Akero(AKRO) ZACKS·2025-01-29 16:16Core Viewpoint - Akero Therapeutics' shares surged 105.7% following the announcement of positive 96-week data from a mid-stage study of efruxifermin (EFX) for liver disease, indicating significant potential for the treatment of compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) [1][3]. Group 1: Study Results - In the SYMMETRY study, 39% of patients receiving 50mg EFX experienced cirrhosis reversal without worsening of MASH, compared to 15% in the placebo group [2]. - The Intent-to-Treat analysis showed that 29% of the 50mg EFX group achieved cirrhosis reversal without MASH worsening, versus approximately 12% in the placebo group [2]. - The effect size in the 50mg group increased from 10% at week 36 to 24% at week 96, demonstrating the advantages of extended EFX treatment [3]. Group 2: Safety and Tolerability - EFX was generally well tolerated in the study, with no deaths in the EFX group and only one in the placebo group due to pneumonia [6]. - No serious adverse events were linked to EFX, with the most common side effects being mild to moderate gastrointestinal issues that were temporary [6]. Group 3: Competitive Landscape - The positive results from Akero's study also positively impacted shares of rival company 89bio (ETNB), which saw a 33.5% increase in stock price [8]. - 89bio is developing pegozafermin for MASH and has initiated phase III studies for F2-F3 and F4 MASH patients [9]. - Madrigal Pharmaceuticals markets Rezdiffra as the first FDA-approved therapy for noncirrhotic MASH, with a regulatory application under review in the EU [11][12]. Group 4: Market Opportunity - Cirrhosis caused by MASH is a severe condition, with approximately 3 million Americans expected to have MASH-related cirrhosis by 2030, representing a significant market opportunity [13]. - Novo Nordisk is also evaluating semaglutide for MASH, with positive results from a pivotal phase III study and plans for regulatory filings in 2025 [14][15].