Akero Therapeutics, Inc. - AKRO STOCK NEWS

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.

Akero Therapeutics (Nasdaq: AKRO) reported Q2 2024 financial results and provided business updates. Key highlights include:

1. Initiated Phase 3 SYNCHRONY Outcomes trial for efruxifermin (EFX) in patients with compensated cirrhosis due to MASH.

2. Presented promising 96-week data from Phase 2b HARMONY study at EASL Congress 2024, showing significant fibrosis improvement.

3. Appointed Scott Gangloff as Chief Technical Officer.

4. Cash position of $848.3 million as of June 30, 2024, expected to fund operations into second half of 2027.

5. R&D expenses increased to $55.3 million in Q2 2024, up from $28.0 million in Q2 2023.

6. Total operating expenses were $65.7 million in Q2 2024, compared to $35.6 million in Q2 2023.

Akero Therapeutics has initiated the SYNCHRONY Outcomes Phase 3 trial to evaluate efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to MASH. This trial, which will enroll patients globally, aims to assess the efficacy and safety of EFX. The primary histology endpoint is fibrosis regression without worsening MASH after 96 weeks, and the primary outcomes endpoint is all-cause mortality and liver-related clinical outcomes.

The SYNCHRONY program includes three trials: Histology, Real-World, and Outcomes, each focused on different stages of MASH. EFX will be administered via the LyoJect 3S dual chamber syringe, a device designed for self-administration.