Latest news with #EFX
Yahoo
20-05-2025
- Health
- Yahoo
Akero Therapeutics and HistoIndex Present New Analyses of Phase 2b HARMONY Trial in Oral and Poster Presentations at the EASL Congress 2025
Analysis of EFX results with AI-based digital pathology underscores the potential value in evaluating histopathology response Data contribute to growing body of support around the anti-fibrotic activity of EFX in patients with pre-cirrhotic MASH SOUTH SAN FRANCISCO, Calif., May 10, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced results from new analyses of the 96-week Phase 2b HARMONY trial of efruxifermin (EFX) in patients with pre-cirrhotic (F2-F3 fibrosis) metabolic dysfunction-associated steatohepatitis (MASH) in an oral presentation and a poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7-10, in Amsterdam, the Netherlands. The presentations corroborate the antifibrotic activity previously reported by conventional pathology for EFX in patients with pre-cirrhotic MASH. Specifically, among patients treated with EFX, digital pathology analysis by HistoIndex's AI-based qFibrosis® showed concordance at the individual level with two non-invasive tests (NIT) of liver fibrosis—ELF test score and liver stiffness measurement (FibroScan®)—with more than half of patients treated with 50mg EFX classified as responders by all three endpoints compared to fewer than 5% of placebo patients. 'One of the challenges of developing a MASH investigational drug is distinguishing treatment effect from placebo 'noise' due to the inherent variability of biopsy sampling coupled with categorical pathology scoring,' said Kitty Yale, chief development officer at Akero. 'As a continuous scoring scale, AI-based qFibrosis®, combined with the two NITs, reduces placebo noise, allowing the potent anti-fibrotic effect of EFX to be clearly differentiated from placebo.' The poster presentation, based on a post-hoc analysis of the 96-week HARMONY trial in patients with F2-F3 MASH quantifying the amount of collagen in each zone of the liver using qFibrosis®, describes how the antifibrotic effect of EFX after 24 weeks treatment was greater than observed by conventional pathology, but after 96 weeks it was similar. For example, qFibrosis® analysis of Week 96 biopsy samples from 50mg EFX patients (N=26) revealed consistency between conventional pathology and qFibrosis®, with totals of 20 (77%) (conventional pathology) and 21 (81%) (qFibrosis®), respectively. However, only 10 of these patients were identified as responders at Week 24 by conventional pathology, whereas 18 of them were detected as responders at Week 24 using qFibrosis®. Details for the presentations are as follows: Oral Presentation Title: Alignment of response assessed by non-invasive fibrosis biomarkers and HistoIndex AI-based qFibrosis histology in metabolic dysfunction associated steatohepatitis (MASH) clinical trials: a new roadmap for robust drug efficacy assessment demonstrated in the HARMONY trialSpeaker: Prof. Quentin M. Anstee, Ph.D., FRCP, Ruth & Lionel Jacobson Chair of Personalised Medicine, Dean of Research & Innovation in the Faculty of Medical Sciences, Newcastle University, UKDate/Time: Saturday, May 10, 2025, from 10:30 am – 10:45 am CETAbstract Identifier: OS-096Oral Session: MASLD: Clinical and therapeutical aspects II Poster presentation Title: qFibrosis enables earlier detection of fibrosis response in Efruxifermin-treated patients with F2-F3 MASH in 96-week HARMONY studySpeaker: Jörn M. Schattenberg, M.D., Professor of Medicine, Director of the Department of Medicine, Saarland University Medical Center, University of Saarland Date/Time: Saturday, May 10, 2025, from 8:30 am – 4:00 pm CETAbstract Identifier: TOP-458Session: Poster - MASLD: Therapy About the HARMONY Study The Phase 2b HARMONY study was a multicenter, randomized, double-blind, placebo-controlled trial in biopsy-confirmed adult MASH patients with fibrosis stage 2 or 3. The study enrolled a total of 128 patients who were randomized to receive once-weekly subcutaneous dosing of 28 mg or 50 mg EFX, or placebo for 24 weeks, 126 of whom received at least one study dose. The primary efficacy endpoint for the study was the proportion of subjects who experienced ≥1-stage fibrosis improvement without worsening of MASH. The study continued for up to 96 weeks. Secondary endpoints at Week 96 included proportion of patients with ≥1-stage fibrosis improvement and no worsening of MASH, proportion of patients with 2-stage fibrosis improvement without worsening of MASH, and proportion of patients with ≥1-stage fibrosis improvement and MASH resolution, as well as changes from baseline in noninvasive markers of liver injury and fibrosis, glycemic control, lipoproteins, and change in body weight as well as safety and tolerability measures. About EFXEfruxifermin (EFX), Akero's lead product candidate for MASH, is currently being evaluated in three ongoing Phase 3 studies. In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death among MASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date. About Akero Therapeutics Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic (F2-F3 fibrosis) MASH, SYNCHRONY Outcomes in patients with compensated cirrhosis (F4) due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (metabolic dysfunction-associated steatotic liver disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at and follow us on LinkedIn and X for more information. