Latest news with #Xtandi
Yahoo
23-05-2025
- Business
- Yahoo
Astellas Pharma and Pfizer's Xtandi shows long-term survival in prostate cancer
Astellas Pharma (ALPMY) and Pfizer (PFE) announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES study, reporting a five-year follow up of overall survival, or OS, benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer treated with Xtandi – enzalutamide -, an androgen receptor pathway inhibitor, plus androgen deprivation therapy vs. placebo plus ADT. These data will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago. In patients with high-volume disease a 36-month improvement in median OS was observed. Additional clinically relevant subgroups of patients were evaluated, showing consistently improved survival: low-volume disease; patients who had previously received docetaxel therapy and those who had not received prior docetaxel therapy. The incidence of treatment-emergent adverse events in the five-year follow-up is consistent with prior ARCHES analyses and no new safety signals were identified. These results of the five-year follow-up from the ARCHES study will be submitted for publication in a peer-reviewed journal in the near future. The median OS in the XTANDI group was 8.0 years and 5.8 years in the NSAA group. OS at 96 months was 50% with Xtandi and 40% for NSAA; progression-free survival also favored Xtandi over NSAA. Mean duration of treatment was longer for Xtandi than NSAA, with 33% remaining on Xtandi and 88% of these patients remained at the full dose of 160 mg. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter 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 PFE: Disclaimer & DisclosureReport an Issue Trump Trade: White House announces 'Golden Dome' missile-defense shield Class Action Lawsuit Against Cerevel Therapeutics Holdings, Inc. Pfizer's Strategic Oncology Moves: Balancing Promise and Risk Pfizer's Strategic Focus and Market Challenges Justify Hold Rating Amid Uncertainties HHS says 'taking immediate steps to implement' Trump drug pricing order
Yahoo
23-05-2025
- Business
- Yahoo
Astellas and Pfizer's Xtandi combo reduces death risk in prostate cancer trial
Astellas and Pfizer have reported five-year follow-up outcomes from the open-label extension of the randomised Phase III ARCHES trial. The study indicated that Xtandi (enzalutamide), combined with androgen deprivation therapy (ADT), showed a 30% decrease in the mortality risk in men with metastatic hormone-sensitive prostate cancer (mHSPC). Patients treated with the combination therapy showed a reduction against those receiving placebo plus ADT. The findings offer a longer-term perspective on the overall survival (OS) benefits of the androgen receptor pathway inhibitor (ARPI), Xtandi. Subjects with high-volume disease experienced a 36-month improvement in median OS. The study also assessed various clinically relevant subgroups, including those with low-volume disease and those previously treated with docetaxel, all demonstrating consistent survival improvements. Additionally, the occurrence of treatment-emergent adverse events in the five-year follow-up aligned with previous analyses from the ARCHES trial, without any new safety concerns identified. The placebo-controlled, multinational, double-blind trial enrolled 1,150 participants across sites in South America, Canada, Europe, the Asia-Pacific region, and the US. Its primary endpoint was radiographic progression-free survival (rPFS), with OS as a key secondary endpoint. The post hoc five-year analysis aimed to provide a comprehensive view of long-term survival benefits. Astellas' medical affairs head and executive vice-president Shontelle Dodson said: 'The survival benefits of intervention with Xtandi in advanced prostate cancer are well-recognised. 'The collective – and growing – body of data for Xtandi continues to reinforce its long-term efficacy and patient impact in prostate cancer, including in the metastatic setting, and shows that Xtandi is changing the trajectory of those living with the disease.' Xtandi has been approved for use in more than 90 nations, including the European Union, Japan, and the US. Astellas is responsible for the global manufacturing and commercialisation outside the US while both companies jointly market the therapy within the US. Last October, Pfizer announced positive top-line data from the Phase III TALAPRO-2 study evaluating the combination of Talzenna (talazoparib) and Xtandi in patients with metastatic castration-resistant prostate cancer (mCRPC). "Astellas and Pfizer's Xtandi combo reduces death risk in prostate cancer trial" was originally created and published by Clinical Trials Arena, 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. 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
Business Insider
23-05-2025
- Business
- Business Insider
Astellas Pharma and Pfizer's Xtandi shows long-term survival in prostate cancer
Astellas Pharma (ALPMY) and Pfizer (PFE) announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES study, reporting a five-year follow up of overall survival, or OS, benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer treated with Xtandi – enzalutamide -, an androgen receptor pathway inhibitor, plus androgen deprivation therapy vs. placebo plus ADT. These data will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago. In patients with high-volume disease a 36-month improvement in median OS was observed. Additional clinically relevant subgroups of patients were evaluated, showing consistently improved survival: low-volume disease; patients who had previously received docetaxel therapy and those who had not received prior docetaxel therapy. The incidence of treatment-emergent adverse events in the five-year follow-up is consistent with prior ARCHES analyses and no new safety signals were identified. These results of the five-year follow-up from the ARCHES study will be submitted for publication in a peer-reviewed journal in the near future. The median OS in the XTANDI group was 8.0 years and 5.8 years in the NSAA group. OS at 96 months was 50% with Xtandi and 40% for NSAA; progression-free survival also favored Xtandi over NSAA. Mean duration of treatment was longer for Xtandi than NSAA, with 33% remaining on Xtandi and 88% of these patients remained at the full dose of 160 mg. Confident Investing Starts Here:
