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Bank of New York Mellon Corp purchased a new position in Summit Therapeutics PLC (NASDAQ:SMMT – Free Report) during the 2nd quarter, according to its most recent filing with the Securities & Exchange Commission. The fund purchased 431,299 shares of the company’s stock, valued at approximately $6,284,000. Bank of New York Mellon Corp owned approximately 0.05% of Summit Therapeutics at the end of the most recent quarter.

Several other large investors also recently made changes to their positions in SMMT. Ball & Co Wealth Management Inc. bought a new stake in Summit Therapeutics during the first quarter worth approximately $28,000. Kestra Advisory Services LLC bought a new position in shares of Summit Therapeutics in the fourth quarter valued at $28,000. Parallel Advisors LLC acquired a new stake in shares of Summit Therapeutics during the 3rd quarter valued at $39,000. T. Rowe Price Investment Management Inc. lifted its position in shares of Summit Therapeutics by 2,654.4% during the 4th quarter. T. Rowe Price Investment Management Inc. now owns 1,873 shares of the company’s stock valued at $33,000 after acquiring an additional 1,805 shares during the last quarter. Finally, Truvestments Capital LLC boosted its stake in shares of Summit Therapeutics by 200.2% during the 4th quarter. Truvestments Capital LLC now owns 2,603 shares of the company’s stock worth $46,000 after acquiring an additional 1,736 shares in the last quarter. Institutional investors own 4.61% of the company’s stock.

Analysts Set New Price Targets A number of equities analysts recently issued reports on the company. HC Wainwright restated a “neutral” rating on shares of Summit Therapeutics in a report on Thursday. Leerink Partners raised shares of Summit Therapeutics from an “underperform” rating to a “market perform” rating and increased their price target for the stock from $12.00 to $13.00 in a research report on Wednesday, August 12th. Jefferies Financial Group set a $15.00 price target on shares of Summit Therapeutics in a report on Friday, July 24th. Cantor Fitzgerald reiterated an “overweight” rating on shares of Summit Therapeutics in a research report on Tuesday. Finally, KeyCorp reiterated an “overweight” rating on shares of Summit Therapeutics in a report on Monday, June 1st. One equities research analyst has rated the stock with a Strong Buy rating, six have given a Buy rating, eight have issued a Hold rating and one has assigned a Sell rating to the company. Based on data from MarketBeat, the stock currently has a consensus rating of “Hold” and a consensus target price of $24.07.

Check Out Our Latest Research Report on SMMT Insider Buying and Selling at Summit Therapeutics In other news, CEO Mahkam Zanganeh bought 3,810,000 shares of Summit Therapeutics stock in a transaction dated Friday, June 12th. The shares were bought at an average price of $13.12 per share, for a total transaction of $49,987,200.00. Following the purchase, the chief executive officer owned 573,883,879 shares of the company’s stock, valued at approximately $7,529,356,492.48. This trade represents a 0.67% increase in their ownership of the stock. The purchase was disclosed in a filing with the Securities & Exchange Commission, which is available through this link. Also, CEO Robert W. Duggan bought 3,810,000 shares of the stock in a transaction dated Friday, June 12th. The stock was purchased at an average cost of $13.12 per share, for a total transaction of $49,987,200.00. Following the acquisition, 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 position. The disclosure for this purchase is available in the SEC filing. Corporate insiders own 83.50% of the company’s stock.

Summit Therapeutics Stock Performance NASDAQ:SMMT opened at $17.60 on Friday. The company has a 50-day moving average of $14.24 and a 200-day moving average of $16.17. The company has a market capitalization of $14.04 billion, a price-to-earnings ratio of -15.71 and a beta of -1.24. Summit Therapeutics PLC has a 52 week low of $12.07 and a 52 week high of $29.23.

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

Summit Therapeutics Company Profile (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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Summit Therapeutics Inc. (NASDAQ:SMMT) stock is trading higher on Thursday after its development partner, Akeso Inc., reported highly favorable overall survival data from a late-stage clinical trial.

The Phase 3 HARMONi-2 study evaluated ivonescimab as a standalone treatment against Merck & Co Inc.’s (NYSE:MRK) Keytruda (pembrolizumab) for locally advanced or metastatic non-small cell lung cancer (NSCLC) presenting positive PD-L1 expression.

Positive Overall Survival ResultsThe multi-center trial took place exclusively in China, with Akeso generating, managing, and analyzing all relevant clinical data.

