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Summit Therapeutics Inc. (Nasdaq: SMMT) today noted that its partner Akeso Inc. announced positive results from the Phase III HARMONi-GI1 study evaluating the n

Research Will Use Lunit's AI-powered Pathology Platform to Analyze H&E Whole-Slide Images and Generate Scalable Insights into Tumor Microenvironment Biology

, /PRNewswire/ -- Lunit Inc. (KRX: 328130) and Summit Therapeutics Inc. (NASDAQ: SMMT) today announced a research agreement to evaluate the use of Lunit SCOPE IO, Lunit's AI-powered pathology platform, for tumor microenvironment analysis in support of Summit's immuno-oncology development programs with ivonescimab.

Lunit and Summit Therapeutics The effort will focus on applying Lunit SCOPE IO to hematoxylin and eosin-stained (H&E) whole-slide images to characterize tumor microenvironment features. The companies aim to explore how AI-powered pathology analysis can support biomarker discovery, patient stratification or selection, and a deeper biological understanding of response to ivonescimab therapies.

Summit is developing ivonescimab, a novel, potential first-in-class investigational PD-1 / VEGF bispecific antibody, in several solid tumors. Lunit SCOPE IO is designed to support immuno-oncology research and biomarker development through AI-powered analysis of H&E slides, enabling scalable assessment of tumor microenvironment features without requiring additional stains or assays.

"Understanding the tumor microenvironment is increasingly important as immuno-oncology moves beyond single-axis checkpoint inhibition toward more complex mechanisms and combinations," said Allen Yang, MD, PhD, Chief Research and Development Strategy Officer of Summit. "We are pleased to work with Lunit to explore how AI-powered pathology can help generate deeper, more scalable insights from routine tissue samples and inform the continued development of ivonescimab."

"Summit is at the forefront of next-generation immuno-oncology development, and we are excited to support its efforts with Lunit SCOPE IO," said Brandon Suh, Lunit CEO. "By extracting quantitative, spatially resolved immune and tumor microenvironment features from standard H&E slides, we believe SCOPE IO can help biopharma partners better understand which patients may benefit from immuno-oncology therapies and why."

This agreement reflects the growing importance of computational pathology in oncology drug development. Routine H&E slides contain rich information about tumor architecture, immune infiltration, stromal organization, and spatial interactions within the tumor microenvironment. However, traditional manual assessment can be difficult to scale and may not fully capture the quantitative and spatial complexity of the tumor-immune interface. AI-powered analysis offers the potential to convert these routinely generated pathology images into reproducible, high-dimensional biomarker data.

The companies expect the work to generate tumor microenvironment insights that may inform future translational research, exploratory biomarker strategies, and clinical development planning. No clinical outcome data are being announced as part of this release.

 *Lunit SCOPE products are for research use only. Not for use in diagnostic procedures or decisions.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit's license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit's license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab's specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of ivonescimab's design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was invented by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 5,000 patients have been treated with ivonescimab in clinical studies globally and over 100,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 17 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, two of which are studies sponsored by cooperative groups, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC (HARMONi, HARMONi-3, HARMONi-7) and expanded its sponsored Phase III clinical development program into colorectal cancer (CRC; HARMONi-GI3) and urothelial carcinoma (bladder cancer; HARMONi-GU1). The two cooperative studies are in head and neck squamous cell carcinoma (HNSCC; ILLUMINE) and biliary tract cancer (BTC; EA2251).

Five Phase III ivonescimab clinical trials have read out to date, all five with positive data. Four of these five studies are in NSCLC and one is in BTC. In addition to Summit's positive HARMONi study in NSCLC, Akeso has had positive read-outs in four single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, HARMONi-6 (each in NSCLC), and HARMONi-GI1 (in BTC) for ivonescimab, including a statistically significant overall survival benefit in all four studies from China.

Akeso is actively conducting additional Phase III clinical studies in settings outside of NSCLC and biliary-tract cancer, including triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit's license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

About Lunit

Founded in 2013, Lunit (KRX: 328130) is a global leader on a mission to conquer cancer through AI. Our clinically validated solutions span medical imaging, breast health, and biomarker analysis, empowering earlier detection, smarter treatment decisions, and more precise outcomes across the cancer care continuum.

Lunit offers a comprehensive suite spanning risk prediction and early detection to precision oncology. Our FDA-cleared Lunit INSIGHT Breast Suite and breast health solutions support cancer screening in thousands of medical institutions worldwide, while the Lunit SCOPE platform is used in research partnership with global pharma and laboratory leaders for biomarker research, and companion diagnostic development.

Trusted by over 10,000 sites in more than 65 countries, Lunit combines deep medical expertise with continuously evolving datasets to deliver measurable impact for patients, clinicians, and researchers alike. Headquartered in Seoul with global offices, Lunit is driving the worldwide fight against cancer. Learn more at lunit.io.

About Summit Therapeutics Inc.

Summit Therapeutics Inc. is a biopharmaceutical oncology 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.

Summit was founded in 2003 and the company's shares are listed on the Nasdaq Global Market (symbol "SMMT"). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK.

For more information, please visit https://www.smmttx.com and follow Summit on X @SMMT_TX.

Lunit Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the expected benefits of the collaboration, the potential use of AI-powered pathology in immuno-oncology development, and the potential application of tumor microenvironment analysis in biomarker research and clinical development. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Neither company undertakes any obligation to update these forward-looking statements, except as required by law.

Summit Forward-Looking Statements

Any statements in this press release about the Company's future expectations, plans and prospects, including but not limited to, statements about dilution to existing stockholders and potential adverse effects on the market price of the Company's common stock, including from future sales by AstraZeneca, the Company's broad discretion over the use of proceeds, and the possibility that the proceeds will not be sufficient to fund operations as long as anticipated, AstraZeneca's ownership and contractual rights, including Third Party acquisition participation, and registration rights, and potential conflicts of interest, the completion of the Private Placement does not depend on the parties entering into a definitive collaboration agreement, the Company's reliance on AstraZeneca for the supply of AstraZeneca's products and other contributions to the clinical trials, the clinical and preclinical development of the Company's product candidates, entry into and actions related to the Company's partnership with Akeso Inc. and other collaborations, the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company's product candidates, the potential commercialization of the Company's product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program ("ATM Program"), the expected proceeds and uses thereof, the Company's estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company's ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company's pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a "positive study" as a clinical study with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing the Company's views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

SOURCE Lunit Inc.

Key Takeaways Summit is testing ivonescimab plus chemotherapy as a first-line treatment for advanced biliary tract cancer.The phase II/III EA2251 study will compare overall survival against Keytruda and Imfinzi plus chemotherapy.The HARMONi-GI1 study showed significant survival benefit for ivonescimab plus chemotherapy versus Imfinzi.
Summit Therapeutics (SMMT - Free Report) is expanding the clinical development of its lead investigational drug, ivonescimab, beyond lung cancer into biliary tract cancer (BTC), a rare and aggressive group of gastrointestinal cancers. The company has announced a clinical trial collaboration with the ECOG-ACRIN Cancer Research Group to evaluate ivonescimab in combination with chemotherapy as a first-line treatment for patients with advanced BTC in the United States.

The registration-enabling phase II/III EA2251 study will compare ivonescimab plus chemotherapy with two established treatment regimens: Merck’s (MRK - Free Report) Keytruda (pembrolizumab) plus chemotherapy and AstraZeneca’s (AZN - Free Report) Imfinzi (durvalumab) plus chemotherapy. The open-label study will randomly assign participants to one of these three treatment groups. Overall survival (OS), which measures how long patients live after treatment begins, will be the study’s primary endpoint.

Merck’s Keytruda and AstraZeneca’s Imfinzi are FDA-approved immunotherapies for multiple cancers, including lung cancer and BTC, with additional indications varying by drug.