Yahoo
13-05-2025
- Business
- Yahoo
Why Verona Pharma plc (VRNA) is Among the Best Performing Healthcare Stocks to Buy Now
We recently published a list of . In this article, we are going to take a look at where Verona Pharma plc (NASDAQ:VRNA) stands against other best performing healthcare stocks to buy now. On April 15, CNBC reported that President Trump's healthcare-focused executive order brought in a win for the sector. Trump directed his health department to collaborate with Congress to revamp a law allowing Medicare to negotiate prescription drug prices. The announcement seeks to bring a change that the pharmaceutical company has lobbied for. Since the negotiation process is included in legislation, Trump's executive order cannot implement the change itself. However, it directs Secretary of Health and Human Services Robert F. Kennedy Jr. to join hands with Congress and change it. CNBC reported that drug makers have been working to delay the eligibility timeline for small-molecule drugs to be available for price negotiations by four years. This typically includes pills and most medications. This goes hand in hand with the 13-year wait until more complex biotech drugs are eligible for Medicare price negotiations. Trump's wide-ranging executive order also focuses on slashing healthcare costs. It comes a day after the administration instituted a national security report on the pharma industry. CNBC called the report 'a precursor to sector-specific tariffs.' READ ALSO: Recession Resistant Investing: 10 Best Grocery Stocks To Buy Now and 11 Most Promising Future Stocks According to Hedge Funds. Medicare's negotiating powers have been a subject of contention, as drug makers have opined that they would suppress innovation and have rallied against the time frame for negotiation eligibility for most drugs. The law now allows the government to negotiate prices for drugs with no competition, which includes complex biotech or biologic medications after 13 years on the market, but 9 years for their administration as capsules and pills. Although they did not provide specifics, White House officials told reporters that other changes to the negotiation process would yield more savings than those attained during the first round under the Biden administration. While the Biden administration negotiated price cuts as steep as 79% for the first ten most expensive drugs to the Medicare program, the Trump administration would negotiate prices for the following 15 medications. This includes Pfizer's cancer drugs Ibrance and Xtandi, as well as Novo Nordisk's blockbuster diabetes and weight-loss treatments Ozempic and Wegovy. We used Finviz to screen healthcare stocks and selected the best performers based on their year-to-date (YTD) performance, as of May 9, 2025. We also included the number of hedge fund holders for each stock as of Q4 2024. We sourced the hedge fund sentiment data from Insider Monkey's database. The list is sorted in ascending order of year-to-date performance. Why do we care about what hedge funds do? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 275% since May 2014, beating its benchmark by 150 percentage points (). A patient in a clinic, taking a medication dose from a nebulizer to treat a respiratory disease. YTD Performance: 36.35% Number of Hedge Fund Holders: 42 Verona Pharma plc (NASDAQ:VRNA) is a UK-based biopharmaceutical company that develops and commercializes therapeutics for treating respiratory diseases with unmet medical needs. The FDA's June 2024 approval of its drug Ohtuvayre to treat chronic obstructive pulmonary disease was a significant catalyst for the company. Analysts project this blockbuster drug's sales potential to top $1 billion by 2029. On May 2, Wells Fargo analyst Tiago Fauth raised the firm's price target on Verona Pharma plc (NASDAQ:VRNA) to $107 from $93, keeping an Overweight rating on the shares. The analyst noted that the fiscal Q1 2025 Ohtuvayre sales of $71 million marked the third consecutive quarter of the drug tracking above Trelegy and Breztri, saying that this 'easily justifies ~$3 billion in peak sales, with ~$5 billion+ being a real possibility.' The analyst further said that Verona Pharma plc (NASDAQ:VRNA) added an incremental $31 million and $35 million in fiscal Q4 2024 and fiscal Q1 2025, respectively, reflecting accelerating growth. This shows that there are reasons to believe in the company's continually accelerating growth. Roth Capital also raised the firm's price target on Verona Pharma plc (NASDAQ:VRNA) to $92 from $83 on April 30, keeping a Buy rating on the stock after it reported fiscal Q1 2025 results. Overall, VRNA ranks 10th on our list of the best performing healthcare stocks to buy now. While we acknowledge the potential for VRNA as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than VRNA but trades at less than 5 times its earnings, check out our report about this cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. 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
13-05-2025
- Business
- Yahoo
Is Tempus AI, Inc. (TEM) the Best Performing Healthcare Stock to Buy Now?