In a preplanned clinical analysis, Akeso revealed that ivonescimab monotherapy provided a statistically significant improvement in overall survival compared to pembrolizumab.

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Overall survival served as a secondary endpoint in the HARMONi-2 study.

The company plans to present the comprehensive findings from this analysis at an upcoming medical conference.

Prior Clinical Milestones And ApprovalsChina’s National Medical Products Administration previously granted marketing authorization for ivonescimab in April 2025, driven by the initial HARMONi-2 results.

During the primary analysis, the Independent Radiologic Review Committee determined that ivonescimab monotherapy showed a significant enhancement in progression-free survival when compared directly to pembrolizumab.

The treatment achieved a hazard ratio of 0.51. Furthermore, the drug demonstrated a clinically meaningful benefit across a variety of patient subgroups.

These subgroups included individuals with high and low PD-L1 expression, alongside those featuring squamous and non-squamous tumor histologies.

Current Regulatory StatusWhile ivonescimab is fully approved and commercially accessible for NSCLC indications in China, its regulatory standing differs significantly in other global markets.

The therapy remains strictly investigational within Summit Therapeutics’ licensed territories.

SMMT Price Action: Summit Therapeutics shares were up 10.79% at $15.55 at the time of publication on Thursday, according to Benzinga Pro data.

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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) today announced the publication of primary analysis results from the global Phase III HARMONi clinical trial in The Lanc

MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that its partner Akeso Inc. announced positive topline results from 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 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 exclusi.

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Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

The GLP-1 market is booming. It may be one of the fastest-growing areas in the pharmaceutical industry, as medicines in this category are showing the potential to treat many conditions beyond diabetes and weight management, including obstructive sleep apnea, osteoarthritis pain, metabolic dysfunction-associated steatohepatitis, and others. It's no wonder investors are looking to capitalize on this by backing companies developing promising GLP-1 drugs.

However, oncology remains the largest therapeutic area by sales, and important breakthroughs are underway in that market. Summit Therapeutics (SMMT -3.27%) and Revolution Medicines (RVMD +1.01%) are two biotechs that could make important contributions to oncology. But are these stocks worth investing in?

Image source: Getty Images.

1. Summit Therapeutics Summit Therapeutics licensed its leading candidate, ivonescimab, from a Chinese drugmaker called Akeso (AKESF -0.87%). Ivonescimab is a bispecific antibody, a newer class of medicines that can target two antigens at once, potentially leading to greater efficacy than older monoclonal antibodies. Ivonescimab showed promise, performing well in a phase 3 study conducted in China, where it was pitted against the world's best-selling cancer drug, Keytruda, in patients with non-small cell lung cancer (NSCLC). Summit Therapeutics requested regulatory approval in the U.S. for ivonescimab in some patients with NSCLC based on data from another clinical study.

The U.S. Food and Drug Administration could issue a decision by mid-November. If approved, this medicine is poised to generate well over $1 billion in annual sales, especially given that it could be a pipeline-in-a-drug and earn approval for many indications in the oncology market. Summit Therapeutics estimates that ivonescimab could rack up over than $15 billion in annual revenue by 2033.

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However, there are several factors to consider before deciding to purchase the company’s shares at this time. The most important may be the following. Summit Therapeutics requested U.S. approval for ivonescimab for patients with NSCLC, despite the medicine failing to demonstrate a statistically significant improvement in overall survival (OS) in the relevant clinical trial. But the U.S. Food and Drug Administration explicitly requested robust OS data to support approval.

The health regulatory agency may still grant ivonescimab its blessing, but there is also a good chance it won't do so for this indication, delaying the drug's launch in the U.S. Summit's shares will likely soar if it can earn this first approval for ivonescimab in the U.S., but they will plunge otherwise.

With that said, is the stock a buy right now? If the medicine can indeed reach $15 billion in revenue by 2033, its current market cap of roughly $10.5 billion makes the stock look cheap, but there is significant uncertainty. So, in my view, investors with an appetite for risk should consider initiating a small position in this healthcare stock and progressively add more as ivonescimab earns various indications in the U.S.

2. Revolution Medicines Revolution Medicines has an exciting approach to treating cancer. Here are the basics of it. Some cancers depend heavily on certain proteins in the body to grow. Medicines often treat them by "disabling" these proteins and slowing down the growth of the cancer. However, the RAS family of proteins, linked to certain cancers, baffled researchers for decades because they had not found a way to shut it off. Until now.