Through this study, Summit aims to determine whether ivonescimab combined with chemotherapy can improve survival in first-line BTC patients compared with existing immunotherapy-based treatments. Clinical trial site activation is expected to begin in the fourth quarter of 2026.

Year to date, shares of SMMT have declined 9.5% compared with the industry’s 2.2% fall.

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The EA2251 study marks the second phase III study evaluating ivonescimab in BTC, following HARMONi-GI1, sponsored by Summit’s Chinese partner, Akeso. In August 2026, the HARMONi-GI1 study met its primary endpoint at a prespecified interim analysis. Ivonescimab combined with chemotherapy demonstrated a statistically significant and clinically meaningful OS benefit compared with AstraZeneca’s Imfinzi plus chemotherapy in patients receiving first-line treatment for BTC.

Detailed results from the HARMONi-GI1 study are scheduled to be presented at a medical conference later this week. These findings could provide further insight into ivonescimab’s potential as a treatment for advanced BTC.

Summit Expands Ivonescimab Into Other CancersSummit’s study in BTC represents another step in the company’s efforts to expand ivonescimab beyond lung cancer into additional tumor types with significant unmet medical needs.

Summit is expanding ivonescimab beyond lung cancer into other solid tumors, including biliary tract, colorectal, bladder, breast and kidney cancer. Its phase III HARMONi-GI3 study is testing ivonescimab plus chemotherapy in metastatic colorectal cancer, while HARMONi-GU1 is evaluating it with Pfizer’s/Astellas’ Padcev in advanced bladder cancer. Partnerships with AstraZeneca, Daiichi Sankyo, Arcus Biosciences and GSK will further advance the drug’s evaluation across different cancer types.

Meanwhile, Summit continues to prioritize lung cancer as its most immediate path to U.S. commercialization. The FDA is reviewing ivonescimab plus chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed following EGFR-TKI treatment, with a decision expected by Nov. 14, 2026.

SMMT’s Zacks Rank Summit currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Key Takeaways Summit advances ivonescimab into phase III testing for first-line metastatic colorectal cancer.Summit launches a global phase II/III study combining ivonescimab with Padcev for advanced bladder cancer.Partnerships with AZN, GSK and Arcus expand combination trials, while AZN commits $2 billion to Summit. Summit Therapeutics (SMMT - Free Report) is working to expand ivonescimab’s growth potential beyond non-small cell lung cancer (NSCLC), its lead development area. The company is advancing the investigational drug across several other cancer types, including colorectal and bladder cancer, to broaden its potential applications.

Alongside its internal development efforts, Summit is also collaborating with established pharmaceutical companies, including AstraZeneca (AZN - Free Report) , GSK plc (GSK - Free Report) and Arcus Biosciences (RCUS - Free Report) , to evaluate ivonescimab in combination with other investigational and marketed cancer therapies.

Summit Advances Ivonescimab Into New Cancer IndicationsColorectal cancer is one of Summit’s most important internal development opportunities beyond lung cancer. In May 2026, a phase II study co-sponsored by Akeso, Summit’s China-based partner, showed promising results for ivonescimab combined with chemotherapy in previously untreated patients with unresectable metastatic colorectal cancer (mCRC).

Building on these findings, Summit is conducting the global phase III HARMONi-GI3 study, which compares ivonescimab plus chemotherapy with bevacizumab plus chemotherapy as a first-line treatment for unresectable mCRC. The study marks Summit’s first clinical program outside NSCLC to advance to phase III, representing an important step in the company’s efforts to expand ivonescimab’s development into additional tumor types.

Summit is also expanding ivonescimab’s development into urothelial carcinoma, the most common type of bladder cancer. The company recently initiated the global phase II/III HARMONi-GU1 study to evaluate ivonescimab in combination with Astellas Pharma and Pfizer’s Padcev (enfortumab vedotin) against Merck’s Keytruda (pembrolizumab) plus Padcev as a first-line treatment for advanced urothelial carcinoma.

The study will directly compare the investigational combination with an established treatment regimen. This approach could help determine whether adding ivonescimab’s dual-targeting mechanism provides additional clinical benefits in a competitive cancer treatment market.

SMMT's Partnerships Boost Ivonescimab’s Growth PotentialBeyond its internal clinical programs, Summit is using strategic collaborations to explore ivonescimab across a wider range of solid tumors.

Earlier this month, Summit's pipeline expansion received a boost from its strategic collaboration with AstraZeneca and Daiichi Sankyo. The companies plan to evaluate ivonescimabin combination with Datroway (datopotamab deruxtecan), a TROP2-targeted antibody-drug conjugate (ADC), across multiple solid tumors, including breast and lung cancers.The collaboration is expected to begin with a phase III study in first-line triple-negative breast cancer (TNBC), an aggressive form of breast cancer with significant treatment challenges.

The agreement builds on Summit’s broader collaboration with AstraZeneca announced last month to evaluate ivonescimab alongside sonesitatug vedotin (Sone-Ve), AstraZeneca’s investigational cancer therapy, in gastrointestinal cancers. As part of the broader agreement, AstraZeneca also committed to a $2 billion investment in Summit, providing substantial financial support for the company’s development strategy.

Earlier this year, Summit also partnered with Arcus Biosciences to evaluate ivonescimab with casdatifan for advanced kidney cancer, with initial data expected by mid-2027. Summit also partnered with GSK to assess ivonescimab in combination with its investigational B7-H3-targeted ADC, risvutatug rezetecan, across multiple solid tumors.

These partnerships provide opportunities to combine ivonescimab with other promising cancer medicines while sharing development responsibilities and costs.

The collaboration reflects Summit’s broader strategy of combining ivonescimab with therapies that target different cancer-related pathways. Such combinations could potentially improve treatment outcomes, although their clinical value will need to be established through studies.

Summit Maintains Its Focus on Lung CancerBesides expanding into other tumor types, Summit continues to prioritize lung cancer, which represents its most immediate potential path to commercialization in the United States. The FDA is currently reviewing an application seeking approval for ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed following EGFR-TKI treatment. A final decision is expected by Nov. 14, 2026.

A potential approval could give Summit its first commercial opportunity in the United States and establish an important foundation for the drug’s further development in lung cancer.

MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced a clinical trial collaboration with the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) to evaluate ivonescimab, a novel, potential first-in-class investigational bispecific antibody, in a registration-enabling Phase II/III study in biliary tract cancer (BTC). The new study, EA2251 (NCT07765433), is designed to evaluate the safety and efficacy of ivonescimab with chemotherapy compared to pembrolizumab or durvalumab plus chemotherapy in the first-line treatment of patients with advanced BTC.

“Biliary tract cancer is often diagnosed at an advanced stage, and despite recent progress, there is a need for more effective first-line options that can extend survival and improve disease control,” said lead investigator Deirdre J. Cohen, MD, MS, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, Director of the Gastrointestinal Oncology Program for the Mount Sinai Health System and Co-Director of the Center of Excellence for Pancreatic Cancer at the Mount Sinai Tisch Cancer Center. “EA2251 will explore a novel therapeutic approach in the front-line setting by evaluating ivonescimab with chemotherapy against current immunotherapy-based standards of care.”

The open-label Phase II/III EA2251 study plans to enroll patients in the U.S. who will be randomized to receive ivonescimab in combination with gemcitabine and cisplatin, or pembrolizumab or durvalumab in combination with gemcitabine and cisplatin as the established standard-of-care comparator regimen. The primary endpoint for the study is overall survival (OS). Activation of clinical trial sites is expected to begin in the fourth quarter of 2026.

“We are honored to collaborate with ECOG-ACRIN on EA2251 as we continue to expand the development program for ivonescimab in areas of meaningful unmet need,” said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. “The sponsorship and conduct of this registration-enabling study by a leading cooperative oncology group underscores the scientific interest in evaluating ivonescimab in difficult-to-treat cancers, including BTC, and supports Summit’s commitment to building a robust body of clinical evidence across multiple tumor types and treatment settings.”