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements'' within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero's business plans and objectives; the potential therapeutic effects and anti-fibrotic activity of EFX, as well as the dosing, safety and tolerability of EFX; and the potential benefits of analyzing results with AI-based digital pathology. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero's ability to execute on its strategy; positive results from any of its clinical studies may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors'' in Akero's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero's other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact:Christina TartagliaPrecision AQ212.362.1200IR@ Media Contact:Peg RusconiDeerfield
Yahoo
20-05-2025
- Business
- Yahoo
Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Trial in the New England Journal of Medicine
Results support potential benefit of efruxifermin (EFX) to elicit fibrosis improvement in patients with compensated cirrhosis (F4 fibrosis) due to MASH 96-week data from SYMMETRY trial presented at EASL Congress 2025 SOUTH SAN FRANCISCO, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced publication of results from the Phase 2b SYMMETRY trial in the New England Journal of Medicine. The publication reports results from the 96-week SYMMETRY study evaluating the efficacy and safety of Akero's lead FGF21 analog efruxifermin (EFX), in participants with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, caused by metabolic dysfunction-associated steatohepatitis (MASH). 'Publication of the Phase 2b SYMMETRY trial results in the New England Journal of Medicine is a significant milestone that affirms the strength of our clinical data and the potentially transformative nature of EFX in the treatment of patients with compensated cirrhosis due to MASH,' said Kitty Yale, chief development officer of Akero. 'We remain encouraged by the potential benefits of treatment with EFX observed in the study, including unprecedented fibrosis improvement in patients with compensated cirrhosis due to MASH after 96 weeks of treatment, and look forward to continuing advancement of our ongoing Phase 3 SYNCHRONY program.' The primary endpoint was ≥1-stage fibrosis improvement without MASH worsening at 36 weeks of treatment, with secondary outcomes of fibrosis improvement without MASH worsening at week 96 and MASH resolution at weeks 36 and 96. Using an intent-to-treat (ITT) analysis of the 36 week results, for which participants with missing biopsies were included as non-responders, 19% of participants in the EFX 50mg group and 18% of participants in the EFX 28mg group met the primary endpoint, compared to 13% for placebo. At week 96, using the same ITT analysis, 29% of participants in the EFX 50mg group and 21% of participants in the EFX 28mg group had fibrosis improvement without MASH worsening, compared to 11% in the placebo group. Most participants in the EFX groups with a fibrosis improvement at week 36 appeared to maintain their response at week 96, with additional new responders observed at week 96, particularly for the EFX 50mg group. EFX was also associated with improvements in noninvasive markers of liver injury and fibrosis, as well as markers of insulin sensitivity and lipid metabolism compared with placebo at week 96. The safety and tolerability of EFX observed in the SYMMETRY trial was consistent with previous trials. Observed adverse events, more common with EFX than placebo, were primarily gastrointestinal (e.g., diarrhea and nausea) or injection site related, with the majority being mild or moderate and transient in nature. About Akero TherapeuticsAkero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic (F2-F3 fibrosis) MASH, SYNCHRONY Outcomes in patients with compensated cirrhosis (F4) due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (metabolic dysfunction-associated steatotic liver disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at and follow us on LinkedIn and X for more information. About MASHMASH is a serious form of MASLD that is estimated to affect 17 million Americans. MASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. Approximately 20% of patients with MASH will progress to cirrhosis, which has a higher risk of mortality. There are no approved treatments for the condition and MASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe. About Cirrhosis Due to MASH Cirrhosis due to MASH (metabolic dysfunction-associated steatohepatitis) is a life-threatening disease with high risk of liver failure, cancer, and death. By 2030, an estimated 3 million Americans are projected to have MASH cirrhosis, which is the fastest growing cause of liver transplants and liver cancer