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The Bull Case For Akeso (SEHK:9926) Could Change Following FDA Clearance Of Global Gastric Cancer Trial

Simply Wall St·12/17/2025 07:21:29
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  • Akeso has recently reported a series of oncology milestones, including FDA approval to start a global Phase III trial of cadonilimab in advanced HER2‑negative gastric cancer and new Phase II/III data on ivonescimab in triple‑negative breast cancer and squamous non‑small cell lung cancer.
  • Together, these updates underscore Akeso’s push to position its bispecific antibodies as potential new standards of care across multiple solid tumors, supported by both efficacy and quality‑of‑life outcomes.
  • We’ll now examine how FDA clearance for cadonilimab’s global Phase III gastric cancer trial could reshape Akeso’s broader investment narrative.

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Akeso Investment Narrative Recap

To own Akeso, you need to believe its bispecific antibody platform can convert a deep oncology pipeline into sustainable profits, despite ongoing losses and dependence on a few lead assets. The FDA’s green light for the global Phase III COMPASSION-37 trial helps elevate cadonilimab onto the international stage, but it does not immediately change the near term profitability challenge or the execution risk around its expanding trial portfolio.

Among the recent updates, the new FDA approved Phase III COMPASSION-37 study in first line HER2 negative advanced gastric cancer looks most relevant, since it positions cadonilimab directly against chemotherapy with or without nivolumab, the current global standard. If COMPASSION-37 and Akeso’s other registrational trials read out well, they could help validate the company’s reliance on cadonilimab and ivonescimab as core value drivers, but if they disappoint, the concentration risk in these two assets becomes far more acute.

Yet even as cadonilimab’s global program advances, investors should be aware that Akeso is still loss making and heavily reliant on a narrow set of therapies...

Read the full narrative on Akeso (it's free!)

Akeso's narrative projects CN¥8.0 billion revenue and CN¥2.0 billion earnings by 2028.

Uncover how Akeso's forecasts yield a HK$172.00 fair value, a 47% upside to its current price.

Exploring Other Perspectives

SEHK:9926 1-Year Stock Price Chart
SEHK:9926 1-Year Stock Price Chart

Six fair value estimates from the Simply Wall St Community span roughly HK$70 to about HK$200, reflecting very different views on Akeso’s potential. Against this wide spread, the recent FDA clearance for a global Phase III cadonilimab trial adds a high stakes execution test that could heavily influence how those expectations evolve over time.

Explore 6 other fair value estimates on Akeso - why the stock might be worth 40% less than the current price!

Build Your Own Akeso Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

  • A great starting point for your Akeso research is our analysis highlighting 2 key rewards that could impact your investment decision.
  • Our free Akeso research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Akeso's overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.