For additional information on EA2251, please see ECOG-ACRIN’s accompanying press release.

EA2251 is the second Phase III study of ivonescimab in BTC; the first is HARMONi-GI1. In August 2026, Akeso Inc. announced the randomized Phase III HARMONi-GI1 study (AK112-309) evaluating ivonescimab plus chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with BTC achieved statistically significant and clinically meaningful superiority in the primary endpoint of OS compared to the durvalumab-based regimen at a pre-specified interim analysis.

Detailed results from HARMONi-GI1 will be presented at the European Society for Medical Oncology 2026 Congress (ESMO 2026) on Sunday, October 25, during the Presidential Symposium from 4:30pm – 6:15pm CET (11:30am – 1:15pm EDT). HARMONi-GI1 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.

About Biliary Tract Cancer

Biliary tract cancer (BTC) is a rare and aggressive group of gastrointestinal (GI) cancers that includes intrahepatic, perihilar, and distal cholangiocarcinoma as well as gallbladder cancer.1 Because BTC often develops with few clear early symptoms, approximately 30% to 50% of patients are diagnosed after the disease has spread, when curative surgery is often no longer an option.2 Prognosis remains poor, with five-year survival rates estimated to be less than 5% for patients diagnosed with distant-stage BTCs.3,4 Despite recent progress in the treatment of advanced BTC, there remains a significant need for additional therapeutic approaches that can improve outcomes for patients facing this difficult-to-treat disease.5

About ECOG-ACRIN

The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is one of the world’s leading scientific organizations, known for innovative multicenter clinical trials involving adults with cancer or at risk of developing it. Its expansive membership network includes over 1,400 hospitals and cancer centers across the United States and around the world, involving nearly 21,000 research professionals and advocates. To learn more, visit www.ecog-acrin.org and follow ECOG-ACRIN on X, Facebook, LinkedIn, YouTube, Instagram, and BlueSky, or call 215-789-3631.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of ivonescimab’s design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was invented by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 5,000 patients have been treated with ivonescimab in clinical studies globally and over 100,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 17 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, two of which are studies sponsored by cooperative groups, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026.

HARMONi is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the Prescription Drug User Fee Act (PDUFA) goal date is November 14, 2026.

HARMONi-3 is a Phase III clinical trial evaluating ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non-squamous NSCLC, irrespective of PD-L1 expression. The clinical trial is evaluating the two histologies as individual, separately powered cohorts with independent statistical powering.

HARMONi-7 is a Phase III clinical trial evaluating ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC.

HARMONi-GU1 is a Phase II/III clinical trial evaluating ivonescimab plus the antibody drug conjugate (ADC) enfortumab vedotin (EV) compared to pembrolizumab plus EV as first-line therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).

ILLUMINE (GORTEC 2024-04) is a Phase III study being conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial designed to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC.

EA2251 is a Phase II/III study being conducted by the ECOG-ACRIN Cancer Research Group, an expansive membership-based scientific organization known for advancing precision oncology through its leadership of major national clinical trials. The randomized, open-label study is designed to evaluate the safety and efficacy of ivonescimab with chemotherapy compared to pembrolizumab or durvalumab plus chemotherapy in the first-line treatment of patients with advanced biliary tract cancer (BTC).

Five Phase III ivonescimab clinical trials have read out to date, all five with positive data. Four of these five studies are in NSCLC and one is in BTC. In addition to Summit’s positive HARMONi study, Akeso has had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in both the HARMONi-A and HARMONi-6 studies. Akeso has also reported a positive read-out (statistically significant OS) in the single-region (China), randomized Phase III HARMONi-GI1 trial in advanced BTC.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression.

HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.

HARMONi-GI1 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced BTC.

Akeso is actively conducting additional Phase III clinical studies in settings outside of NSCLC and biliary-tract cancer, including triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

About Summit Therapeutics Inc.

Summit Therapeutics Inc. is a biopharmaceutical oncology 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.

Summit was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol "SMMT"). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK.

For more information, please visit https://www.smmttx.com and follow Summit on X @SMMT_TX.

Summit Forward-Looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the risk that the private placement does not close on the anticipated timeline or at all, including because required regulatory clearances are not obtained or other closing conditions are not satisfied, dilution to existing stockholders, and potential adverse effects on the market price of the Company's common stock, including from future sales by AstraZeneca, the Company's broad discretion over the use of proceeds, and the possibility that the proceeds will not be sufficient to fund operations as long as anticipated, AstraZeneca’s ownership and contractual rights, including Third Party acquisition participation, and registration rights, and potential conflicts of interest, the completion of the Private Placement does not depend on the parties entering into a definitive collaboration agreement, the Company's reliance on AstraZeneca for the supply of AstraZeneca’s products and other contributions to the clinical trials, the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc. and other collaborations, the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

References
1. Valle JW, Kelley RK, Nervi B, Oh DY, Zhu AX. Biliary tract cancer. Lancet. 2021;397(10272):428-444.
2. Jiang Y, Jiang L, Li F, Li Q, Yuan S, Huang S, et al. The epidemiological trends of biliary tract cancers in the United States of America. BMC Gastroenterol. 2022;22(1):546. doi:10.1186/s12876-022-02637-8.
3. American Cancer Society. Survival rates for bile duct cancer. Accessed October 12, 2026.
4. American Cancer Society. Survival rates for gallbladder cancer. Accessed October 12, 2026.
5. Wang L, Singhal M, Valderrama A, Nepal B, Kamble S, Eluri M, et al. Real-world treatment patterns, resource utilization and costs in biliary tract cancers in the USA. Future Oncol. 2024;20(34):2625-2636. doi:10.1080/14796694.2024.2379237.

Summit Therapeutics and the Summit Therapeutics logo are registered trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved.

More News From Summit Therapeutics

MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced the successful closing of AstraZeneca's (LSE/STO/NYSE: AZN) strategic equity investment in Summit. The equity investment will support continued acceleration of the development of ivonescimab, a novel, potential first-in-class investigational PD-1 / VEGF bispecific antibody. Pursuant to the terms of the Securities Purchase Agreement entered into by Summit and AstraZeneca, AstraZeneca purchased an aggregate of approxi.

MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (Nasdaq: SMMT) today announced a clinical trial collaboration agreement with Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/NYSE: AZN) to evaluate ivonescimab, a novel, potential first-in-class investigational PD-1 / VEGF bispecific antibody, in combination with Datroway® (datopotamab deruxtecan), a TROP2-directed antibody drug conjugate (ADC), across multiple solid tumor settings, intending to include breast and lung cancer. The companies i.

Summit Therapeutics PLC (NASDAQ:SMMT – Get Free Report)’s stock price gapped up prior to trading on Tuesday. The stock had previously closed at $15.48, but opened at $18.91. Summit Therapeutics shares last traded at $16.3970, with a volume of 10,558,930 shares traded.

