FDA Accepts Summit Therapeutics' BLA for Ivonescimab
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2h ago
0mins
Source: Benzinga
- 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.
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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: 15.640
Low
18.00
Averages
42.49
High
131.90
Current: 15.640
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.
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.
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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.
Continue Reading