Revolution Medicines' candidates have shown the ability to treat some of these cancers, previously considered "undruggable," in clinical trials. In one phase 3 study, the company's leading candidate, daraxonrasib, posted outstanding results in patients with metastatic pancreatic cancer. Daraxonrasib was pitted against the current standard of care, cytotoxic chemotherapy, in this study. Daraxonrasib was associated with a median OS of 13.2 months, versus 6.7 months with cytotoxic chemotherapy. Revolution Medicines' leading candidate could become the new standard of care in this niche.

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The biotech will also target several other indications with daraxonrasib, and it is developing additional therapies that should contribute over the medium term. But is Revolution Medicines attractive at current levels? The company's current market cap is $45 billion. That's almost unheard of for a clinical-stage biotech, reflecting the market's confidence in Revolution Medicines' approach to treating cancer. However, my view is that the stock is a bit too expensive at current levels, and there may not be that much upside left. Investors should wait for a pullback before initiating a position in this otherwise promising biotech company.

Posted by Defense World Staff on Aug 12th, 2026

Summit Therapeutics PLC (NASDAQ:SMMT – Get Free Report) passed above its fifty day moving average during trading on Tuesday . The stock has a fifty day moving average of $14.28 and traded as high as $15.73. Summit Therapeutics shares last traded at $15.11, with a volume of 4,959,993 shares changing hands.

Wall Street Analyst Weigh In Several equities analysts have recently issued reports on the stock. HC Wainwright reaffirmed a “neutral” rating on shares of Summit Therapeutics in a research note on Thursday, August 6th. Cantor Fitzgerald reiterated an “overweight” rating on shares of Summit Therapeutics in a report on Friday, July 24th. KeyCorp reissued an “overweight” rating on shares of Summit Therapeutics in a research note on Monday, June 1st. Weiss Ratings restated a “sell (d-)” rating on shares of Summit Therapeutics in a report on Friday, July 17th. Finally, Sanford C. Bernstein started coverage on shares of Summit Therapeutics in a research report on Thursday, May 21st. They issued an “underperform” rating and a $7.70 price target on the stock. One research analyst has rated the stock with a Strong Buy rating, six have assigned a Buy rating, six have given a Hold rating and two have issued a Sell rating to the company. According to data from MarketBeat.com, Summit Therapeutics has a consensus rating of “Hold” and an average price target of $25.37.

Check Out Our Latest Research Report on SMMT

Summit Therapeutics Trading Up 1.6% The firm has a market cap of $12.05 billion, a price-to-earnings ratio of -13.49 and a beta of -1.23. The stock has a 50-day moving average of $14.28 and a two-hundred day moving average of $16.33.

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

Insider Transactions at Summit Therapeutics In other news, CEO Robert W. Duggan purchased 3,810,000 shares of Summit Therapeutics stock in a transaction that occurred on Friday, June 12th. The stock was acquired at an average price of $13.12 per share, for a total transaction of $49,987,200.00. Following 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 purchase was disclosed in a legal filing with the SEC, which is available at this link. Also, CFO Manmeet Singh Soni acquired 50,000 shares of the firm’s stock in a transaction that occurred on Thursday, June 4th. The stock was purchased at an average cost of $14.45 per share, with a total value of $722,500.00. Following the purchase, the chief financial officer directly owned 3,123,603 shares in the company, valued at approximately $45,136,063.35. This trade represents a 1.63% increase in their position. The disclosure for this purchase is available in the SEC filing. Insiders have bought a total of 7,870,000 shares of company stock valued at $103,616,900 over the last ninety days. Corporate insiders own 83.50% of the company’s stock.

Institutional Trading of Summit Therapeutics Large investors have recently added to or reduced their stakes in the company. AQR Capital Management LLC boosted its position in shares of Summit Therapeutics by 5.0% in the first quarter. AQR Capital Management LLC now owns 65,623 shares of the company’s stock worth $1,266,000 after buying an additional 3,134 shares during the period. MIRAE ASSET GLOBAL ETFS HOLDINGS Ltd. raised its position in Summit Therapeutics by 1.1% during the first quarter. MIRAE ASSET GLOBAL ETFS HOLDINGS Ltd. now owns 65,411 shares of the company’s stock valued at $1,273,000 after buying an additional 694 shares during the period. Creative Planning lifted its stake in Summit Therapeutics by 6.7% in the 2nd quarter. Creative Planning now owns 21,390 shares of the company’s stock worth $455,000 after acquiring an additional 1,336 shares in the last quarter. Legal & General Group Plc lifted its stake in Summit Therapeutics by 33.8% in the 2nd quarter. Legal & General Group Plc now owns 26,367 shares of the company’s stock worth $561,000 after acquiring an additional 6,662 shares in the last quarter. Finally, Quantbot Technologies LP purchased a new stake in Summit Therapeutics in the 2nd quarter worth about $132,000. 4.61% of the stock is owned by institutional investors and hedge funds.

