Akero Therapeutics, Inc. is a clinical-stage company, which engages in the development of treatments for patients with serious metabolic diseases. The firm's lead product candidate, efruxifermin (EFX), is an analog of fibroblast growth factor 21, or FGF21, which is an endogenously expressed hormone that protects against cellular stress and regulates metabolism of lipids, carbohydrates, and proteins throughout the body. The company was founded by Jonathan Young and Timothy Rolph in January 2017 and is headquartered in South San Francisco, CA.
相关临床试验
12
1 进行中
药物批准
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批准总数
监管机构
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监管机构数
成立时间
2017
进行中（未招募）
1
8.3%
已完成
3
25.0%
招募中
8
66.7%
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- Yuhan registered a U.S. patent on July 21 covering bicyclic fused ring derivatives that inhibit the LOX enzyme family, a preclinical small-molecule anti-fibrosis candidate. - The patent lists idiopathic pulmonary fibrosis, MASH, chronic kidney disease and liver cirrhosis as target indications, positioning the asset across multiple organ fibrosis markets. - The LOX inhibitor differs mechanistically from Yuhan's disclosed MASH candidate YH25724, which acts on FGF21 and GLP-1 and entered domestic Phase 1 planning in May. - Industry analysts see potential licensing value as global fibrosis and MASH dealmaking accelerates, though Yuhan cautions the candidate remains preclinical and success is unproven.
- The global NASH treatment market is projected to grow from USD 8.75 billion in 2025 to USD 46.87 billion by 2032, expanding at a CAGR of 27.1%. - Madrigal's Rezdiffra, approved in March 2024, created the first dedicated liver-directed prescription pathway for noncirrhotic NASH with moderate-to-advanced fibrosis. - Novo Nordisk's Wegovy gained FDA approval in August 2025 for MASH with F2–F3 fibrosis, connecting liver treatment to established obesity and diabetes care networks. - Late-stage pipeline candidates from Eli Lilly, Akero Therapeutics, 89bio, Inventiva, and Boehringer Ingelheim could create a multi-mechanism, segmented treatment market.
- D&D Pharmatech completed a $165 million convertible bond issuance to accelerate development of its MASH drug DD01 and pipeline expansion. - The company's shares surged 14% on expectations for 48-week tissue biopsy results from DD01's Phase 2 trial to be presented at EASL. - DD01, a dual GLP-1/glucagon receptor agonist, showed early signals of liver fat reduction and fibrosis improvement in U.S. patients at 12 and 24 weeks. - Positive results could trigger licensing discussions as major pharma companies invest billions in MASH treatments, with recent acquisitions reaching up to $5.2 billion.
- DelveInsight's 2025 analysis reveals over 30 companies are actively developing more than 30 therapeutic candidates for liver cirrhosis, driven by rising global prevalence of liver diseases, particularly NAFLD associated with obesity and metabolic syndrome. - Sagimet Biosciences received FDA Breakthrough Therapy and Fast Track designations for denifanstat in February 2025, while Madrigal Pharmaceuticals plans to launch REZDIFFRA in Europe starting with Germany in the second half of 2025. - Multiple Phase III trials are progressing, including Akero Therapeutics' completed enrollment in the SYNCHRONY Real-World study with results expected in the first half of 2026, and ongoing ENLIGHTEN trials for MASH cirrhosis. - Key investigational therapies advancing through clinical development include Volixibat, TVB-2640, belapectin, RTX001, and LPCN 1148, representing diverse mechanisms of action from sodium-bile acid cotransporter inhibition to macrophage cell therapy.
- Novo Nordisk is shutting down its entire cell therapy division and laying off nearly all 250 employees as part of CEO Mike Doustdar's strategic restructuring. - The company is terminating its type 1 diabetes program that aimed to develop glucose-responsive insulin and potentially curative stem cell therapies, including a glucose-sensitive insulin candidate in Phase I development. - Novo is also ending cell therapy programs for Parkinson's disease and chronic heart failure, while seeking partners to continue developing these innovations. - The move is part of a broader cost-cutting initiative to reduce headcount by 11% and generate $1.25 billion in annualized savings through 2026, with Doustdar refocusing the company on its core diabetes and obesity business.
- Expedition Therapeutics closed an oversubscribed $165 million Series A financing co-led by Sofinnova Investments and Novo Holdings to advance EXPD-101, a next-generation DPP1 inhibitor targeting neutrophilic inflammation in COPD. - EXPD-101 demonstrated favorable safety and pharmacokinetics in Phase 1 studies with no dose-limiting toxicities and clear target engagement, supporting once-daily oral dosing for potential first-in-class therapy. - The funding will support a global Phase 2 trial in COPD and broader indication expansion, addressing the significant unmet need in non-type 2 COPD which affects nearly 70% of patients. - Current COPD therapies offer limited benefits particularly for non-type 2 patients, positioning EXPD-101 as a potential breakthrough treatment for millions of patients lacking effective options.
- Novo Nordisk has agreed to acquire Akero Therapeutics for up to $5.2 billion in cash, paying $54 per share upfront with an additional $6 per share contingent on regulatory approval. - The acquisition centers on Akero's flagship treatment efruxifermin (EFX), a late-stage therapy for metabolic dysfunction-associated steatohepatitis (MASH), addressing a high unmet medical need. - The deal represents a 42% premium to Akero's closing price prior to market speculation and marks the 8th M&A transaction this year for International Biotechnology Trust's portfolio holdings. - Portfolio managers expect continued strong M&A activity in biotech as large pharmaceutical companies face challenging patent expiries and seek to acquire innovative treatments.
- Novo Nordisk announced the acquisition of Akero Therapeutics for up to $5.2 billion, gaining access to efruxifermin (EFX), a promising treatment for metabolic dysfunction-associated steatohepatitis (MASH). - Akero shareholders will receive $54 per share upfront plus a potential $6 per share contingent payment if EFX receives full U.S. approval by June 2031. - The acquisition complements Novo Nordisk's GLP-1 based metabolic treatments and positions the company to accelerate EFX's Phase 3 SYNCHRONY program development. - EFX has demonstrated the ability to reverse fibrosis, resolve MASH, and improve cardiovascular risk factors in Phase 2 trials, addressing a critical unmet medical need.
- Roche announced a definitive merger agreement to acquire 89bio for $14.50 per share in cash plus contingent value rights, totaling up to $3.5 billion. - The acquisition centers on pegozafermin, a Phase III FGF21 analog designed to treat moderate to severe MASH fibrosis with anti-fibrotic and anti-inflammatory mechanisms. - MASH affects an estimated 5-7% of the global adult population, with the US expected to have approximately 14 million F2-F4 MASH patients by 2030. - The deal strengthens Roche's cardiovascular, renal, and metabolic disease portfolio and offers potential for combination development with incretins.
- TREM2-expressing macrophages play crucial roles in metabolic dysfunction-associated steatohepatitis (MASH) by regulating both lipid metabolism and immune homeostasis through specialized signaling pathways. - These macrophages facilitate lipid clearance and cholesterol efflux while suppressing pro-inflammatory cytokines, potentially serving as a compensatory mechanism against hepatic lipotoxicity and chronic inflammation. - Soluble TREM2 levels show promise as an early diagnostic biomarker for MASH, appearing before other laboratory markers in both patients and mouse models. - Therapeutic targeting of TREM2 presents opportunities for stage-specific interventions, though careful consideration is needed as these macrophages may shift toward pro-fibrotic roles in advanced disease stages.
