Akero Therapeutics Stock Price, News & Analysis

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 41^st 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.