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Darzalex Monotherapy OK'd for Smoldering Multiple Myeloma
Darzalex Monotherapy OK'd for Smoldering Multiple Myeloma

Medscape

timea day ago

  • Health
  • Medscape

Darzalex Monotherapy OK'd for Smoldering Multiple Myeloma

At its June 2025 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended extending the indications for Darzalex (daratumumab) solution for injection as monotherapy to the treatment of adult patients with smoldering multiple myeloma at high risk of developing multiple myeloma. Darzalex is a monoclonal antibody used to treat adults with multiple myeloma and light chain amyloidosis. Good Response to Treatment Daratumumab attaches to the CD38 protein, found in large amounts on abnormal white blood cells in multiple myeloma and light chain amyloidosis. By attaching to CD38 on these cells, daratumumab activates the immune system to kill the abnormal white blood cells. Darzalex as monotherapy was investigated in two main studies involving multiple myeloma patients whose disease relapsed after, or was refractory to, at least two previous treatments, including a proteasome inhibitor and an immunomodulatory medicine. Response to treatment was measured by the disappearance of, or at least a 50% reduction in, protein produced by multiple myeloma cells. In the first study, around 29% of the patients who received daratumumab responded to treatment. In the second study, 36% of patients responded. In these studies, daratumumab was not compared with any other treatment. Full Indications The CHMP highlighted that the full indications for Darzalex solution for injection for will now be: For multiple myeloma: In combination with lenalidomide and dexamethasone or with bortezomib, melphalan, and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant In combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma In combination with bortezomib, thalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy For smoldering multiple myeloma: As monotherapy for the treatment of adult patients with smoldering multiple myeloma at high risk of developing multiple myeloma For light chain (AL) amyloidosis: In combination with cyclophosphamide, bortezomib, and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain amyloidosis The indications for Darzalex concentrate for solution for infusion remained unchanged, the CHMP said. Rob Hicks is a retired UK National Health Service doctor. A well-known TV and radio broadcaster, he has written several books and has regularly contributed to national newspapers, magazines, and online publications.

Top Analyst Reports for Johnson & Johnson, T-Mobile US & Boeing
Top Analyst Reports for Johnson & Johnson, T-Mobile US & Boeing

