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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 (AKRO) announced a positive End-of-Phase 2 meeting with the FDA regarding its SYNCHRONY Phase 3 clinical trials for efruxifermin (EFX) targeting nonalcoholic steatohepatitis (NASH), a severe liver disease affecting over 17 million Americans. The program includes three studies: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes, with patient enrollment expected to begin in the second half of 2023. EFX aims to demonstrate efficacy in improving fibrosis and resolving NASH, with the overall program designed for at least 1,500 patients. Akero's confidence is supported by promising results from earlier trials.
Akero Therapeutics (Nasdaq: AKRO) reported its fourth quarter and full year financial results for 2022, showcasing significant progress in developing efruxifermin (EFX) for non-alcoholic steatohepatitis (NASH). The company highlighted the success of the HARMONY trial and EFX's Breakthrough Therapy Designation as strong indicators of its potential. For 2022, Akero's cash and equivalents totaled $351.4 million, enough to sustain operations into 2025. While R&D expenses increased to $85.3 million, administrative costs rose to $29.9 million, reflecting higher personnel costs. The company anticipates reporting results from the SYMMETRY study in 2023.
Akero Therapeutics (Nasdaq: AKRO) announced the appointment of Patrick Lamy as Senior Vice President of Commercial Strategy. Lamy, with over 25 years of experience in liver disease and commercial execution, will bolster efforts in advancing Efruxifermin (EFX), a candidate for treating NASH. Following promising results from the HARMONY study, Akero's leadership emphasized the importance of Lamy's expertise in transforming patient care for those suffering from NASH. EFX, currently in Phase 2b trials, aims to address serious metabolic conditions with significant unmet needs.
Akero Therapeutics (Nasdaq: AKRO) announced its participation in the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 10:30 a.m. P.T. in San Francisco, CA. The company's management will present their innovative treatments aimed at serious metabolic diseases, particularly non-alcoholic steatohepatitis (NASH), which currently lacks approved therapies. A live webcast of the presentation will be accessible on their investor relations website, with an archived replay available afterward.
Akero Therapeutics (AKRO) has completed enrollment for its Phase 2b SYMMETRY study, assessing efruxifermin (EFX) in non-alcoholic steatohepatitis (NASH) patients with compensated cirrhosis (F4). Results for this study are expected in Q4 2023, while outcomes from the Cohort D expansion, evaluating EFX with GLP-1 therapy, are anticipated in Q2 2023. EFX, designated as a Breakthrough Therapy, aims to address urgent unmet needs in the NASH space, with a focus on fibrosis regression and improving metabolic parameters.
Akero Therapeutics announced that efruxifermin (EFX) has been granted Breakthrough Therapy Designation by the FDA for treating nonalcoholic steatohepatitis (NASH). This designation follows significant results from the Phase 2b HARMONY study, where both 50mg and 28mg doses of EFX met primary and secondary histology endpoints after 24 weeks. With an estimated 17 million Americans affected by NASH and no approved therapies available, this milestone could expedite the development of EFX as a potential treatment. Further trial results are expected in late 2023.
Akero Therapeutics (Nasdaq: AKRO) announced participation in two significant investor conferences this November. The company will engage in a fireside chat at the Jefferies London Healthcare Conference on November 17 at 8:00 a.m. GMT, and again at the EvercoreISI HealthCONx Conference on November 29 at 12:10 p.m. ET. Akero focuses on developing treatments for serious metabolic diseases like non-alcoholic steatohepatitis (NASH), with its lead candidate, efruxifermin (EFX), currently in two Phase 2b clinical trials.
Akero Therapeutics (Nasdaq: AKRO) is set to present significant findings from its Phase 2b HARMONY study on efruxifermin (EFX) for treating pre-cirrhotic NASH at the AASLD The Liver Meeting 2022. The oral presentation will detail Week 24 results, emphasizing EFX's potential as a foundational monotherapy for NASH. Additionally, a poster presentation will explore EFX’s unique molecular structure and its implications for pharmacological engagement. NASH affects 17 million Americans, with no approved treatments, highlighting the urgency for effective therapies.
Akero Therapeutics (Nasdaq: AKRO) reported its Q3 2022 financial results, highlighting promising Week 24 outcomes from the Phase 2b HARMONY study for EFX in pre-cirrhotic NASH. Key findings include 41% of patients on 50mg EFX showing fibrosis improvement, double the placebo rate. The company raised approximately $230 million in a recent public offering and believes its cash reserves will support operations until 2025. Operating expenses rose to $36.1 million, up from $24.4 million in Q3 2021, primarily due to increased R&D costs.
Akero Therapeutics (Nasdaq: AKRO) announced its participation in the H.C. Wainwright 6th Annual NASH Virtual Investor Conference on October 17, 2022, at 12:00 p.m. E.T. The webcast will be accessible via the company's investor relations website, with an archived replay available afterward.
Akero is focused on developing innovative treatments for serious metabolic diseases, particularly non-alcoholic steatohepatitis (NASH), which currently has no approved therapies. Their lead candidate, efruxifermin (EFX), shows promise as a potential best-in-class option for NASH treatment.
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