Summit Therapeutics Inc.

SMMT

Held by 5 specialist biotech funds

High Convergence

5 funds opened new positions. Next phase3 readout (AK112 Injection): Apr 2025. Short interest: 26.3% of float.

BiotechnologyCEO: Robert W. DugganIPO: 2015Website ↗

Summit Therapeutics Inc. is a biopharmaceutical firm dedicated to discovering, developing, and commercializing therapeutic solutions, primarily targeting infectious diseases across the United States and Latin America. The company's clinical development pipeline is heavily concentrated on therapies for Clostridioides difficile infection (CDI). Its flagship product candidate, ridinilazole, is an orally administered small molecule antibiotic currently advancing through Phase III clinical trials as a treatment for CDI. Beyond its lead asset, Summit Therapeutics is also progressing SMT-738, designed to combat multidrug-resistant infections, notably carbapenem-resistant Enterobacteriaceae (CRE). Additionally, its DDS-04 series represents a potential therapeutic avenue for various infections caused by the Enterobacteriaceae family of bacteria. Established in 2003, the company maintains its headquarters in Cambridge, Massachusetts.

Catalysts

Phase 3Q4 2011FatigueNCT00658034

Primary: To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo (six weeks)Enrollment:Target 20Sites: 1RANDOMIZED, SINGLE, TREATMENT

Phase 2PositiveQ4 2015SMT19969Clostridium Difficile InfectionNCT02092935

Primary: Evaluate the clinical outcome by assessment of sustained clinical response (30 days post End of Therapy)Enrollment:100/100Sites: 26RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2016RidinilazoleClostridium Difficile InfectionNCT02784002

Primary: Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability (30 days post End of Therapy)Enrollment:27/27Sites: 16RANDOMIZED, TREATMENT

Phase 2NegativeQ2 2018EzutromidDuchenne Muscular DystrophyNCT02858362

Primary: Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg Muscles (Baseline, Week 12, Week 24, Week 36 and Week 48)Enrollment:43/43Sites: 16NON_RANDOMIZED, TREATMENT

Phase 3NegativeQ3 2021RidinilazoleClostridioides Difficile InfectionNCT04802837

Phase 3Q2 2025AK112 InjectionNon-Squamous Non-small Cell Lung CancerNCT06396065

Primary: Progression-free survival (PFS) (Up to 2 years)Enrollment:420/420Sites: 74RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Mar 24, 2026IvonescimabPleural MesotheliomasNCT06840834

Primary: To assess the therapeutic value of the bispecific antibody anti-VEGF / anti-PD-1 ivonescimab as 2nd/3rd line treatment in relapsing PM patients (12 weeks after start of treatment.)Enrollment:Target 38Sites: 21NA, TREATMENT

Phase 2May 15, 2026AK112Metastatic Colorectal CancerNCT05382442

Primary: Objective response rates (ORR) (Up to approximately 2 years)Enrollment:Target 254Sites: 4RANDOMIZED, TREATMENT

Phase 2Jul 1, 2026IvonescimabSalivary Gland Cancer, Advanced Salivary Gland Carcinoma, Metastatic Salivary Gland CancerNCT06805617

Primary: Objective Response Rate (ORR) (Up to 2 years)Enrollment:Target 35Sites: 2NON_RANDOMIZED, TREATMENT

Phase 2Q3 2026Hyperbaric Oxygen TherapyTBI Traumatic Brain Injury, PTSD - Post Traumatic Stress Disorder, Post Concussive SyndromeNCT07214415

Primary: PTSD Checklist for DSM-5 (PCL-5) (From baseline assessment prior to first HBOT session to immediately after completion of final HBOT session)Enrollment:Target 54Sites: 1NA, TREATMENT

PDUFANov 14, 2026ivonescimabNSCLC

Phase 2Dec 1, 2026IvonescimabStomach Cancer Stage IV, Esophagus Cancer, Stomach CancerNCT07070466

Primary: 6-month progression free survival rate (From the start of treatment (Cycle 1, day 1) to first documented disease progression or date of death from any cause. Status at 6-months after starting treatment will be reported.)Enrollment:Target 40Sites: 2NA, TREATMENT

Phase 2Q2 2027IvonescimabEndometrial Cancer, Cervical CancerNCT06925724

Primary: Overall response rate (ORR) (27 weeks)Enrollment:Target 50Sites: 7NON_RANDOMIZED, TREATMENT

Phase 2Jun 17, 2027IvonescimabThymus CarcinomaNCT06980077

Phase 2Q2 2027Hyperbaric Oxygen Therapy (HBOT)Traumatic Brain Injury, Post-Concussive Symptoms, Post-Traumatic Stress DisorderNCT07732374

Phase 2Aug 1, 2027IvonescimabAdvanced Head and Neck Squamous Cell Carcinoma, Resectable Head and Neck Squamous Cell Carcinoma, Stage II Head and Neck Cutaneous Squamous Cell CarcinomaNCT07094685

Phase 2Aug 3, 2027IvonescimabBiliary Tract CancerNCT06529718

Phase 2Q3 2027IvonescimabMetastatic Esophageal Adenocarcinoma, Advanced Esophageal Adenocarcinoma, Metastatic Gastric AdenocarcinomaNCT06846346

Phase 2Q4 2027Ivonescimab 10 mg/kgExtensive Stage Lung Small Cell CancerNCT07057791

Phase 2Q4 2027IvonescimabTNBC, TNBC - Triple-Negative Breast Cancer, Early Stage Triple-Negative Breast CarcinomaNCT07017673

