Summit Therapeutics Files Biologics License Application for Ivonescimab
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 29 2026
0mins
Should l Buy SMMT?
Summit Therapeutics announced that the FDA has accepted for filing Summit's biologics license application seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth factor receptor-mutated locally advanced or metastatic non-squamous non-small cell lung cancer post-tyrosine kinase inhibitor therapy. The FDA provided a Prescription Drug User Fee Act goal action date of November 14.
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Analyst Views on SMMT
Wall Street analysts forecast SMMT stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for SMMT is 42.49 USD with a low forecast of 18.00 USD and a high forecast of 131.90 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
12 Analyst Rating
8 Buy
3 Hold
1 Sell
Moderate Buy
Current: 13.850
Low
18.00
Averages
42.49
High
131.90
Current: 13.850
Low
18.00
Averages
42.49
High
131.90
About SMMT
Summit Therapeutics Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of patient, physician, caregiver and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Its lead development candidate is ivonescimab, a novel, potential first-in-class bispecific antibody intending to combine the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects of an anti-VEGF compound into a single molecule. Ivonescimab is being developed by both Akeso and the Company in multiple Phase III clinical trials. It is also developing ivonescimab in non-small cell lung cancer and other solid tumor settings. Ivonescimab is approved in China in combination with chemotherapy for patients with EGFR-mutated non-small cell lung cancer whose tumors have progressed following an EGFR-TKI based on the results of the HARMONi-A clinical trial.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Exelixis and Summit Therapeutics: Promising Drug Candidates Ahead
- Exelixis Drug Progress: Exelixis is advancing its next-gen cancer drug zanzalintinib with an FDA application, expecting several phase 3 clinical trials in 2023; positive results could significantly boost stock prices and enhance its market position in oncology.
- Cabometyx Patent Cliff: With Cabometyx facing patent expiration by 2030, Exelixis is diversifying its product lineup through new drug development to ensure sustained growth and competitiveness in the market.
- Summit Drug Ivonescimab: Summit Therapeutics' ivonescimab has outperformed the best-selling drug Keytruda in trials and is undergoing 42 clinical studies; FDA approval could lead to a significant stock price increase by 2026.
- Massive Market Potential: Ivonescimab is projected to reach peak sales of $53 billion, and despite clinical and regulatory risks, its extensive range of indications showcases Summit's substantial potential in the biopharmaceutical sector.
See More
Exelixis and Summit Therapeutics: Future Prospects
- Exelixis Drug Progress: Exelixis is advancing its next-gen cancer drug zanzalintinib's FDA application, expected to replace Cabometyx by 2030, which would significantly enhance the company's market position in oncology.
- Clinical Trial Plans: Exelixis plans to initiate several phase 3 clinical trials this year and release two late-stage data sets, with positive results potentially driving stock price increases and ensuring continued growth before Cabometyx's patent expiration.
- Summit Drug Potential: Summit Therapeutics' ivonescimab has outperformed the best-selling drug Keytruda in comparative studies, and if it secures FDA approval in the U.S., it could significantly boost the company's stock price and market share.
- Extensive Clinical Research: Summit is conducting 42 clinical studies for ivonescimab, with analysts estimating peak sales could reach $53 billion, showcasing its vast potential across various indications despite clinical and regulatory risks.
See More
Summit Therapeutics Grants Stock Options to New Employees
- Stock Option Grants: Summit Therapeutics awarded a total of 257,368 stock options to 20 new employees, aimed at attracting and retaining talent in accordance with Nasdaq Listing Rule 5635(c)(4).
- Option Terms: The options have an exercise price of $16.56 per share and a ten-year term, reflecting the closing price on January 26, 2026, indicating the company's confidence in future stock performance.
- Vesting Schedule: The awarded options will vest in equal annual installments over four years, which not only incentivizes long-term employee retention but also enhances team stability and cohesion.
- Company Overview: Founded in 2003, Summit Therapeutics focuses on developing biopharmaceutical therapies that improve patient quality of life, listed on Nasdaq, showcasing its ongoing growth potential in the biopharmaceutical sector.
