Summit Therapeutics SMMT has emerged as one of the most closely watched oncology biotech companies following the rapid advancement of its lead cancer candidate, ivonescimab. Summit in-licensed rights to develop and commercialize ivonescimab in most major global markets outside China from China-based Akeso in early 2023.
Since in-licensing rights to ivonescimab, Summit Therapeutics has transformed from a small biotech player into a late-stage oncology company with a growing global development program centered around the candidate.
Ivonescimab is a dual PD-1/VEGF inhibitor being evaluated in multiple late-stage studies across different settings in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Unlike currently marketed immuno-oncology therapies that target only the PD-1 pathway, ivonescimab simultaneously targets both PD-1 and VEGF, a differentiated mechanism that management believes could redefine the treatment landscape and emerge as the next standard of care in NSCLC.
Year to date, shares of SMMT have declined 0.1% compared with the industry’s 6.4% fall.
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Investor attention remains focused on the company’s expanding late-stage pipeline and upcoming regulatory milestones.
SMMT Rides on Ivonescimab’s Development Progress
Building on the success of the Akeso-sponsored studies in China, Summit Therapeutics is sponsoring multiple global and multi-regional clinical studies to support regulatory approvals in its licensed territories.
In May 2025, SMMT reported encouraging results from the phase III HARMONi study, which evaluated ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed after treatment with an EGFR-TKI. The study met one of its two primary endpoints — progression-free survival (PFS). Although the study did not meet the overall survival (OS) endpoint, the data showed a favorable trend toward OS. Based on these results, Summit Therapeutics submitted a biologics license application with the FDA in January 2026. A final decision on ivonescimab’s approval is expected by Nov. 14, 2026.
The company is currently enrolling patients in three late-stage studies on ivonescimab — two in NSCLC (HARMONi-3 and HARMONi-7) and one in CRC (HARMONi-GI3).
HARMONi-3 is evaluating ivonescimab against Merck’s MRK blockbuster drug Keytruda, as first-line treatment for metastatic squamous and non-squamous NSCLC, while HARMONi-7 is evaluating ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. A data readout from the squamous cohort of the HARMONi-3 study is expected in the second half of 2026, which could be an important catalyst for the stock.
Enrollment in the non-squamous NSCLC cohort is expected to be completed by the end of second-quarter 2026, with PFS data anticipated in the first half of 2027.
Summit Therapeutics PLC Price and Consensus
Summit Therapeutics PLC price-consensus-chart | Summit Therapeutics PLC Quote
Beyond lung cancer, Summit Therapeutics has expanded development into gastrointestinal cancers through the HARMONi-GI3 study, the company’s first late-stage study outside NSCLC. The study is evaluating the candidate in combination with chemotherapy against bevacizumab plus chemotherapy in first-line unresectable metastatic colorectal cancer.
Like HARMONi-GI3, Summit plans to start more late-stage studies on ivonescimab and intends to provide updates in the near future.
Strategic Collaborations Expand Development Potential
Summit Therapeutics expanded the potential of ivonescimab through a collaboration with drug giant GSK plc GSK to evaluate the candidate in combination with GSK’s investigational B7-H3-targeting antibody drug conjugate, risvutatug rezetecan, across multiple solid tumors, including small cell lung cancer (SCLC). The company has partnered with GORTEC, MD Anderson Cancer Center, Pfizer and Revolution Medicines to accelerate ivonescimab’s preclinical and clinical development across several solid tumor indications beyond its current core development plan.
SMMT's Zacks Rank & Estimates
Summit Therapeutics currently has a Zacks Rank #2 (Buy). Over the past 30 days, estimates for SMMT’s 2026 loss per share have narrowed from $1.31 to $1.17, and 2027 estimates for loss per share have improved from $1.38 to $1.21.
Positive regulatory updates and the successful development of ivonescimab could support the further momentum for the stock in 2026.
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This article originally published on Zacks Investment Research (zacks.com).