Yahoo

time11-06-2025

  • Business
  • Yahoo

Top Analyst Reports for Johnson & Johnson, T-Mobile US & Boeing

Tuesday, June 10, 2025 The Zacks Research Daily presents the best research output of our analyst team. Today's Research Daily features new research reports on 16 major stocks, including Johnson & Johnson (JNJ), T-Mobile US, Inc. (TMUS), and The Boeing Co. (BA), as well as one micro-cap stock, Franklin Financial Services Corp. (FRAF). The Zacks microcap research is unique, as our research content on these small and under-the-radar companies is the only research of its type in the country. These research reports have been hand-picked from the roughly 70 reports published by our analyst team today. You can see all of today's research reports here >>> Ahead of Wall Street The daily 'Ahead of Wall Street' article is a must-read for all investors who would like to be ready for that day's trading action. The article comes out before the market opens and attempts to make sense of that morning's economic releases and how they will affect that day's market action. You can read this article for free on our home page, and can actually sign up there to get an email notification as this article comes out each morning. You can read today's AWS here >>> Pre-Market Futures Have Fingers Crossed for Trade Deals Today's Featured Research Reports Shares of Johnson & Johnson have gained +5.8% over the past year against the Zacks Large Cap Pharmaceuticals industry's decline of -15.4%. The company's Innovative Medicine unit is showing a growth trend, driven by existing products like Darzalex, Tremfya, and Erleada, and continued uptake of new launches, including Spravato, Carvykti, and Tecvayli. J&J is making rapid progress with its pipeline and has been on an acquisition spree lately, which has strengthened its pipeline. However, sales in the MedTech segment have slowed down due to headwinds in Asia-Pacific markets like China and competitive pressure in some categories. The launch of Stelara generics is eroding the drug's sales in 2025. Uncertainty around talc lawsuits remains. (You can read the full research report on Johnson & Johnson here >>>) T-Mobile US' shares have outperformed the Zacks Wireless National industry over the past year (+33.4% vs. +28.3%). The company is gaining from healthy growth in service revenues driven by industry-leading postpaid net customer additions. In the first quarter, the company added 1.3 million postpaid net customers while postpaid net account additions were 205,000, both metrics being the best in the industry. Backed by robust demand for its postpaid services and cost discipline, the company has presented a bullish outlook for fiscal 2025. However, the highly competitive and saturated nature of the U.S. wireless market could adversely affect its financial results. (You can read the full research report on T-Mobile US here >>>) Shares of Boeing have outperformed the Zacks Aerospace - Defense industry over the past year (+17.2% vs. +15.5%). The company remains the largest U.S. aircraft manufacturer in the commercial aerospace sector. Soaring air travel should bolster the company's jet service business unit. The outlook for its defense business remains optimistic, buoyed by strengthening U.S. defense budget provisions. The acquisition of Spirit AeroSystems should strengthen Boeing's long-term revenue generation prospects. However, the shortage of labor continues to pose a threat to aerospace manufacturers like Boeing. Trade tensions between the United States and China may cause Boeing to be unsuccessful in the timely delivery of its 737 jets and thereby hurt its operational performance. (You can read the full research report on Boeing here >>>) Franklin Financial Services' shares have outperformed the Zacks Banks - Northeast industry over the past year (+35.7% vs. +17.0%). The company offers a compelling investment case supported by robust 11.2% loan growth driven by commercial real estate and residential lending, alongside a 15.7% rise in average loan balances. Strong deposit expansion of 18.1% enhances funding stability, with 85% of deposits insured or collateralized. The Wealth Management division boosts noninterest income and diversification, with AUM up 6.4%. A strategic $4.3 million securities restructuring enhances long-term profitability despite short-term earnings drag. (You can read the full research report on Franklin