See More
FDA Accepts Summit Therapeutics' BLA for Ivonescimab
- BLA Acceptance: The FDA has accepted Summit Therapeutics' Biologics License Application for ivonescimab in combination with chemotherapy for EGFR-mutated advanced non-small cell lung cancer, with a decision expected by November 14, 2026.
- Clinical Trial Results: The Phase 3 HARMONi trial showed a median overall survival of 16.8 months for ivonescimab plus chemotherapy compared to 14.1 months for chemotherapy alone, indicating significant therapeutic potential.
- Future Research Plans: Summit anticipates completing enrollment in the squamous cohort of the HARMONi-3 trial in the first half of 2026, with primary endpoint analysis expected in the second half of 2026, further advancing ivonescimab's clinical development.
- New Study Initiation: The company has initiated the Phase 3 HARMONi-GI3 study for first-line unresectable metastatic colorectal cancer, aiming to expand ivonescimab's clinical development program to meet market needs.
See More
Summit Therapeutics' FDA Application Accepted for Ivonescimab
- FDA Acceptance: Summit Therapeutics announced that the U.S. FDA has accepted its Biologics License Application (BLA) for ivonescimab, developed in partnership with Akeso, marking a significant advancement in lung cancer treatment.
- Targeted Treatment Advantage: The drug specifically targets patients with advanced or metastatic non-squamous non-small cell lung cancer who have previously received tyrosine kinase inhibitors, potentially providing a new treatment option and enhancing the company's competitiveness in the biopharmaceutical market.
- Clinical Trial Success: Ivonescimab outperformed Merck's Keytruda in late-stage trials for non-small cell lung cancer, becoming the first drug to achieve this milestone, which further boosts investor confidence in the company.
- Action Date Set: The FDA has set a target action date of November 14, 2026, for the BLA, supported by data from its Phase 3 HARMONi global trial, indicating potential market opportunities ahead.
See More
Summit Submits BLA for Ivonescimab in NSCLC
- FDA Filing Accepted: The FDA has accepted Summit Therapeutics' Biologics License Application (BLA) for ivonescimab, targeting EGFR-mutated non-small cell lung cancer, with a decision expected by November 14, 2026, highlighting a significant unmet medical need.
- Clinical Trial Results: The BLA submission is based on the Phase III HARMONi trial results, which compared ivonescimab plus chemotherapy to placebo plus chemotherapy, indicating potential survival benefits for patients with EGFR mutations, thus enhancing treatment options.
- Global Patient Reach: Ivonescimab has been administered to over 4,000 patients in clinical trials globally, and more than 60,000 patients in commercial settings in China, showcasing its extensive market potential and clinical applicability.
- Future Development Plans: Summit plans to continue patient enrollment in the HARMONi and HARMONi-3 trials initiated in 2023, and to launch HARMONi-7 in 2025, further expanding ivonescimab's application across various cancer types and strengthening the company's competitive position in oncology.
See More
Exelixis and Summit Therapeutics: Promising Drug Candidates Ahead
- Exelixis Drug Progress: Exelixis is advancing its next-gen cancer drug zanzalintinib with an FDA application, expecting several phase 3 clinical trials in 2023; positive results could significantly boost stock prices and enhance its market position in oncology.
- Cabometyx Patent Cliff: With Cabometyx facing patent expiration by 2030, Exelixis is diversifying its product lineup through new drug development to ensure sustained growth and competitiveness in the market.
- Summit Drug Ivonescimab: Summit Therapeutics' ivonescimab has outperformed the best-selling drug Keytruda in trials and is undergoing 42 clinical studies; FDA approval could lead to a significant stock price increase by 2026.
- Massive Market Potential: Ivonescimab is projected to reach peak sales of $53 billion, and despite clinical and regulatory risks, its extensive range of indications showcases Summit's substantial potential in the biopharmaceutical sector.
See More
Exelixis and Summit Therapeutics: Future Prospects
- Exelixis Drug Progress: Exelixis is advancing its next-gen cancer drug zanzalintinib's FDA application, expected to replace Cabometyx by 2030, which would significantly enhance the company's market position in oncology.
- Clinical Trial Plans: Exelixis plans to initiate several phase 3 clinical trials this year and release two late-stage data sets, with positive results potentially driving stock price increases and ensuring continued growth before Cabometyx's patent expiration.
