Latest news with #AkeroTherapeutics
Yahoo
22-05-2025
- Business
- Yahoo
Why Akero Therapeutics, Inc. (AKRO) Skyrocketed Today
We recently published a list of . In this article, we are going to take a look at where Akero Therapeutics, Inc. (NASDAQ:AKRO) stands against other stocks that skyrocketed today. Ten companies boasted whopping gains on Tuesday despite a wider market pessimism, as a flurry of corporate developments, including impressive earnings and bullish outlooks, sparked buying appetite. In contrast, Wall Street's main indices all finished in the red territory. The Dow Jones was down by 0.27 percent, the S&P 500 dropped 0.39 percent, and the tech-heavy Nasdaq declined 0.38 percent. In this article, we named the 10 best-performing stocks during the trading session and detailed the reasons behind their gains. To come up with the list, we considered only the stocks with a $2 billion market capitalization and $5 million in trading volume. A scientist in a lab coat examining a sample under a microscope in a laboratory. Akero Therapeutics snapped a two-day losing streak on Tuesday, jumping 24.72 percent to close at $47.57 apiece as investors gobbled up shares following news that it was exploring a sale. According to a report by StreetInsider, Akero Therapeutics, Inc. (NASDAQ:AKRO) is now in talks with an investment bank to assist with the process. However, it added that the company's early interest and strategic review might not necessarily translate to a sale. In its latest earnings release, Akero Therapeutics, Inc. (NASDAQ:AKRO) widened its net loss by 32.6 percent to $70.7 million from $53.3 million in the same period last year. Operating expenses surged by 34.9 percent to $80.88 million from $59.95 million year-on-year. Net loss per common share was at 90 cents, similar to the same period a year ago. Akero Therapeutics, Inc. (NASDAQ:AKRO) 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). Overall, AKRO ranks 10th on our list of today's best-performing stocks. While we acknowledge the potential of AKRO as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AKRO and that has 100x upside potential, check out our report about this . 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
21-05-2025
- Business
- Yahoo
Why Akero Therapeutics, Inc. (AKRO) Skyrocketed Today
We recently published a list of . In this article, we are going to take a look at where Akero Therapeutics, Inc. (NASDAQ:AKRO) stands against other stocks that skyrocketed today. Ten companies boasted whopping gains on Tuesday despite a wider market pessimism, as a flurry of corporate developments, including impressive earnings and bullish outlooks, sparked buying appetite. In contrast, Wall Street's main indices all finished in the red territory. The Dow Jones was down by 0.27 percent, the S&P 500 dropped 0.39 percent, and the tech-heavy Nasdaq declined 0.38 percent. In this article, we named the 10 best-performing stocks during the trading session and detailed the reasons behind their gains. To come up with the list, we considered only the stocks with a $2 billion market capitalization and $5 million in trading volume. A scientist in a lab coat examining a sample under a microscope in a laboratory. Akero Therapeutics snapped a two-day losing streak on Tuesday, jumping 24.72 percent to close at $47.57 apiece as investors gobbled up shares following news that it was exploring a sale. According to a report by StreetInsider, Akero Therapeutics, Inc. (NASDAQ:AKRO) is now in talks with an investment bank to assist with the process. However, it added that the company's early interest and strategic review might not necessarily translate to a sale. In its latest earnings release, Akero Therapeutics, Inc. (NASDAQ:AKRO) widened its net loss by 32.6 percent to $70.7 million from $53.3 million in the same period last year. Operating expenses surged by 34.9 percent to $80.88 million from $59.95 million year-on-year. Net loss per common share was at 90 cents, similar to the same period a year ago. Akero Therapeutics, Inc. (NASDAQ:AKRO) 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). Overall, AKRO ranks 10th on our list of today's best-performing stocks. While we acknowledge the potential of AKRO as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AKRO and that has 100x upside potential, check out our report about this . 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.
