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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) has completed enrollment of a cohort of 30 NASH patients with compensated cirrhosis (F4), Child-Pugh Class A, for a trial assessing safety and tolerability of efruxifermin (EFX). This randomized 16-week trial has a primary focus on patients at high risk of liver complications. Akero expects to report results in the first half of 2021. NASH, affecting 17 million Americans, can lead to serious liver conditions. EFX, designed to enhance metabolic balance, has shown potential in addressing NASH-related health issues.
Akero Therapeutics (Nasdaq: AKRO) announced that CEO Andrew Cheng will present virtually at the H.C. Wainwright 4th Annual NASH Conference on October 5, 2020, at 12:00 p.m. E.T. The presentation will be accessible via a live webcast on the company's website, www.akerotx.com. Akero focuses on developing treatments for non-alcoholic steatohepatitis (NASH) with its lead product candidate, AKR-001, currently in a Phase 2a clinical trial. For more information, visit Akero's website.
Akero Therapeutics (Nasdaq: AKRO) announced FDA approval for an adaptive Phase 2b/3 trial design for its lead candidate, efruxifermin (EFX), targeting non-alcoholic steatohepatitis (NASH). This innovative study will assess two EFX doses over 24 weeks before selecting one for Phase 3 evaluation, set to commence in the first half of 2021. The FDA's guidance follows positive histological data from the BALANCED study, enhancing confidence in EFX's potential as a treatment. Akero aims to reverse the NASH epidemic, which affects approximately 17 million Americans.
Akero Therapeutics (Nasdaq: AKRO) will participate in a fireside chat at Morgan Stanley's 18th Annual Global Healthcare Conference at 3:45 p.m. ET on September 14, 2020. The clinical-stage biotechnology company focuses on treatments for non-alcoholic steatohepatitis (NASH) and other metabolic disorders. A live webcast will be available through their investor relations section, with an archived replay following the event. Akero's lead product, AKR-001, is currently in a Phase 2a clinical trial aimed at reversing the NASH epidemic.
Akero Therapeutics (Nasdaq: AKRO) reported second quarter 2020 results, showcasing significant histological improvements in non-alcoholic steatohepatitis (NASH) patients treated with efruxifermin (EFX). After 16 weeks, 48% of patients saw at least one-stage fibrosis improvement. Additionally, EFX demonstrated reductions in liver fat and improvements in glycemic control and body weight. The company raised approximately $216.4 million through a public offering. Cash equivalents stand at $305.6 million post-offering, supporting its ongoing clinical trials and research programs.
On July 21, 2020, Akero Therapeutics (Nasdaq: AKRO) announced the publication of Phase 1 clinical trial data for efruxifermin (EFX) in Cell Reports Medicine. The study indicates EFX significantly improves insulin sensitivity and lipid metabolism in type 2 diabetes patients with a half-life of 3-3.5 days, enabling weekly dosing. Akero's CEO highlighted that EFX met all endpoints in the Phase 2a BALANCED study, showing the largest reductions in liver fat and histological improvements to date, suggesting a promising clinical profile for treating non-alcoholic steatohepatitis (NASH).
Akero Therapeutics (Nasdaq: AKRO) announced the pricing of an underwritten public offering of 5,228,166 shares of common stock at $36.00 per share, expected to raise approximately $188.2 million before expenses. A 30-day option is granted to underwriters for an additional 784,224 shares. The offering is anticipated to close on July 10, 2020, subject to customary conditions. J.P. Morgan, Morgan Stanley, Jefferies, and Evercore are the joint managers for this offering. The company aims to support its mission of developing therapies for non-alcoholic steatohepatitis (NASH).
Akero Therapeutics (Nasdaq: AKRO) has initiated an underwritten public offering of 4,750,000 shares of its common stock, with the possibility of an additional 712,500 shares available to underwriters. This offering is aimed at strengthening its financial position to support the development of treatments for non-alcoholic steatohepatitis (NASH). J.P. Morgan Securities, Morgan Stanley, Jefferies, and Evercore are serving as joint book-running managers. The offering's completion is subject to market conditions and regulatory approval.
Akero Therapeutics (Nasdaq: AKRO) announced plans to discuss new efficacy and safety data from its Phase 2a BALANCED study of AKR-001 for patients with nonalcoholic steatohepatitis (NASH). The results, including biopsy data, will be shared during a conference call and webcast on June 30, 2020, at 4:30 p.m. ET. Akero aims to address the growing NASH epidemic by developing innovative treatments, with AKR-001 as their lead candidate currently in clinical trials.
Akero Therapeutics (Nasdaq: AKRO) announced the dosing of the first subject in Cohort C of its Phase 2a BALANCED trial for NASH, targeting 30 patients with compensated cirrhosis. This expansion aims to assess the safety and tolerability of AKR-001, designed to alleviate liver fat and inflammation. Prior trial results indicated promising efficacy in reducing liver fat. NASH affects 17 million Americans, posing significant health risks. The primary aim is to evaluate AKR-001's potential to delay liver disease progression.
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