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Wire

Regeneron Pharmaceuticals More Likely to Retain Eylea HD Patent, RBC Says

Regeneron Pharmaceuticals' (REGN) patent on Eylea HD is more likely to be retained, with the Patent Trial and Appeal Board, or PTAB, due to issue a final decision on an ongoing patent dispute by March 2027, RBC Capital Markets said in a Thursday note.The patent, which covers Eylea HD's formulation and method of treatment, was issued in 2024 and is set to expire May 10, 2039, according to the note. Alvotech (ALVO) has challenged the patent, with the PTAB to hear arguments on Dec. 4 and issue a decision by March 3, 2027, the brokerage said."Our read and feedback suggests Regeneron is likely in a stronger position, particularly against Alvotech's prior art arguments," RBC said. The patent serves as the company's strongest defense for Eylea HD, blocking potential biosimilars, the investment firm noted.RBC has a sector perform rating on Regeneron Pharmaceuticals, with a $737 price target.Price: $795.00, Change: $-12.65, Percent Change: -1.57%

$ALVO$REGN
Sectors

Sector Update: Healthcare Stocks Decline Late Afternoon

Healthcare stocks were lower late Monday afternoon, with the NYSE Healthcare Index decreasing 0.5% and the State Street Health Care Select Sector SPDR ETF (XLV) down 0.3%.The iShares Biotechnology ETF (IBB) shed 0.4%.In corporate news, Eli Lilly (LLY) has agreed to buy Merida Biosciences for up to $2.875 billion in cash, as it seeks to expand its portfolio of autoimmune and allergic disease therapies, the companies said Monday. Lilly shares were down 1.1%.Takeda Pharmaceutical (TAK), Bayer, CSL, and other mid-size biotech firms are set to announce new pricing deals with the White House on Monday, the Financial Times reported, citing two sources familiar with the matter. The deals will be similar to those finalized by large pharmaceutical companies in which they agreed to lower prices in exchange for tariff relief, according to the report. Takeda shares were down 0.1%.Exelixis (EXEL) said Monday that the US Court of Appeals for the Federal Circuit has affirmed a key portion of the 2024 judgment of the US District Court for the District of Delaware in its favor in the lawsuit Exelixis vs. MSN Laboratories. Exelixis were up 0.4%.Alvotech (ALVO) shares rose past 5% after it said Monday a biologics license application for AVT80 as a proposed interchangeable biosimilar to Entyvio has been accepted for review by the US Food and Drug Administration.

$ALVO$EXEL$LLY$TAK
Wire

Update: Alvotech Shares Rise After FDA Accepts Biologics License Application for AVT80

(Updates to add share movement in the headline and the first paragraph.)Alvotech's (ALVO) shares rose nearly 5% in Monday trading after the company said that its biologics license application for AVT80 as a proposed interchangeable biosimilar to Entyvio was accepted for review by the US Food and Drug Administration.Entyvio is approved as a treatment for adults with moderately to severely active ulcerative colitis and Crohn's disease, according to the statement. The application is backed by data that demonstrate the biosimilarity between AVT80 and Entyvio.AVT80 is under a partnership between Alvotech and Teva Pharmaceutical Industries (TEVA), with Alvotech in charge of development and manufacturing and Teva responsible for commercialization, according to the statement.Price: $5.19, Change: $+0.24, Percent Change: +4.85%

$ALVO$TEVA
Sectors

Sector Update: Healthcare Stocks Decline Monday Afternoon

Healthcare stocks were lower Monday afternoon, with the NYSE Healthcare Index decreasing 0.5% and the State Street Health Care Select Sector SPDR ETF (XLV) down 0.4%.The iShares Biotechnology ETF (IBB) shed 0.3%.In corporate news, Eli Lilly (LLY) has agreed to buy Merida Biosciences for up to $2.875 billion in cash, as it seeks to expand its portfolio of autoimmune and allergic disease therapies, the companies said Monday. Lilly shares were down 1.6%.Alvotech (ALVO) shares rose past 4% after it said Monday a biologics license application for AVT80 as a proposed interchangeable biosimilar to Entyvio has been accepted for review by the US Food and Drug Administration.Axsome Therapeutics (AXSM) shares added 0.3% after it said Monday that it has dosed the first patient in its phase 3 trial evaluating AXS-05, its experimental drug intended for smoking cessation.

