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Highlights Include Phase II Data Supporting Clinical Development Expansion for Ivonescimab

MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced that ivonescimab data will be featured in numerous presentations at the European Society for Medical Oncology 2026 Congress (ESMO 2026), taking place October 23-27, 2026, in Madrid, Spain.

Across 10 presentations at ESMO 2026, ivonescimab data will span a broad range of tumor types, led by positive overall survival findings from Akeso Inc.’s Phase III HARMONi-GI1 study of ivonescimab plus chemotherapy compared to durvalumab plus chemotherapy in first-line advanced biliary tract cancer, which is selected as a Late-Breaking Abstract for the Presidential Symposium. HARMONi-GI1 is a multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. On October 21, Summit and ECOG-ACRIN Cancer Research Group announced the initiation of the open-label Phase II/III EA2251 study, which 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. Activation of clinical trial sites is expected to begin in the fourth quarter of 2026.

Additional data include findings from investigator-sponsored trials (ISTs). A rapid oral presentation and a proffered paper will feature ivonescimab-based regimens in first-line recurrent/metastatic thymic carcinoma and advanced renal cell carcinoma, respectively. The program also highlights emerging endometrial cancer (EC) data, alongside continued development in gastrointestinal cancers such as esophageal, gastric/GEJ, and pancreatic cancers; glioblastoma; and head and neck squamous cell carcinoma.

In a Phase II study in EC conducted at Memorial Sloan Kettering Cancer Center in New York, NY, ivonescimab monotherapy met the study’s primary endpoint for objective response rate with a manageable safety profile without new safety signals in previously treated patients with second-line and later EC. The strength of these results supported expansion of the IST led by Drs. Maria Rubinstein, MD, and Vicky Makker, MD, and provided a meaningful signal to inform opportunities for further development of ivonescimab in EC.

“The breadth of the ivonescimab data at ESMO underscores the expanding body of clinical evidence across a diverse range of tumor types and treatment settings,” said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. “Our ambition for ivonescimab extends beyond any single indication. We are focused on advancing a rigorous clinical development program to determine where this novel IO bispecific antibody could make a meaningful difference for patients. We look forward to engaging with the global oncology community on these data at ESMO 2026.”

The ESMO 2026 ivonescimab presentations are listed below by tumor type:

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 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 and expanded its sponsored Phase III clinical development program into colorectal cancer (CRC) and urothelial carcinoma (bladder cancer).

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.

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 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

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.

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MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that its partner Akeso Inc. announced positive overall survival (OS) results from the randomized, double-blind Phase III HARMONi-2 study evaluating ivonescimab monotherapy against pembrolizumab monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression. HARMONi-2 (AK112-303) 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.

In this preplanned analysis of OS, a secondary endpoint in the HARMONi-2 study, Akeso reported that ivonescimab monotherapy demonstrated a statistically significant improvement compared to pembrolizumab monotherapy. Results from this HARMONi-2 analysis are scheduled to be presented at an upcoming medical conference.

Akeso received marketing authorization for ivonescimab from China’s National Medical Products Administration (NMPA) based on the results of HARMONi-2 in April 2025. In the study’s primary analysis, ivonescimab monotherapy demonstrated a statistically significant improvement in the trial’s primary endpoint, progression-free survival (PFS) by Independent Radiologic Review Committee (IRRC), when compared to pembrolizumab monotherapy, achieving a hazard ratio (HR) of 0.51 (95% CI: 0.38, 0.69; p<0.0001). A clinically meaningful benefit was demonstrated across clinical subgroups, including those with PD-L1 low expression, PD-L1 high expression, squamous, and non-squamous histologies.1

The HARMONi-2 study was conducted by Akeso in China, where ivonescimab is approved and commercially available for indications in 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) 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 4,000 patients have been treated with ivonescimab in clinical studies globally and over 70,000 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 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 goal Prescription Drug User Fee Act (PDUFA) 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 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.

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 biliary tract cancer (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 all three studies from China. Akeso has also reported a statistically significant OS benefit 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 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:

Xiong A, Wang L, Chen J, Wu L, Liu B, Yao J, et al. Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China. Lancet. 2025;405(10481):839-849. doi:10.1016/S0140-6736(24)02722-3. 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.

