Latest news with #Repatha
Time of India
25-05-2025
- Entertainment
- Time of India
Rosie O'Donnell reveals dramatic weight loss after using Mounjaro; How safe is it for women in 60s?
Rosie O'Donnell can't recognize herself anymore! The 63-year-old former star of 'The View' recently opened up about her weight loss journey and showcased her new, slimmer figure. O'Donnell credited Mounjaro for her dramatic transformation in a recent Instagram post. In her post, she shared a screenshot of a video taken of her onstage, where she wore dark pants and a light green sweater while holding a microphone and mic stand, appearing to engage with the audience. She captioned the photo, "I can't believe this is me now," and included the hashtags '#mounjaro,' '#weightloss,' and '#bodydismorphia.' O'Donnell moved to Ireland a few months ago with her 12-year-old child, Clay. Sharing updates and insights about her weight loss journey, O'Donnell said in a TikTok video in March. 'I've lost more weight. I am on Mounjaro for my diabetes, and one of the side effects is weight loss." She added, "But it's also because I had a chef for over two years in Los Angeles, and now I'm cooking for Clay and me.' The 'Harriet the Spy' actress admitted she's 'always had a weight issue' as she discussed shopping for new clothes at a boutique in Dublin. She shared that she had to shop in Dublin for new clothes that fit her better following her weight loss. Recounting her journey after years of battling weight issues, she said, "I'm one of those people who always had a weight issue, and now that I'm a size large—instead of an XL or a XXL—I find it shocking. I really do. I find it completely shocking." After suffering a heart attack in 2012, O'Donnell underwent vertical sleeve gastrectomy the following year. She told People in 2015, 'That surgery changed my life,' revealing she dropped from 240 pounds down to 176. In January 2023, O'Donnell revealed that her doctor had prescribed her Mounjaro and Repatha two months prior, with noticeable results already. She clarified, "One I take every other week and one I take once a week." At the she also shared, 'Christmas, I stopped drinking anything except water,' revealing she had already shed 10 pounds. She added, 'I really stopped drinking like five or six Diet Cokes a day. All I drink is water now. ' While she mostly credited Mounjaro for her physical transformation, O'Donnell also revealed some major lifestyle changes as well. Apart from the medication, she mentioned, 'My appetite has decreased significantly; it's probably the meds. And I'm trying to move more. So, all those things combined—that's what it is," she said at the time. What is Mounjaro? Approved by the US Food and Drug Administration for type 2 diabetes and packaged as an injection, Mounjaro (tirzepatide) has already sparked discussions over its effectiveness in managing weight, with some claiming it is superior to Ozempic, the popular weight loss drug. Tirzepatide is an antidiabetic medication used to treat type 2 diabetes and for weight management and is administered via subcutaneous injections (under the skin). In the United States, it is sold under the brand name Mounjaro for diabetes treatment and Zepbound for weight loss and treatment of obstructive sleep apnea. Mounjaro is administered via weekly injections in the thigh, stomach, or arm. Several prominent figures, including Elon Musk, Meghan Trainor, and Amy Schumer , have publicly shared their experiences with the drug in recent months. Is Mounjaro safe for women in their 60s? Mounjaro is FDA-approved for treating type 2 diabetes, and its use has been studied in various age groups, including older adults, and there are no specific age restrictions mentioned in the Mounjaro prescribing information. Mounjaro is generally considered safe for use in women in their 60s as well. However, it is crucial to discuss it with a healthcare professional who can assess individual health risks, including any pre-existing conditions, medications, and lifestyle factors, to determine if Mounjaro is appropriate for them. Amy Schumer's ROYAL Shade? Meghan Markle & Kate Middleton BOTH Get Mentioned | WATCH
Mint
23-05-2025
- Health
- Mint
Strokes and heart attacks kill. New drugs are coming to prevent them.