$ALVO$AXSM$LLY
Wire

Alvotech's Q4 Approval, Launch Timelines Remain Intact, UBS Says

Alvotech's (ALVO) Q4 approval and launch timelines remain intact, with upcoming approval and launch catalysts providing potential upside, UBS said in a note.The brokerage said the stock reacted positively, despite the Q2 results being relatively in-line, on the back of the timelines.UBS said it remains confident in FDA approval following the recent inspection closure and assigned Q4 FDA goal date. For AVT05, management remains confident in a Q4 launch despite ongoing litigation with Johnson & Johnson, UBS said.For AVT16, management continues to express confidence in a near-term US launch opportunity, as well as in securing a favorable IP outcome and FDA approval, UBS said.UBS maintained buy rating and $6 price target.Price: $5.35, Change: $+0.92, Percent Change: +20.65%

$ALVO
Research

BofA Securities Initiates Alvotech at Buy With $7 Price Target

Alvotech (ALVO) has an average rating of overweight and mean price target of $6.47, according to analysts polled by FactSet.Price: $4.73, Change: $+0.30, Percent Change: +6.79%

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Wire

Alvotech Signs Licensing Deal With Lotus Pharmaceutical for Proposed Biosimilars

Alvotech (ALVO) has signed a licensing and commercialization agreement with Lotus Pharmaceutical for proposed biosimilars to durvalumab and emicizumab in the US and eight selected Asian markets, the company said Friday.Under the semi-exclusive US agreement, Alvotech said it will retain the right to commercialize both products directly alongside Lotus, while Lotus will commercialize the products through its US-based, wholly owned Alvogen subsidiary.Lotus will hold exclusive commercialization rights in South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia, the company said.Alvotech will retain responsibility for product development and obtaining and maintaining marketing authorizations in the US, it said.The agreement could provide Alvotech with up to about $150 million in upfront and milestone payments, in addition to ongoing revenue from supplying the commercial products.Alvotech shares were 6.8% higher in early Friday trading.Price: $4.55, Change: $+0.28, Percent Change: +6.56%

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Commodities

Exchange-Traded Funds, Equity Futures Lower Pre-Bell Wednesday Ahead of Fed Chair Warsh's International Debut

