Welcome to our dedicated page for Akero Therapeutics news (Ticker: AKRO), a resource for investors and traders seeking the latest updates and insights on Akero Therapeutics stock.
About Akero Therapeutics
Akero Therapeutics, Inc. (Nasdaq: AKRO) is a clinical-stage biotechnology company dedicated to developing transformative treatments for serious metabolic diseases with high unmet medical needs. Headquartered in South San Francisco, California, Akero specializes in addressing metabolic dysfunction-associated steatohepatitis (MASH), a severe form of liver disease that affects millions globally and currently has no approved therapies. MASH is characterized by excessive liver fat accumulation, inflammation, and fibrosis, which can progress to cirrhosis, liver failure, and even death. It is the fastest-growing cause of liver transplants and liver cancer in the United States and Europe.
Core Product and Innovative Approach
Akero’s lead product candidate, efruxifermin (EFX), is a long-acting Fc-FGF21 fusion protein designed to mimic the biological activity of native fibroblast growth factor 21 (FGF21). EFX has demonstrated the potential to address the core drivers of MASH pathogenesis, including reducing liver fat, suppressing inflammation, reversing fibrosis, and improving metabolic parameters such as insulin sensitivity and lipid profiles. This holistic approach positions EFX as a potential first-in-class therapeutic for MASH and related metabolic conditions.
Clinical Development Program
Akero is advancing its clinical pipeline through rigorous, multi-phase trials that demonstrate its commitment to scientific excellence and patient outcomes:
- Phase 2b Trials: The HARMONY and SYMMETRY studies have shown statistically significant improvements in fibrosis, liver health, and metabolic markers, with sustained and expanding efficacy over 96 weeks of treatment.
- Phase 3 SYNCHRONY Program: This comprehensive program includes three global trials—SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes—targeting pre-cirrhotic MASH (F2-F3 fibrosis) and compensated cirrhosis (F4 fibrosis). These studies aim to confirm the efficacy, safety, and tolerability of EFX across diverse patient populations.
Market Significance and Competitive Position
Akero operates in the highly specialized field of metabolic disease therapeutics, addressing a significant unmet need in MASH treatment. By focusing on a disease with no approved therapies and leveraging its innovative FGF21 analog, EFX, the company is poised to become a leader in this space. Its clinical data suggest that EFX has the potential to offer a differentiated, first-in-class solution for patients with advanced liver fibrosis and cirrhosis.
Commitment to Patients and Future Growth
Akero’s mission is to transform the standard of care for patients with serious metabolic diseases. With a robust pipeline, promising clinical results, and a strategic focus on addressing a critical gap in liver disease treatment, Akero is well-positioned to deliver long-term value to patients and stakeholders. The company’s ongoing Phase 3 trials and its dedication to scientific innovation underscore its commitment to improving patient outcomes and advancing the field of metabolic therapeutics.
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.
Akero Therapeutics (AKRO) has successfully closed its upsized public offering, issuing 8,846,154 shares at $26.00 each, raising approximately $230 million in gross proceeds. This offering included the full exercise of an underwriters' option for an additional 1,153,846 shares. J.P. Morgan, Morgan Stanley, and Jefferies managed the offering with Canaccord Genuity as a lead manager. The company is focused on developing treatments for serious metabolic diseases, notably NASH, with its lead candidate, efruxifermin (EFX), currently in two Phase 2b trials.
Akero Therapeutics (Nasdaq: AKRO) has announced an upsized public offering of 7,692,308 shares at a price of $26.00 per share, aiming to raise approximately $200 million. The underwriters have a 30-day option to purchase an additional 1,153,846 shares. The offering is set to close on or around September 19, 2022, subject to customary conditions. J.P. Morgan, Morgan Stanley, and Jefferies serve as joint book-running managers. Proceeds are intended to advance Akero's clinical development pipeline, particularly for its lead product candidate, efruxifermin, targeting serious metabolic diseases.
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