The analyst highlighted that major pharmaceutical companies are already pursuing GLP-1-based therapies for MASH, but he believes efruxifermin could complement these treatments.
Akero Therapeutics, Inc. shares surged over 113% early on Monday, hitting highs last seen in mid-June 2023.
The stock is on course for its best trading day since Sept. 13, 2022, following the release of promising topline week 96 results from its SYMMETRY trial.
The Phase 2b study evaluated Akero’s lead product candidate, efruxifermin (EFX), in patients with biopsy-confirmed compensated cirrhosis (Child-Pugh Class A) caused by metabolic dysfunction-associated steatohepatitis (MASH).
Among the 181 enrolled patients who received at least one dose, those treated with 50mg of EFX achieved a 39% reversal of cirrhosis without worsening MASH, compared to 15% for the placebo group.
In the Intent-to-Treat population, 29% of patients on 50mg EFX showed reversal of cirrhosis with no MASH progression, compared to 12% for placebo.
Akero noted the effect size in the 50mg group more than doubled from weeks 36 to 96, highlighting the long-term benefits of EFX treatment.
The therapy was generally well-tolerated, with no deaths reported in the EFX groups.
Citi analyst Jonathan Woo hailed the data as a “best-case scenario,” emphasizing the trial’s significance in addressing an underserved MASH population, according to The Fly.
Woo highlighted that major pharmaceutical companies are already pursuing GLP-1-based therapies for MASH, but he believes efruxifermin could complement these treatments, offering a unique positioning in a growing market.
Citi reiterated its ‘Buy’ rating on Akero stock, with a price target of $65 — more than double its current levels.
Sentiment on Stocktwits shifted turned 'extremely bullish' early Monday as retail investors largely praised the data, even as some skeptics pointed to the trial’s relatively small size and questioned whether the results warranted the stock’s steep rise.
MASH, previously referred to as NASH, is a severe liver disorder that can lead to cancer or liver failure. It is caused by fat accumulation in the liver, leading to inflammation and fibrosis over time. Despite its prevalence, effective treatments remain scarce.
In March 2024, Madrigal Pharmaceuticals’ Rezdiffra became the first FDA-approved treatment for MASH with moderate to advanced fibrosis. However, the FDA has not yet approved GLP-1 drugs for MASH, though early trials show promise.
Akero reported $717 million in cash, cash equivalents, and marketable securities as of the third quarter of 2024 against $36 million in total debt.
The company expects this liquidity to fund its Phase 3 SYNCHRONY Histology and Real-World studies through key readouts and operations into the second half of 2027.
Over the past 12 months, Akero’s stock has gained over 18%, though it remains down more than 6% year-to-date.
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