Key Summit Therapeutics News Here are the key news stories impacting Summit Therapeutics this week:

Positive Sentiment: AstraZeneca’s investment validates Summit and provides substantial funding. AstraZeneca will invest $2 billion for an approximately 12% stake in Summit and collaborate on multiple clinical studies involving ivonescimab. The investment gives Summit additional resources to advance development while bringing validation from a major global pharmaceutical company. AstraZeneca’s $2 Billion Vote of Confidence Leaves Summit Therapeutics Trading Well Below Street Targets Positive Sentiment: Analysts characterized the transaction as a “win-win.” UBS said the partnership could benefit both companies by supporting ivonescimab’s development and potentially broadening its commercial opportunity. The strategic collaboration also helped drive a sharp rally in Summit shares after the announcement. AstraZeneca’s $2 Billion Investment in Summit Therapeutics Seen as ‘Win-Win,’ UBS Says Positive Sentiment: The deal substantially exceeds Summit’s recent market valuation. Commentary noted that AstraZeneca agreed to a valuation that the public market had not been matching, suggesting potential upside if ivonescimab’s clinical results support the partnership’s expectations. Summit Shares Jump on $2B Strategic Investment From AstraZeneca Neutral Sentiment: Clinical execution remains the key near-term issue. Two clinical milestones expected in 2026 are likely to determine whether Summit’s valuation converges toward analyst targets or remains pressured. Positive trial data could further support the AstraZeneca deal, while disappointing results would weaken the investment thesis. AstraZeneca’s $2 Billion Vote of Confidence Leaves Summit Therapeutics Trading Well Below Street Targets Negative Sentiment: The transaction does not eliminate biotechnology risk. Summit remains dependent on successful clinical development and regulatory progress for ivonescimab. The equity investment also introduces some dilution for existing shareholders, while the large valuation implied by AstraZeneca’s purchase could raise expectations ahead of the upcoming data readouts. Analysts Offer Insights on Healthcare Companies Analysts Set New Price Targets Several equities research analysts recently weighed in on SMMT shares. Stifel Nicolaus dropped their price target on Summit Therapeutics from $45.00 to $38.00 and set a “buy” rating on the stock in a research report on Friday, July 24th. Citigroup reiterated a “buy” rating and issued a $43.00 price objective (up from $40.00) on shares of Summit Therapeutics in a report on Friday, September 25th. Morgan Stanley lowered Summit Therapeutics to an “outperform” rating in a research report on Tuesday. Cantor Fitzgerald reissued an “overweight” rating on shares of Summit Therapeutics in a research report on Tuesday, September 22nd. Finally, Leerink Partners upgraded shares of Summit Therapeutics from an “underperform” rating to a “market perform” rating and boosted their target price for the company from $12.00 to $13.00 in a report on Wednesday, August 12th. One research analyst has rated the stock with a Strong Buy rating, nine have assigned a Buy rating, eight have given a Hold rating and one has issued a Sell rating to the company’s stock. According to data from MarketBeat.com, Summit Therapeutics currently has a consensus rating of “Moderate Buy” and a consensus target price of $28.45.

Check Out Our Latest Report on SMMT Summit Therapeutics Price Performance The stock’s 50 day simple moving average is $15.01 and its two-hundred day simple moving average is $16.34. The firm has a market cap of $13.49 billion, a P/E ratio of -15.10 and a beta of -1.24.

Summit Therapeutics (NASDAQ:SMMT – Get Free Report) last issued its quarterly earnings results on Thursday, July 23rd. The company reported ($0.28) EPS for the quarter, missing analysts’ consensus estimates of ($0.27) by ($0.01). Equities research analysts anticipate that Summit Therapeutics PLC will post -1.2 earnings per share for the current year.

Institutional Investors Weigh In On Summit Therapeutics A number of institutional investors have recently modified their holdings of SMMT. Ball & Co Wealth Management Inc. bought a new position in shares of Summit Therapeutics during the first quarter valued at $28,000. Parallel Advisors LLC boosted its stake in Summit Therapeutics by 4,178.0% in the 1st quarter. Parallel Advisors LLC now owns 2,139 shares of the company’s stock worth $41,000 after purchasing an additional 2,089 shares in the last quarter. Fifth Third Bancorp grew its position in Summit Therapeutics by 24.4% during the 1st quarter. Fifth Third Bancorp now owns 3,732 shares of the company’s stock valued at $71,000 after purchasing an additional 732 shares during the last quarter. Osterweis Capital Management Inc. purchased a new stake in Summit Therapeutics during the 2nd quarter valued at about $73,000. Finally, Havemeyer Place LP bought a new stake in Summit Therapeutics during the 4th quarter valued at about $109,000. 4.61% of the stock is owned by hedge funds and other institutional investors.

Summit Therapeutics Company Profile (Get Free Report)

Summit Therapeutics plc is a clinical-stage biopharmaceutical company focused on developing innovative cancer treatments. The company’s lead program is ivonescimab, an investigational bispecific antibody designed to combine immune checkpoint inhibition targeting PD-1 with anti-angiogenic activity targeting VEGF. Summit is evaluating ivonescimab in clinical studies for multiple solid tumors, including non-small cell lung cancer.

Summit obtained exclusive rights from Akeso, Inc to develop and commercialize ivonescimab in markets outside China, including the United States and other international territories.

Further Reading Five stocks we like better than Summit Therapeutics Deutsche Bank Makes a Contrarian Call on Netflix—What Does It Mean for Investors? O’Reilly Automotive’s Stock Slump Hides a Stronger Business McDonald’s Stock Slump Makes Its AI Pricing Bet Even Riskier Broadcom’s AI Growth Story Faces a $161 Billion Anthropic Test Receive News & Ratings for Summit Therapeutics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Summit Therapeutics and related companies with MarketBeat.com's FREE daily email newsletter.

Key Takeaways Summit Therapeutics shares jumped after AstraZeneca agreed to invest $2 billion in the company.The deal will fund ivonescimab development and clinical studies with AstraZeneca's oncology medicines.Summit's cash position could rise sharply as it advances multiple phase III ivonescimab studies. Shares of Summit Therapeutics (SMMT - Free Report) rose 22% in pre-market trading on Tuesday after it announced that AstraZeneca (AZN - Free Report) had agreed to invest $2 billion in the company to accelerate development of its lead pipeline drug, ivonescimab.

The deal is structured as a strategic equity investment, with AstraZeneca purchasing approximately 108,955 shares of preferred stock convertible into shares of Summit’s common stock at a 1:1,000 ratio. At the conversion ratio, the investment represents an effective common-stock price of $18.36 per share, roughly 19% above Summit's closing price on Sept. 28.

Once completed, AstraZeneca will hold rights equivalent to about 12% of Summit's outstanding common stock, or about 10.6% on a fully diluted basis. The transaction is expected to close by the end of the week, subject to customary conditions.

SMMT’s Deal With AZN Extends Beyond Equity StakeThe equity investment is accompanied by two separate clinical-development arrangements between Summit and AstraZeneca, both centered on combining ivonescimab with AstraZeneca's oncology portfolio.

Under the first agreement, the companies will evaluate ivonescimab in combination with AstraZeneca's Claudin 18.2-targeting antibody-drug conjugate (ADC), sonesitatug vedotin (sone-ve), for gastrointestinal cancers. The companies intend to initiate clinical studies of the combination imminently.

The companies have also signed a non-binding memorandum of understanding for a broader global development program that would evaluate ivonescimab in combination with multiple AstraZeneca cancer medicines, including additional ADCs.

Importantly, the arrangements are non-exclusive, with each company retaining its existing development and commercial rights to its respective molecule. For the combination studies, the companies will contribute their respective medicines and jointly share the costs of clinical development.

SMMT’s Stock PerformanceYear to date, the company’s shares have lost about 12% compared with the industry’s 4% decline.

Image Source: Zacks Investment Research

Deal Gives Summit More Financial FlexibilityThe $2 billion investment should significantly strengthen Summit's balance sheet as it expands the development of ivonescimab. The company had about $691 million in cash and short-term investments as of June 30, 2026, meaning the AstraZeneca investment is nearly three times its existing liquidity.

The additional funds are expected to give Summit greater flexibility to fund multiple clinical programs and reduce its near-term reliance on the capital markets. The transaction also provides a notable external endorsement of Summit's strategy, although the investment does not eliminate the clinical and regulatory risks associated with ivonescimab. The conversion would not only increase SMMT’s share count but also result in dilution for existing shareholders.

For AstraZeneca, the deal provides an opportunity to test ivonescimab alongside its own oncology portfolio, without acquiring Summit or obtaining exclusive rights to ivonescimab.

