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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 has completed enrollment of the double-blind portion of its Phase 3 SYNCHRONY Real-World study, focusing on the safety and tolerability of Efruxifermin (EFX) in patients with MASH or MASLD. A total of 601 patients have been enrolled since the study's initiation in November 2023. The study assesses the safety and tolerability of EFX, administered once-weekly in 50mg doses, over 52 weeks.
The SYNCHRONY Real-World study is a randomized, double-blind, placebo-controlled trial, with primary endpoints on safety and tolerability. Secondary endpoints include changes in non-invasive markers of liver fibrosis and injury, as well as lipoproteins, glycemic control, and body weight. An open-label cohort includes patients previously assigned to placebo in Phase 2b studies. Data from this study are expected in the first half of 2026.
Akero's Chief Development Officer, Kitty Yale, noted the rapid enrollment as indicative of the significant need for MASH treatments and optimism surrounding EFX's potential. Previous Phase 2 studies have shown improvements in liver histology and non-invasive liver health markers.
Akero Therapeutics (Nasdaq: AKRO), a clinical-stage company focused on developing treatments for serious metabolic diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's management will deliver a presentation on Tuesday, January 14, 2025, at 11:15 a.m. Pacific Time.
Interested parties can access a live webcast of the presentation through the investor relations section of Akero's website at www.akerotx.com. An archived version of the presentation will also be made available on the company's website following the live broadcast.
Akero Therapeutics (Nasdaq: AKRO) has announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. The company's management will engage in a fireside chat on Tuesday, December 3, 2024, at 9:10 a.m. ET. The presentation will be accessible through a live webcast via the investor relations section of Akero's website at www.akerotx.com, with an archived replay available afterward. Akero is a clinical-stage company focused on developing treatments for serious metabolic diseases with high unmet medical needs.
Akero Therapeutics presented new analyses of its Phase 2b HARMONY study for efruxifermin (EFX) in treating metabolic dysfunction-associated steatohepatitis (MASH). Over 40% of participants treated with EFX 50mg for 96 weeks showed regression of liver fibrosis across three measures, compared to 0% for placebo. 30% of participants receiving EFX 50mg achieved almost complete MASH disease reversal. The study demonstrated consistent improvements in liver health markers, with AI-based digital pathology confirming conventional histopathology assessments. The 50mg dose showed superior results compared to the 28mg dose, with significant reductions in fibrosis in both perisinusoidal and periportal zones of the liver.
Akero Therapeutics (Nasdaq: AKRO) has announced its upcoming participation in the Jefferies London Healthcare Conference. The company's management will engage in a fireside chat on Tuesday, November 19, 2024, at 12:00 p.m. GMT. Akero, which focuses on developing treatments for serious metabolic diseases, will make the presentation available via live webcast through their investor relations website. An archived replay will be accessible on www.akerotx.com following the live event.
Akero Therapeutics (AKRO) reports Q3 2024 financial results and progress in its Phase 3 SYNCHRONY program for efruxifermin (EFX) in MASH treatment. The company reached a milestone with first patient dosing in SYNCHRONY Outcomes study for compensated cirrhosis. Cash position stands at $787.1 million, expected to fund operations into H2 2027. Q3 operating expenses increased to $81.7 million from $46.6 million year-over-year, mainly due to expanded clinical trials. Phase 3 SYNCHRONY Real-World and Histology studies are progressing, with results expected in 2026 and H1 2027, respectively. Phase 2b SYMMETRY study week 96 results anticipated in February 2025.
Akero Therapeutics (Nasdaq: AKRO) announced upcoming presentations at the 75th Annual AASLD The Liver Meeting® 2024, showcasing data on efruxifermin (EFX) for treating pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH). The presentations include:
1. An oral presentation on EFX's significant improvement of liver fibrosis at Week 96 in the HARMONY study.
2. A late-breaking poster on EFX's reduction of at-risk MASH and near-complete histological disease reversal at Week 96.
3. Another late-breaking poster on AI and digital-based pathology corroborating fibrosis reduction observed with EFX treatment.
All presentations will be given by Dr. Mazen Noureddin from Houston Methodist Hospital. The meeting takes place from November 15-19, 2024, in San Diego.
Akero Therapeutics (Nasdaq: AKRO), a clinical-stage company focused on developing treatments for serious metabolic diseases, has announced its participation in the H.C. Wainwright 8th Annual MASH Virtual Conference. The company's management will engage in a fireside chat on Monday, October 7, 2024, at 11:00 a.m. E.T.
Interested parties can access a live webcast of the presentation through the investor relations section of Akero's website at www.akerotx.com. For those unable to attend the live event, an archived replay will be made available on the company's website following the presentation.
Akero Therapeutics (Nasdaq: AKRO) has initiated dosing in the Phase 3 SYNCHRONY Outcomes trial, evaluating efruxifermin (EFX) for treating compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). This study is part of the broader SYNCHRONY Phase 3 program, which includes two other ongoing trials: SYNCHRONY Histology and SYNCHRONY Real-World. The program aims to assess EFX's efficacy in improving fibrosis, resolving MASH, and impacting long-term clinical outcomes across various stages of liver disease.
Key points:
- First patient dosed in SYNCHRONY Outcomes trial for compensated cirrhosis (F4) due to MASH
- SYNCHRONY program evaluates EFX in different stages of MASH severity
- Patients self-administer EFX using LyoJect 3S dual chamber syringe
- Week 96 results from Phase 2b SYMMETRY study expected in Q1 2025
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company focused on developing treatments for serious metabolic diseases, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The presentation is scheduled for Wednesday, September 4, 2024, at 7:45 a.m. E.T. in New York, NY.
Investors and interested parties can access a live webcast of the presentation through the investor relations section of Akero's website at www.akerotx.com. For those unable to attend the live event, an archived replay will be made available on the company's website following the presentation.
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