Earnings summaries and quarterly performance for Summit Therapeutics.
Executive leadership at Summit Therapeutics.
Board of directors at Summit Therapeutics.
Research analysts who have asked questions during Summit Therapeutics earnings calls.
Mitchell Kapoor
H.C. Wainwright & Co.
6 questions for SMMT
Also covers: CTMX, HALO, INM +7 more
YN
Yigal Nochomovitz
Citigroup Inc.
6 questions for SMMT
Also covers: ALDX, APLS, ARCT +22 more
Mohit Bansal
Wells Fargo & Company
4 questions for SMMT
Also covers: ABBV, AMGN, BMRN +16 more
RB
Reni Benjamin
Citizens JMP Securities
4 questions for SMMT
Also covers: ALLO, BCAB, BGNE +7 more
Kelly Shi
Jefferies
3 questions for SMMT
Also covers: ADCT, AGEN, ALDX +17 more
Asthika Goonewardene
Truist Securities
2 questions for SMMT
Also covers: ALLO, AUTL, BNTX +9 more
BC
Bradley Canino
Stifel
2 questions for SMMT
Also covers: ARVN, CELC, KURA +2 more
Cory Kasimov
Evercore ISI
2 questions for SMMT
Also covers: BBIO, BMRN, BNTX +5 more
ES
Eric Schmidt
Cantor Fitzgerald & Co.
2 questions for SMMT
Also covers: ADCT, AGIO, BIIB +9 more
Karina Rabayeva
Truist Securities
2 questions for SMMT
Also covers: AUTL, CGEN, MRSN +1 more
BC
Brad Canino
Stifel Financial Corp.
1 question for SMMT
Also covers: BPMC, KYTX
Clara Dong
Jefferies
1 question for SMMT
Also covers: AUTL, HRTX, INSM +1 more
CK
Cory Kazimov
Evercore
1 question for SMMT
Dara Azar
Stifel
1 question for SMMT
Also covers: AFMD, KURA
DD
David Dai
UBS Group AG
1 question for SMMT
Also covers: IMCR, IOVA, KURA +2 more
Salveen Richter
Goldman Sachs
1 question for SMMT
Also covers: ACAD, AGIO, ALLO +20 more
TV
Tyler Van Buren
TD Cowen
1 question for SMMT
Also covers: ADVM, ALLO, ARQT +12 more
Recent press releases and 8-K filings for SMMT.
Summit Therapeutics: FDA Accepts BLA for Ivonescimab
SMMT
Product Launch
New Projects/Investments
- On January 29, 2026, Summit Therapeutics Inc. announced the U.S. Food & Drug Administration (FDA) accepted for filing its Biologics License Application (BLA) for ivonescimab.
- The BLA seeks approval for ivonescimab in combination with chemotherapy for patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) post-tyrosine kinase inhibitor (TKI) therapy.
- The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
- The BLA filing is based on the overall results of the Phase III HARMONi trial, and ivonescimab previously received Fast Track designation from the US FDA.
6 days ago
Summit Therapeutics Provides Update on Ivonescimab Development and Financials
SMMT
Product Launch
New Projects/Investments
Guidance Update
- Summit Therapeutics submitted a Biologics License Application (BLA) to the FDA in Q4 2025 for ivonescimab in second-line EGFR mutant non-small cell lung cancer, with a regulatory decision anticipated around the end of 2026.
- Ivonescimab has demonstrated four positive Phase III readouts and secured two approvals in China, while currently enrolling three global Phase III trials across non-small cell lung cancer and colorectal cancer indications.
- The company entered 2026 with a cash balance of approximately $710 million and is debt-free, supported by a $500 million capital raise in October.
- Key upcoming catalysts for 2026 include the completion of enrollment for the Harmony III squamous cohort in H1 2026, with progression-free survival (PFS) and interim overall survival (OS) data expected in H2 2026, and the launch of additional new Phase III studies.
Jan 12, 2026, 5:45 PM
Summit Therapeutics Provides Ivonescimab Clinical and Financial Update
SMMT
Product Launch
New Projects/Investments
Guidance Update
- Summit Therapeutics submitted a Biologics License Application (BLA) for ivonescimab to the FDA in Q4 2025, with a regulatory decision anticipated around the end of 2026.
