H.C. Wainwright maintains buy on Akero stock

On Friday, H.C. Wainwright reaffirmed its Buy rating and $50.00 price target for Akero Therapeutics (NASDAQ:AKRO), representing significant upside potential from the current trading price of $24.01. According to InvestingPro data, analyst targets range from $35 to $65, with a strong consensus recommendation of 1.45 (where 1 is Strong Buy).

The firm's analyst highlighted the recent completion of patient enrollment for the Phase 3 SYNCHRONY Real-World study (NCT06161571) on January 13. This marks a significant milestone for Akero, as the study aims to evaluate the safety and effectiveness of efruxifermin (EFX) in treating a broad spectrum of metabolic-associated steatohepatitis (MASH) or metabolic-associated steatohepatitis liver disease (MASLD) patients.

The SYNCHRONY Real-World study is notable for its comprehensive inclusion of patients across fibrosis stages F1-F4. It features a 52-week double-blind, placebo-controlled segment where patients are assigned to either weekly subcutaneous doses of EFX 50 mg or a placebo.

While the company's financial health score is rated as "FAIR" by InvestingPro, it maintains a strong liquidity position with a current ratio of 17.25 and holds more cash than debt on its balance sheet. Additionally, there is an open-label cohort for participants who previously received a placebo in the Phase 2b HARMONY or SYMMETRY studies and will now be administered EFX 50 mg.

The primary focus of the study is to assess the safety and tolerability of EFX over a 52-week period. This includes monitoring for adverse events, serum laboratory results, ECGs, ultrasounds, vital signs, and the use of concurrent medications. Secondary objectives are to observe changes in non-invasive indicators of liver fibrosis and injury, lipoproteins, glycemic control, and body weight.

H.C. Wainwright anticipates that EFX will show a positive safety and tolerability profile at the end of the 52-week period. The firm also expects to see signs of fibrosis improvement, drawing confidence from the encouraging Week 96 data from the Phase 2b HARMONY study (NCT04767529). Notably, the stock has shown resilience with a beta of -0.2, indicating it often moves independently of broader market trends.

The analyst's report, titled "EFX Efficacy Continues to Improve Out to Week 96; SYNCHRONY Outcomes Study to Start This Month; Affirm Buy," provides a comprehensive analysis of these expectations. The results of the study are projected to be available in the first half of 2026, with the next earnings announcement scheduled for March 13, 2025.

In other recent news, Keros Therapeutics has voluntarily paused dosing in certain arms of its Phase 2 TROPOS Trial due to unanticipated cases of pericardial effusion among participants. The decision was made after a safety review and affects the 3.0 mg/kg and 4.5 mg/kg treatment arms. However, the 1.5 mg/kg level continues, as supported by an independent Data Monitoring Committee and a select group of unblinded individuals at Keros.

In other recent developments, Citi has initiated coverage on Akero Therapeutics with a positive outlook, assigning the stock a Buy rating. The recommendation is based on the potential of Akero's drug efruxifermin, currently under development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The firm believes efruxifermin could be a leading therapy for MASH, particularly in cases with moderate to advanced fibrosis.

Akero Therapeutics has announced significant outcomes from its Phase 2b HARMONY study evaluating the efficacy of efruxifermin (EFX) in treating MASH. The study revealed that after 96 weeks of EFX treatment, over 40% of participants exhibited regression of liver fibrosis. Furthermore, 30% of those treated with EFX 50mg achieved near-complete reversal of MASH-related disease, including fibrosis regression to minimal levels, resolution of steatohepatitis, and normalization of liver fat content.

In addition, Akero has made progress with its Phase 3 trial for a treatment aimed at MASH patients with compensated cirrhosis, named SYNCHRONY Outcomes. The trial is evaluating the efficacy of efruxifermin (EFX) in patients with fibrosis stage 4 (F4) and plans to enroll approximately 1,150 patients.

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