Akero Therapeutics Stock Price, News & Analysis

Akero Therapeutics (Nasdaq: AKRO) published 96-week results from its Phase 2b HARMONY trial in The Lancet, evaluating efruxifermin (EFX) in patients with pre-cirrhotic MASH. The trial demonstrated significant efficacy with 49% of patients receiving 50mg EFX achieving at least one stage fibrosis improvement compared to 19% for placebo.

Key findings include 40% and 37% of patients achieving MASH resolution in the 28mg and 50mg groups respectively, versus 19% for placebo. The composite endpoint of MASH resolution and fibrosis improvement was met by 35% and 28% of participants in the 50mg and 28mg groups. Notably, 92% of week 24 responders maintained their response at week 96.

EFX was generally well-tolerated, with mainly mild to moderate gastrointestinal events reported. The results support EFX's potential to reduce disease progression in MASH patients.

Akero Therapeutics (Nasdaq: AKRO) reported significant progress in its clinical programs for EFX, a potential first- and best-in-class therapy for MASH (Metabolic dysfunction-Associated SteatoHepatitis). The company's 96-Week Phase 2b SYMMETRY trial results were published in the New England Journal of Medicine, demonstrating statistically significant reversal of compensated cirrhosis in MASH patients.

At EASL 2025, three presentations highlighted EFX's anti-fibrotic activity across all MASH stages. The data showed promising results in high-risk patient subgroups, including those with cryptogenic cirrhosis and type 2 diabetes. New analyses from the HARMONY study confirmed consistent fibrosis improvement in pre-cirrhotic MASH patients using both conventional and AI-based analysis methods.

Financially, Akero reported $1.09 billion in cash and equivalents as of June 30, 2025, expected to fund operations into 2028. Q2 operating expenses increased to $80.9 million, up from $65.7 million in the previous year, primarily due to ongoing Phase 3 trials.

Akero Therapeutics (NASDAQ: AKRO), a clinical-stage biotechnology company focused on developing treatments for serious metabolic diseases, has announced its participation in the Goldman Sachs 46th Annual Global Healthcare Conference. The company's management will deliver a presentation on Tuesday, June 10, 2025, at 2:40 p.m. ET. Interested parties can access the live webcast through the investor relations section of Akero's website at www.akerotx.com. An archived recording of the presentation will be made available on the company's website following the live event.

Akero Therapeutics (Nasdaq: AKRO), a clinical-stage biotechnology company focused on developing treatments for serious metabolic diseases, has announced its participation in the upcoming Jefferies Global Healthcare Conference. The company's management will deliver a presentation on Wednesday, June 4, 2025, at 8:45 a.m. Pacific Time. Investors and interested parties can access the live webcast through Akero's investor relations website section at www.akerotx.com, with an archived replay available after the event.

Akero Therapeutics (NASDAQ: AKRO) reported significant Q1 2025 results, highlighted by groundbreaking Phase 2b SYMMETRY study outcomes showing statistically significant reversal of cirrhosis in MASH patients after 96 weeks of efruxifermin (EFX) treatment. Key findings include 39% of patients in the 50mg EFX group showing ≥1-stage fibrosis improvement, representing a 24% effect size over placebo. The company strengthened its financial position with a $402.5M follow-on offering, ending Q1 with $1.13B in cash reserves. Operating expenses increased to $80.9M, up from $60.0M in Q1 2024. The Phase 3 SYNCHRONY program continues to advance, with preliminary results from Real-World study expected in H1 2026. The SYMMETRY results were published in the New England Journal of Medicine and presented at EASL 2025, highlighting EFX's potential as a first- and best-in-class therapy for MASH treatment.

Akero Therapeutics (NASDAQ: AKRO) presented new analyses of their Phase 2b HARMONY trial for efruxifermin (EFX) in pre-cirrhotic MASH patients at EASL Congress 2025. The study utilized HistoIndex's AI-based qFibrosis® digital pathology analysis alongside conventional methods. Key findings showed that among patients treated with 50mg EFX, over 50% were classified as responders across all three endpoints (qFibrosis®, ELF test score, and FibroScan®), compared to less than 5% in the placebo group. At Week 96, the 50mg EFX group (N=26) showed similar response rates between conventional pathology (77%) and qFibrosis® (81%). Notably, qFibrosis® detected more responders at Week 24 (18 patients) compared to conventional pathology (10 patients), suggesting earlier detection of treatment response.

Akero Therapeutics (NASDAQ: AKRO) announced the publication of its Phase 2b SYMMETRY trial results in the New England Journal of Medicine, evaluating efruxifermin (EFX) for treating compensated cirrhosis due to MASH. The 96-week study showed significant fibrosis improvement, with 29% of participants in the EFX 50mg group and 21% in the 28mg group showing improvement compared to 11% in the placebo group.

At week 36, the primary endpoint of ≥1-stage fibrosis improvement without MASH worsening was achieved by 19% and 18% of participants in the 50mg and 28mg groups respectively, versus 13% for placebo. The treatment demonstrated improvements in liver injury markers, insulin sensitivity, and lipid metabolism. Safety profile was consistent with previous trials, with mainly mild to moderate gastrointestinal side effects.

Akero Therapeutics (NASDAQ: AKRO) presented 96-week results from its Phase 2b SYMMETRY trial of efruxifermin (EFX) at EASL Congress 2025. The trial evaluated EFX in patients with compensated cirrhosis caused by MASH. Key findings showed that 39% of patients treated with EFX 50mg demonstrated fibrosis improvement compared to 15% in the placebo group (p=0.009) among patients with baseline and week 96 biopsies. In the intent-to-treat population, 29% of EFX 50mg patients showed improvement versus 11% for placebo (p=0.031). The treatment effect more than doubled from Week 36 to Week 96, highlighting the importance of longer treatment duration. EFX demonstrated efficacy across patient subgroups, including those with type 2 diabetes and those on GLP-1 or statin medications. The safety profile remained consistent with previous trials, with mainly mild to moderate gastrointestinal side effects.

Akero Therapeutics (NASDAQ: AKRO), a clinical-stage biotech company focused on developing treatments for serious metabolic diseases, has announced its participation in the upcoming BofA Securities 2025 Healthcare Conference. The company's management will deliver a presentation on Tuesday, May 13, 2025, at 1:40 p.m. Pacific Time. Investors and interested parties can access the live webcast through Akero's investor relations website at www.akerotx.com, where an archived replay will also be available after the presentation.