- The company reported a cash balance of approximately $710 million entering 2026 and remains debt-free, following a $500 million capital raise in October.
- Upcoming clinical milestones for ivonescimab include expected completion of enrollment for the squamous cohort of the HARMONi-3 trial in H1 2026, with progression-free survival and interim overall survival data in H2 2026.
- Ivonescimab has completed four positive Phase III studies and has received two approvals in China for non-small cell lung cancer indications.
- Summit Therapeutics announced new clinical collaborations for ivonescimab with Revolution Medicines (expected to begin dosing this quarter) and GSK (expected to start mid-2026).
Jan 12, 2026, 5:45 PM
Summit Therapeutics Provides Update on Ivonescimab Development and Financial Position
SMMT
New Projects/Investments
Guidance Update
Product Launch
- Summit Therapeutics' lead asset, ivonescimab, has completed four positive Phase III studies and is positioned as a potential first-mover in the PD-1/VEGF space, targeting a market estimated to exceed $100 billion annually.
- A Biologics License Application (BLA) for ivonescimab was submitted to the FDA in Q4 2025 for second-line EGFR mutant non-small cell lung cancer, with a regulatory decision anticipated around the end of 2026.
- The company is actively enrolling three global Phase III trials (Harmony III, Harmony VII, Harmony GI III), with key data readouts expected for Harmony III's squamous arm (PFS and interim OS in H2 2026) and non-squamous arm (PFS in H1 2027).
- Summit Therapeutics reported a cash balance of approximately $710 million entering 2026, following a $500 million capital raise in October 2025, and remains debt-free.
Jan 12, 2026, 5:45 PM
Summit Therapeutics Submits BLA for Ivonescimab and Announces GSK Collaboration
SMMT
Product Launch
New Projects/Investments
Guidance Update
- Summit Therapeutics submitted a Biologics License Application (BLA) to the U.S. FDA in Q4 2025 for ivonescimab in combination with chemotherapy for the second-line or later treatment of patients with EGFR-mutated non-small cell lung cancer (NSCLC). A decision from the FDA is anticipated by the fourth quarter of 2026.
- As of December 31, 2025, the company reported a preliminary unaudited balance of approximately $710 million in cash, cash equivalents, and short-term investments, with no debt.
- The company announced a clinical trial collaboration with GSK to evaluate ivonescimab in combination with GSK's B7-H3 antibody drug conjugate (ADC), risvutatug rezetecan, across multiple solid tumor settings, with clinical trials expected to begin in mid-2026.
Jan 12, 2026, 12:43 PM
Summit Therapeutics Reviews 2025 Accomplishments and Future Strategy for Ivonescimab
SMMT
New Projects/Investments
Product Launch
Guidance Update
- Summit Therapeutics highlighted significant accomplishments in 2025 for ivonescimab, including 14 Phase 3 clinical trials launched globally (4 global, 10 in China) with over 3,000 patients administered ivonescimab in a clinical setting.
- Key readouts in 2025 demonstrated ivonescimab's efficacy, with Harmony 6 showing a strong PFS signal in combination with chemotherapy, and Harmony A achieving statistically significant overall survival.
- The company emphasized the remarkable consistency of data from East to West and across different treatment settings (PFS to OS, monotherapy to chemo combination), reinforcing ivonescimab's broad applicability.
- Summit is expanding ivonescimab's reach beyond non-small cell lung cancer, having opened enrollment in a frontline colorectal cancer study and planning a clinical trial collaboration with Revolution Medicines in early 2026 for RAS inhibitors.
- Management believes ivonescimab holds a first-in-class and best-in-class advantage, with four successful Phase 3 readouts, setting a high bar for competitors.
Dec 3, 2025, 7:10 PM
Summit Therapeutics Discusses Ivonescimab Clinical Development and Future Strategy
SMMT
New Projects/Investments
Product Launch
- Summit Therapeutics' ivonescimab has been administered to over 3,000 patients in clinical settings and over 40,000 patients in the commercial market in China. The company and its partner Akeso have launched 14 Phase 3 clinical trials for ivonescimab, including four global Phase 3s and 10 in China.