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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MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced the expansion of its global registration-enabling clinical development program for the novel, potential first-in-class investigational bispecific antibody ivonescimab, into urothelial carcinoma, or bladder cancer, with the initiation of the global, multi-regional Phase II/III HARMONi-GU1 trial. Summit is starting a randomized Phase II/III clinical study, HARMONi-GU1, to evaluate ivonescimab plus the antibody-drug co.

Summit Therapeutics Inc. is upgraded from Sell to Hold as the FDA reviews its BLA for ivonescimab, with a decision expected by November 14, 2026. SMMT's pivotal HARMONI study showed statistically significant PFS but only a favorable trend in OS; updated data with a hazard ratio of 0.76 has been submitted. Competition is intensifying, with multiple large pharmas developing similar VEGF/PD-1 bispecifics; no acquisition or major partnership offers have materialized for SMMT.

Aggregate cash and cash equivalents and short-term investments were $690.7 million.

Company Raises Capital But Says More Funding Will Be NeededDuring the second quarter of 2026, the company raised $230.8 million in gross proceeds through its ATM facility. Subsequent to June 2026, the company raised an additional $68.4 million in gross proceeds through its ATM facility.

In its SEC quarterly filing, the cancer drug developer reported that it has an accumulated deficit of $2,699.3 million, and expects to continue to generate operating losses for the foreseeable future.

Cash and cash equivalents and short-term investments are not sufficient to fund the company’s planned operations for a period of at least one year.

Going Concern Warning Highlights Future Cash RequirementsSummit 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.

Ridinilazole Sale Adds Potential PaymentsEarlier in July, Summit Therapeutics agreed to sell ridinilazole, an investigational Phase 3 precision antibiotic, to Toronto-based Biossil, Inc.

Summit will receive $500,000 upfront and up to $104.5 million in regulatory and commercial milestones, plus tiered royalties on net sales.

SMMT Price Action: Summit Therapeutics shares were down 6.78% at $13.96 at the time of publication on Friday, according to Benzinga Pro data.

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HAYWARD, Calif. & MIAMI--(BUSINESS WIRE)---- $SMMT--Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, and Summit Therapeutics Inc. (Nasdaq: SMMT), a biopharmaceutical company focused on patient-friendly oncology therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical ne.

Why Wall Street Is Backing These 3 Comeback StocksSummit Therapeutics NASDAQ: SMMT executives used the company’s latest earnings call to emphasize updated survival data for ivonescimab, outline the timing of key late-stage trial readouts and detail the company’s cash position as it prepares for a potential U.S. regulatory decision later this year.

Chairman and Co-Chief Executive Officer Bob Duggan said Summit remains focused on ivonescimab, its PD-1/VEGF bispecific antibody and lead investigational asset. Duggan said ivonescimab has produced positive data in four Phase III clinical studies to date, leading to two approvals in China, with one additional filing under review there. He said 15 Phase III trials are ongoing or have read out across multiple tumor types, and that Summit and partner Akeso have initiated 52 clinical trials evaluating the drug.

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MarketBeat Week in Review – 11/4 - 11/8Duggan also said more than 4,000 patients have been dosed with ivonescimab in Summit- or Akeso-sponsored clinical trials globally, while more than 70,000 patients have received the drug commercially in China.

Updated HARMONi Data Submitted to FDA President and Co-Chief Executive Officer Dr. Maky Zanganeh highlighted an updated overall survival analysis from the global Phase III HARMONi trial, which evaluated ivonescimab plus chemotherapy versus chemotherapy alone in patients with EGFR-mutated non-small cell lung cancer after TKI therapy.

Summit Therapeutics: Is Their Lung Cancer Drug a Game Changer?Zanganeh said the latest analysis, with a June 2026 data cutoff, showed Western patients had reached a median follow-up of more than 23 months, while Asian patients remained at a median follow-up of 33 months. The company reported an overall survival hazard ratio of 0.76 in both the total population and the Western regional data.

