Latest news with #Uplizna
Yahoo
21-05-2025
- Business
- Yahoo
AMGN Down 10% in 3 Months: How to Play the Stock as Tariff Woes Linger
Amgen's AMGN stock has declined 10.4% in the past three months. A lot of this price decline is related to the broader macroeconomic uncertainty. Stocks have been on a roller-coaster ride since President Trump unveiled sky-high tariffs in early April and China came up with retaliatory tariffs. Last week, China and the United States struck a deal that eased trade tensions and resulted in a stock market recovery. Though the massive tariffs imposed by the United States and retaliatory tariffs by China and some other countries are now on a pause, it is only a temporary suspension, and no one knows what will happen after the 90-day tariff suspension ends. The uncertainty around tariffs and trade production measures remains, which has muted economic growth. Although pharmaceuticals have been exempted from tariffs in the first round, they could be Trump's target in the next round, considering the President's goal to shift pharmaceutical production back to the United States, primarily from European and Asian countries. Trump and the Republican government also continue to stress on the control of drug prices with the latest attempt being his 'most favored nations' policy.' Let's understand AMGN's strengths and weaknesses to better analyze how to play the stock in the uncertain macro environment. Amgen's revenues grew 9% year over year in the first quarter of 2025, driven by growing patient demand for its innovative medicines. Amgen is seeing declining revenues from oncology biosimilars and some legacy established products like Enbrel. Pricing headwinds and competitive pressure are hurting sales of many products. Sales of some key brands, like Otezla and Lumakras, have been lukewarm. However, revenues from key older medicines like Prolia, Repatha and Blincyto and new drugs like Tavneos and Tezspire are driving the top line. Rare disease drugs like Tepezza, Krystexxa and Uplizna, added from last year's acquisition of Horizon Therapeutics, are also boosting top-line growth. Amgen is also evaluating Kyprolis, Otezla, Nplate, Repatha, Lumakras, Tezspire, Uplizna and Blincyto for additional indications. Approval for the expanded use of these drugs can potentially drive further top-line growth. Uplizna was approved for IgG4-related disease in the United States in April 2025. Amgen's regulatory application for Uplizna in myasthenia gravis is under review in the United States, with an FDA decision expected on Dec. 14, 2025. Tezspire is under review in the United States for chronic rhinosinusitis with nasal polyps, with an FDA decision expected on Oct. 19, 2025. Amgen has invested several billion dollars in M&A deals over the last decade, which has bolstered its product portfolio and diversified its pipeline. Amgen is developing MariTide, a GIPR/GLP-1 receptor, as a single dose in a convenient autoinjector device with a monthly and, possibly, less frequent dosing. This key feature differentiates it from Eli Lilly's LLY and Novo Nordisk's NVO popular GLP-1-based obesity drugs, Zepbound and Wegovy, which are weekly injections. In clinical studies, it has shown predictable and sustained weight loss and a meaningful impact on cardiometabolic parameters. In March, Amgen initiated two phase III studies on MariTide in obesity as part of its comprehensive MARITIME phase III program. Separate phase III studies on MariTide in obesity, with or without type II diabetes, are currently enrolling patients. Additional MARITIME phase III studies on MariTide in specific obesity-related conditions are expected to be launched throughout 2025. Separate phase II studies on obesity and type II diabetes are also ongoing, with data readouts expected in the second half. An interesting BiTE drug, Imdelltra (tarlatamab), was approved for pre-treated advanced small cell lung cancer (ES-SCLC) in May 2024. Several phase III studies are currently ongoing on tarlatamab in earlier-line settings across extensive-stage and limited-stage SCLC. Imdelltra is believed to have blockbuster potential, as there are limited treatment options in late-line SCLC. Another important candidate, rocatinlimab, is being evaluated in phase III studies for atopic dermatitis and prurigo nodularis. Several data readouts are expected over the next six to 12 months, which could be important catalysts for the stock. Amgen has successfully launched some new biosimilar products this year, which generated impressive sales in the first quarter. In January, Amgen launched Wezlana, the first biosimilar version of J&J's JNJ blockbuster drug, Stelara. Wezlana generated sales of $150 million in the quarter. Wezlana was approved by the FDA in 2023 but was not launched until January 2025, as per a settlement with J&J. Amgen launched the first biosimilar version of Regeneron's Eylea, Pavblu, in the fourth quarter of 2024, which generated sales of $99 million in the first quarter of 2025. Another key biosimilar product, Bekemv, a biosimilar version of AstraZeneca's Soliris, was approved in the United States in May 2024 and was launched in the second quarter of 2025. In the first quarter of 2025, Amgen's biosimilar products generated impressive sales of $735 million, which rose 35% year over year. Amgen's new biosimilar launches will play a key role in mitigating the impact of Amgen's upcoming loss of exclusivity (LOE) over the next few years. Phase III studies are ongoing to evaluate biosimilar versions of Bristol-Myers' Opdivo (ABP 206), Merck's Keytruda (ABP 234) and Roche's Ocrevus (ABP 692). Patents for RANKL antibodies (including sequences) for Prolia and Xgeva expired in February 2025 in the United States and will expire in November 2025 in some European countries. Sales of these best-selling drugs