Financial Services here >>>) Other noteworthy reports we are featuring today include CrowdStrike Holdings, Inc. (CRWD), Schlumberger Ltd. (SLB), and Tesla, Inc. (TSLA). Mark VickerySenior Editor Note: Sheraz Mian heads the Zacks Equity Research department and is a well-regarded expert of aggregate earnings. He is frequently quoted in the print and electronic media and publishes the weekly Earnings Trends and Earnings Preview reports. If you want an email notification each time Sheraz publishes a new article, please click here>> Today's Must Read J&J's (JNJ) Innovative Medicine Strong, MedTech Slows Down T-Mobile (TMUS) Rides on Healthy Demand, Strong Cash Flow Increasing Defense Orders Drive Boeing (BA), Amid Labor Shortage Featured Reports SLB Stock Positioned to Benefit From New Digital BusinessThe Zacks analyst projects SLB to gain from its New Digital segment by leveraging its extensive data resources and global expertise, positioning it as a leader in autonomy and AI-driven solutions. United Airlines (UAL) Rides on Air Travel Demand, Costs AilThe Zacks analyst is impressed with the fact that increased air-travel demand is aiding United Airlines' top-line performance. However, rising fuel costs continues to weigh on the bottom line. Improving Clearing and Transaction Fees Aid CME Group (CME)Per the Zacks analyst, CME is set to grow on higher clearing and transaction fees as market position, diverse derivative product lines and global reach drive volumes. However, escalating expense ails. New Order Volume Growth Aids Lennar (LEN), Macro Woes AilPer the Zacks analyst, Lennar is driving sales volume through is dynamic pricing model. However, ongoing affordability concerns in the housing market and high mortgage rates remain a concern. Post Holdings (POST) to Benefit From Solid Foodservice UnitPer the Zacks analyst, Post Holdings is likely to keep gaining from its Foodservice segment strength. Notably, unit sales grew 9.6% in the second quarter, backed by pricing and shake contributions. Powell (POWL) Gains From Strong Utility & Commercial MarketsPer the Zacks analyst, solid momentum across Powell's electric utility and commercial & other industrial markets, fueled by strong orders and healthy levels of project activity, will lend it momentum. CrowdStrike (CRWD) Rides on Product Strength, AcquisitionsPer the Zacks analyst, CrowdStrike is gaining from solid contributions of its growth-oriented products, primarily Falcon platform. Also, buyouts like Adaptive Shield and Flow Security are positive. New Upgrades Align Technology (ALGN) Banks on Solid Clear Aligner UptakePer the Zacks analyst, strong uptake of Align Technology's Invisalign DSP touch-up cases in North America supports Clear Aligner volume growth. Strength across APAC and EMEA regions is another plus. Focus on Alternatives to Support Affiliated Managers (AMG)Per the Zacks analyst, Affiliated Managers is well-placed for growth, driven by successful partnerships, global distribution capability, focus on alternative strategies, and a solid balance sheet. End-Market Strength & Diversification Aids Amphenol (APH)Per the Zacks analyst, Amphenol benefits from a diversified business model that lowers volatility of individual geographies. New Downgrades Backlog Decline and Tariff Woes to Weigh on Oshkosh (OSK)Falling backlog levels are likely to slow Oshkosh's revenue momentum, while tariff challenges could weigh on near-term margins, making the Zacks analyst bearish on the stock for now. Elevated Cost Inflation Hurt Conagra's (CAG) PerformancePer the Zacks analyst, Conagra is experiencing cost inflation for a while now, which is affecting its profitability. Higher input and protein costs are expected to persist into fiscal 2026. Tesla (TSLA) Hit by Falling Sales & Musk-Trump FeudTesla's EV sales are slipping across key markets including Europe and China. A public spat between CEO Musk and US President Trump has just made matters worse, per the Zacks analyst. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report The Boeing Company (BA) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report Schlumberger Limited (SLB) : Free Stock Analysis Report Tesla, Inc. (TSLA) : Free Stock Analysis Report T-Mobile US, Inc. (TMUS) : Free Stock Analysis Report Franklin Financial Services Corp. (FRAF): Free Stock Analysis Report CrowdStrike (CRWD) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio

Glenmark's blood cancer drug ISB 2001 shows promising results in trial
Glenmark's blood cancer drug ISB 2001 shows promising results in trial

Time of India

time02-06-2025

  • Business
  • Time of India

Glenmark's blood cancer drug ISB 2001 shows promising results in trial

Ichnos Glenmark Innovation, a clinical stage biotechnology company focused on oncology, has announced promising results for an innovative drug used for the treatment of relapsed or refractory multiple myeloma (RRMM), a rare form of blood cancer that affects plasma cells in bone marrow. Coded ISB 2001, the drug demonstrated an overall response rate (ORR) of 79% in a Phase 1 global study based on finding from patients who were administered a recommended dose. Patients who had exhausted other advanced treatments, such as CAR-T cell therapy and bi-specific antibodies, also showed encouraging results when given the drug. IGI is an alliance between the New York-based scientific research group Ichnos Sciences and Indian drug maker Glenmark. Senior haematologists say that the drug could potentially be an important candidate in the treatment of patients - who exhaust other therapy options due - to its unique mechanism of engaging the body's T cells (that are a vital part of the immune system) along with the attacking two sites on the tumour cell. Dr Shyam Rathi, consultant, clinical hematology, PD Hinduja Hospital & Medical Research Centre in Mumbai, said: 'It can definitely be a game changer in treatment of multiple myeloma which keeps relapsing thus exhausting treatment options quickly. This new drug looks very attractive because it targets two different sites on the cancer cell and it engages the body's own T-cells.' 'We have existing bi-specific antibodies where the target is only one antigen and they develop resistance very fast. However, ISB 2001 targets the two sites on the cancer cell and we expect some better results. It looks exciting in the future.' In lay terms, ISB 2001 binds to three sites on the cancer tumour. First, the ISB 2001 activates the CD-3 T-lymphocytes, which are the cells that have the natural attacking power against tumour cells. Next, it binds to two additional sites. The first is BCMA (a protein found on myeloma cells), which is the target for bi-specific antibodies but there is also CD38, which is the binding site of the widely prescribed drug called daratumumab, branded as Darzalex by Johnson & Johnson. Glenmark, which is pinning a lot of hopes on the new drug, is in advanced talks with multiple global Big Pharma companies for a licensing deal, Chairman and Managing Director Glenn Saldanha told analysts over an earnings call recently. 'The discussions are progressing really well, and we anticipate a positive outcome very quickly,' said Saldhana. He said a deal for ISB 2001 will 'really be transformational for Glenmark' and 'will overshadow anything else that we are doing in the near term.' 'You should see some visibility around a licensing deal pretty quickly.' Last year Ichnos and Glenmark entered into a partnership for discovery of cutting-edge therapies, specifically to treat blood related cancers and malignancies like multiple myeloma. The global market for multiple myeloma treatment is seeing a surge. The business for such drugs is expected to rise to $33 billion by 2030, up from $23.5 billion in 2023,according to Bloomberg Intelligence estimates. Hang Quach, professor of haematology at the University of Melbourne noted that the data presented on ISB 2001 highlighted the 'remarkable anti-myeloma activity of this first-in-class trispecific antibody-T cell engager in heavily pre-treated RRMM patients' including those who have exhausted other approved therapies. According to Quach, ISB 2001 has the potential 'to redefine the treatment landscape for multiple myeloma, offering new hope for patients with limited therapeutic options.' The drug demonstrated a favourable safety profile throughout the dose-escalation phase, with no dose-limiting toxicities (DLTs) reported.

Daratumumab or Darzalex Market Research Report 2025: Epidemiology, Pipeline Analysis, Insights & Forecasts, 2019-2024, 2024-2029F, 2034F
Daratumumab or Darzalex Market Research Report 2025: Epidemiology, Pipeline Analysis, Insights & Forecasts, 2019-2024, 2024-2029F, 2034F

Yahoo

time15-05-2025

  • Business
  • Yahoo

Daratumumab or Darzalex Market Research Report 2025: Epidemiology, Pipeline Analysis, Insights & Forecasts, 2019-2024, 2024-2029F, 2034F

Major players operating in the daratumumab or darzalex market are Genmab A/S, Janssen Biotech Inc. North America was the largest region in the daratumumab or darzalex market in 2024. The regions covered in daratumumab or darzalex report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the daratumumab or darzalex market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain. Dublin, May 15, 2025 (GLOBE NEWSWIRE) -- The "Daratumumab or Darzalex Market Report 2025: Epidemiology, Pipeline Analysis, Market Insights & Forecasts" report has been added to Daratumumab or Darzalex market report delivers an in-depth analysis of the market's key characteristics, including size, growth potential, and segmentation. It provides a detailed breakdown of the market across major regions and leading countries, highlighting historical data and future growth projections. The report also examines the competitive landscape, market share insights, emerging trends, and strategic developments shaping the market. Daratumumab, also known by its brand name Darzalex, is a monoclonal antibody used in the treatment of certain cancers, primarily multiple myelomas. It is designed to target and bind to CD38, a protein highly expressed on the surface of multiple myeloma cells, as well as other malignant and normal immune cells. The growth observed during the historic period can be attributed to factors such as the adoption of multiple research channels, increased feasibility of biomanufacturing operations, higher usage of monoclonal antibodies (mAbs), a growing number of strategic initiatives, and an increase in the secretion of growth during the forecast period is driven by increasing clinical evidence supporting its effectiveness, rising adoption in earlier treatment lines, growing demand for biologics, heightened patient awareness, an increasing incidence of blood cancers, and a rising prevalence of chronic diseases. Major trends in the forecast period include technological advancements, new product launches, product and service offerings, strategic partnerships, mergers and acquisitions, innovations in radiation technologies, and increased increasing incidence of bone marrow cancers is expected to drive the growth of the daratumumab (Darzalex) market in the future. Bone marrow cancers, such as multiple myeloma and leukemia, begin in the bone marrow, causing abnormal blood cell production that disrupts normal body functions. The rise in bone marrow cancer cases can be attributed to factors like an aging population, better detection methods, and environmental, lifestyle, and genetic influences. Daratumumab (Darzalex) is used to treat multiple myeloma by targeting and eliminating abnormal plasma cells in the bone marrow. For example, in January 2024, the American Cancer Society projected 89,190 lymphoma cases and 35,780 myeloma cases, compared to 89,010 and 34,470 in 2022, respectively. This rise in bone marrow cancer incidence is driving the expansion of the daratumumab (Darzalex) growing adoption of biologics and targeted therapies is expected to further fuel the growth of the daratumumab (Darzalex) market. Targeted therapies use drugs or other substances to specifically identify and attack molecules involved in disease progression, such as cancer. The increasing use of biologics and targeted therapies is driven by the rising prevalence of chronic diseases and advancements in precision medicine, which allow for more personalized and effective treatments. Daratumumab is part of these targeted therapies, as it specifically targets CD38, a protein highly expressed on malignant plasma cells in multiple myeloma. For instance, in December 2023, the Advanced Therapy Treatment Centers (ATTC) reported a 31% increase in annual investments in advanced therapies in 2022, with the UK accounting for 14% of global commercial advanced therapy medicinal product (ATMP) clinical trials. This growing adoption of biologics and targeted therapies is contributing to the growth of the daratumumab (Darzalex) market.A key trend in the daratumumab (Darzalex) market is the shift toward early intervention strategies, such as combination therapies, to enhance the effectiveness of treating multiple myeloma and other cancers. Combination therapies use two or more drugs with different mechanisms of action to improve efficacy, reduce resistance, and potentially lower adverse effects compared to monotherapy. For example, in July 2024, Johnson & Johnson received U.S. FDA approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation therapy in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant (ASCT). This approval introduces a quadruplet therapy option for patients at initial diagnosis, potentially improving treatment primary types of daratumumab (Darzalex) are 100 mg injection and 400 mg injection. The 100 mg injection refers to a dose of the medication administered via injection, containing 100 milligrams (mg) of the active ingredient. These drugs are distributed through various channels, including pharmacies, hospitals, and other medical distribution networks. They are used in the treatment of conditions such as follicular lymphoma, mantle cell lymphoma, multiple myeloma, diffuse large B-cell lymphoma, and Topics Covered: 1. Executive Summary2. Daratumumab or Darzalex Market Characteristics3. Daratumumab or Darzalex Market Biologic Drug Characteristics3.1. Molecule Type3.2. Route of Administration (ROA)3.3. Mechanism of Action (MOA)3.4. Safety and Efficacy4. Daratumumab or Darzalex Market Trends and Strategies5. Daratumumab or Darzalex Market - Macro Economic Scenario Macro Economic Scenario Including the Impact of Interest Rates, Inflation, Geopolitics, and the Recovery from COVID-19 on the Market6. Global Daratumumab or Darzalex Growth Analysis and Strategic Analysis Framework6.1. Global Daratumumab or Darzalex PESTEL Analysis (Political, Social, Technological, Environmental and Legal Factors, Drivers and Restraints)6.2. Analysis of End Use Industries6.3. Global Daratumumab or Darzalex Market Growth Rate Analysis6.4. Global Daratumumab or Darzalex Historic Market Size and Growth, 2019-2024, Value ($ Billion)6.5. Global Daratumumab or Darzalex Forecast Market Size and Growth, 2024-2029, 2034F, Value ($ Billion)6.6. Global Daratumumab or Darzalex Total Addressable Market (TAM)7. Global Daratumumab or Darzalex Market Pricing Analysis & Forecasts8. Daratumumab or Darzalex Market Segmentation8.1. Global Daratumumab or Darzalex Market, Segmentation by Drug Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion 100Mg Injection 400Mg Injection 8.2. Global Daratumumab or Darzalex Market, Segmentation by Distribution Channel, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion Pharmacies Hospital Other Distribution Channels 8.3. Global Daratumumab or Darzalex Market, Segmentation by Application, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion Follicular Lymphoma Mantle Cell Lymphoma Multiple Myeloma Diffuse Large B Cell Lymphoma Other Applications 9. Global Daratumumab or Darzalex Market Epidemiology of Clinical Indications9.1. Drug Side Effects9.2. Incidence and Prevalence of Clinical Indications10. Daratumumab or Darzalex Market Regional and Country Analysis10.1. Global Daratumumab or Darzalex Market, Split by Region, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion10.2. Global Daratumumab or Darzalex Market, Split by Country, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Halozyme, J&J slide as analyst cuts rating on CMS draft guidance
Halozyme, J&J slide as analyst cuts rating on CMS draft guidance

