Akero Therapeutics Stock Price, News & Analysis

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.

Akero Therapeutics has announced significant findings from the Phase 2b HARMONY study on efruxifermin (EFX) presented at the EASL Congress 2024. The 96-week data demonstrated that EFX achieved a ≥1-stage improvement in fibrosis without worsening metabolic dysfunction-associated steatohepatitis (MASH) in patients. At 96 weeks, 75% of patients on 50 mg EFX and 46% on 28 mg EFX showed improvement, compared to 24% for placebo. Additionally, 36% and 31% of patients on 50 mg and 28 mg EFX, respectively, exhibited a 2-stage improvement in fibrosis. The treatment was well tolerated, with no liver injury or decompensation events. A poster presentation highlighted EFX's positive impact on extracellular matrix remodeling and liver injury biomarkers, suggesting enhanced metabolic and liver health.

Akero Therapeutics (Nasdaq: AKRO), a clinical-stage company developing treatments for serious metabolic diseases, announced it will present at the Jefferies Global Healthcare Conference on June 5, 2024, at 4:00 p.m. ET in New York. The presentation will be available via live webcast on the company's investor relations webpage, with an archived replay accessible afterward.

Akero Therapeutics, Inc. (Nasdaq: AKRO) reported successful Week 96 results from the Phase 2b HARMONY study, showing significant improvements in fibrosis stage with the drug EFX in patients with pre-cirrhotic MASH. The company is well-funded with over $900 million in cash following an equity offering. Phase 3 SYNCHRONY studies are on track, including the SYNCHRONY Outcomes study for patients with cirrhosis. Akero also closed a public offering of common stock, raising approximately $366.9 million. Financially, the company has $903.7 million in cash and saw increased expenses related to clinical studies and operations.

Akero Therapeutics, a clinical-stage company focused on treatments for metabolic diseases, will present at the BofA Securities 2024 Health Care Conference on May 14, 2024, in Las Vegas, NV. The presentation can be accessed through the company's website.

Akero Therapeutics, Inc. appoints Scott Gangloff as Chief Technology Officer. Gangloff brings 30 years of experience in biopharmaceutical development and manufacturing, having led teams through BLAs and product approvals. He will contribute to the commercialization and manufacturing strategy of efruxifermin, a Phase 3 trial drug for MASH treatment.