Forty years after the first statin drug started lowering levels of artery-choking cholesterol, heart attacks and strokes remain the world's biggest killers. This year, we'll see test results on some drugs that cut cholesterol even more. Statins are cheap and effective drugs for reducing blood levels of the 'bad" cholesterol known as LDL, which gunks up arteries over time. A quarter of Americans have high LDL. But only about half of patients stay on their prescribed statins, and the drugs don't get LDL low enough in some 10% of patients. A pack of new cardiovascular drugs are being tried as pills, biweekly or semiannual shots, and even as once-for-a-lifetime infusions. And their benefits all seem additive to those of statins and each other. Successful trial results in the next few years could save thousands of lives and generate billions in new annual revenue for drugmakers. The companies working on them range from pharmaceutical companies—like Eli Lilly, Merck, and AstraZeneca—to biotechs—like Amgen and Regeneron Pharmaceuticals—to gene-editing specialists—like Crispr Therapeutics and Verve Therapeutics. Regeneron and Sanofi took the first big step beyond statins in 2015 with Praluent, a biweekly injection of antibodies that sop up the enzyme called PCSK9, which strongly effects blood levels of LDL. Amgen followed just weeks later, with the PCSK9 antibody Repatha. In 2021, Novartis launched Leqvio, which blocks the genetic instructions for making PCSK9 and can be injected just twice a year. The PCSK9 drugs are lifesavers for families with genetically-high LDL levels. But they require regular injections and can cost $30,000 a year for the rest of a patient's life. The cost and hassle has led to sales that are good, but not as great as expected. Regeneron and Sanofi's Praluent sales were $585 million in 2024. For the same year, Amgen's Repatha pulled in $2.2 billion, up 15% year over year. Last year's sales of Leqvio for Novartis were $260 million, up 80%. To address these drugs' cost and convenience issues, Merck is testing a pill treatment that it code-named MK-0616. The company is betting the drug will help replace some of the revenue it will lose after patents expire on its huge-selling cancer drug, Keytruda. On April 7, Merck finished the once-daily pill's Phase 3 trial in about 300 people with inherited high-LDL cholesterol. In August, it expects to complete the broader study among some 2,800 patients with serious cardiovascular problems. Both studies measure reductions in LDL—which regulators accept as good-enough proof that cardiovascular problems will also be prevented. Analysts hope the company will report results at the November 2025 meeting of the American Heart Association. Merck aims for a bigger market than just high-LDL families, so a third Phase 3 for MK-0616 will use the gold-standard test of whether those on the pill actually have fewer heart attacks, strokes, or other cardiovascular calamities. That study, which is enrolling over 14,000 people, won't finish until 2029. While Merck's pill could find its way to a larger population than today's PCSK9 injections, it still has some convenience issues. Patients have to take MK-0616 on an empty stomach and shouldn't be on certain other drugs. That's why AstraZeneca is pushing ahead with its own PCSK9 pill, dubbed AZD0780, which requires no fasting. In March, the company said the pill achieved deep reductions in LDL in a Phase 2 study on patients whose statin treatment wasn't doing the job. The size of the cardio market and the current PCSK9 drugs' issues have also caught the eye of the gene-editing industry. These companies' Crispr technology can zero in on a particular, troublesome stretch in the 3 billion links of our DNA, and then permanently inactivate it, or make a repair. So far, genetic-medicine firms have struggled to convince investors that there's real money to be made from the Nobel Prize-winning technology. Companies like Crispr Therapeutics initially focused on dire, but relatively uncommon diseases like sickle cell disorder. Revenue has been slow to come. Verve Therapeutics, however, focused on cardiovascular disease from the start. It licensed a second-generation Crispr technology called base-editing, from the company Beam Therapeutics. Base-editing gently changes a single letter at a time in DNA genetic code. By permanently disrupting the code for PCSK9, Verve's one-time treatment could lower LDL for life. The stock perked up in April when the company reported initial Phase 1 data that showed no serious side effects among 14 patients—with LDL reductions of around 60% even two years after the one-time treatment. That reduction is comparable to today's PCSK9 injectables. Eli Lilly has an option to partner on Verve's cardio programs, and could opt in this year. Other genetic-medicine approaches to PCSK9 are exploring nonpermanent, but long-lasting fixes. The privately held Scribe Therapeutics has reported intriguing results in monkeys from 'epigenetic" edits of the molecules