in the United States and Europe. About the SYMMETRY Trial SYMMETRY was a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in adult patients with biopsy-confirmed compensated cirrhosis (F4, Child-Pugh A) due to MASH. The study randomized 182 patients, and 181 received once-weekly subcutaneous EFX 28mg or 50mg, or placebo for 96 weeks. The primary efficacy endpoint was the proportion of patients with ≥1-stage fibrosis improvement without worsening of MASH at Week 36. Secondary efficacy measures at Week 96 included ≥1 stage fibrosis improvement without worsening of MASH, MASH resolution, change from baseline in liver enzymes, noninvasive markers of liver fibrosis, serum markers of glucose and lipid metabolism, as well as safety and tolerability measures. About EFXEfruxifermin (EFX), Akero's lead product candidate for MASH, is currently being evaluated in three ongoing Phase 3 studies. In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death among MASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements'' within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero's business plans and objectives; the potential transformative nature and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; the future potential and long-term benefits of EFX following the preliminary topline week 96 results of Akero's Phase 2b SYMMETRY study; and the ongoing SYNCHRONY Phase 3 program,. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero's ability to execute on its strategy; positive results from any of its clinical studies may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors'' in Akero's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero's other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact:Christina TartagliaPrecision Media Contact:Peg RusconiDeerfield 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
16-05-2025
- Business
- Yahoo
Enerflex's (TSE:EFX) Solid Earnings Have Been Accounted For Conservatively
Investors signalled that they were pleased with Enerflex Ltd.'s (TSE:EFX) most recent earnings report. This reaction by the market reaction is understandable when looking at headline profits and we have found some further encouraging factors. We've discovered 1 warning sign about Enerflex. View them for free. Many investors haven't heard of the accrual ratio from cashflow, but it is actually a useful measure of how well a company's profit is backed up by free cash flow (FCF) during a given period. The accrual ratio subtracts the FCF from the profit for a given period, and divides the result by the average operating assets of the company over that time. This ratio tells us how much of a company's profit is not backed by free cashflow. That means a negative accrual ratio is a good thing, because it shows that the company is bringing in more free cash flow than its profit would suggest. That is not intended to imply we should worry about a positive accrual ratio, but it's worth noting where the accrual ratio is rather high. To quote a 2014 paper by Lewellen and Resutek, "firms with higher accruals tend to be less profitable in the future". Over the twelve months to March 2025, Enerflex recorded an accrual ratio of -0.10. That indicates that its free cash flow was a fair bit more than its statutory profit. In fact, it had free cash flow of US$245m in the last year, which was a lot more than its statutory profit of US$74.0m. Enerflex shareholders are no doubt pleased that free cash flow improved over the last twelve months. Having said that, there is more to the story. We can see that unusual items have impacted its statutory profit, and therefore the accrual ratio. See our latest analysis for Enerflex That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. While the accrual ratio might bode well, we also note that Enerflex's profit was boosted by unusual items worth US$17m in the last twelve months. While we like to see profit increases, we tend to be a little more cautious when unusual items have made a big contribution. When we analysed the vast majority of listed companies worldwide, we found that significant unusual items are often not repeated. And that's as you'd expect, given these boosts are described as 'unusual'. If Enerflex doesn't see that contribution repeat, then all else being equal we'd expect its profit to drop over the current year. In conclusion, Enerflex's accrual ratio suggests its statutory earnings are of good quality, but on the other hand the profits were boosted by unusual items. Given the contrasting considerations, we don't have a strong view as to whether Enerflex's profits are an apt reflection of its underlying potential for profit. If you want to do dive deeper into Enerflex, you'd also look into what risks it is currently facing. Case in point: We've spotted 1 warning sign for Enerflex you should be aware of. In this article we've looked at a number of factors that can impair the utility of profit numbers, as a guide to a business. But there is always more to discover if you are capable of focussing your mind on minutiae. Some people consider a high return on equity to be a good sign of a quality business. While it might take a little research on your behalf, you may find this free collection of companies boasting high return on equity, or this list of stocks with significant insider holdings to be useful. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. 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
