On Tuesday, H.C. Wainwright maintained a Buy rating and a $50.00 stock price target for Akero Therapeutics (NASDAQ:AKRO), as the company progresses with its Phase 3 trial for a treatment aimed at MASH patients with compensated cirrhosis. The trial, named SYNCHRONY Outcomes, is evaluating the efficacy of efruxifermin (EFX) in patients with fibrosis stage 4 (F4). This follows the announcement on September 9 that the first patient has been dosed in the study.
SYNCHRONY Outcomes is a randomized, placebo-controlled Phase 3 trial which plans to enroll approximately 1,150 F4 MASH patients. Participants are receiving weekly injections of either 50 mg EFX or a placebo. The primary endpoint of the trial's first cohort is to assess fibrosis regression without worsening of MASH after a 96-week treatment period. Post this phase, the trial will continue to monitor patients to evaluate primary outcomes related to mortality and liver-related clinical events.
The study will also track key secondary endpoints such as changes in non-invasive markers of liver injury and fibrosis, improvements in glycemic control, and lipid levels. The initiation of the SYNCHRONY studies represents a significant step for Akero, as it now has all three Phase 3 trials of EFX underway.
Investors are looking forward to the Week 96 data release from the ongoing Phase 2b SYMMETRY study, which is expected in the first quarter of 2025. This data will provide insights into the long-term effects of EFX on F4 MASH patients and is considered a crucial near-term milestone for Akero and its EFX treatment.
The reaffirmation of the Buy rating and the $50 stock price target reflect the firm's positive outlook on Akero's therapeutic developments.
InvestingPro Insights
As Akero Therapeutics (NASDAQ:AKRO) advances through its Phase 3 trial for efruxifermin (EFX), insights from InvestingPro provide a snapshot of the company's financial health and market performance.
Akero currently holds a market capitalization of $1.86 billion, and despite not being profitable over the last twelve months, the company holds more cash than debt on its balance sheet, which is a positive sign for investors considering the financial stability of the firm. Moreover, three analysts have revised their earnings upwards for the upcoming period, indicating potential optimism in the company's future performance.
The stock price has seen a strong return over the last three months, with a 19.34% price total return, demonstrating investor confidence in the midst of ongoing clinical trials. However, it's worth noting that the company's stock price often moves in the opposite direction of the market, which could suggest a degree of volatility or idiosyncratic risk associated with Akero's shares.
For those interested in further analysis and additional InvestingPro Tips, which can provide deeper insights into Akero's financial metrics and market performance, there are 9 additional tips available at: https://www.investing.com/pro/AKRO
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