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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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.

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.