- In 2025, ivonescimab demonstrated a strong PFS signal in the Harmony 6 study and a statistically significant overall survival benefit in the Harmony A study. The Harmony 2 study also showed a clinically meaningful early ad hoc look with a hazard ratio of 0.777 for overall survival.
- The company believes ivonescimab is both first-in-class and best-in-class, supported by four successful Phase 3 studies.
- Summit plans to initiate a clinical trial collaboration with Revolution Medicines in early 2026 to explore ivonescimab with multiple RAS inhibitors across various tumor settings.
- The Harmony 3 study is expected to complete enrollment shortly, with readouts anticipated in 2026, including an interim overall survival look in the second half of 2026.
Dec 3, 2025, 7:10 PM
Summit Therapeutics Discusses Ivanesimab Clinical Progress and Future Strategy
SMMT
New Projects/Investments
Revenue Acceleration/Inflection
Product Launch
- Summit Therapeutics highlighted the significant progress of ivonescimab in 2025, including 14 Phase 3 clinical trials (4 global, 10 in China) with over 3,000 patients in clinical settings and over 40,000 patients in the commercial market in China.
- Key clinical trial readouts in 2025 demonstrated strong results, such as a strong PFS signal in the Harmony 6 study and a clinically meaningful overall survival (OS) hazard ratio of 0.777 in an ad hoc look from Harmony 2. The Harmony A study also achieved a statistically significant OS benefit.
- The company is expanding ivonescimab's application beyond lung cancer, with a frontline colorectal cancer study now enrolling patients, and plans for a clinical trial collaboration with Revolution Medicines in early 2026 to explore RAS inhibitors in multiple tumor settings.
- Executive Chairman Robert Duggan stated that the company expects sufficient written data within the next 12 months to demonstrate ivonescimab's value, which could lead to a strategic partnership focused on maintaining control and maximizing wealth.
Dec 3, 2025, 7:10 PM
Summit Therapeutics Provides Update on Ivonescimab Development and Financial Position
SMMT
Product Launch
New Projects/Investments
Guidance Update
- Summit Therapeutics anticipates ending FY 2025 with nearly $700 million in cash and has a proven ability to raise significant capital rapidly, having raised $500 million in 48 hours on two separate occasions.
- By 2025, ivonescimab (Ivo) has achieved four positive Phase 3 clinical trial readouts (HARMONY-A, HARMONY-2, HARMONY-6) in non-small cell lung cancer (NSCLC), demonstrating strong efficacy and a pristine safety profile.
- The company intends to submit its application for ivonescimab in EGFR mutant NSCLC in Q4 2025 and projects potential market entry for frontline squamous NSCLC in 2027.
- Summit is strategically expanding its Phase 3 development program beyond NSCLC, with a frontline colorectal cancer trial currently enrolling and further solid tumor indications planned.
Dec 2, 2025, 3:30 PM
Summit Therapeutics Highlights Strong Clinical Data and Financial Position for Ivonescimab
SMMT
Product Launch
New Projects/Investments
Guidance Update
- Summit Therapeutics has achieved four positive Phase III clinical trial readouts for its oncology drug, ivonescimab (Ivo), demonstrating strong efficacy and a "pristine safety profile" against competitors, with 50,000 patients dosed by Akeso by June.
- The company anticipates ending FY 2025 with nearly $700 million in the bank and has a track record of rapidly securing capital, including two instances of raising $500 million within 48 hours.
- Key upcoming milestones include the planned submission of an application for EGFR in Q4 2025 and the expected completion of enrollment for the HARMONi-3 squamous cohort in H1 2026, with data readout in H2 2026 and potential market entry for frontline squamous lung cancer by 2027.
- Summit is expanding its Phase III program beyond lung cancer, with a frontline colorectal trial underway, and is prioritizing independent development over immediate large pharma partnerships to maintain strategic control and accelerate progress.
Dec 2, 2025, 3:30 PM
Quarterly earnings call transcripts for Summit Therapeutics.
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