The broad market exchange-traded fund SPDR S&P 500 ETF Trust (SPY) was down 0.2%, and the actively traded Invesco QQQ Trust (QQQ) retreated by 0.5% in Wednesday's premarket activity, ahead of remarks from Federal Reserve Chair Kevin Warsh in his first international speech at the European Central Bank's annual forum in Portugal.US stock futures were also lower, with S&P 500 Index futures down 0.2%, Dow Jones Industrial Average futures slipping 0.3%, and Nasdaq futures retreating 0.4% before the start of regular trading.Mortgage applications rose by 0.04% in the week ended June 26, according to Mortgage Bankers Association data released Wednesday.Outplacement firm Challenger, Gray & Christmas said on Wednesday that companies planned to cut 45,849 jobs in June, well below 97,006 in May and down from 47,999 a year ago.ADP's monthly measure of private payrolls showed a 98,000 increase in June, well below expectations compiled by Bloomberg as of 7:35 am ET for an increase of 120,000.Warsh is slated to speak at 9 am ET.The final Purchasing Managers' manufacturing index for June will be released at 9:45 am ET, followed by the Institute for Supply Management's manufacturing index for the same month at 10 am ET.The weekly EIA domestic petroleum inventories report is due at 10:30 am ET.In premarket action, bitcoin was down by 0.2%. Among cryptocurrency ETFs, the cryptocurrency fund ProShares Bitcoin Strategy ETF (BITO) was 0.6% lower, Ether ETF (EETH) retreated by 0.6%, and Bitcoin & Ether Market Cap Weight ETF (BETH) declined by 0.1%.Power Play:IndustrialThe State Street Industrial Select Sector SPDR ETF (XLI) retreated by 0.4%, while the Vanguard Industrials Index Fund (VIS) and the iShares US Industrials ETF (IYJ) were flat.Bloom Energy (BE) stock was up more than 7% before the opening bell after Brookfield Asset Management (BAM) expanded its strategic partnership with Bloom, increasing its financing framework for artificial intelligence infrastructure power projects to $25 billion from $5 billion.Winners and Losers:FinancialThe State Street Financial Select Sector SPDR ETF (XLF) retreated by 0.1%. Direxion Daily Financial Bull 3X Shares (FAS) was down 0.3%, while its bearish counterpart, Direxion Daily Financial Bear 3X Shares (FAZ), was 0.5% higher.Klarna (KLAR) shares traded up more than 7% in early hours activity after a court ruled in favor of its PriceRunner unit, awarding it $1.97 billion in damages in an antitrust lawsuit against Alphabet's (GOOG, GOOGL) Google.Health CareThe State Street Health Care Select Sector SPDR ETF (XLV) retreated by 0.04%, the Vanguard Health Care Index Fund (VHT) was up 0.2%, while the iShares US Healthcare ETF (IYH) slipped 0.03%. The iShares Biotechnology ETF (IBB) was 0.1% lower.Alvotech (ALVO) stock was up more than 3% premarket after the company said it has amended its agreements with GoldenTree Asset Management and other lenders to obtain a term loan facility of up to $75 million in additional capital.ConsumerThe State Street Consumer Staples Select Sector SPDR ETF (XLP) was down 0.2%, the Vanguard Consumer Staples Index Fund ETF Shares (VDC) retreated by 0.2%, and the iShares US Consumer Staples ETF (IYK) was up 0.2%. The State Street Consumer Discretionary Select Sector SPDR ETF (XLY) gained marginally by 0.02%. The VanEck Retail ETF (RTH) was inactive, while the State Street SPDR S&P Retail ETF (XRT) was inactive.Kroger (KR) shares were down more than 2% pre-bell after the company said it has agreed to acquire regional supermarket chain Giant Eagle in a $1.65 billion deal, expanding its presence across northern Ohio, western Pennsylvania, West Virginia, Maryland and Indiana.TechnologyThe State Street Technology Select Sector SPDR ETF (XLK) retreated 0.7%, and the iShares US Technology ETF (IYW) was 0.1% lower, while the iShares Expanded Tech Sector ETF (IGM) was up 0.3%. Among semiconductor ETFs, the State Street SPDR S&P Semiconductor ETF (XSD) was down 0.6%, while the iShares Semiconductor ETF (SOXX) fell by 1.6%.Microsoft (MSFT) shares were up more than 1% in Premarket activity after Business Insider reported the technology giant is planning to cut "thousands" of roles in sales and consulting, in addition to its Xbox gaming division.EnergyThe iShares US Energy ETF (IYE) was 1.5% higher, while the State Street Energy Select Sector SPDR ETF (XLE) was down by 0.3%.Shell (SHEL) stock was down more than 1% before market open, a day after Bloomberg News reported the company is close to a deal to sell over 600 retail fuel outlets in South Africa to Abu Dhabi National Oil's retail arm for a deal valued at around $1 billion.CommoditiesFront-month US West Texas Intermediate crude oil retreated by 0.5% to $69.14 per barrel on the New York Mercantile Exchange. Natural gas was down by 1.3% to $3.23 per 1 million British Thermal Units. The United States Oil Fund (USO) declined by 1.5%, while the United States Natural Gas Fund (UNG) was 0.6% lower.Gold futures for July were up by 0.2% to $4,046.90 an ounce on the Comex. Silver futures was down by 0.9% to $59.40 an ounce. SPDR Gold Shares (GLD) advanced by 0.3%, and the iShares Silver Trust (SLV) was 0.6% lower.