2 High-Flying Stocks Worth Your Attention and 1 to Be Wary Of
Expensive stocks often command premium valuations because the market thinks their business models are exceptional. However, the downside is that high expectations are already baked into their prices, leaving little room for error if they stumble even slightly. Determining whether a company's quality justifies its price causes headaches for nearly all investors, which is why we started StockStory - to help you separate the real opportunities from the speculative ones. Keeping that in mind, here are two high-flying stocks expanding their competitive advantages and one where the price is not right. Forward P/E Ratio: 34.9x Holding detailed financial records on over 800 million consumers worldwide and dating back to 1899, Equifax (NYSE:EFX) is a global data analytics company that collects, analyzes, and sells consumer and business credit information to lenders, employers, and other businesses. Why Are We Wary of EFX? Expenses have increased as a percentage of revenue over the last five years as its adjusted operating margin fell by 6.8 percentage points Performance over the past two years shows its incremental sales were less profitable, as its 4% annual earnings per share growth trailed its revenue gains Low returns on capital reflect management's struggle to allocate funds effectively, and its falling returns suggest its earlier profit pools are drying up Equifax is trading at $276.98 per share, or 34.9x forward P/E. Check out our free in-depth research report to learn more about why EFX doesn't pass our bar. Forward P/S Ratio: 22.2x Founded by two grad students of Harvard Business School, Cloudflare (NYSE:NET) is a software-as-a-service platform that helps improve the security, reliability, and loading times of internet applications. Why Are We Backing NET? Billings have averaged 27.9% growth over the last year, showing it's securing new contracts that could potentially increase in value over time Revenue outlook for the upcoming 12 months is outstanding and shows it's on track to gain market share User-friendly software enables clients to ramp up spending quickly, leading to the speedy recovery of customer acquisition costs Cloudflare's stock price of $142.38 implies a valuation ratio of 22.2x forward price-to-sales. Is now the time to initiate a position? Find out in our full research report, it's free. Forward EV/EBITDA Ratio: 34.2x Launched by Reed Hastings as a DVD mail rental company until its famous pivot to streaming in 2007, Netflix (NASDAQ: NFLX) is a pioneering streaming content platform. Why Is NFLX a Good Business? Global Streaming Paid Memberships are rising, meaning the company can increase revenue without incurring additional customer acquisition costs if it can cross-sell additional products and features Highly efficient business model is illustrated by its impressive 27% EBITDA margin, and its operating leverage amplified its profits over the last few years Free cash flow margin jumped by 18.6 percentage points over the last few years, giving the company more resources to pursue growth initiatives, repurchase shares, or pay dividends At $1,110 per share, Netflix trades at 34.2x forward EV/EBITDA. Is now the right time to buy? See for yourself in our comprehensive research report, it's free. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. Put yourself in the driver's seat and build a durable portfolio by checking out our Top 9 Market-Beating Stocks. 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-small-cap company Comfort Systems (+782% five-year return). Find your next big winner with StockStory today for free. Sign in to access your portfolio
Business Insider
11-05-2025
- Business
- Business Insider
Akero Therapeutics announces new analyses of Phase 2b HARMONY trial
Akero Therapeutics (AKRO) announced results from new analyses of the 96-week Phase 2b HARMONY trial of efruxifermin, EFX, in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis, MASH, in an oral presentation and a poster presentation at the European Association for the Study of the Liver, EASL, Congress 2025 taking place May 7-10, in Amsterdam, the Netherlands. The presentations corroborate the antifibrotic activity previously reported by conventional pathology for EFX in patients with pre-cirrhotic MASH. Specifically, among patients treated with EFX, digital pathology analysis by HistoIndex's AI-based qFibrosis showed concordance at the individual level with two non-invasive tests of liver fibrosis-ELF test score and liver stiffness measurement-with more than half of patients treated with 50mg EFX classified as responders by all three endpoints compared to fewer than 5% of placebo patients. Protect Your Portfolio Against Market Uncertainty
