Latest news with #Tryngolza
Yahoo
20-05-2025
- Health
- Yahoo
Ionis reports positive data from study of olezarsen for hypertriglyceridemia
Ionis Pharmaceuticals has reported positive topline outcomes from the randomised, global Phase III Essence study of Tryngolza (olezarsen) in individuals with moderate hypertriglyceridemia and, or at risk for, atherosclerotic cardiovascular disease (ASCVD). This condition is characterised by fasting triglyceride (TG) levels between ≥150mg/dL and <500mg/dL. The multicentre, double-blind, placebo-controlled Essence study was carried out with the TIMI Study Group, the company's research partner. It enrolled 1,478 subjects aged 18 years and above diagnosed with or at risk for ASCVD, and 9% of them had fasting triglycerides of ≥500mg/dL at baseline. Subjects received either 50mg or 80mg of olezarsen or a placebo every four weeks via subcutaneous injection for 12 months. The primary endpoint focused on the percentage change from baseline in fasting TG levels at the six-month mark, compared to the placebo. Key secondary endpoints were changes in TG levels at 12 months, the proportion of subjects achieving fasting TG levels of <150mg/dL, and the percentage variations in other lipid parameters against the placebo over the treatment period. The trial, which included subjects already on standard of care, lipid-lowering medications, achieved its primary endpoint. A significant decrease in TG levels was observed, with a placebo-adjusted 61% decrease at the 80mg monthly dose and a 58% decrease at the 50mg dose over a six-month period, compared to the placebo. In addition, the therapy met all key secondary endpoints, with the majority of subjects achieving normal TG levels of <150mg/dL. Olezarsen also demonstrated a favourable tolerability and safety profile in the trial. Ionis Pharmaceuticals global cardiovascular development senior vice-president Sam Tsimikas said: 'Following the Food and Drug Administration (FDA) approval and encouraging launch of Tryngolza (olezarsen) for people living with familial chylomicronaemia syndrome (FCS), a rare, genetic form of severely elevated TGs, these data support olezarsen's potential tobenefit the much broader population of people living with severe hypertriglyceridemia (sHTG).' The investigational RNA-targeted medicine is designed to decrease the body's apolipoprotein C III (apoC-III) production, a protein for regulating the metabolism of triglyceride in the blood. Last November, Ionis announced the design for a pivotal Phase III trial of ION582, an investigational treatment for Angelman syndrome (AS), following discussions with the US FDA. "Ionis reports positive data from study of olezarsen for hypertriglyceridemia" 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.
Yahoo
11-02-2025
- Business
- Yahoo
Why Insiders Are Selling Ionis Pharmaceuticals, Inc. (IONS) Recently
We recently compiled a list of the . In this article, we are going to take a look at where Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) stands against the other feminist stocks. We previously covered 10 Mid-Cap Stocks Insiders Are Buying Recently. Why should investors analyze insider trading activity? Insiders, or people in high positions within a company—such as executives and directors—can have crucial insights into the company's strategic moves, plans, and initiatives. When, for example, a CEO invests their own capital in company stocks, it can indicate strong confidence in the company's future results. What does it mean when insiders are selling their shares? It doesn't necessarily mean bad news for the stock. Sometimes, large shareholders just want to trim their holdings to more appropriate position sizes based on the risk/reward potential. It is important to note that both insider selling and buying can be driven by various motives. Therefore, any insider trading activity should be analyzed within the broader context of the company's fundamentals, industry trends, and overall market conditions. Many insider purchases don't necessarily mean the company will be successful. That's why due diligence before any investment is of the utmost importance. Investors should also take into account and carefully analyze underlying reasons for insider transactions. However, insider trading activity in combination with other relevant factors can offer valuable insights into a company's capabilities, helping investors make more informed investment decisions. To identify the 10 mid-cap stocks insiders are selling recently, we considered only stocks with a market capitalization of between $2 billion and $10 billion. We first used Insider Monkey's insider trading stock screener and looked for stocks with at least two insiders buying over the last two months. With each stock we note the number of recent insider sales and the company's current market capitalization. But why is it important to follow insider activity? Our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds, focusing on insider trading and stock picks from hedge fund investor newsletters and conferences. 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 (see more details here) A scientist in a laboratory making a breakthrough discovery in biotechnology. Number of Insiders Selling: 10 Market Capitalization: $5.152B Ionis Pharamceuticals is a biotechnology company focused on discovering and developing RNA-targeted therapeutics. Currently, it has six marketed medicines and a pipeline in innovative therapies across areas of neurology, cardiology and rare diseases. In December 2024, the U.S. Food and Drug Administration (FDA) greenlighted Tryngolza, an RNA-targeted therapy developed by Ionis for the treatment of familial chylomicronemia syndrome (FCS). Tryngolza is the first-ever FDA-approved treatment that significantly and substantially reduces triglyceride levels in adults with FCS and offers clinically meaningful reduction in AP events when used with an appropriate diet (≤20 grams of fat per day). In January and February, 10 insiders, including CEO, CCO, and CBO sold approximately $5.12 million worth of Ionis Pharmaceuticals shares at an average price of around $32.54 per share. The stocks is now trading at $31.48, having lost 9.95% year-to-date. As many as 18 analysts have 'Buy' as the average rating for Ionis stock, while the stock price target is $62.0. David Lebowitz, an analyst from Citi, recently gave a 'Buy' rating on the company's shares, while the associated price target remains the same at $67.00. Ionis is also one of the 12 Best Healthcare Stocks to Buy According to Analysts. Over the last 12 months, the company's shares lost 37.51%. Overall IONS ranks 3rd on our list of the mid-cap stocks insiders are selling recently. While we acknowledge the potential of IONS as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than IONS but that trades at less than 5 times its earnings, check out our report about the . READ NEXT: 20 Best AI Stocks To Buy Now and Complete List of 59 AI Companies Under $2 Billion in Market Cap Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