Summit’s Progress With IvonescimabIvonescimab is a bispecific antibody designed to simultaneously target PD-1 and VEGF, two pathways that are already established targets in cancer treatment. The drug was originally developed by Akeso, with Summit holding exclusive development and commercialization rights across major markets outside China. Akeso retains the rights to market the drug in China, where it is currently approved to treat multiple non-small cell lung cancer (NSCLC) indications.

An FDA filing is currently under review seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed following EGFR-TKI treatment. A final decision is expected by Nov. 14, 2026.

Summit is pursuing a broad global development program for ivonescimab. It is advancing the drug across multiple phase III studies — HARMONi-3 in first-line metastatic NSCLC, HARMONi-7 in first-line metastatic PD-L1 high (≥50%) NSCLC and HARMONi-GI3 in first-line metastatic colorectal cancer. Last month, the company initiated the phase II/III HARMONi-GU1 study, evaluating ivonescimab plus Pfizer’s (PFE - Free Report) /Astellas’ Padcev as first-line treatment for advanced urothelial or bladder cancer.

SMMT’s Zacks RankSummit currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AstraZeneca Plc (NYSE:AZN) on Tuesday agreed to invest $2 billion in newly issued equity in Summit Therapeutics Inc. (NASDAQ:SMMT) to accelerate the development of ivonescimab in combination with antibody-drug conjugates (ADCs) across tumor types.

In July 2025, media reports circulated related to the potential partnership between the companies worth up to $15 billion.

Clinical Collaboration Expands into Sone-Ve Combination TrialsSummit and AstraZeneca have also entered into a clinical collaboration agreement to evaluate sonesitatug vedotin (Sone-Ve) in combination with ivonescimab.

Sone-Ve is a potential global first-in-class CLDN18.2-targeting ADC with a monomethyl auristatin E (MMAE) payload, with several ongoing trials underway in gastrointestinal cancers.

The companies intend to initiate trials in GI cancers under the collaboration imminently.

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Under the terms of this agreement, each company will contribute its respective medicine for the planned combination trials and jointly contribute to trial costs.

Each company will retain development and commercial rights to its respective medicines.

Ivonescimab Shows Overall Survival AdvantageEarlier in September, Summit Therapeutics’ partner Akeso Inc. revealed overall survival data from the Phase 3 HARMONi-2 trial evaluating ivonescimab against pembrolizumab.

The findings showed that ivonescimab significantly extended survival for first-line patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer.

During its second quarter earnings release, Summit said it continues to evaluate options to finance operating cash needs for product candidates further.

The company said that if it is unable to obtain funding when required in the future, it could be required to delay or reduce research and development programs, product portfolio expansion, or future commercialization efforts.

These conditions raise substantial doubt about the ability to continue as a going concern.

SMMT/AZN Price Action: Summit Therapeutics shares were up 17.57% at $18.20, and AstraZeneca shares were up 0.99% at $167.79 during premarket trading on Tuesday, according to Benzinga Pro data.

Photo courtesy: Shutterstock

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AstraZeneca PLC (LSE:AZN, NASDAQ:AZN), the FTSE 100 pharmaceutical company, will invest $2 billion in Summit Therapeutics Inc as part of a wider cancer drug collaboration.

The investment will give AstraZeneca rights equivalent to about 12% of Summit’s outstanding common stock, or about 10.6% on a fully diluted basis.

The companies will also begin clinical trials combining Summit’s ivonescimab with AstraZeneca’s sonesitatug vedotin in gastrointestinal cancers.

Sonesitatug vedotin is an antibody-drug conjugate (ADC), a treatment designed to carry a cancer-killing drug directly to tumour cells.

Ivonescimab is a bispecific antibody that targets programmed death-1 (PD-1), which helps cancer evade the immune system, and vascular endothelial growth factor (VEGF), which supports tumour blood vessel growth.

AstraZeneca and Summit said trials of the combination are expected to begin imminently, with both companies contributing their medicines and sharing trial costs.

Each company will retain development and commercial rights to its own treatment.

The companies have also signed a memorandum of understanding covering a broader global programme that could combine ivonescimab with other AstraZeneca cancer medicines, including additional ADCs.

AstraZeneca said the collaboration supports its strategy of combining ADCs with newer immunotherapies across several cancer types.

The deal follows positive high-level results from AstraZeneca’s CLARITY-Gastric01 trial of sonesitatug vedotin in previously treated Claudin-18.2-positive advanced gastric cancer.

The company said the trial showed a statistically significant improvement in overall survival compared with the investigator’s choice of treatment.

Ivonescimab is already approved in China for some patients with non-small cell lung cancer and is under review by the US Food and Drug Administration for another form of the disease.

Summit has exclusive rights to develop and commercialise ivonescimab in major markets outside China, while Akeso Inc retains rights in China and other regions.

AstraZeneca expects the equity investment to close within one week, subject to customary regulatory clearances.

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Summit Therapeutics (SMMT.O) said on Monday that British drugmaker AstraZeneca (AZN.L) would invest $2 billion in ​the company and collaborate on a ‌series of studies testing their cancer treatments together.

Summit's shares rose over 15% in extended trading following the ​announcement.

Here are some details:

AstraZeneca will buy ​preferred shares in Summit at an equivalent ⁠price of $18.36 per common share, representing ​an 18.6% premium to Summit's Monday closing price ​of $15.48.

The investment marks a major vote of confidence in ivonescimab, a next-generation cancer treatment licensed by Summit from ​China's Akeso (9926.HK).

Ivonescimab works by simultaneously blocking PD-1, ​which helps cancer evade the immune system, and VEGF, ‌which ⁠tumors use to grow blood vessels, helping the immune system better find and attack cancer cells.

As part of the partnership, the ​two companies will ​also ⁠launch clinical trials combining ivonescimab with AstraZeneca's cancer treatments.

They have also ​signed a preliminary agreement to explore ​testing ⁠ivonescimab with several other AstraZeneca medicines, including its antibody-drug conjugates, a class of treatments that ⁠deliver ​cancer-killing drugs directly to tumor ​cells.

The transaction is expected to close by the end ​of the week.

MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (Nasdaq: SMMT) today noted that data from the Phase III HARMONi-GI1 trial, conducted in China and sponsored by Akeso, Inc., featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab, will be featured as part of the Presidential Symposium II at the European Society for Medical Oncology 2026 Congress (ESMO 2026) which takes place October 23–27, 2026, in Madrid, Spain. The presentation will take place on Sunday, October 25 during the Presidential Symposium from 4:30pm – 6:15pm CET (11:30am – 1:15pm EDT).

The HARMONi-GI1 study is evaluating ivonescimab plus chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC). HARMONi-GI1 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.

On August 25, 2026, Akeso announced topline results from HARMONi-GI1. Akeso reported that, at a pre-specified interim analysis, the ivonescimab-based regimen achieved statistically significant and clinically meaningful superiority in the primary endpoint of overall survival (OS) compared to the durvalumab-based regimen. The study also met the key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR).

About the ESMO 2026 Presidential Symposium Presentation
Presidential Symposium Presentation
Presentation Title: Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double-blinded, phase 3 trial (HARMONi-GI1)
Presenter: Jian Zhou, MD (Shanghai, China)
ESMO Presentation No.: Presidential Symposium II, LBA8
Session Date & Time: Sunday, October 25, 2026, 4:30pm – 6:15pm CET (11:30am – 1:15pm EDT)

In China, ivonescimab is approved and commercially available for indications in non-small cell lung cancer (NSCLC). Ivonescimab remains investigational and is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of ivonescimab’s design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) and increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 5,000 patients have been treated with ivonescimab in clinical studies globally and over 100,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026.

Akeso is actively conducting additional Phase III clinical studies in settings outside of NSCLC and biliary-tract cancer, including triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

About Summit Therapeutics Inc.

Summit Therapeutics Inc. is a biopharmaceutical oncology 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.

Summit was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol "SMMT"). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK.

For more information, please visit https://www.smmttx.com and follow Summit on X @SMMT_TX.

