Akero Therapeutics (AKRO) has upcoming FDA regulatory milestones for Efruxifermin. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Akero Therapeutics (AKRO).
Over the past two years, Akero Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Efruxifermin and Efruxifermin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Efruxifermin FDA Regulatory Timeline and Events
Efruxifermin is a drug developed by Akero Therapeutics for the following indication: Non-alcoholic steatohepatitis (NASH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Efruxifermin
- Announced Date:
- November 7, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH)
Announcement
Akero Therapeutics, Inc. announced new findings from the SYMMETRY and HARMONY Phase 2b trials of efruxifermin in patients with compensated cirrhosis (F4c) due to metabolic dysfunction-associated steatohepatitis (MASH) and pre-cirrhotic (F2-F3) MASH, respectively.
AI Summary
New post-hoc analyses from the 96-week SYMMETRY Phase 2b trial show that efruxifermin has clear antifibrotic effects in patients with compensated cirrhosis (F4c) due to metabolic dysfunction-associated steatohepatitis (MASH). The treatment led to statistically significant reductions in clinically significant portal hypertension risk, as measured by Baveno criteria. Significantly more participants on efruxifermin met thresholds for meaningful improvements in noninvasive fibrosis markers. AI-assisted digital pathology confirmed these benefits, revealing consistent decreases in total fibrosis and septa area—key indicators of cirrhosis severity.
In the 96-week HARMONY Phase 2b trial involving pre-cirrhotic (F2–F3) MASH patients, AI-powered histology analysis also reinforced earlier conventional pathology findings. This digital pathology work showed that efruxifermin consistently reduced fibrosis and improved liver microarchitecture. Together, these results suggest efruxifermin may both reverse liver damage and lower the risk of disease progression across different stages of MASH.
Read Announcement- Drug:
- Efruxifermin
- Announced Date:
- October 7, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH)
Announcement
Akero Therapeutics, Inc. announced two upcoming oral presentations and a poster presentation at the 76th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2025 taking place November 7-11, 2025, in Washington, DC.
AI Summary
Akero Therapeutics, Inc. will present data at the 76th AASLD The Liver Meeting® 2025 in Washington, DC, on November 7–11, 2025. The company will share findings from its 96-week Phase 2b studies of efruxifermin in metabolic dysfunction-associated steatohepatitis (MASH).
Two oral presentations will report results from the Phase 2b SYMMETRY trial in patients with compensated cirrhosis (F4c) due to MASH. On Sunday, November 9, at 12:00 PM ET, Dr. Vlad Ratziu will discuss improvements in non-invasive tests suggesting fibrosis regression. At 2:45 PM ET, Dr. Mazen Noureddin will present how efruxifermin improved portal hypertension markers using Baveno VII criteria.
A poster presentation on Monday, November 10, from 11:30 AM to 12:30 PM ET will feature AI-powered histology analysis from the HARMONY study in pre-cirrhotic (F2–F3) MASH. Dr. Jörn M. Schattenberg will highlight how efruxifermin alters liver microarchitecture in this group.
Read Announcement- Drug:
- Efruxifermin
- Announced Date:
- May 9, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH)
Announcement
Akero Therapeutics, Inc presented results from the Phase 2b SYMMETRY trial demonstrating the potential of efruxifermin (EFX) to improve fibrosis in compensated cirrhosis (F4) caused by metabolic dysfunction-associated steatohepatitis (MASH), in a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7-10, in Amsterdam, the Netherlands.
AI Summary
At the EASL Congress 2025 in Amsterdam, Akero Therapeutics shared encouraging results from its Phase 2b SYMMETRY trial. The study focused on efruxifermin (EFX), showing its potential to improve fibrosis in patients with compensated cirrhosis (F4) caused by MASH, a severe form of liver disease. In this trial, patients receiving the 50mg dose of EFX experienced significant improvements in liver fibrosis compared to those on placebo. The 96-week data highlighted that EFX not only reduced fibrosis but also stabilized liver function without worsening MASH. These findings suggest that EFX might become a breakthrough treatment option for patients with advanced liver disease by addressing a critical unmet need. Akero plans to continue evaluating EFX in further Phase 3 studies to better understand its effects across different stages of MASH.
Read Announcement- Drug:
- Efruxifermin
- Announced Date:
- January 27, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH)
Announcement
Akero Therapeutics, Inc today released preliminary topline week 96 results from SYMMETRY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH).
AI Summary
Akero Therapeutics recently shared promising preliminary week 96 results from its Phase 2b SYMMETRY study. The trial is evaluating efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (MASH). In patients who had both baseline and week 96 biopsies, 39% of those treated weekly with 50mg EFX experienced at least a one-stage improvement in liver fibrosis without a worsening of MASH, compared to 15% in the placebo group. In the larger group including all patients, 29% of those on 50mg EFX showed improvement compared to roughly 12% for placebo, which highlights the potential benefit of longer treatment duration. These findings suggest that efruxifermin could help reverse cirrhosis caused by MASH with a good safety profile, encouraging further clinical evaluation.
Read Announcement- Drug:
- Efruxifermin
- Announced Date:
- January 24, 2025
- Target Action Date:
- January 27, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH)
Announcement
Akero Therapeutics, Inc will hold an investor conference on Monday, January 27, 2025, at 8:00 a.m. ET to share preliminary topline week 96 results from its SYMMETRY study, a double-blind, placebo-controlled Phase 2b study evaluating the efficacy of efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (MASH).
