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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 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.
Akero Therapeutics (Nasdaq: AKRO) reported promising results from its Phase 2a clinical trial of efruxifermin (EFX) in cirrhotic patients with non-alcoholic steatohepatitis (NASH). Key findings include:
- 33% of EFX patients improved fibrosis by one stage without worsening NASH.
- 25% achieved NASH resolution.
- 58% showed histological improvements.
EFX was generally well-tolerated, with mild side effects noted. The trial's findings suggest potential for EFX as a foundational treatment for cirrhotic NASH, paving the way for further studies.
Akero Therapeutics, Inc. (Nasdaq: AKRO) announced plans to discuss new efficacy and safety data from the expansion cohort of its Phase 2a clinical trial for efruxifermin (EFX), aimed at treating adults with cirrhotic non-alcoholic steatohepatitis (NASH). The update, including biopsy results, will be presented in a press release and a webcast on March 22, 2021, at 4:30 p.m. ET. Akero is focused on developing treatments for NASH, a condition without current approved therapies.
Akero Therapeutics (Nasdaq: AKRO) reported its fourth quarter and full year financial results for 2020, showcasing promising data from the Phase 2a BALANCED study on efruxifermin (EFX) for treating NASH. Notably, 50% of patients with baseline fibrosis F2 or F3 showed a two-stage improvement in fibrosis after 16 weeks. The company holds $268.4 million in cash and equivalents at year-end. R&D expenses rose to $64.9 million, reflecting investment in EFX clinical trials. Akero plans to present more data by April 2021 and expects to complete enrollment in the Phase 2b HARMONY study this year.
Akero Therapeutics (Nasdaq: AKRO) announced its participation in two upcoming virtual investor conferences in March 2021. The Cowen 41st Annual Healthcare Conference is scheduled for March 2, while the 2021 H.C. Wainwright Global Life Sciences Conference will take place on March 9. The company will offer live webcasts of its presentations, which will be accessible through their investor relations website. Akero is focused on developing therapies for non-alcoholic steatohepatitis (NASH), with its lead program, EFX, currently in Phase 2 clinical trials.
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage biotechnology firm, has announced its participation in the 39th Annual J.P. Morgan Healthcare Conference, scheduled for January 12, 2021, at 10:50 a.m. EST. Investors can view the live webcast through the company's website, with an archived version available for 30 days post-event.
Akero is focused on developing innovative treatments for non-alcoholic steatohepatitis (NASH) and metabolic disorders. Its lead drug candidate, Efruxifermin (EFX), is undergoing a Phase 2a clinical trial.
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage biotechnology company focused on treatments for non-alcoholic steatohepatitis (NASH) and metabolic disorders, will present at Evercore’s 3rd Annual HealthCONx virtual conference. The fireside chat is scheduled for 11:20 a.m. ET on December 3, 2020. A live webcast and a replay will be accessible on the company's investor relations website for 30 days post-event. Akero's lead candidate, Efruxifermin (formerly AKR-001), is currently in a Phase 2a clinical trial, aiming to combat the NASH epidemic.
Akero Therapeutics (Nasdaq: AKRO) presented new data from its Phase 2a BALANCED study at The Liver Meeting®, highlighting efruxifermin (EFX) as a promising monotherapy for non-alcoholic steatohepatitis (NASH). The study revealed significant reductions in liver fat, with 100% of patients in the 50mg EFX group achieving over 50% relative reduction. Additionally, 50% of patients with fibrosis stage F2 or F3 experienced a two-stage improvement. EFX, showing positive effects on glycemic control, is expected to enter a Phase 2b/3 trial in 2021, supported by EMA’s PRIME designation.
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