Shares of Summit Therapeutics SMMT have rallied 24% over the past three months, driven by accelerating clinical momentum, financial strength and growing investor confidence in ivonescimab, its lead cancer therapy. The candidate has demonstrated encouraging clinical data and is increasingly viewed as a potential competitor to established cancer therapies. SMMT is developing ivonescimab in collaboration with China-based Akeso. Ivonescimab is currently approved only in China for two distinct NSCLC indications.
FDA Accepted Ivonescimab BLA for NSCLC
The primary catalyst behind the stock rally is the FDA acceptance of SMMT’s biologics license application (BLA) in January, seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with third-generation EGFR-TKIs. The regulatory body has set a target action date of Nov. 14, 2026.
The FDA plans to conduct a comprehensive review of the application, including mid-cycle and late-cycle meetings. If no major issues arise, labeling discussions may take place prior to the PDUFA action date.
The BLA submission was based on data from the phase III HARMONi study evaluating ivonescimab plus platinum-doublet chemotherapy versus placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic NSCLC post EGFR-TKI therapy. The primary endpoints were progression-free survival (PFS) and overall survival (OS).
The study demonstrated a statistically significant and clinically meaningful improvement in PFS. Although it did not reach statistical significance at the time of analysis, treatment with ivonescimab plus platinum-doublet chemotherapy showed a favorable trend toward OS.
Year to date, shares of Summit have risen 20.8% compared with the industry’s 2.2% growth.
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SMMT’s Collaboration With GSK
In January 2026, Summit announced a collaboration with GSK plc GSK to evaluate ivonescimab in combination with risvutatug rezetecan, GSK’s novel investigational B7-H3-targeting antibody drug conjugate, across multiple solid tumor settings, including small cell lung cancer. Each company will retain full rights to its respective products. Patient dosing is expected to commence in mid-2026.
SMMT’s Other Pipeline Progress
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 the candidate against Merck’s MRK blockbuster PD-L1 drug Keytruda (pembrolizumab) as a first-line treatment for metastatic squamous or non-squamous NSCLC, while HARMONi-7 is evaluating ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
Patient enrollment in the phase III HARMONi-GI3 study, evaluating the candidate in combination with chemotherapy against bevacizumab plus chemotherapy in first-line unresectable metastatic colorectal cancer, is ongoing.
Strong Balance Sheet
Another key factor supporting the stock’s performance is Summit Therapeutics’ strong balance sheet. As of Dec. 31, 2025, the company had cash, cash equivalents and short-term investments totaling $713.4 million with no debt.
With a substantial cash position and minimal financial risk, the company is well-positioned to fund ongoing clinical studies and potential commercialization efforts without near-term dilution risk.
Summit Therapeutics PLC Price and Consensus
Summit Therapeutics PLC price-consensus-chart | Summit Therapeutics PLC Quote
SMMT’s Zacks Rank and Stock to Consider
Summit Therapeutics currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Catalyst Pharmaceuticals CPRX, currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 10.8% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
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This article originally published on Zacks Investment Research (zacks.com).