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
Globe and Mail
19-05-2025
- Business
- Globe and Mail
NASH Pipeline Appears Robust With 80+ Key Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, 'Nonalcoholic Steatohepatitis Pipeline Insight, 2025' report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in Nonalcoholic Steatohepatitis pipeline landscape. It covers the NASH Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the NASH Pipeline Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the NASH Pipeline. Dive into DelveInsight's comprehensive report today! @ NASH Pipeline Outlook Key Takeaways from the NASH Pipeline Report In May 2025, Novo Nordisk A/S announced a study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period. In May 2025, Akero Therapeutics Inc. conducted a phase 2b study Evaluating the Safety and Efficacy of Efruxifermin in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH). DelveInsight's NASH Pipeline report depicts a robust space with 80+ active players working to develop 80+ pipeline therapies for NASH treatment. The leading NASH Companies such as Guangdong Raynovent Biotech, Dr. Falk Pharma GmbH, Enyo Pharma, Viking Therapeutics, Eli Lilly and Company, Sagimet Biosciences, Terns, Sinew Pharma, Madrigal Pharmaceuticals, Hepion Pharmaceuticals, Poxel SA, Pfizer, CytoDyn, Altimmune, Oramed, Ltd, PharmaKing, Can-Fite Biopharma, Cirius Therapeutics and others. Promising NASH Pipeline Therapies such as Semaglutide, HEC96719, DA-1241, Sitagliptin, Saroglitazar Magnesium 2mg, Vonafexor, PF-06835919, BMS-986036 and others. Stay ahead with the most recent pipeline outlook for NASH. Get insights into clinical trials, emerging therapies, and leading companies with NASH@ NASH Treatment Drugs NASH Emerging Drugs Profile Lanifibranor: Inventiva Pharma Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (PPAR) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While other PPAR agonists target only one or two PPAR isoforms for activation. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH. Currently, the drug is in Phase III stage of its clinical trial for the treatment of NASH. MSDC-0602K: Cirius Therapeutics MSDC-0602K, a second-generation oral insulin sensitizer, is designed to selectively modulate the mitochondrial pyruvate carrier (MPC) while minimizing direct PPAR-gamma activation. The MPC mediates at the cellular level the effects of over nutrition, a major cause of Nonalcoholic fatty liver disease NAFLD/NASH and Type 2 diabetes. In preclinical studies, modulation of the MPC has been shown to improve insulin sensitivity, lipid metabolism, and inflammation. Currently the drug is in Phase III stage of Clinical trial for the treatment of NASH. TERN-501: Terns Pharmaceuticals TERN-501 is a THR-β agonist with high metabolic stability, enhanced liver distribution and greater selectivity for THR-β compared to other THR-β agonists in development. Agonism of THR-β increases fatty acid metabolism via mitochondrial oxidation and affects cholesterol synthesis and metabolism. As a result, THR-β stimulation has the ability to reduce hepatic steatosis and improve serum lipid parameters including LDL cholesterol and triglycerides. In vivo NASH studies in a rodent model have demonstrated that low-doses of TERN-501 achieved complete resolution of steatosis and reductions in serum lipids, hepatic inflammation and fibrosis. TERN-501 has high liver distribution and is 23-fold more selective for THR-β than for THR-α activation in a cell free assay, thereby minimizing the risk of cardiotoxicity and other off-target effects associated with non-selective THR stimulation. Currently, the drug is in Phase II stage of its clinical trial for the treatment of NASH. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity (ionic salt of two active moieties). It is a novel orally active ionic salt of berberine and ursodeoxycholic acid, substantially reduced liver fat while improving glycemic control and other cardiometabolic biomarkers in adults with nonalcoholic steatohepatitis (NASH) and type 2 diabetes (T2DM). Currently, it is in Phase II trials for the treatment of primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH). The NASH Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of NASH with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for NASH Treatment. NASH Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. NASH Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the NASH market Explore groundbreaking therapies and clinical trials in the NASH Pipeline. Access DelveInsight's detailed report now! @ New NASH Drugs NASH Companies Guangdong Raynovent Biotech, Dr. Falk Pharma GmbH, Enyo Pharma, Viking Therapeutics, Eli Lilly and Company, Sagimet Biosciences, Terns, Sinew Pharma, Madrigal Pharmaceuticals, Hepion Pharmaceuticals, Poxel SA, Pfizer, CytoDyn, Altimmune, Oramed, Ltd, PharmaKing, Can-Fite Biopharma, Cirius Therapeutics and others. Nonalcoholic Steatohepatitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical NASH Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Unveil the future of NASH Treatment. Learn about new drugs, NASH Pipeline developments, and key companies with DelveInsight's expert analysis @ NASH Market Drivers and Barriers Scope of the NASH Pipeline Report Coverage- Global NASH Companies- Guangdong Raynovent Biotech, Dr. Falk Pharma GmbH, Enyo Pharma, Viking Therapeutics, Eli Lilly and Company, Sagimet Biosciences, Terns, Sinew Pharma, Madrigal Pharmaceuticals, Hepion Pharmaceuticals, Poxel SA, Pfizer, CytoDyn, Altimmune, Oramed, Ltd, PharmaKing, Can-Fite Biopharma, Cirius Therapeutics and others. NASH Pipeline Therapies- Semaglutide, HEC96719, DA-1241, Sitagliptin, Saroglitazar Magnesium 2mg, Vonafexor, PF-06835919, BMS-986036 and others. NASH Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination NASH Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on NASH Pipeline Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ NASH Companies, Key Products and Unmet Needs Table of Contents Introduction Executive Summary Nonalcoholic Steatohepatitis: Overview Pipeline Therapeutics Therapeutic Assessment Nonalcoholic Steatohepatitis– DelveInsight's Analytical Perspective Late Stage Products (Phase III) Lanifibranor: Inventiva Pharma Drug profiles in the detailed report….. Mid Stage Products (Phase II) TERN-501: Terns Pharmaceuticals Drug profiles in the detailed report….. Early Stage Products (Phase I) LY3849891: Eli Lilly and Company Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name : Company name Drug profiles in the detailed report….. Inactive Products Nonalcoholic Steatohepatitis Key Companies Nonalcoholic Steatohepatitis Key Products Nonalcoholic Steatohepatitis- Unmet Needs Nonalcoholic Steatohepatitis- Market Drivers and Barriers Nonalcoholic Steatohepatitis- Future Perspectives and Conclusion Nonalcoholic Steatohepatitis Analyst Views Nonalcoholic Steatohepatitis Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
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
