1.4% after the company released its Q1 financial results.On the winning side, Eni (E) stock was up 2.7% after the European energy firm and Repsol said they are planning to boost output at Venezuela's Cardon IV offshore gas field, according to a Reuters report. Bed Bath & Beyond (BBBY) shares were up 29% after the company reported a narrower Q1 adjusted loss and higher revenue. Coca-Cola stock was up 3% after the company published its Q1 financial results.

Dow JonesNasdaq CompositeS&P 500$BBBY$E$KO$MSFT$NVS$ORCL
Sectors

Sector Update: Health Care

Health care stocks were mixed premarket Tuesday, with the State Street Health Care Select Sector SPDR ETF (XLV) gaining by 0.7% and the iShares Biotechnology ETF (IBB) unchanged.Novartis (NVS) shares retreated 0.6% pre-bell after the company reported lower Q1 core earnings and net sales.

$IBB$NVS$XLV
Japan

US Equity Futures Mixed Pre-Bell Amid Continued Middle East Standoff, AI Spending Concerns

US equity futures were mixed pre-bell Tuesday as the US-Iran standoff continues with no end in sight, while concerns about heavy spending on data centers were brought into focus amid reports of OpenAI's missed targets.Dow Jones Industrial Average futures were 0.2% higher, S&P 500 futures were down 0.6%, and Nasdaq futures were 1.1% lower.President Donald Trump was unhappy with Iran's latest proposal to end the Middle East conflict, Reuters reported, citing a US official. Iran had proposed to reopen the Strait of Hormuz by deferring nuclear talks to a later date, while Trump wants nuclear issues dealt with from the outset.Microsoft-backed (MSFT) OpenAI recently missed internal targets for new users and revenue, raising concerns among company leaders about being able to support its massive spending on data centers, according to a Wall Street Journal report that cited sources familiar with the matter.Traders digested the latest round earnings. Coca-Cola (KO) reported higher Q1 adjusted earnings and revenue, while Novartis (NVS) posted a decline in Q1 core earnings and net sales.Oil prices were higher, with front-month global benchmark North Sea Brent crude up 4% at $105.74 per barrel and US West Texas Intermediate crude 5.4% higher at $101.75 per barrel.The February S&P Case-Shiller home price index, scheduled for release at 9 am ET, is expected to show a 0.2% gain following a similar increase in the preceding month, according to estimates compiled by Bloomberg.The April consumer confidence index, due at 10 am ET, is projected to fall to 89.0 from 91.8.

Dow JonesNasdaq CompositeS&P 500$KO$MSFT$NVS
Research

Research Alert: Novartis Q1 2026 Results Miss On U.s. Generic Headwinds

CFRA, an independent research provider, has providedwith the following research alert. Analysts at CFRA have summarized their opinion as follows:Novartis' Q1 2026 results came in below consensus, with net sales declining 1% (-5% in constant currencies [cc]) and core EPS of USD1.99 missing the consensus of USD2.08. Core operating income fell 14% cc, with margin contracting 4.1%-pts to 37.3% as generic pressures intensified, particularly for Entresto, which declined 46% cc. Growth products Kisqali (+55% cc) and Pluvicto (+70% cc) provided some offset to the generic headwinds. Novartis reiterated its 2026 guidance for low-single-digit sales growth cc and a low-single-digit core operating income decline cc, expecting a challenging 1H before a 2H improvement. Multiple Phase 3 readouts expected in 2H 2026, including remibrutinib in multiple sclerosis, could strengthen the mid- to long-term growth outlook. In our view, while the company has solid growth momentum in newer assets and a broad pipeline, Entresto represents the single largest near-term patent risk among European peers, limiting the potential for rapid replacement despite growth in other products.

$NVS
Asia Markets

Exchange-Traded Funds, Equity Futures Lower Pre-Bell Thursday as Fragile Middle East Ceasefire Lifts Oil Prices

The broad market exchange-traded fund SPDR S&P 500 ETF Trust (SPY) was down 0.4% and the actively traded Invesco QQQ Trust (QQQ) was 0.3% lower in Thursday's premarket activity as doubts over the durability of a Middle East ceasefire lift oil prices.US stock futures were also lower, with S&P 500 Index futures down 0.4%, Dow Jones Industrial Average futures slipping 0.5%, and Nasdaq futures retreating 0.4% before the start of regular trading.US initial jobless claims rose to a level of 219,000 in the week ended April 4 from an upwardly revised 203,000 level in the previous week, compared with expectations for a smaller increase to 210,000 in survey of analysts compiled by Bloomberg.Personal income declined 0.1% in February following January's 0.4% gain, compared with the expected 0.3% gain in a survey conducted by Bloomberg as of 7:35 am ET.US economic growth, measured by gross domestic product, was revised lower to a 0.5% increase in Q4 from a 0.7% gain in the second estimate, compared with estimates for no revision in a survey compiled by Bloomberg as of 7:35 am ET.Wholesale inventory data for February are due to be released at 10 am ET, followed by weekly natural gas stocks data at 10:30 am ET.In premarket activity, bitcoin was down by 0.3%. Among cryptocurrency ETFs, the cryptocurrency fund ProShares Bitcoin Strategy ETF (BITO) was 0.2% lower, Ether ETF (EETH) fell 1.5%, and Bitcoin & Ether Market Cap Weight ETF (BETH) was flat.Power Play:ConsumerThe State Street Consumer Staples Select Sector SPDR ETF (XLP) retreated marginally by 0.01%, while the Vanguard Consumer Staples Index Fund ETF Shares (VDC) was 0.01% higher, and the iShares US Consumer Staples ETF (IYK) was up 0.5%. The State Street Consumer Discretionary Select Sector SPDR ETF (XLY) lost 0.1%. The VanEck Retail ETF (RTH) was inactive, while the State Street SPDR S&P Retail ETF (XRT) was 1.3% lower.Simply Good Foods (SMPL) shares were down more than 19% pre-bell after the company posted lower fiscal Q2 adjusted earnings and net sales.Winners and Losers:FinancialThe State Street Financial Select Sector SPDR ETF (XLF) retreated 0.6%. Direxion Daily Financial Bull 3X Shares (FAS) was down 1.7%, while its bearish counterpart Direxion Daily Financial Bear 3X Shares (FAZ) was 1.9% higher.Whitestone REIT (WSR) shares were up more than 11% pre-bell after the company said it has agreed to be acquired by Ares Management (ARES) for $19 per common share or operating partnership unit in an all-cash deal valued at about $1.70 billion. Ares stock was 1.5% higher.TechnologyThe State Street Technology Select Sector SPDR ETF (XLK) retreated 0.2%, and the iShares US Technology ETF (IYW) was 0.1% higher, while the iShares Expanded Tech Sector ETF (IGM) was down 0.1%. Among semiconductor ETFs, the State Street SPDR S&P Semiconductor ETF (XSD) was inactive, while the iShares Semiconductor ETF (SOXX) declined by 0.3%.Aehr Test Systems (AEHR) shares were down more than 2% in premarket activity, a day after the company said it plans to sell up to $60 million of its common shares via an at-the-market offering.Health CareThe State Street Health Care Select Sector SPDR ETF (XLV) retreated by 0.1%, the Vanguard Health Care Index Fund (VHT) was down 0.1%, while the iShares US Healthcare ETF (IYH) was flat. The iShares Biotechnology ETF (IBB) was 0.7% lower.Novartis (NVS) stock was down more than 1% premarket after closing the prior session with a 2% gain. The company said Thursday it will expand its programs to find and treat patients with heart disease and cancer in "hard-to-reach" communities worldwide.IndustrialThe State Street Industrial Select Sector SPDR ETF (XLI) declined by 0.7%, while the Vanguard Industrials Index Fund (VIS) gained 0.4% and the iShares US Industrials ETF (IYJ) was down 0.8%.American Airlines Group (AAL) stock was down more than 1% before the opening bell, a day after the Federal Aviation Administration said the airline should pay a $255,000 civil penalty for allegedly breaching drug and alcohol regulations.EnergyThe iShares US Energy ETF (IYE) was up 0.2%, while the State Street Energy Select Sector SPDR ETF (XLE) advanced by 0.5%.Occidental Petroleum (OXY) stock was up more than 1% before Thursday's opening bell after the company said it had discovered oil at the Bandit prospect, co-owned by Chevron (CVX) and Woodside Energy (WDS), in the Gulf of Mexico. Chevron stock was 0.8% higher, while Woodside advanced 0.5%.CommoditiesFront-month US West Texas Intermediate crude oil rose by 4.4% to $98.57 per barrel on the New York Mercantile Exchange. Natural gas retreated by 0.2% to $2.72 per 1 million British Thermal Units. The United States Oil Fund (USO) was up by 2%, while the United States Natural Gas Fund (UNG) was 0.3% lower.Gold futures for May were up by 0.1% at $4,781.00 an ounce on the Comex. Silver futures declined by 1% to $74.60 an ounce. SPDR Gold Shares (GLD) was 0.4% higher, and the iShares Silver Trust (SLV) advanced by 0.03%.

Dow JonesNasdaq CompositeS&P 500$AAL$AEHR$ARES$BETH$BITO$CVX$EEM$EETH$EXI$FAS$FAZ$GLD$IBB$IGM$IGV$IPK$IVV$IWM$IYE$IYH$IYJ$IYK$IYW$NVS$OXY$PMR$QQQ$RTH$SLV$SMPL$SOXX$SPY$UNG$USO$VDC$VHT$VIS$WDS$WSR$XLE$XLF$XLI$XLK$XLP$XLV$XLY$XRT$XSD

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