are expected to erode significantly in 2025, mainly in the second half, due to patent erosion. Sales of Amgen's rare disease drugs, mainly Tepezza, have slowed down, which is a concern. The Medicare Part D redesign is expected to hurt sales of some of Amgen's drugs in future quarters. Enbrel and Otezla have been selected by the Centers for Medicare & Medicaid Services for Medicare Part D price setting beginning in 2026 and 2027, respectively. Pricing headwinds and competitive pressure are hurting sales of many products. Weakness in some key brands like Otezla and Lumakras creates potential revenue headwinds. Amgen's stock has risen 7.3% so far this year against a decrease of 3.1% for the industry. The stock has also outperformed the sector and S&P 500 index, as seen in the chart below. Image Source: Zacks Investment Research From a valuation standpoint, Amgen is reasonably priced. Going by the price/earnings ratio, the company's shares currently trade at 13.12 forward earnings, which is lower than 14.74 for the industry. The stock is also trading below its five-year mean of 13.80. Image Source: Zacks Investment Research The Zacks Consensus Estimate for earnings has risen from $20.59 to $20.79 per share for 2025 over the past 30 days. For 2026, the consensus mark for earnings has risen from $21.19 to $21.23 per share over the same timeframe. Image Source: Zacks Investment Research After analyzing the factors discussed above, we believe the company is well placed to maintain long-term revenue growth, driven by continued strong volume growth of key drugs, Repatha, Evenity and Prolia and increasing contribution from new innovative medicines like Tezspire, Tavneos and Imdelltra. It is expected to see continued clinical success from its mid- to late-stage pipeline. Though the initial data from MariTide studies were below expectations, MariTide has the potential to be a game-changer for Amgen. Along with all these factors, Amgen's consistently rising estimates, reasonable valuation and decent stock price appreciation are good enough reasons for those who own this Zacks Rank #3 (Hold) stock to stay invested for now. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 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 Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report Amgen Inc. (AMGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
05-04-2025
- Business
- Yahoo
Why a Clutch of Pharmaceutical and Biotech Stocks Escaped the Market's Swoon on Thursday
As predicted by many analysts, economists, and investors, the sweeping tariffs announced by the Trump administration on Wednesday decimated the stock market on Thursday. It had one of its worst trading days in years, and almost no sector of the economy was spared. Two areas that suffered relatively light damage, however, were pharmaceuticals and biotech. Although few stocks in these fields thrived, some didn't fall as much as other titles. Compared to the S&P 500's (SNPINDEX: ^GSPC) 4.8% tumble, Catalyst Pharmaceuticals' (NASDAQ: CPRX) 1.5% drop was mild, as was Veeva Systems' (NYSE: VEEV) 2% slide. The rare stock actually landed in positive territory, specifically Amgen's (NASDAQ: AMGN) 1.5% rise and AstraZeneca's (NASDAQ: AZN) 2.4% bump. The main reason for this is that, somewhat unexpectedly, the Trump administration didn't impose tariffs on manufacturers of pharmaceutical goods. Previously, the president stated rather emphatically that foreign pharma makers would be slapped with 25% duties on their wares. Yet, the sector was very notable for its absence on the long list of duties imposed by the government. That doesn't mean it'll stay that way, as it's only been granted a temporary exemption. However, the duration of this opt-out is uncertain, so it's not like drugmakers and affiliated companies have entirely dodged the bullet. In fact, it seems that the administration is gearing up to roll out a set of tariffs specifically targeting pharmaceutical exports soon. At this early stage, it's uncertain why the exemption happened. The pharma industry has powerful lobbyists, and in the run-up to Wednesday's tariff announcement at the White House, they were (naturally) pushing for a break. Speculation seemed to be that they were concentrating on levies being phased in, as opposed to the full 25% -- or whatever the final figure -- being implemented right away. Those lobbyists, not to mention interested parties in the biotech and pharma fields, plus ordinary citizens worried about the prices of their medicines, have also been quick to mention the potential effect of higher costs for the inputs that go into the production of drugs. Pharma manufacturing is a complex process, drawing from products made all over the world, so heavy tariffs will be unavoidably painful. The president seems to be aware of this. Following the announcement, Trump said he still aimed to bolster domestic manufacturing by healthcare companies on our soil. They are expected to come "roaring back," and if that doesn't happen, "they got a big tax to pay." Trump provided few if any additional details. Despite this rather large threat hanging over its head, the industry continues to pump out good news here and there -- at least for now. One of the more encouraging items hitting the headlines on Thursday came from Amgen. The U.S. Food and Drug Administration (FDA) expanded its approval of its Uplizna drug to include immunoglobulin G4-related disease (IgG4-RD). This is a rare disorder where the immune system produces inflammation and scarring in the body's organs; Uplizna is now the first and only drug approved to treat it. In its press release trumpeting the FDA's move, Amgen quoted its executive vice president of research and development Jay Bradner as saying it "marks a significant turning point for IgG4-RD patients and physicians who now have a proven treatment that targets a key driver of the disease, reducing the risk of flares and reliance on harmful long-term steroid use." Even if and when those tariffs hit this sector, we can expect companies within it to continue doing their level best to earn regulatory approvals and develop promising medications. Unfortunately, we also need to accept that the costs to manufacture and develop these wares might rise precipitously, too. Before you buy stock in Catalyst Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Catalyst Pharmaceuticals wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $676,774!