Dow JonesNasdaq CompositeS&P 500$ALVO$BAM$BE$BETH$BITO$EEM$EETH$EXI$FAS$FAZ$GLD$GOOG$GOOGL$IBB$IGM$IGV$IPK$IVV$IWM$IYE$IYH$IYJ$IYK$IYW$KLAR$KR$MSFT$PMR$QQQ$RTH$SHEL$SLV$SOXX$SPY$UNG$USO$VDC$VHT$VIS$XLE$XLF$XLI$XLK$XLP$XLV$XLY$XRT$XSD
Sectors

Sector Update: Healthcare Stocks Flat to Higher Pre-Bell Tuesday

Healthcare stocks were flat to higher pre-bell Tuesday, with the State Street Health Care Select Sector SPDR ETF (XLV) up 0.2% and the iShares Biotechnology ETF (IBB) unchanged.Zai Lab (ZLAB) stock was up more than 2% after the company said the European Medicines Agency has granted orphan drug designation to its experimental therapy, zocilurtatug pelitecan, for the treatment of pulmonary neuroendocrine carcinomas, a type of lung cancer.Alvotech (ALVO) shares were down more than 8% after the company said it has priced an underwritten public offering of about 22.7 million shares at $3.75 per share, for gross proceeds of about $85 million.Edgewise Therapeutics (EWTX) shares were up nearly 8% after the company said its phase 2 Cirrus-HCM trial of EDG-7500 met key efficacy and safety endpoints in obstructive and non-obstructive hypertrophic cardiomyopathy, supporting advancement to phase 3.

$ALVO$EWTX$XLK$XSD$ZLAB
Commodities

Exchange-Traded Funds, Equity Futures Higher Pre-Bell Tuesday Ahead of Fed Policy Meeting