that turn genes on and off. And PCSK9 isn't the only strong lever on cholesterol levels. Another that our body uses to control blood levels of cholesterol is a protein called CETP. Early in May, NewAmsterdam Pharma reported on a couple of Phase 3 trials of obicetrapib, its antibody that blocks CETP. By itself, the antibody cut LDL levels by a third. Combined with a statin, LDL levels fell by half. Another lever on LDL is ANGPTL3, a protein controlling blood levels of LDL and harmful triglycerides. Since 2021, Regeneron has marketed Evkeeza, an antibody that inhibits ANGPTL3. Sales of the drug to patients with inherited high cholesterol were $126 million in 2024. Lilly, Arrowhead Pharmaceuticals, and Regeneron are all testing so-called siRNA drugs that interfere with cellular production of ANGPTL3. They are injections that work for as long as a year at a time. Verve began Phase 1 trials in November 2024 on a base-editing treatment that permanently disrupts the genetic instructions for ANGPTL3. It hopes to report some data later this year. Crispr Therapeutics, meanwhile, is further along in trials of a one-and-done edit that blocks ANGPTL3. In April, it reported that LDL dropped by two-thirds, among the first 10 patients treated. No serious side effects surfaced in the first months after infusion. For rare but deadly disorders, gene-editing fixes are priced above $1 million. The Crispr crowd thinks it can find a price that is attractive to the healthcare payers that cover the expensive siRNA injections now given to patients with inherited high levels of cholesterol. 'If you're talking about siRNA, that is $30,000 a year for 50 years," said Crispr Therapeutics Chief Executive Samarth Kulkarni at an April conference. 'We could spend one-tenth of that and charge $150,000 for a single-shot therapy. For the payer, the economic argument is very clear." Write to Bill Alpert at
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
15-05-2025
- Business
- Yahoo
AMGN Q1 Earnings Call: Product Pipeline and Margin Expansion Drive Outperformance
Biotech company Amgen (NASDAQ:AMGN) reported Q1 CY2025 results topping the market's revenue expectations , with sales up 9.4% year on year to $8.15 billion. The company expects the full year's revenue to be around $35 billion, close to analysts' estimates. Its non-GAAP profit of $4.90 per share was 15% above analysts' consensus estimates. Is now the time to buy AMGN? Find out in our full research report (it's free). Revenue: $8.15 billion vs analyst estimates of $8.03 billion (9.4% year-on-year growth, 1.5% beat) Adjusted EPS: $4.90 vs analyst estimates of $4.26 (15% beat) Adjusted EBITDA: $4.99 billion vs analyst estimates of $4.67 billion (61.2% margin, 6.7% beat) The company reconfirmed its revenue guidance for the full year of $35 billion at the midpoint Management reiterated its full-year Adjusted EPS guidance of $20.60 at the midpoint Operating Margin: 14.5%, up from 13.3% in the same quarter last year Free Cash Flow Margin: 12%, up from 6.2% in the same quarter last year Market Capitalization: $141 billion Amgen's first quarter results were shaped by broad-based volume growth and new product launches across general medicine, rare diseases, inflammation, and oncology. Management highlighted the performance of 14 products with double-digit growth, as well as strong uptake of new biosimilars. CEO Robert Bradway emphasized, 'We delivered multiple positive Phase III readouts, initiated four new Phase III studies, and launched three new products or indications.' Looking ahead, Amgen's full-year guidance centers on further execution in its late-stage clinical pipeline and continued momentum in recently launched therapies. CFO Peter Griffith noted increased R&D investment to support assets such as MariTide, a potential obesity therapy, and ongoing expansion in the biosimilars portfolio. Management also acknowledged uncertainties from tariffs and tax policy, stating the company's manufacturing investments position it to adapt as needed. Amgen's management attributed the quarter's performance to the breadth of its product portfolio and significant progress in clinical development. Key growth areas included cardiovascular, bone health, rare disease, and oncology, with biosimilars delivering meaningful contributions. Broad product portfolio growth: Fourteen medicines delivered double-digit sales growth, spanning cardiovascular, bone health, rare disease, and oncology. Amgen's biosimilars segment generated over $700 million in revenue, up 35% year over year. General medicine expansion: Products like Repatha and EVENITY benefited from improved patient access, expanded prescriber base, and direct-to-consumer initiatives. Management cited ongoing clinical trials targeting large, underserved populations in cardiovascular and obesity-related diseases. Rare disease launches: UPLIZNA launched as the first FDA-approved treatment for IgG4-related disease, with early physician adoption. TEPEZZA expanded internationally, including approvals