* Now, it's worth noting Stock Advisor's total average return is 824% — a market-crushing outperformance compared to 164% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of April 1, 2025 Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Amgen and Veeva Systems. The Motley Fool recommends AstraZeneca Plc. The Motley Fool has a disclosure policy. Why a Clutch of Pharmaceutical and Biotech Stocks Escaped the Market's Swoon on Thursday was originally published by The Motley Fool Sign in to access your portfolio
Yahoo
03-04-2025
- Health
- Yahoo
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
By Deena Beasley, Mariam Sunny and Siddhi Mahatole (Reuters) -The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares in patients with a rare immune system-related condition, the regulator said on Thursday. The drug, also known as inebilizumab, has now become the first FDA-approved treatment for Immunoglobulin G4-related disease (IgG4-RD), a rare condition in which an overactive immune system can lead to inflammation and scarring in various organs, including the pancreas, liver and kidneys. Uplizna, given by infusion, is designed to bind to a protein located on the surface of B cells, the underlying inflammatory cause of IgG4-RD and other autoimmune conditions. "By removing or depleting these B cells throughout the body, both in the circulating blood and in the tissue, there's a chance for Uplizna to confer a real benefit," said Jay Bradner, Amgen's head of research and development. Around 20,000 people in the U.S. suffer from the condition, he said. The approval was based on data from a late-stage study in which Uplizna helped reduce the risk of flares by 87% compared to a placebo. "This would be a fairly compelling drug that is infrequent, fairly safe, and very effective," TD Cowen analyst Yaron Werber told Reuters ahead of the decision. Werber estimates Uplizna to generate global peak sales of $1.3 billion by 2030 for IgG4-RD alone. Uplizna, which was already approved for a rare, severe neuroinflammatory disease called neuromyelitis optica spectrum disorder, brought in sales of $379 million in 2024. Steroids — usually used to manage IgG4-RD — have many negative effects on patients, including mood changes, weight gain and osteoporosis, said Dr. Matthew Baker, associate division chief of immunology and rheumatology at Stanford University. "The goal with a treatment like this is to definitely minimize steroid exposure, and I think it certainly will do that," Dr. Baker said. Sign in to access your portfolio
Bloomberg
03-04-2025
- Health
- Bloomberg
Amgen Wins FDA Nod for Uplizna to Treat Rare Disease
US regulators approved Amgen Inc. 's Uplizna as the first and only treatment for a rare inflammatory condition that causes tumor-like growths in organs. Uplizna was first approved in 2020 to treat another rare disease that affects the optic nerve and spinal cord. On Thursday, the US Food and Drug Administration cleared it for immunoglobulin G4-related disease, or IgG4-RD, after the treatment received Breakthrough Therapy designation to expedite the approval process.
Reuters
03-04-2025
- Health
- Reuters
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
April 3 (Reuters) - The U.S. Food and Drug Administration has approved expanded use of Amgen's (AMGN.O), opens new tab drug, Uplizna, to help reduce the risk of flares in patients with a rare immune system-related condition, the regulator said on Thursday. The drug, also known as inebilizumab, has now become the first FDA-approved treatment for Immunoglobulin G4-related disease (IgG4-RD), a rare condition in which an overactive immune system can lead to inflammation and scarring in various organs, including the pancreas, liver and kidneys. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Uplizna, given by infusion, is designed to bind to a protein located on the surface of B cells, the underlying inflammatory cause of IgG4-RD and other autoimmune conditions. "By removing or depleting these B cells throughout the body, both in the circulating blood and in the tissue, there's a chance for Uplizna to confer a real benefit," said Jay Bradner, Amgen's head of research and development. Around 20,000 people in the U.S. suffer from the condition, he said. The approval was based on data from a late-stage study in which Uplizna helped reduce the risk of flares by 87% compared to a placebo. "This would be a fairly compelling drug that is infrequent, fairly safe, and very effective," TD Cowen analyst Yaron Werber told Reuters ahead of the decision. Werber estimates Uplizna to generate global peak sales of $1.3 billion by 2030 for IgG4-RD alone. Uplizna, which was already approved for a rare, severe neuroinflammatory disease called neuromyelitis optica spectrum disorder, brought in sales of $379 million in 2024. Steroids — usually used to manage IgG4-RD — have many negative effects on patients, including mood changes, weight gain and osteoporosis, said Dr. Matthew Baker, associate division chief of immunology and rheumatology at Stanford University. "The goal with a treatment like this is to definitely minimize steroid exposure, and I think it certainly will do that," Dr. Baker said.