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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Summit Therapeutics Inc. (SMMT) Q2 2026 Earnings Call July 23, 2026 4:30 PM EDT

Company Participants

Dave Gancarz - Chief Business & Strategy Officer
Robert Duggan - Co-CEO & Executive Chairman
Mahkam Zanganeh - Co-CEO, President & Director
Manmeet Soni - COO, CFO & Director
Allen Yang - Chief R&D Strategy Officer

Conference Call Participants

Yigal Nochomovitz - Citigroup Inc., Research Division
Nicholas Lorusso - TD Cowen, Research Division
Salveen Richter - Goldman Sachs Group, Inc., Research Division
Bradley Canino - Guggenheim Securities, LLC, Research Division
William Zhang - Wells Fargo Securities, LLC, Research Division
David Dai
Reni Benjamin - Citizens JMP Securities, LLC, Research Division
Eric Schmidt - Cantor Fitzgerald & Co., Research Division
Dara Azar - Stifel, Nicolaus & Company, Incorporated, Research Division
Faisal Khurshid - Jefferies LLC, Research Division

Presentation

Operator

Good afternoon, and welcome to Summit Therapeutics Q2 2026 Earnings Call. [Operator Instructions] We do not expect any technical difficulties today. However, in the event that we lose the webcast connection and are unable to provide any updates, please wait up to 10 minutes for resolution. Please refer to the company's website for updates. Please note that today's call is being recorded. [Operator Instructions]

At this time, I would like to turn the call over to Dave Gancarz, Summit Therapeutics Chief Business and Strategy Officer. You may proceed.

Dave Gancarz
Chief Business & Strategy Officer

Good afternoon, and thank you for joining us. On today's call, we will provide an update on our second quarter 2026 financial results and operational progress. This afternoon's press release is available on our website, www.smmttx.com. Our Form 10-Q was also filed today and is available on our website and via the SEC's website. Today's call is being simultaneously webcast, and an archived replay will also be made available later today on our website.

Joining me on the call today is Bob

Key Takeaways Summit sold ridinilazole rights to Biossil for upfront cash, milestones and royalties.SMMT's phase III ridinilazole program missed its primary endpoint despite encouraging exploratory benefits.Summit said the divestiture supports its strategic focus on developing ivonescimab in oncology. Summit Therapeutics (SMMT - Free Report) has entered into an agreement with Toronto-based Biossil Inc. to divest its investigational antibiotic candidate, ridinilazole. The late-stage asset was being developed for the treatment of patients with clostridioides difficile infection (CDI), a serious bacterial infection of the colon.

Financial Terms of Summit’s Deal With BiossilPer 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 milestone payments. The company is eligible to receive tiered royalties on future net sales of the product.

Year to date, Summit's shares have lost 11.6% compared with the industry’s 2.8% decline.

Image Source: Zacks Investment Research

Ridinilazole's Clinical ProfileSummit evaluated ridinilazole in the phase III Ri-CoDIFy program, combining the Ri-CoDIFy 1 and Ri-CoDIFy 2 studies for patients with CDI, versus vancomycin, the standard of care in 2021, with a twice-daily dosing regimen.

Although the primary endpoint of these studies was not met, the antibiotic showed several clinically encouraging exploratory benefits. These include better preservation of the gut microbiome, lower recurrence rates, reduced toxin production, favorable tolerability and a convenient dosing regimen compared with the current standard of care.

Summit held a Type C meeting with the FDA in 2022 to discuss a possible pathway to advance ridinilazole with the goal of achieving marketing authorization. Following the meeting, the company determined that ridinilazole would likely require at least one additional phase III study to support regulatory approval. Conducting another large-scale CDI study would have required significant time and financial resources, with an uncertain likelihood of success. As a result, the company decided to seek a development partner or divest the asset rather than continue its development independently.

Clostridioides difficile infection is a contagious bacterial infection of the colon that causes severe diarrhea and inflammation and can lead to serious complications such as sepsis, bowel perforation and death. It is a major healthcare-associated infection, causing nearly 500,000 cases and contributing to more than 29,000 deaths annually in the United States.

Summit Shifts Strategic Focus to OncologySummit believes Biossil's AI-driven drug development platform is well-positioned to further advance the ridinilazole program. The divestiture also enables Summit to sharpen its strategic focus on oncology, particularly the development of its lead investigational oncology drug, ivonescimab.

Ivonescimab is currently being evaluated in multiple late-stage clinical studies across several treatment settings in non-small cell lung cancer (NSCLC) and colorectal cancer. Summit is developing the therapy in partnership with China-based Akeso. In January, the FDA accepted Summit’s biologics license application (BLA), seeking approval of ivonescimab plus chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with third-generation EGFR-TKIs. The BLA filing was based on encouraging results from the phase III HARMONi study. The FDA decision is expected by Nov. 14, 2026.

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

Some better-ranked stocks in the biotech sector are Neurocrine Biosciences (NBIX - Free Report) , Amarin Corporation (AMRN - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.48. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.79. NBIX shares have gained 21.3% year to date.

Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.

Over the past 60 days, loss-per-share estimates for Amarin Corporation have narrowed from $15.20 to 65 cents for 2026. Over the same period, estimates for loss per share have also narrowed from $13.00 to 51 cents for 2027. AMRN shares have risen 3% year to date.

Amarin Corporation’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 50.02%.

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $4.92 from $4.81. LQDA shares have gained 121.8% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.