Summit Forward-Looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc. and other collaborations, the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Summit Therapeutics and the Summit Therapeutics logo are registered trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved.

MIAMI--(BUSINESS WIRE)---- $SMMT--Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that its partner Akeso Inc. announced that updated data, including overall survival (OS), from the randomized, double-blind Phase III HARMONi-2 trial featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab is being presented at the International Association for the Study of Lung Cancer's (IASLC) 2026 World Conference on Lung Cancer (WCLC 2026) in Seoul, Republic of Korea. The HARMON.

Key Takeaways Summit Therapeutics rose 17.3% after ivonescimab beat Keytruda on overall survival in phase III PD-L1 NSCLC.Ivonescimab previously showed a PFS benefit in the same NSCLC population across multiple clinical subgroups.SMMT is advancing ivonescimab in phase III studies across NSCLC indication, colorectal and urothelial cancers. Summit Therapeutics (SMMT - Free Report) stock climbed 17.3% on Thursday after its Chinese partner Akeso reported positive overall survival (OS) results for ivonescimab in a head-to-head phase III study against Merck’s (MRK - Free Report) blockbuster oncology drug, Keytruda (pembrolizumab), in certain patients with non-small cell lung cancer (NSCLC). The data provided fresh clinical validation for SMMT’s lead oncology candidate and increased investor focus on the drug’s potential in the United States and other licensed markets.

Summit Therapeutics is developing ivonescimab in collaboration with Akeso. The company acquired an exclusive license from Akeso in 2022 to develop and market the drug in the United States, Canada, Europe and Japan. SMMT later amended this collaboration agreement in June 2024, expanding its licensing deal to cover Latin America (including Mexico and all countries in Central America, South America and the Caribbean), the Middle East and Africa. Akeso retains the rights to market the drug in China, where the drug is approved for three NSCLC indications. Ivonescimab remains investigational in Summit’s licensed territories.

Akeso’s phase III HARMONi-2 study evaluated ivonescimab monotherapy against MRK’s Keytruda monotherapy in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. In the latest preplanned analysis, Akeso reported that ivonescimab monotherapy achieved a statistically significant improvement in OS versus Keytruda monotherapy, meeting a key secondary endpoint of the HARMONi-2 study. The China-based study had previously demonstrated a statistically significant progression-free survival (PFS) benefit, with an HR of 0.51, across multiple clinical subgroups. Additional details are expected at an upcoming medical conference.

The HARMONi-2 result is particularly relevant because Summit Therapeutics is conducting the global Phase III HARMONi-7 study, including sites in the United States, to evaluate ivonescimab monotherapy versus Merck’s Keytruda monotherapy in patients with previously untreated metastatic NSCLC and high PD-L1 expression. The study is designed to assess both PFS and OS and is currently enrolling patients.

Year to date, SMMT shares have lost 2% compared with the industry’s 0.9% decline.

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SMMT’s Progress With IvonescimabSummit Therapeutics is currently pursuing U.S. regulatory approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed after treatment with an EGFR-TKI. The submission is based on positive results from the phase III HARMONi study, which evaluated the combination for this indication. The study met one of its two primary endpoints — PFS. Although the study did not meet the OS endpoint, which the FDA had previously identified as a key requirement for filing, the data showed a favorable trend toward OS. The agency is expected to make a decision by Nov. 14, 2026, potentially providing SMMT with an additional regulatory milestone for the candidate in the United States.

Summit Therapeutics is also advancing ivonescimab across other NSCLC indications while expanding the candidate’s development into additional cancer types. The company is conducting HARMONi-3, a global phase III study evaluating ivonescimab plus chemotherapy against MRK’s Keytruda plus chemotherapy as a first-line treatment for metastatic NSCLC. The study comprises separate squamous and non-squamous patient cohorts. Enrollment in the squamous cohort has been completed, with data expected in the second half of 2026, while results from the non-squamous cohort are anticipated in the first half of 2027.

Summit Therapeutics is also evaluating ivonescimab in HARMONi-GI3, a global phase III study for first-line unresectable metastatic colorectal cancer. The study is comparing ivonescimab plus chemotherapy with bevacizumab plus chemotherapy and represents the company’s first clinical development program for ivonescimab outside NSCLC, broadening the candidate’s potential commercial opportunity.

Summit Therapeutics is further expanding ivonescimab into genitourinary oncology through the phase II/III HARMONi-GU1 study, which was initiated in August 2026. The study is evaluating ivonescimab plus enfortumab vedotin against Merck’s Keytruda plus enfortumab vedotin as a first-line treatment for previously untreated locally advanced or metastatic urothelial carcinoma.

SMMT’s Zacks Rank and Stocks to ConsiderSummit currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 6.7% year to date.

AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.

Over the past 30 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 71.5% year to date.

Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.

Summit Therapeutics is positioned as a high-conviction buy into the November 2026 FDA PDUFA decision for ivonescimab in NSCLC. SMMT's ivonescimab demonstrates robust PFS and statistically significant OS benefits in multiple Phase III trials, supporting best-in-class potential versus PD-1 monotherapy. Financials reflect intentional capital deployment, with $690M+ cash and 4–5 quarters of runway to fund late-stage clinical catalysts and regulatory milestones.

MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced the publication of primary analysis results from the global Phase III HARMONi clinical trial in The Lancet Oncology. In HARMONi, ivonescimab in combination with platinum-doublet chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo plus platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mu.

Summit Therapeutics Inc. (NASDAQ:SMMT) announced that The Lancet Oncology published primary analysis results from its global Phase 3 HARMONi trial.

Significant Progression-Free Survival ImprovementsThe study evaluated ivonescimab combined with platinum-doublet chemotherapy against a placebo and chemotherapy regimen.

This treatment targets patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) who experienced disease progression after using a third-generation EGFR tyrosine kinase inhibitor.

The trial data showed that patients receiving the ivonescimab combination experienced a median progression-free survival (PFS) of 6.8 months, compared to 4.4 months for the placebo group.

This represents a statistically significant improvement with a hazard ratio of 0.52. Independent radiographic reviewers confirmed these findings, noting consistent benefits across preplanned subgroups.

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Manageable Safety Profile And Survival TrendsWhile the primary overall survival (OS) analysis showed a positive trend for the ivonescimab combination, it did not reach statistical significance at that time.

Researchers observed a manageable safety profile, reporting severe treatment-related hemorrhage events in less than 1% of patients.

Following the primary data, the company shared an updated OS analysis based on a June 2026 data cut-off.

This follow-up demonstrated a continued positive OS trend, revealing a 0.76 hazard ratio for Western patients. The efficacy and safety profile remained consistent across both Asian and Western demographics.

Upcoming Presentations And Regulatory MilestonesSummit Therapeutics will present further details from this updated data analysis at the 2026 World Conference on Lung Cancer on September 15.

Meanwhile, the Food and Drug Administration assigned a November 14, 2026, action date for the company’s Biologics License Application.

In August, Summit Therapeutics partner Akeso Inc. noted that China approved ivonescimab in combination with chemotherapy for the first-line treatment of patients with advanced squamous non-small cell lung cancer.

SMMT Price Action: Summit Therapeutics shares were up 4.05% at $13.24 at the time of publication on Tuesday, according to Benzinga Pro data.

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Summit Therapeutics Inc. (NASDAQ:SMMT) partner Akeso Inc. on Wednesday released positive topline findings from its randomized Phase 3 HARMONi-GI1 clinical trial (or AK112-309).

The study evaluated ivonescimab paired with chemotherapy against durvalumab combined with chemotherapy as a first-line therapy for patients diagnosed with advanced biliary tract cancer.

Ivonescimab Demonstrates Superior Survival EndpointA pre-specified interim analysis revealed that the ivonescimab combination achieved statistically significant and clinically meaningful superiority in overall survival over the durvalumab combination.