Yahoo

time14-05-2025

  • Business
  • Yahoo

Halozyme, J&J slide as analyst cuts rating on CMS draft guidance

Shares of Halozyme Therapeutics (HALO) and Jonhson & Johnson (JNJ) are under pressure on Tuesday after Leerink downgraded the stocks to Underperform and Market Perform, respectively. This comes after the Centers for Medicare and Medicaid Services issued draft guidance for 2028 Inflation Reduction Act drug price controls, which the firm says creates risk that hyaluronidase combination products may not be protected from IRA price negotiations for 13 years after combo approval. Quickly and easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter DOWNGRADES ON CMS ACTION: On Tuesday, Leerink analyst David Risinger downgraded Halozyme to Underperform from Market Perform with a price target of $47, down from $63, and Leerink downgraded Johnson & Johnson to Market Perform from Outperform with a price target of $153, down from $169. The firm, however, is not making any changes to its revenue projections this time as it awaits final guidance from CMS in the second half of 2025. Leerink explains that the catalyst for its downgrades is that CMS issued draft guidance for 2028 IRA drug price controls that creates risk that hyaluronidase combination products may not be protected from IRA price negotiations for 13 years after combo approval. The 'surprise' is CMS draft guidance language suggests that combination products, which do not enhance efficacy, may be negotiated 13 years after the original active ingredient was approved, rather than 13 years after combination approval. The firm notes that Halozyme could face U.S. revenue pressure from Opdivo SC in 2028, Darzalex Faspro in 2029 and Ocrevus SC in 2031. In addition, CMS action may reduce new business opportunities to license ENHANZE. A caveat is that the Street already anticipates the company's Faspro royalty to decline from 5% to 2.5% in 2029 and go to zero in 2032. Its new investment thesis on Halozyme is that Leerink expects shares to underperform because it will be difficult for investors to assign value to the company's major growth drivers since they could start to roll over in 3-5 years. Regarding Johnson & Johnson, the firm notes Darzalex Faspro may be price controlled in 2029 rather than 2034 as it had been assuming. In the case of Darzalex, it was approved in November 2015, and Darzalex Faspro was approved in 2020. Leerink has been modeling that Darzalex Faspro will generate $10.7B in U.S. sales in 2028, or 16% of J&J Worldwide Pharma sales of $66.4B and 10% of total company sales of $96.8B. The firm believes that U.S. Darzalex's profit contribution could be approximately $8.6B in 2028, or 22% of its total company operating profit estimate of $39.1B. If it is price controlled in 2029, the drug's U.S. profit contribution could take a meaningful hit, it points out. Leerink's new investment thesis is that J&J's 5-year growth prospects are at risk of downward revisions if Darzalex Faspro is price controlled in 2029, and we are not anticipating an upward re-rating of the stock in the near-medium term. The firm also highlights that in its 2028 draft guidance, CMS included a new paragraph suggesting a possible reconsideration of its approach to fixedcombination drug negotiations. It believes this development raises concerns for multiple Halozyme's products and J&J's Darzalex Faspro. PRICE ACTION: In Tuesday morning trading, shares of Johnson & Johnson dropped almost 3% to $149.87, while Halozyme's stock has plunged about 27% and is now trading at $49.02. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on HALO: Disclaimer & DisclosureReport an Issue Coinbase, Caterpillar upgraded: Wall Street's top analyst calls Halozyme downgraded to Underperform from Market Perform at Leerink Cautious Optimism for Halozyme Amid Uncertainties: Hold Rating Maintained Halozyme Therapeutics Reports Strong Earnings and Growth Halozyme's Strong Financial Performance and Strategic Developments Justify Buy Rating with $75 Price Target Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

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