Summit Takes Neutral Stance on Risk/Reward Dynamics as Piper Launches Coverage on Biotech Cancer Stocks
Piper Sandler's Coverage Launch: Piper Sandler initiated coverage on several cancer-focused biotech companies, giving a Neutral rating to Summit Therapeutics (SMMT) due to perceived high investor expectations and downside risks.
Revolution Medicines Rating: Revolution Medicines (RVMD) received an Overweight rating with a target price of $75 per share, driven by positive data for its lead asset daraxonrasib in treating pancreatic ductal adenocarcinoma.
Tango Therapeutics Potential: Analyst Kelsey Goodwin expressed optimism about Tango Therapeutics (TNGX), assigning an Overweight rating and a target of $11 per share, citing potential for its PRMT5-inhibitor TNG462 in various cancers.
UroGen Pharma Outlook: UroGen Pharma (URGN) was also rated Overweight with a target of $36 per share, as confidence grows around the market launch of its bladder cancer drug Zusduri and upcoming clinical updates.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.