This primary endpoint result highlights a notable outcome, as durvalumab combined with chemotherapy is currently the preferred first-line immunotherapy regimen recommended by international medical guidelines and recognized as the optimal standard of care.

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Furthermore, the trial met its key secondary endpoints, including progression-free survival and objective response rate.

Akeso plans to share comprehensive safety and efficacy data from this initial readout at an upcoming medical congress and publish the complete findings within a peer-reviewed journal.

First Phase 3 Trial To Beat Gold StandardThe HARMONi-GI1 trial stands as the first Phase 3 study in biliary tract cancer to show a statistically significant positive overall survival outcome against the global gold standard of a PD-L1 monoclonal antibody paired with chemotherapy, marking a major milestone in treating this complex disease.

Akeso sponsored the single-region, multi-center trial in China, exclusively generating, managing, and analyzing all associated data.

Regulatory Status Across Global MarketsIvonescimab is currently approved and commercially available in China for non-small cell lung cancer indications.

The therapeutic agent remains investigational and has not secured approval from regulatory authorities across Summit’s licensed territories, which encompass the U.S. and Europe.

SMMT Price Action: Summit Therapeutics shares were up 7.82% at $14.40 at the time of publication on Wednesday, according to Benzinga Pro data.

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Key Takeaways Summit shares have risen 6.5% after ivonescimab showed superior overall survival in advanced BTC.The HARMONi-GI1 study also met key endpoints for progression-free survival and objective response rate.Positive BTC results strengthen ivonescimab's broader development case across CRC and genitourinary cancer. Shares of Summit Therapeutics (SMMT - Free Report) rose 6.5% on Wednesday after the company’s partner Akeso announced positive top-line results from the phase III HARMONi-GI1 study conducted in China in certain patients with biliary tract cancer (BTC).

The study evaluated ivonescimab plus chemotherapy versus AstraZeneca (AZN - Free Report) ’s blockbuster cancer drug Imfinzi (durvalumab) plus chemotherapy as a first-line treatment in patients with advanced BTC, a rare group of cancers affecting the bile ducts and gallbladder. Imfinzi, a PD-L1 monoclonal antibody, holds approvals across multiple cancer indications and is a key revenue driver for AZN.

At a pre-specified interim analysis, the ivonescimab-based regimen achieved statistically significant and clinically meaningful superiority over the durvalumab-based regimen on the primary endpoint of overall survival (OS). The study also met the key secondary endpoints of progression-free survival and objective response rate. 

While Akeso did not provide any data supporting these numbers, it expects to report detailed results from the study at a future medical meeting and publish them in a peer-reviewed journal.

Summit is developing ivonescimab in collaboration with Akeso. The company acquired an exclusive license from Akeso in 2022 to develop and market the drug in the United States, Canada, Europe and Japan. Summit later amended this collaboration agreement in June 2024, expanding its licensing deal to cover Latin America (including Mexico and all countries in Central America, South America and the Caribbean), the Middle East and Africa. Akeso retains the rights to market the drug in China, where the drug is approved for three non-small cell lung cancer (NSCLC) indications.

Year to date, shares of SMMT have declined 18.6% against the industry’s 3.2% growth.

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A Key Validation Beyond NSCLCThe HARMONi-GI1 results represent an important milestone for ivonescimab because they provide the first phase III evidence of the drug delivering an OS benefit over an established anti-PD-(L)1-based regimen plus chemotherapy in advanced BTC.

The positive outcome therefore strengthens the broader development case for the drug and raises expectations to extend well beyond its initial NSCLC focus.

SMMT’s Progress With IvonescimabSummit is pursuing a broad global development program for ivonescimab.

In May 2025, the company announced positive phase III HARMONi data evaluating ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed following EGFR-TKI treatment. Based on these results, Summit submitted a biologics license application to the FDA in January 2026, with a regulatory decision expected by Nov. 14, 2026.

Summit is currently advancing ivonescimab in several late-stage programs. In NSCLC, the company is evaluating the candidate in the HARMONi-3 and HARMONi-7 phase III studies. Beyond lung cancer, the HARMONi-GI3 study is evaluating ivonescimab plus chemotherapy against bevacizumab plus chemotherapy as first-line treatment for patients with unresectable metastatic colorectal cancer (CRC). This represents Summit’s first study outside NSCLC.

Earlier this month, the company initiated the global phase II/III HARMONi-GU1 study in genitourinary cancer. The study is evaluating ivonescimab plus enfortumab vedotin (EV) against Merck’s (MRK - Free Report) Keytruda (pembrolizumab) plus EV as first-line treatment for patients with advanced urothelial or bladder cancer.

Our Take on the ResultsWhile Summit’s near-term value proposition remains closely tied to ivonescimab’s development in NSCLC, the successful HARMONi-GI1 outcome suggests that the drug could have meaningful potential across multiple cancer indications. Positive results in BTC, alongside ongoing programs in CRC and genitourinary cancer, could expand the drug’s addressable market substantially if subsequent studies confirm these benefits.

SMMT’s Zacks Rank  Summit currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that, on August 12, 2026, its partner Akeso Inc. (Akeso, HKEX Code: 9926.HK) announced receipt of marketing authorization in China from the National Medical Products Administration (NMPA) for the use of ivonescimab, a novel, potential first-in-class investigational bispecific antibody, in combination with chemotherapy for the first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC). Thi.

NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Lowey Dannenberg P.C., a preeminent law firm in obtaining redress for consumers and investors, is investigating whether certain officers and directors of Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit” or the “Company”) breached their fiduciary duties to shareholders in connection with a $520 million loan transaction between the Company and its Executive Chairman, Robert W.

Posted by Defense World Staff on Aug 3rd, 2026

Summit Therapeutics PLC (NASDAQ:SMMT – Get Free Report) has earned a consensus rating of “Hold” from the sixteen analysts that are presently covering the stock, Marketbeat.com reports. Two analysts have rated the stock with a sell recommendation, six have issued a hold recommendation, seven have issued a buy recommendation and one has issued a strong buy recommendation on the company. The average twelve-month target price among brokers that have updated their coverage on the stock in the last year is $26.1545.

SMMT has been the topic of several research analyst reports. Weiss Ratings restated a “sell (d-)” rating on shares of Summit Therapeutics in a report on Friday, July 17th. KeyCorp reissued an “overweight” rating on shares of Summit Therapeutics in a research report on Monday, June 1st. Citigroup initiated coverage on Summit Therapeutics in a research note on Wednesday, April 8th. They issued a “buy” rating on the stock. Jefferies Financial Group set a $15.00 target price on Summit Therapeutics in a research report on Friday, July 24th. Finally, HC Wainwright reaffirmed a “neutral” rating on shares of Summit Therapeutics in a research note on Thursday, July 23rd.

View Our Latest Stock Report on SMMT

Summit Therapeutics Stock Performance SMMT stock opened at $13.02 on Monday. The firm has a 50 day simple moving average of $14.65 and a 200 day simple moving average of $16.48. Summit Therapeutics has a 52 week low of $12.25 and a 52 week high of $30.98. The stock has a market cap of $10.39 billion, a P/E ratio of -11.62 and a beta of -1.23.

Summit Therapeutics (NASDAQ:SMMT – Get Free Report) last released its quarterly earnings data on Thursday, July 23rd. The company reported ($0.28) earnings per share for the quarter, missing the consensus estimate of ($0.27) by ($0.01). Sell-side analysts predict that Summit Therapeutics will post -1.2 EPS for the current year.

