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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) 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.
Akero Therapeutics (Nasdaq: AKRO) has announced an underwritten public offering of $175 million in shares of its common stock, with an option for underwriters to purchase an additional $26.25 million. This offering is part of the company's strategy to develop treatments for serious metabolic diseases, including non-alcoholic steatohepatitis (NASH). The offering is subject to market conditions and involves major underwriters including J.P. Morgan and Morgan Stanley. An effective shelf registration statement has been filed with the SEC for this purpose.
Akero Therapeutics (Nasdaq: AKRO) announces significant topline results from its Phase 2b HARMONY study of efruxifermin (EFX) for nonalcoholic steatohepatitis (NASH) treatment.
Patients receiving 50mg and 28mg doses showed notable improvements: 41% and 39% had fibrosis improvement, and 76% and 47% achieved NASH resolution, far surpassing placebo rates. Additionally, EFX led to better liver fat, enzyme control, and weight management.
Results signal strong potential for EFX in addressing NASH, a major health crisis, with detailed discussions in an investor webcast.
Akero Therapeutics will host an investor webcast on September 13, 2022, at 8:00 a.m. ET to present clinical data from the Phase 2b HARMONY study. This study assesses the effectiveness of efruxifermin (EFX) in patients with pre-cirrhotic non-alcoholic steatohepatitis (NASH). The trial involved 128 patients and seeks to measure improvements in liver fibrosis and other related health metrics. Despite being a potentially best-in-class treatment for NASH, no approved therapies currently exist for this condition.
Akero Therapeutics (Nasdaq: AKRO) announced promising results from its Phase 2a BALANCED trial on efruxifermin (EFX) for treating non-alcoholic steatohepatitis (NASH) patients with cirrhosis. The results showed that 33% of patients improved by one fibrosis stage without worsening NASH, and 25% achieved NASH resolution. EFX was well-tolerated and led to significant decreases in liver stiffness and serum markers of fibrosis. Upcoming data from the Phase 2b HARMONY and SYMMETRY studies are highly anticipated, further highlighting EFX's potential.
Akero Therapeutics (Nasdaq: AKRO) reported its Q2 2022 results, highlighting a $25 million equity investment from Pfizer and a $100 million loan from Hercules Capital to advance efruxifermin (EFX) development. Cash reserves totaled $180.7 million, expected to fund operations until Q3 2024. Key clinical trial updates include upcoming results from the Phase 2b HARMONY study in September and the SYMMETRY study anticipated in late 2023. Research and development expenses for Q2 were $21.4 million, down from $24 million year-over-year.
Akero Therapeutics (Nasdaq: AKRO) announced promising results from a post hoc analysis of its Phase 2a BALANCED study on efruxifermin (EFX) presented at the 2022 International Liver Congress. The analysis revealed that EFX improved liver histopathology and non-invasive markers in NASH patients, specifically among those carrying the PNPLA3 I148M variant, which significantly increases the risk of disease progression. The study involved 58 patients and suggests EFX's potential to address unmet needs in high-risk NASH patients. EFX is currently under evaluation in two Phase 2b trials, with results expected soon.
Akero Therapeutics (Nasdaq: AKRO) announced a $25 million equity investment from Pfizer at $9.90 per share and a $100 million term loan facility from Hercules Capital. The financing aims to support the ongoing development of efruxifermin (EFX), targeting nonalcoholic steatohepatitis (NASH). If fully drawn, the loan extends Akero's cash runway to Q3 2024, two years beyond the anticipated HARMONY study readout. Pfizer will acquire approximately 6.7% of Akero's shares and join a newly formed Scientific Advisory Board.
Akero Therapeutics (Nasdaq: AKRO) announced it will present findings at the Keystone Symposium on Tissue Fibrosis and Repair, June 12-16, 2022. The presentations will showcase the potential of efruxifermin (EFX) to reverse fibrosis in patients with nonalcoholic steatohepatitis (NASH). Notably, data from the Phase 2a BALANCED trial demonstrates significant reductions in liver collagen synthesis markers. Chief Scientific Officer Tim Rolph emphasized EFX's promise as an antifibrotic therapy, with patients showing substantial improvement after just 16 weeks of treatment.
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