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Akero Therapeutics, Inc. (Nasdaq: AKRO) is a clinical-stage biotechnology company based in South San Francisco, developing innovative treatments for major metabolic diseases, including non-alcoholic steatohepatitis (NASH). Focused on creating best-in-class medicines, Akero's lead clinical program centers on efruxifermin (EFX), a modified FGF21 protein designed to reduce liver fat, inflammation, and fibrosis. EFX is engineered to target both the liver and adipose tissue, offering potential comprehensive benefits to NASH patients.
Building on over two decades of FGF21 research, Akero has achieved significant milestones. Their Phase 2b HARMONY study, evaluating EFX in pre-cirrhotic NASH patients, demonstrated impressive results at Week 96, including substantial fibrosis improvement and liver health biomarkers. Additionally, the SYNCHRONY program encompasses multiple Phase 3 clinical trials aimed at both cirrhotic and pre-cirrhotic NASH patients, further validating the efficacy and safety profile of EFX.
Akero's rigorous clinical trials and outstanding engagement with the FDA underscore their commitment to addressing high unmet medical needs. Their recent public stock offering has bolstered financial stability, ensuring sustained progress in their groundbreaking research and development efforts. For more information, visit Akero Therapeutics and follow them on LinkedIn and Twitter.
Akero Therapeutics (Nasdaq: AKRO) reported its Q2 2021 financial results, highlighting the ongoing development of efruxifermin (EFX) for treating non-alcoholic steatohepatitis (NASH). The company has initiated a second Phase 2b clinical trial for late-stage cirrhotic NASH patients, following significant progress in previous trials, including a published study demonstrating fibrosis regression. As of June 30, 2021, Akero's cash and marketable securities totaled $230 million, expected to support operations through Q3 2023. R&D expenses rose to $24 million, reflecting increased costs related to EFX programs.
Akero Therapeutics (Nasdaq: AKRO) announced the appointment of Judy Chou, Ph.D., to its board of directors as an independent director. Dr. Chou brings 25 years of biotech experience, including roles at Bayer Pharmaceuticals and AltruBio, where she managed drug development and biomanufacturing. Her strategic insights are expected to aid Akero’s lead drug, efruxifermin, which is in a Phase 2b clinical trial for non-alcoholic steatohepatitis (NASH). This appointment reflects Akero's commitment to advancing innovative therapies in a critical therapeutic area.
Akero Therapeutics announced the publication of results from its Phase 2a BALANCED trial of efruxifermin (EFX) in the treatment of non-alcoholic steatohepatitis (NASH), showing significant reductions in liver fat and improvement in fibrosis after just 16 weeks of treatment. In the study, 48% of EFX patients normalized liver fat levels versus 5% in the placebo group. EFX demonstrated improved metabolic markers and was generally well tolerated, with minimal serious adverse events reported. The trial results contribute to the development of potentially groundbreaking NASH therapies.
Akero Therapeutics (Nasdaq: AKRO) announced new analyses from its Phase 2a BALANCED study, which evaluates efruxifermin (EFX) for treating non-alcoholic steatohepatitis (NASH). Presented at the American Diabetes Association's 81st Scientific Sessions, findings show EFX significantly improves glucose metabolism and insulin sensitivity in NASH patients with type 2 diabetes. Additionally, increased adiponectin levels correlate with better liver health. Akero's ongoing studies suggest EFX may uniquely address metabolic dysregulation in NASH, positioning it as a promising treatment option.
Akero Therapeutics (AKRO) announced significant findings from its Phase 2a BALANCED study of efruxifermin (EFX) for treating non-alcoholic steatohepatitis (NASH). Presented at the 2021 International Liver Congress, analyses reveal that a liver fat reduction of ≥17 U/L, coupled with normalizing liver fat, enhances the predictive power for NASH resolution. Key results show 69% of patients on 28mg EFX achieved ≥50% liver fat reduction, and 53% normalized liver fat by week 12. The company’s ongoing Phase 2b trials further explore EFX's potential in advanced fibrosis patients.
Akero Therapeutics (Nasdaq: AKRO) will present results from its Phase 2a BALANCED study at the 2021 EASL Congress on June 26, showcasing efruxifermin (EFX) improvements in NASH patients with compensated cirrhosis. Additionally, two presentations will occur at the 81st ADA Meeting from June 25-29. Akero emphasizes EFX's potential to reverse liver injury, improve glycemic control, and enhance lipoprotein profiles. With ongoing Phase 2b trials, the company aims to address the unmet medical needs in NASH, particularly for patients with type 2 diabetes.
Akero Therapeutics (Nasdaq: AKRO), a biotech firm focused on cardio-metabolic therapies, will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 2:30 p.m. (ET). The company is developing treatments for non-alcoholic steatohepatitis (NASH), a condition currently lacking approved therapies. Its lead candidate, EFX, is undergoing a Phase 2b clinical trial named HARMONY, targeting NASH patients with F2/F3 fibrosis. Akero is based in South San Francisco. For more details, visit www.akerotx.com.
Akero Therapeutics (Nasdaq: AKRO) reported its first-quarter financial results for 2021, revealing significant progress in its NASH treatment program. Notably, 58% of patients treated with efruxifermin (EFX) showed improvement in fibrosis after 16 weeks, compared to 0% in the placebo group. The company has initiated two Phase 2b trials for NASH this year and plans to present additional data at upcoming conferences. Financially, Akero holds $250 million in cash, projecting sufficient funds through Q3 2023. Operating expenses rose to $15.1 million from $12.4 million year-over-year.
Akero Therapeutics (Nasdaq: AKRO) has appointed Yuan Xu, Ph.D., as an independent director to its board. Dr. Xu brings significant biopharmaceutical experience, having previously served as CEO of Legend Biotech and held senior roles at Merck, Novartis, Gilead, and GlaxoSmithKline. Her expertise will be instrumental as Akero advances its lead candidate, efruxifermin, into late-stage development for non-alcoholic steatohepatitis (NASH), a condition currently without approved therapies. This strategic move aims to bolster the company’s efforts in delivering innovative treatments.
Akero Therapeutics (Nasdaq: AKRO) announced the randomization of the first patient in its Phase 2b clinical study of Efruxifermin (EFX) for patients with F2/F3 non-alcoholic steatohepatitis (NASH), also known as the HARMONY study. This milestone reflects the company's continued progress, with screening and enrollment ahead of schedule. The trial aims to evaluate fibrosis regression after 24 weeks of treatment. EFX offers a potential new treatment option for NASH, a disease lacking FDA-approved therapies, impacting millions.
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