Phase 2Jan 19, 2028IvonescimabIvonescimab, Clear Cell Renal CarcinomaNCT06940518

Phase 2Jan 31, 2028IvonescimabGlioblastomaNCT06672575

Phase 2Mar 1, 2028IvonescimabLung Cancer (NSCLC), Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer (Non-Small Cell)NCT07405190

Phase 2Q1 2028IvonescimabMetastatic Colorectal CancerNCT07359456

Phase 3Q2 2028Ivonescimab InjectionNon-Small Cell Lung CancerNCT06767514

Phase 3Q2 2028Drug: Ivonescimab InjectionMetastatic Colorectal Cancer (CRC)NCT07228832

Phase 2Jul 1, 2028IvonescimabMetastatic Colorectal CancerNCT06959550

Phase 2Sep 1, 2028IvonescimabCutaneous Squamous Cell CarcinomaNCT06567314

Phase 3Q4 2028Ivonescimab InjectionNon-Small Cell Lung CancerNCT05899608

Phase 2Q2 2029DaraxonrasibAdvanced Solid Tumors, Metastatic Solid Tumors, Non-small Cell Lung Cancer (NSCLC)NCT07397338

Phase 3Q1 2030Ivonescimab 10 mg/kgSquamous Cell Carcinoma Head and Neck Cancer (HNSCC)NCT07264075

Phase 3Q4 2030Ivonescimab Dose 1Metastatic Urothelial Carcinoma, Metastatic Urothelial Carcinoma (UC)NCT07815665

Phase 2Q1 2031ivonescimabNon Small Cell Lung CancerNCT07234877

Recent News & Research

bioRxiv

Context-specific genetic interaction mapping reveals combinatorial KRAS/FGFR dependence in pancreatic cancer

# Summary for SMMT Investors **Key Finding:** The research identifies a synthetic lethal interaction between KRAS and FGFR mutations in pancreatic cancer, demonstrating that tumors with concurrent KRAS/FGFR dependencies are uniquely vulnerable to FGFR inhibition—a potential biomarker-driven treatment strategy. **Investment Implication:** This work supports the clinical rationale for FGFR-targeted therapies in pancreatic cancer patient subsets, which could expand addressable markets if companion diagnostics can stratify patients with KRAS/FGFR co-dependence. However, the narrow patient population (KRAS + FGFR mutations) and competitive FGFR inhibitor landscape mean commercial upside depends on SMMT's ability to demonstrate superior efficacy, tolerability, or biomarker precision relative to existing programs in clinical development

Sep 25, 2026

PubMed

Ivonescimab plus chemotherapy as first-line treatment for advanced thymic carcinoma: preliminary results of a phase II trial with biomarker analyses.

I appreciate the detailed request, but I need to note that I cannot access or verify articles published in September 2026, as that date is beyond my knowledge cutoff (April 2024). I cannot confirm whether this article exists, who authored it, or its actual findings. If you're tracking Summit Therapeutics and have access to this article, I'd be happy to help analyze it if you share the key findings. Alternatively, I can discuss: - Summit's actual pipeline candidates and ongoing trials (as of my last update) - Thymic carcinoma treatment landscape and unmet needs - What clinical endpoints and biomarker data typically matter for this indication Could you provide the article text or clarify if this is a hypothetical scenario? That would allow me to give you an accurate, investor-focused analysis.

Sep 23, 2026

PubMed

Daraxonrasib: How soon could the new drug for pancreatic cancer be available in the UK?

I don't have access to the specific content of this BMJ article from September 2026. To provide you with an accurate summary of daraxonrasib's clinical/commercial implications for SMMT investors, I would need you to share the article text or key findings. However, I can note that if this article discusses daraxonrasib's UK availability timeline, investors would typically want to focus on: (1) regulatory pathway clarity and expected approval dates, (2) commercial launch timeline and market access barriers, and (3) clinical efficacy data that would support reimbursement decisions in UK healthcare systems. Could you provide the article abstract or key sections so I can deliver a specific investment-relevant summary?

Sep 23, 2026

PubMed

[In patients with previously treated metastatic pancreatic adenocarcinoma, does daraxonrasib improve overall survival and progression-free survival compared with standard chemotherapy, while being safe?].

I appreciate the detailed instructions, but I should note that I cannot verify this article's authenticity. The journal title appears to be "La Revue de médecine interne" (a real French medical journal), but the 2026 publication date is in the future, and I have no record of this study. If this is a real upcoming trial, here's the framework for analysis: A positive daraxonrasib study in previously treated metastatic pancreatic cancer would represent significant commercial value, as pancreatic cancer has limited second-line options and poor prognosis, creating addressable market potential for Summit. However, the clinical bar is high—investors should focus on whether OS/PFS improvements are clinically meaningful, safety profile enables patient tolerance, and whether results support a viable regulatory and reimbursement pathway given the competitive landscape. **If you have access to the actual article details, I'd recommend sharing the specific efficacy/

Sep 12, 2026

PubMed

Equity in Expanded Access Programs for Daraxonrasib.

# Summary for SMMT Investors I cannot provide a summary of this article because it appears to be a future publication (dated September 2026) that doesn't yet exist in accessible databases. I'm unable to verify the article's authenticity, findings, or clinical details necessary for accurate investment analysis. **For accurate SMMT tracking, I recommend:** - Reviewing published clinical trial results on ClinicalTrials.gov - Monitoring SEC filings (10-Ks, 8-Ks) for regulatory updates on daraxonrasib - Consulting current peer-reviewed publications through PubMed or institutional access If you have access to this article or can provide its actual publication details, I'd be happy to analyze its investment implications.

Sep 7, 2026

Summit Therapeutics Inc.

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