The broad market exchange-traded fund SPDR S&P 500 ETF Trust (SPY) was up 0.04%, and the actively traded Invesco QQQ Trust (QQQ) advanced 0.2% in Tuesday's premarket activity, ahead of the Fed's monetary policy committee meeting on interest rates.A decision on interest rates is due tomorrow.US stock futures were also higher, with S&P 500 Index futures up 0.01%, Dow Jones Industrial Average futures advancing 0.1%, and Nasdaq futures gaining 0.2% before the start of regular trading.In premarket action, bitcoin was down by 0.3%. Among cryptocurrency ETFs, the cryptocurrency fund ProShares Bitcoin Strategy ETF (BITO) was 0.3% lower, Ether ETF (EETH) retreated by 1.4%, and Bitcoin & Ether Market Cap Weight ETF (BETH) declined by 0.02%.Power Play:HealthcareThe State Street Health Care Select Sector SPDR ETF (XLV) advanced 0.2%, the Vanguard Health Care Index Fund (VHT) was up 0.2%, while the iShares US Healthcare ETF (IYH) was inactive. The iShares Biotechnology ETF (IBB) was down 0.7%.Alvotech (ALVO) stock was down more than 6% premarket after the company priced an underwritten public offering of about 22.7 million shares at $3.75 per share, for gross proceeds of about $85 million.Winners and Losers:IndustrialThe State Street Industrial Select Sector SPDR ETF (XLI) advanced 0.2%, while the Vanguard Industrials Index Fund (VIS) was up 0.5% and the iShares US Industrials ETF (IYJ) was inactive.SpaceX (SPCX) stock was up more than 4% before the opening bell following a 19.6% rise at the prior close. The company said it has signed an agreement to acquire Cursor in a deal with an implied equity value of $60 billion.TechnologyThe State Street Technology Select Sector SPDR ETF (XLK) advanced 0.5%, and the iShares US Technology ETF (IYW) was 0.6% higher, while the iShares Expanded Tech Sector ETF (IGM) was down 1.5%. Among semiconductor ETFs, the State Street SPDR S&P Semiconductor ETF (XSD) increased by 0.4%, while the iShares Semiconductor ETF (SOXX) rose by 0.5%.Qualcomm (QCOM) shares were up more than 4% in premarket activity after CEO Cristiano Amon told CNBC the company is developing more than 40 new AI device designs as it prepares for the next wave of "agent" powered consumer electronics.ConsumerThe State Street Consumer Staples Select Sector SPDR ETF (XLP) was down 0.1%, and the Vanguard Consumer Staples Index Fund ETF Shares (VDC) was up 1.1%. The iShares US Consumer Staples ETF (IYK) was inactive. The State Street Consumer Discretionary Select Sector SPDR ETF (XLY) gained by 0.1%. The VanEck Retail ETF (RTH) was inactive, while the State Street SPDR S&P Retail ETF (XRT) was 1.1% higher.Tesla (TSLA) shares were down nearly 1% pre-bell after closing Monday with a 1.2% gain. Global electric vehicle sales are expected to be slower than previously expected, especially in the United States, hurt by the withdrawal of regulatory support for electrification in the country, according to a Tuesday note published by BloombergNEF.FinancialThe State Street Financial Select Sector SPDR ETF (XLF) advanced 0.2%. Direxion Daily Financial Bull 3X Shares (FAS) was up 0.5%, while its bearish counterpart, Direxion Daily Financial Bear 3X Shares (FAZ), was 0.5% lower.Fiserv (FISV) shares were up more than 1% pre-bell after the company said it has launched tender offers to buy all $750 million of 5.15% senior notes due 2027, and all $2 billion of 4.40% senior notes due 2049.EnergyThe iShares US Energy ETF (IYE) was flat, while the State Street Energy Select Sector SPDR ETF (XLE) was down by 0.3%.TotalEnergies (TTE) stock was up nearly 1% before market open, a day after the European Commission said it had approved a joint venture between TotalEnergies and Masdar focused on renewable energy projects in the Asia-Pacific region.CommoditiesFront-month US West Texas Intermediate crude oil retreated by 2.9% to $78.40 per barrel on the New York Mercantile Exchange. Natural gas advanced by 0.9% to $3.18 per 1 million British Thermal Units. The United States Oil Fund (USO) declined by 3.9%, while the United States Natural Gas Fund (UNG) was 0.2% lower.Gold futures for July advanced by 0.2% to $4,360.00 an ounce on the Comex. Silver futures rose by 0.4% to $70.44 an ounce. SPDR Gold Shares (GLD) was up by 0.6%, and the iShares Silver Trust (SLV) rose by 0.7%.

Dow JonesNasdaq CompositeS&P 500$ALVO$BETH$BITO$EEM$EETH$EXI$FAS$FAZ$FISV$GLD$IBB$IGM$IGV$IPK$IVV$IWM$IYE$IYH$IYJ$IYK$IYW$PMR$QCOM$QQQ$RTH$SLV$SOXX$SPCX$SPY$TSLA$TTE$UNG$USO$VDC$VHT$VIS$XLE$XLF$XLI$XLK$XLP$XLV$XLY$XRT$XSD
Wire

Alvotech Says FDA Agreed to Review Application for Biosimilar of Entyvio; Shares Rise Pre-Bell

Alvotech (ALVO) said Monday the US Food and Drug Administration has agreed to review its licensing application for a proposed interchangeable biosimilar to the biologic medicine Entyvio for the treatment of ulcerative colitis and Crohn's disease.The company is responsible for developing, as well as producing the medication, while Teva Pharmaceutical (TEVA) oversees market distribution, the company said.The submission has testing data to provide the biological equivalence between the proposed alternative therapy and the original.A prior trial testing a separate variation of the treatment successfully achieved all primary targets to serve as the core clinical similarity evidence for both formulations.Shares of Alvotech added more than 4% in Monday premarket activity.Price: $3.71, Change: $+0.17, Percent Change: +4.90%

$ALVO$TEVA

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