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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 Q3 2020 financial results, highlighting significant advancements in its NASH treatment, efruxifermin (EFX).
The company raised over $216 million through an equity offering and received FDA feedback facilitating an adaptive Phase 2b/3 clinical trial. EFX also gained PRIME designation from EMA, underscoring its potential in the NASH market.
Cash reserves stood at $291.9 million as of September 30, 2020, while operating expenses increased to $21.5 million for Q3 due to higher research and development costs.
Akero Therapeutics (Nasdaq: AKRO), a biotechnology company focused on treatments for non-alcoholic steatohepatitis (NASH), will present at two investor conferences in November 2020. The 29th Annual Credit Suisse Healthcare Conference is scheduled for November 9 at 1:15 PM EST, and the Jefferies Global Healthcare Conference on November 17 at 1:45 PM EST. Live webcasts will be available on their website, with archived replays following the presentations. Akero is dedicated to reversing the NASH epidemic through innovative medicines, particularly their lead candidate, efruxifermin.
Akero Therapeutics (Nasdaq: AKRO) announced that the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation to efruxifermin (EFX), an investigational treatment for non-alcoholic steatohepatitis (NASH). This designation follows promising results from the Phase 2a BALANCED study, where 48% of patients showed significant improvement. The PRIME program aims to expedite the development of EFX as it addresses unmet medical needs in NASH, which affects millions globally.
Akero Therapeutics (Nasdaq: AKRO) announced that an abstract detailing analyses from the Phase 2a BALANCED study of efruxifermin (EFX) has been accepted for presentation at The Liver Meeting Digital Experience 2020, scheduled for November 13-16. The presentation will highlight significant reductions in liver fat and ALT levels among NASH patients after 16 weeks of EFX treatment. NASH affects around 17 million Americans, highlighting the potential market need and impact of EFX in treating this condition. The next Phase 2b/3 pivotal study is set to begin in early 2021.
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).
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