Insider Activity at Summit Therapeutics In other Summit Therapeutics news, CEO Mahkam Zanganeh acquired 3,810,000 shares of the business’s stock in a transaction that occurred on Friday, June 12th. The shares were purchased at an average price of $13.12 per share, with a total value of $49,987,200.00. Following the completion of the transaction, the chief executive officer owned 573,883,879 shares in the company, valued at $7,529,356,492.48. The trade was a 0.67% increase in their ownership of the stock. The acquisition was disclosed in a filing with the SEC, which can be accessed through this hyperlink. Also, CFO Manmeet Singh Soni bought 50,000 shares of Summit Therapeutics stock in a transaction on Thursday, June 4th. The stock was acquired at an average price of $14.45 per share, with a total value of $722,500.00. Following the completion of the purchase, the chief financial officer directly owned 3,123,603 shares of the company’s stock, valued at approximately $45,136,063.35. The trade was a 1.63% increase in their ownership of the stock. The SEC filing for this purchase provides additional information. In the last quarter, insiders bought 7,870,000 shares of company stock valued at $103,616,900. 83.50% of the stock is owned by corporate insiders.

Institutional Inflows and Outflows Several hedge funds have recently modified their holdings of SMMT. Price T Rowe Associates Inc. MD boosted its holdings in Summit Therapeutics by 106.5% in the fourth quarter. Price T Rowe Associates Inc. MD now owns 9,371,415 shares of the company’s stock worth $163,907,000 after purchasing an additional 4,832,592 shares in the last quarter. Baker BROS. Advisors LP raised its holdings in Summit Therapeutics by 7.9% during the fourth quarter. Baker BROS. Advisors LP now owns 36,391,063 shares of the company’s stock valued at $636,480,000 after buying an additional 2,668,089 shares in the last quarter. Norges Bank bought a new position in Summit Therapeutics during the fourth quarter valued at about $24,030,000. TD Asset Management Inc lifted its position in shares of Summit Therapeutics by 124.2% in the fourth quarter. TD Asset Management Inc now owns 1,205,272 shares of the company’s stock worth $21,080,000 after buying an additional 667,742 shares during the last quarter. Finally, Polymer Capital Management HK LTD lifted its position in shares of Summit Therapeutics by 73.9% in the fourth quarter. Polymer Capital Management HK LTD now owns 1,421,155 shares of the company’s stock worth $24,856,000 after buying an additional 603,879 shares during the last quarter. Institutional investors and hedge funds own 4.61% of the company’s stock.

About Summit Therapeutics (Get Free Report)

Summit Therapeutics plc is a clinical‐stage biotechnology company dedicated to the discovery and development of precision medicines for serious and life‐threatening diseases. The company applies a targeted approach to drug design, focusing on novel mechanisms of action that differentiate its candidates from existing therapies.

Summit’s lead asset, ridinilazole (formerly SMT19969), is being developed to treat Clostridioides difficile infections and has received both Fast Track and Qualified Infectious Disease Product designations from the U.S.

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Resources Investor Relations Journalists Agencies Client Login Send a Release News Products Contact , /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Summit Therapeutics Inc. (NASDAQ: SMMT) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms.

If you are a long-term SMMT stockholder please contact Sophia Anne Silayan by email at [email protected] or call (833) 672-0814. The consultation and case are free with no obligation to you. Kuehn Law pays all case costs and does not charge its investor clients. Shareholders should contact the firm immediately as there may be limited time to enforce your rights. 

Why Your Participation Matters:

As a shareholder your voice matters, and by getting involved, you contribute to the integrity and fairness of the financial markets. Your investment. Your voice. Your future.™ 

For additional information, please visit Shareholder Derivative Litigation - Kuehn Law.

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Contacts:
Kuehn Law, PLL
Justin Kuehn, Esq.
53 Hill Street, Suite 605
Southampton, NY 11968
[email protected]
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Key Takeaways SMMT reported a wider-than-expected Q2 loss and ended the quarter with higher cash after ATM fundraising.Summit submitted updated ivonescimab survival data to the FDA during its ongoing BLA review.SMMT expanded ivonescimab efforts with late-stage studies and a new Arcus collaboration. Summit Therapeutics (SMMT - Free Report) reported a second-quarter 2026 loss per share of 28 cents, wider than the Zacks Consensus Estimate of a loss of 26 cents per share. In the year-ago period, the company had incurred a loss of 76 cents per share.

The company currently lacks a marketed product in its portfolio. As a result, it did not record revenues in the quarter.

More on SMMT’s Q2 ResultsResearch and development (R&D) expenses were $157.7 million, down 24.2% year over year. General and administrative expenses plunged 82.6% year over year to $62.8 million. The substantial decline in operating costs was primarily due to a significant reduction in stock-based compensation expenses. However, total operating expenses increased 13% sequentially, reflecting higher R&D spending associated with the continued clinical development of ivonescimab.

As of June 30, 2026, Summit had cash, cash equivalents and short-term investments totaling $690.7 million, compared with $598.7 million as of March 31, 2026.

During the second quarter of 2026, Summit raised $230.8 million in gross proceeds through its at-the-market (ATM) facility, followed by an additional $68.4 million in gross proceeds after quarter-end, further strengthening its liquidity position.

SMMT’s Pipeline UpdatesThe lead program in the company’s pipeline is ivonescimab, a dual PD-1/VEGF inhibitor being evaluated in multiple late-stage studies across different settings in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). SMMT is developing ivonescimab in collaboration with China-based Akeso. Ivonescimab is currently approved only in China for two distinct NSCLC indications.

In January, the FDA accepted the company's biologics license application (BLA) seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutant, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with third-generation EGFR-TKIs. The BLA filing was based on encouraging September 2025 results from the phase III HARMONi study. The FDA decision is expected by Nov. 14, 2026.

In July 2026, Summit reported more favorable OS data from the HARMONi study, with longer follow-up, demonstrating a consistent survival benefit with ivonescimab across Western and Asian patient populations. The analysis showed a hazard ratio (HR) of 0.76 in the overall intent-to-treat population, with the same HR of 0.76 observed independently in both the Western and Asian subgroups, reinforcing the geographic consistency of the treatment benefit.

The updated OS data have been submitted to the FDA as part of the ongoing BLA review, which could extend the FDA’s review timeline.

Year to date, shares of SMMT have lost 14.4% compared with the industry’s 3.9% decline.

Image Source: Zacks Investment Research

The company is evaluating ivonescimab in three late-stage studies, two in NSCLC (HARMONi-3 and HARMONi-7) and one in CRC (HARMONi-GI3).

HARMONi-3 is evaluating the drug against Merck’s (MRK - Free Report) blockbuster PD-L1 drug Keytruda (pembrolizumab) as a first-line treatment for metastatic squamous or non-squamous NSCLC, while HARMONi-7 is evaluating ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

In the HARMONi-3 study, under the revised design, squamous and non-squamous NSCLC cohorts are being analyzed separately, with progression-free survival (PFS) and overall survival as primary endpoints. Patient enrollment in both cohorts has been completed. The final PFS results are expected in the second half of 2026 and in the first half of 2027 for the squamous and non-squamous NSCLC cohorts, respectively.

Patient enrollment in the phase III HARMONi-GI3 study, evaluating the candidate in combination with chemotherapy against bevacizumab plus chemotherapy in first-line unresectable metastatic colorectal cancer, is ongoing.

The company agreed to divest its investigational antibiotic, ridinilazole to Toronto-based Biossil Inc. in mid-July. The late-stage asset is being developed for the treatment of patients with clostridioides difficile infection, a serious bacterial infection of the colon. Per the agreement, Biossil will assume responsibility for the further development and commercialization of ridinilazole. In return, Summit will receive an upfront payment of $500,000 and will be eligible for up to $104.5 million in regulatory and commercial milestones, plus tiered royalties on net sales.

In July, Summit announced a collaboration with Arcus Biosciences (RCUS - Free Report) to evaluate RCUS' investigational HIF-2α inhibitor, casdatifan, in combination with ivonescimab for the treatment of clear cell renal cell carcinoma, including first-line metastatic disease. Arcus will sponsor and conduct the study, while both companies will share development costs and retain commercial rights to their respective therapies. Initial study data are expected by mid-2027.

SMMT’s Zacks Rank  Summit currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.