We recently published a list of . In this article, we are going to take a look at where Tempus AI, Inc. (NASDAQ:TEM) stands against other best performing healthcare stocks to buy now. On April 15, CNBC reported that President Trump's healthcare-focused executive order brought in a win for the sector. Trump directed his health department to collaborate with Congress to revamp a law allowing Medicare to negotiate prescription drug prices. The announcement seeks to bring a change that the pharmaceutical company has lobbied for. Since the negotiation process is included in legislation, Trump's executive order cannot implement the change itself. However, it directs Secretary of Health and Human Services Robert F. Kennedy Jr. to join hands with Congress and change it. CNBC reported that drug makers have been working to delay the eligibility timeline for small-molecule drugs to be available for price negotiations by four years. This typically includes pills and most medications. This goes hand in hand with the 13-year wait until more complex biotech drugs are eligible for Medicare price negotiations. Trump's wide-ranging executive order also focuses on slashing healthcare costs. It comes a day after the administration instituted a national security report on the pharma industry. CNBC called the report 'a precursor to sector-specific tariffs.' READ ALSO: Recession Resistant Investing: 10 Best Grocery Stocks To Buy Now and 11 Most Promising Future Stocks According to Hedge Funds. Medicare's negotiating powers have been a subject of contention, as drug makers have opined that they would suppress innovation and have rallied against the time frame for negotiation eligibility for most drugs. The law now allows the government to negotiate prices for drugs with no competition, which includes complex biotech or biologic medications after 13 years on the market, but 9 years for their administration as capsules and pills. Although they did not provide specifics, White House officials told reporters that other changes to the negotiation process would yield more savings than those attained during the first round under the Biden administration. While the Biden administration negotiated price cuts as steep as 79% for the first ten most expensive drugs to the Medicare program, the Trump administration would negotiate prices for the following 15 medications. This includes Pfizer's cancer drugs Ibrance and Xtandi, as well as Novo Nordisk's blockbuster diabetes and weight-loss treatments Ozempic and Wegovy. We used Finviz to screen healthcare stocks and selected the best performers based on their year-to-date (YTD) performance, as of May 9, 2025. We also included the number of hedge fund holders for each stock as of Q4 2024. We sourced the hedge fund sentiment data from Insider Monkey's database. The list is sorted in ascending order of year-to-date performance. Why do we care about what hedge funds do? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 275% since May 2014, beating its benchmark by 150 percentage points (). A technician in a lab coat standing in a cleanroom with energy storage systems in the background. YTD Performance: 81.78% Number of Hedge Fund Holders: 17 Tempus AI Inc. (NASDAQ:TEM) is a healthcare technology company that brings AI and machine learning to healthcare. The company provides next-generation diagnostics across various disease areas by employing technology capabilities. It leverages analytics and data to personalize medicine and has a product line spanning data, genomics, and AI applications. Tempus AI, Inc. (NASDAQ:TEM) focuses on building platforms for cardiology, oncology, infectious diseases, neuropsychiatry, and radiology. On May 7, analyst Daniel Brennan of TD Cowen maintained a Buy rating on Tempus AI, Inc. (NASDAQ:TEM), retaining the price target of $62.00. The analyst based the rating on the company's strong fiscal Q1 performance, as it reported better-than-expected gross margins and EBITDA along with a 3% sales beat. The core Genomics segment and the recently acquired Ambry business are the primary contributors to this performance. The overall financial outlook for Tempus AI, Inc. (NASDAQ:TEM) remains positive despite a higher-than-expected cash burn due to one-off factors that are expected to simmer down in the following quarter. Management raised the full-year 2025 revenue guidance to $1.25 billion, reflecting around 80% year-over-year growth. This notable improvement in guidance highlights robust performance in the genomics and data businesses and the contribution from the AstraZeneca-Pathos deal. Overall, TEM ranks 1st on our list of the best performing healthcare stocks to buy now. While we acknowledge the potential for TEM as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than TEM but trades at less than 5 times its earnings, check out our report about this cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. 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
