Latest news with #Darzalex


Time of India
4 days ago
- 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.
Yahoo
15-05-2025
- 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
Yahoo
14-05-2025
- 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
Yahoo
07-05-2025
- Business
- Yahoo
The Zacks Analyst Blog Highlights Johnson & Johnson and AbbVie
Sales in J&J's MedTech business are facing continued headwinds in the Asia Pacific, specifically in China. Sales in China are being hurt by the impact of the volume-based procurement (VBP) program and the anticorruption campaign. J&J does not expect any improvement in its business in the Asia Pacific region, specifically in China, in 2025. Competitive pressure is also hurting sales growth in some MedTech businesses. J&J is also making rapid progress with its pipeline and has been on an acquisition spree lately, which has strengthened its pipeline. Its Innovative Medicine unit is showing a growth trend. The segment's sales rose 4.4% in the first quarter of 2025 on an organic basis despite the loss of exclusivity (LOE) for its multi-billion-dollar product, Stelara, and the negative impact of the Part D redesign. In 2025, J&J expects growth in the Innovative Medicine segment in the face of Stelara biosimilar entrants to be driven by its key products such as Darzalex, Tremfya, Spravato and Erleada, as well as new drugs like Carvykti, Tecvayli and Talvey, and new indications for Tremfya and Rybrevant. J&J's biggest strength is its diversified business model, which helps it to withstand economic cycles more effectively. It operates through more than 275 subsidiaries. It seems that 2025 will be a "catalyst year" for JNJ and ABBV, with both expecting their revenues and profits to improve. But which one is a better investment option today? Let's take a closer look at their fundamentals, growth prospects and challenges to make an informed choice. Johnson & Johnson and AbbVie are two major U.S. pharmaceutical companies with robust pipelines and global operations. Both companies have a strong presence in immunology, oncology and neuroscience areas. Other than that, J&J also has drugs for cardiovascular and metabolic diseases, pulmonary hypertension and infectious diseases, along with a strong presence in the medical devices segment. Chicago, IL – May 7, 2025 – announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Johnson & Johnson JNJ and AbbVie ABBV. Story continues The company lost U.S. patent exclusivity of its blockbuster drug, Stelara, in 2025. Stelara sales declined 33.7% in the first quarter of 2025. The launch of generics is expected to significantly erode the drug's sales, hurting J&J's sales and profits in 2025. J&J faces more than 62,000 lawsuits for its talc-based products, primarily baby powders. The lawsuits allege that its talc products contain asbestos, which caused many women to develop ovarian cancer. J&J insists that its talc-based products are safe and do not cause cancer. The company permanently discontinued the sales of its talc-based Johnson's Baby Powder. Last month, a bankruptcy court in Texas rejected J&J's proposed bankruptcy plan to settle its talc lawsuits after a two-week trial in Houston. J&J will go back to the traditional tort system to fight the lawsuits individually with its bankruptcy strategy to settle the lawsuits failing for the third time. The Case for AbbVie AbbVie has successfully navigated the LOE of its blockbuster drug, Humira, which once generated more than 50% of its total revenues. It has accomplished this by launching two other successful new immunology medicines, Skyrizi and Rinvoq, which are performing extremely well, bolstered by approvals in new indications and should support top-line growth in the next few years. On the first-quarter conference call in April, AbbVie also raised its EPS guidance for 2025, driven by stronger-than-expected sales of Rinvoq and Skyrizi. AbbVie expects to record combined Skyrizi and Rinvoq sales of more than $31 billion in 2027. The company's oncology strategy is also gaining traction, supported by increasing contributions from newer products, Elahere and Epkinly. AbbVie has several early/mid-stage pipeline candidates with blockbuster potential. The company expects several regulatory submissions, approvals and key data readouts in the next 12 months. AbbVie has also been on an acquisition spree in the past couple of years, which is strengthening its pipeline. It has signed several M&A deals in the immunology space, its core area, while also signing some early-stage deals in oncology and neuroscience areas. It recently forayed into the lucrative obesity space through a licensing deal with Denmark-based Gubra for the latter's experimental obesity drug. However, the company faces some near-term headwinds like Humira's biosimilar erosion, increasing competitive pressure on cancer drug Imbruvica and a slow market growth trend for Juvederm fillers in the United States and China due to challenging market conditions. How Do Estimates Compare for JNJ & ABBV? The Zacks Consensus Estimate for J&J's 2025 sales and EPS implies a year-over-year increase of 2.7% and 6.2%, respectively. The EPS estimate for 2025 has risen from $10.58 per share to $10.60 per share over the past 30 days, while that for 2026 has declined from $11.07 per share to $10.98 per share over the same timeframe. The Zacks Consensus Estimate for AbbVie's 2025 sales and EPS implies a year-over-year increase of 6.4% and 21.2%, respectively. The EPS estimate for 2025 has declined from $12.30 per share to $12.26 per share over the past 30 days, while that for 2026 has risen from $13.97 per share to $14.06 per share over the same timeframe. Price Performance and Valuation of J&J & ABBV Despite tariff fears and market volatility, stocks of both JNJ and ABBV have risen this year. Year to date, J&J's stock has risen 8.1%, while AbbVie's stock has risen 12.4% compared with the industry's increase of 2.4% J&J looks a tad more attractive than ABBV from a valuation standpoint. Going by the price/earnings ratio, J&J's shares currently trade at 14.44 forward earnings, slightly lower than 15.70 for the industry, and its 5-year mean of 15.89. AbbVie's shares currently trade at 15.22 forward earnings, slightly lower than the industry but much higher than the stock's 5-year mean of 12.23. JNJ or ABBV: Which is a Better Pick? AbbVie & J&J have a Zacks Rank #3 (Hold) each, which makes choosing one stock a difficult task. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. J&J has shown steady revenue and EPS growth for years. J&J considers 2025 to be a "catalyst year," positioning the company for growth in the second half of the decade. J&J expects operational sales growth in both the Innovative Medicine and MedTech segments to be higher in the second half of 2025 than in the first. While newly launched products should drive growth in the Innovative Medicines segment in the second half, the MedTech segment may benefit from new products and easier comps. J&J expects growth to accelerate from 2026 onward. However, though J&J's Innovative Medicines unit is showing a growing trend, the softness in the MedTech unit is a concern. The legal battle surrounding its talc lawsuits has created a bearish sentiment around the stock. On the other hand, AbbVie has faced its biggest challenge — Humira's patent cliff — quite well and looks well-positioned for continued strong growth in the years ahead. The company saw a rapid return to sales growth in 2024 after revenues declined in 2023 due to Humira LOE, driven by its ex-Humira platform. AbbVie's ex-Humira drugs rose more than 20% in the first quarter of 2025. J&J, in sharp contrast, faces LOE of one of its biggest drugs, Stelara, in 2025. Boosted by its new product launches, AbbVie expects to return to robust mid-single-digit revenue growth in 2025 with a high single-digit CAGR through 2029, as it has no significant LOE event for the rest of this decade. Despite its steeper valuation, AbbVie is a clear-cut winner due to rising estimates, stock price appreciation, a solid pipeline, and better prospects for sales and profit growth. Why Haven't You Looked at Zacks' Top Stocks? Since 2000, our top stock-picking strategies have blown away the S&P's +7.7% average gain per year. Amazingly, they soared with average gains of +48.4%, +50.2% and +56.7% per year. Today you can access their live picks without cost or obligation. See Stocks Free >> Media Contact Zacks Investment Research 800-767-3771 ext. 9339 support@ Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit for information about the performance numbers displayed in this press release. 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 Johnson & Johnson (JNJ) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
17-04-2025
- Business
- Yahoo
J&J projects $400m tariff hit but raises sales outlook
Johnson & Johnson Innovative Medicine (J&J) addressed the potential impact of pharmaceutical tariffs during its Q1 2025 earnings call, as the US government intensifies its scrutiny of foreign drug supply chains. The company's chief financial officer Joseph Wolk said the company expects a $400m cost tied to newly proposed and existing tariffs, with the largest burden stemming from China's retaliatory duties on US-origin goods. With the possibility of pharma-specific tariffs looming and the Department of Commerce announcing the launch of a Section 232 investigation into pharmaceutical imports on 14 April, investors were watching closely for commentary from J&J on US trade policy. The investigation gives President Donald Trump 90 days to determine whether tariffs should be imposed on national security grounds. CEO Joaquin Duato said the company is analysing the Section 232 process, noting it had been anticipated and would be treated as a normal regulatory development. 'It's important that companies in healthcare partner with the administration to look to mitigate some of the vulnerabilities that exist today in our healthcare supply chain,' Duato said. 'We plan to do it in this process to make sure that we have enough manufacturing capacity here in the US to be able to address multiple scenarios. We want to be deferential to the administration and their process,' he added. Many large pharma companies like MSD and Novartis have announced plans to increase manufacturing activity in the US against the backdrop of these tariff announcements, and J&J announced its own $55m US investment in March 2025. 'Since President Trump's 2017 tax reform, the investment in manufacturing – both in medtech and in pharmaceuticals – has significantly increased. When you think about our recent announcement of investing $55bn over the next four years at the completion of this investment plan, essentially all our advanced medicines that are used in the US will be manufactured in the US,' said Duato. J&J indicated that most of the projected $400m tariff impact will affect its Medtech division. The total includes duties from China, as well as import tariffs from Mexico and Canada not excluded under the United States–Mexico–Canada Agreement (USMCA). Wolk noted that mitigation strategies are limited due to existing price controls and contractual agreements, particularly in the pharmaceutical segment. Tariff-related costs will primarily be recorded as inventory before impacting future profit and loss statements. Despite the headwinds, J&J posted Q1 results above analyst expectations. Revenue for the quarter rose by 2.4% to $21.9bn, with operational growth of 4.2% and adjusted operational growth of 3.3%. Oncology products, including multiple myeloma drug Darzalex (daratumumab), remained key contributors. The company raised its 2025 sales forecast by $700m to $92bn at the midpoint, reflecting the addition of Caplyta (lumateperone) following its $14.6bn acquisition of Intra-Cellular Therapies. However, J&J lowered its adjusted operational EPS growth projection to 6.2%, down from 8.7%, citing dilution from the acquisition. Adjusted reported EPS growth remains unchanged at 6.2%, consistent with guidance first issued in January 2025. J&J also reported regulatory approvals for two key therapies in 1Q: the US Food and Drug Administration (FDA) cleared Tremfya (guselkumab) for Crohn's disease, and the European Commission (EC) approved Rybrevant (amivantamab-vmjw) for specific lung cancer indications. Medtech operational sales rose 4.1%, with growth driven by cardiovascular and general surgery segments. Orthopaedics showed weakness, particularly in spine and sports medicine. Legal challenges remain ongoing. In April 2025, a Texas court blocked J&J's attempt to resolve talc-related liabilities via a bankruptcy filing by its subsidiary Red River Talc. J&J previously expressed its intention to defend itself against the claims, which it insists are 'meritless' and 'premised on junk science'. J&J intends to recover up to $7bn from legal reserves. "J&J projects $400m tariff hit but raises sales outlook" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio