• Summit Therapeutics has submitted a Biologics License Application to the FDA for ivonescimab plus chemotherapy in EGFR‑mutated non-squamous non-small cell lung cancer and separately entered a clinical trial collaboration with GSK to test ivonescimab with GSK’s B7‑H3 antibody-drug conjugate across several solid tumors, including small cell lung cancer.
• Together, these steps deepen ivonescimab’s clinical footprint across lung and other solid tumors, positioning Summit as a more central player in next-generation oncology combinations.
• We’ll now explore how the ivonescimab BLA filing shapes Summit’s investment narrative, including the expanding role of combination oncology therapies.

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What Is Summit Therapeutics' Investment Narrative?

To own Summit Therapeutics today, you need to believe ivonescimab can progress from an encouraging late‑stage asset into a commercial oncology franchise, despite the company’s zero revenue, very large losses and rich valuation on book value. The newly submitted BLA in EGFR‑mutated NSCLC crystallizes a clear, time‑bound catalyst around the FDA’s review, while the GSK collaboration extends the story into a broader combination-therapy platform rather than a single‑indication bet. In the near term, the BLA and any regulatory feedback look more important for the stock than the GSK trial, which will not start dosing until mid‑2026 and is unlikely to move fundamentals quickly. The biggest risks remain binary: clinical, regulatory or safety setbacks for ivonescimab, and the need to keep funding heavy R&D in a business that is still entirely loss‑making.

However, investors should also recognise how exposed Summit still is to a single lead asset. Despite retreating, Summit Therapeutics' shares might still be trading above their fair value and there could be some more downside. Discover how much.

Exploring Other Perspectives

Explore 6 other fair value estimates on Summit Therapeutics - why the stock might be a potential multi-bagger!

Build Your Own Summit Therapeutics Narrative

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

• A great starting point for your Summit Therapeutics research is our analysis highlighting 2 key rewards and 2 important warning signs that could impact your investment decision.
• Our free Summit Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Summit Therapeutics' 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.