AI Summary
Akero Therapeutics will host an investor conference on Monday, January 27, 2025, at 8:00 a.m. ET. During the webcast, the company will present preliminary topline week 96 data from its SYMMETRY study. This is a Phase 2b, double-blind, placebo-controlled trial that looks at the effectiveness of efruxifermin (EFX) in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). The study enrolled patients diagnosed with liver cirrhosis linked to MASH, and it aims to show improvements in liver fibrosis and overall liver function over time. Investors can view the live call along with a slide presentation, and the event will be available on Akero’s website immediately afterward for those who miss the live stream.
Read Announcement- Drug:
- Efruxifermin
- Announced Date:
- January 13, 2025
- Target Action Date:
- H1 2026
- Estimated Target Date Range:
- January 1, 2026 - June 30, 2026
- Indication:
- Non-alcoholic steatohepatitis (NASH)
Announcement
Akero Therapeutics, Inc announced that Data from SYNCHRONY Real-World study anticipated in the first half of 2026
AI Summary
Akero Therapeutics, Inc. announced that it has completed enrollment in the double-blind portion of its Phase 3 SYNCHRONY Real-World study. The study evaluates the safety and tolerability of its lead candidate, EFX, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and metabolic dysfunction-associated steatotic liver disease (MASLD). A total of 601 patients have been enrolled since November 2023, demonstrating strong patient interest and highlighting the urgent need for effective MASH treatments.
Importantly, the company expects to report the study’s data in the first half of 2026. This upcoming data release will shed light on EFX’s potential benefits, including improvements in liver histology and non-invasive markers for liver health. Akero remains committed to advancing transformational treatments for serious metabolic diseases and hopes that these results will further support the development of therapeutic options for patients in need.
Read Announcement- Drug:
- Efruxifermin
- Announced Date:
- January 13, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH)
Announcement
Akero Therapeutics, Inc. announced it has completed enrollment of patients in the double-blind portion of the Phase 3 SYNCHRONY Real-World study of EFX in patients with metabolic dysfunction-associated steatohepatits (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD) (F1-F4).
AI Summary
Akero Therapeutics, Inc. announced that it has completed enrollment of 601 patients in the double-blind portion of its Phase 3 SYNCHRONY Real-World study, which is testing its lead product candidate, EFX. The study focuses on patients with metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD) across fibrosis stages F1 to F4. Participants are receiving once-weekly subcutaneous doses of either 50 mg EFX or a placebo. The key goals of this study are to assess the safety and tolerability of EFX over 52 weeks, along with its effects on markers of liver fibrosis and injury, and other metabolic factors such as glycemic control and body weight.
The enrollment, completed just over a year after the study began in November 2023, highlights the urgent need for new treatments in MASH and MASLD. Akero plans to release data from this study in the first half of 2026.
Read Announcement
Efruxifermin (HARMONY) FDA Regulatory Events
Efruxifermin (HARMONY) is a drug developed by Akero Therapeutics for the following indication: Non-alcoholic steatohepatitis (NASH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Efruxifermin (HARMONY)
- Announced Date:
- August 14, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH)
Announcement
Akero Therapeutics, Inc. announced publication of 96-week results from the Phase 2b HARMONY trial in The Lancet.
AI Summary
Akero Therapeutics announced the publication of 96-week results from its Phase 2b HARMONY trial in The Lancet. The study enrolled adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced fibrosis, randomly assigning them to once-weekly efruxifermin (EFX) or placebo. Continued treatment from week 24 to week 96 led to near-complete disease reversal in almost one-third of participants on the 50 mg dose.
At week 96, 49% of the 50 mg EFX group achieved at least one-stage fibrosis improvement without worsening MASH versus 19% for placebo (p=0.003). MASH resolution without fibrosis worsening occurred in 37–40% of EFX-treated patients compared to 19% with placebo, and a composite endpoint of both outcomes was met by up to 35% of those on EFX.
Most early responders (92%) maintained benefits at week 96, and 63% of initial non-responders improved by week 96. EFX was generally well tolerated, with mild to moderate gastrointestinal events and a small bone density reduction. These durable improvements highlight EFX’s potential as a long-term therapy for pre-cirrhotic MASH.
Read Announcement- Drug:
- Efruxifermin (HARMONY)
- Announced Date:
- May 10, 2025
- Indication:
- Non-alcoholic steatohepatitis (NASH)
Announcement
Akero Therapeutics, Inc. announced results from new analyses of the 96-week Phase 2b HARMONY trial of efruxifermin (EFX) in patients with pre-cirrhotic (F2-F3 fibrosis) metabolic dysfunction-associated steatohepatitis (MASH) in an oral presentation and a poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7-10, in Amsterdam, the Netherlands.
AI Summary
Akero Therapeutics, Inc. recently presented new analyses from the 96‐week Phase 2b HARMONY trial at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam. The study evaluated efruxifermin (EFX) in patients with pre-cirrhotic (F2-F3 fibrosis) metabolic dysfunction-associated steatohepatitis (MASH). In both an oral and a poster presentation, the company shared that AI-based digital pathology, using HistoIndex’s qFibrosis®, aligned well with non-invasive tests such as the ELF test score and FibroScan®. More than half of the patients treated with the 50mg EFX dose were identified as responders across all assessments, compared to fewer than 5% in the placebo group. These analyses highlight EFX’s anti-fibrotic activity, revealing that the use of continuous and sensitive digital scoring can better differentiate treatment effects from placebo response and enable earlier detection of fibrosis response in MASH patients.
Read Announcement
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