- Summit Drug Potential: Summit Therapeutics' ivonescimab has outperformed the best-selling drug Keytruda in comparative studies, and if it secures FDA approval in the U.S., it could significantly boost the company's stock price and market share.
- Extensive Clinical Research: Summit is conducting 42 clinical studies for ivonescimab, with analysts estimating peak sales could reach $53 billion, showcasing its vast potential across various indications despite clinical and regulatory risks.
See More
Summit Therapeutics Grants Stock Options to New Employees
- Stock Option Grants: Summit Therapeutics awarded a total of 257,368 stock options to 20 new employees, aimed at attracting and retaining talent in accordance with Nasdaq Listing Rule 5635(c)(4).
- Option Terms: The options have an exercise price of $16.56 per share and a ten-year term, reflecting the closing price on January 26, 2026, indicating the company's confidence in future stock performance.
- Vesting Schedule: The awarded options will vest in equal annual installments over four years, which not only incentivizes long-term employee retention but also enhances team stability and cohesion.
- Company Overview: Founded in 2003, Summit Therapeutics focuses on developing biopharmaceutical therapies that improve patient quality of life, listed on Nasdaq, showcasing its ongoing growth potential in the biopharmaceutical sector.
See More
FDA Accepts Summit Therapeutics' BLA for Ivonescimab
- BLA Acceptance: The FDA has accepted Summit Therapeutics' Biologics License Application for ivonescimab in combination with chemotherapy for EGFR-mutated advanced non-small cell lung cancer, with a decision expected by November 14, 2026.
- Clinical Trial Results: The Phase 3 HARMONi trial showed a median overall survival of 16.8 months for ivonescimab plus chemotherapy compared to 14.1 months for chemotherapy alone, indicating significant therapeutic potential.
- Future Research Plans: Summit anticipates completing enrollment in the squamous cohort of the HARMONi-3 trial in the first half of 2026, with primary endpoint analysis expected in the second half of 2026, further advancing ivonescimab's clinical development.
- New Study Initiation: The company has initiated the Phase 3 HARMONi-GI3 study for first-line unresectable metastatic colorectal cancer, aiming to expand ivonescimab's clinical development program to meet market needs.
See More
Summit Therapeutics' FDA Application Accepted for Ivonescimab
- FDA Acceptance: Summit Therapeutics announced that the U.S. FDA has accepted its Biologics License Application (BLA) for ivonescimab, developed in partnership with Akeso, marking a significant advancement in lung cancer treatment.
- Targeted Treatment Advantage: The drug specifically targets patients with advanced or metastatic non-squamous non-small cell lung cancer who have previously received tyrosine kinase inhibitors, potentially providing a new treatment option and enhancing the company's competitiveness in the biopharmaceutical market.
- Clinical Trial Success: Ivonescimab outperformed Merck's Keytruda in late-stage trials for non-small cell lung cancer, becoming the first drug to achieve this milestone, which further boosts investor confidence in the company.
- Action Date Set: The FDA has set a target action date of November 14, 2026, for the BLA, supported by data from its Phase 3 HARMONi global trial, indicating potential market opportunities ahead.
See More
Summit Submits BLA for Ivonescimab in NSCLC
- FDA Filing Accepted: The FDA has accepted Summit Therapeutics' Biologics License Application (BLA) for ivonescimab, targeting EGFR-mutated non-small cell lung cancer, with a decision expected by November 14, 2026, highlighting a significant unmet medical need.
- Clinical Trial Results: The BLA submission is based on the Phase III HARMONi trial results, which compared ivonescimab plus chemotherapy to placebo plus chemotherapy, indicating potential survival benefits for patients with EGFR mutations, thus enhancing treatment options.
- Global Patient Reach: Ivonescimab has been administered to over 4,000 patients in clinical trials globally, and more than 60,000 patients in commercial settings in China, showcasing its extensive market potential and clinical applicability.
- Future Development Plans: Summit plans to continue patient enrollment in the HARMONi and HARMONi-3 trials initiated in 2023, and to launch HARMONi-7 in 2025, further expanding ivonescimab's application across various cancer types and strengthening the company's competitive position in oncology.
See More