and launches in Japan and a positive regulatory opinion in Europe. Oncology pipeline momentum: Bispecific T cell engagers such as BLINCYTO and IMDELLTRA showed continued adoption and positive clinical data. IMDELLTRA demonstrated survival benefits in small cell lung cancer, with new Phase III studies underway. Biosimilars market penetration: Recent biosimilar launches, including PAVBLU and WEZLANA, were met with positive reception from prescribers. The company's approach focused on early U.S. launches and reliable supply to capture market share. Management's outlook for the remainder of the year is anchored by ongoing clinical advancement and new launches, while cautioning about external factors such as tariffs and increased R&D investment. Pipeline advancement: Significant late-stage studies for therapies like MariTide in obesity and Olpasiran in cardiovascular disease are expected to drive future growth, with management increasing R&D spending to support these programs. Expanding biosimilars: New biosimilar launches and further commercialization efforts are anticipated to diversify revenue streams and address pricing pressures in core therapy areas. External policy risks: Management flagged potential headwinds from evolving tax and tariff policies, emphasizing Amgen's historical ability to adapt through manufacturing investments and operational agility. Terence Flynn (Morgan Stanley): Asked about key data expectations for MariTide at the ADA meeting. Management said data would focus on 52-week efficacy and tolerability but not new long-term results. Salveen Richter (Goldman Sachs): Inquired about UPLIZNA's commercial strategy for IgG4-related disease. Amgen outlined targeted outreach to rheumatologists and plans for broader physician engagement. Michael Yee (Jefferies): Pressed on MariTide's tolerability and competition from oral obesity drugs. Management expressed confidence in design for efficacy and tolerability, with ongoing development of oral options. Trung Huynh (UBS): Questioned Repatha's position amid new competition. Amgen stressed product profile advantages and improved patient access, with room for multiple therapies in the market. David Amsellem (Piper Sandler): Asked what will drive growth for TEPEZZA. Management pointed to expanded prescriber education and international launches, with potential future benefit from a subcutaneous form. In coming quarters, the StockStory team will monitor (1) progress and data releases from late-stage clinical trials, especially for MariTide and bemarituzumab; (2) commercial adoption and prescriber uptake of newly launched therapies like UPLIZNA in IgG4-related disease and PAVBLU in biosimilars; and (3) updates on international expansion of key rare disease drugs. Execution in R&D and navigating policy changes will also be important indicators of Amgen's trajectory. Amgen currently trades at a forward P/E ratio of 13×. In the wake of earnings, is it a buy or sell? Find out in our free research report. Market indices reached historic highs following Donald Trump's presidential victory in November 2024, but the outlook for 2025 is clouded by new trade policies that could impact business confidence and growth. While this has caused many investors to adopt a "fearful" wait-and-see approach, we're leaning into our best ideas that can grow regardless of the political or macroeconomic climate. Take advantage of Mr. Market by checking out our Top 5 Strong Momentum Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today. 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Yahoo
15-05-2025
- Business
- Yahoo
Amgen owes $406 million for monopolizing cholesterol drug market, US jury says
By Blake Brittain (Reuters) -A federal jury in Delaware said on Thursday that biotech company Amgen owes competitor Regeneron more than $406 million for engaging in anticompetitive behavior to increase sales of its cholesterol-reduction drug Repatha at the expense of Regeneron's rival drug Praluent. The jury agreed with Regeneron that Amgen unlawfully bundled Repatha with two of its blockbuster anti-inflammatory drugs to persuade pharmacy benefit managers to buy it instead of Praluent. The verdict includes $271.2 million for Regeneron in punitive damages. Amgen said in a statement that it "has always competed fairly and in compliance with the antitrust laws" and "look[s] forward to post-trial proceedings." "Larger companies should not be allowed to use anticompetitive tactics to push competitors out of the market," Regeneron CEO Leonard Schleifer said in a statement. Tarrytown, N.Y.-based Regeneron filed the lawsuit in 2022, accusing Amgen of engaging in an anticompetitive scheme to drive Amgen's drug out of the market. Thousand Oaks, California-based Amgen denied the allegations and countered that Regeneron's business decisions caused lost Praluent sales. Regeneron earned more than $241 million from sales of Praluent in the U.S. last year, while Amgen made over $1.1 billion from U.S. Repatha sales, according to company reports.