“The hazard ratio for Western patients has improved with more follow-up time,” Zanganeh said, adding that the Western results are now consistent with the magnitude of overall survival benefit seen in Asian patients, who had longer follow-up at the primary analysis.

Summit said no new safety signals were observed in the latest data cut, and that the safety profile remained acceptable and manageable, consistent with previous Phase III results of ivonescimab plus chemotherapy.

Zanganeh said Summit has made the updated results available to the U.S. Food and Drug Administration. The company’s biologics license application for ivonescimab plus chemotherapy in the EGFR-mutated non-small cell lung cancer post-TKI setting remains under FDA review, with a target PDUFA date of Nov. 14. Zanganeh noted that the FDA has previously said a statistically significant overall survival benefit is necessary to support marketing authorization in this setting.

Key Trial Timelines Remain in Focus Summit also provided updates on several global Phase III studies. HARMONi-3 is evaluating ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in first-line metastatic non-small cell lung cancer in both squamous and non-squamous histologies, which will be analyzed separately.

Zanganeh said enrollment has been completed in both cohorts. Summit expects to reach the number of events needed for a progression-free survival analysis in the squamous cohort in the second half of this year, along with an early interim look at overall survival. The company expects a separate overall survival interim analysis in the first half of 2027. For the non-squamous cohort, Summit expects to reach the number of events for a progression-free survival analysis in the first half of 2027.

In the question-and-answer session, Chief Business and Strategy Officer Dave Gancarz said the HARMONi-3 squamous PFS timing is likely “towards the middle to back end of 2026,” rather than in the near term. He said the first-half 2027 overall survival analysis should have median follow-up generally consistent with the HARMONi-6 analysis and the updated Western patient data from HARMONi.

Summit said HARMONi-7, which compares ivonescimab monotherapy against pembrolizumab monotherapy in first-line non-small cell lung cancer with high PD-L1 expression, continues to enroll. HARMONi-GI3 is evaluating ivonescimab plus chemotherapy versus bevacizumab plus chemotherapy as first-line therapy in unresectable colorectal cancer.

Combination Collaborations Expand Development Plans Zanganeh also reviewed Summit’s collaborations with Revolution Medicines, GSK and Arcus Biosciences. The Revolution Medicines collaboration began enrolling in the first quarter and is evaluating ivonescimab with three novel RAS inhibitors across solid tumor settings including pancreatic, colorectal and non-small cell lung cancers.

Summit expects its GSK collaboration, which will evaluate ivonescimab with GSK’s B7-H3 antibody-drug conjugate in multiple solid tumors, to enroll its first patient later this quarter. The company also announced a collaboration with Arcus to evaluate ivonescimab with Arcus’ HIF-2α inhibitor casdatifan in first-line metastatic clear cell renal cell carcinoma. Summit expects initial data from that collaboration by mid-next year.

The company also pointed to ILLUMINE, a Phase III head and neck cancer study sponsored by European cooperative group GORTEC, which is enrolling in Europe and is expected to begin in China later this year.

Cash Position Rises, Expenses Increase Chief Operating Officer and Chief Financial Officer Manmeet Soni said Summit ended the second quarter of 2026 with $690.7 million in cash, up from $598.7 million at the end of the first quarter. Soni attributed the $92 million increase primarily to $231 million raised through the company’s at-the-market facility, partially offset by approximately $140 million used in operating activities during the quarter.

Soni said Summit filed a prospectus supplement for a new ATM facility of up to $380 million to provide additional financing flexibility. He also said the company currently has no debt on its balance sheet.

Total GAAP operating expenses were $220.5 million in the second quarter, compared with $195.2 million in the first quarter. Non-GAAP operating expenses, which exclude stock-based compensation, were $151.8 million, compared with $122.4 million in the prior quarter. Soni said the increase was primarily driven by higher research and development expenses related to clinical trial costs for HARMONi-GI3, HARMONi-3 and HARMONi-7.

Commercial Preparation Underway In response to an analyst question, Soni said Summit is preparing for a possible U.S. commercial launch ahead of the Nov. 14 PDUFA date. He said the company has hired its commercial leadership team, market access staff and marketing personnel, while field force hiring would typically occur closer to the regulatory date. Gancarz added that the company has also ramped up medical science liaisons.

Duggan closed the call by reiterating management’s confidence in ivonescimab. “We know that ivonescimab works,” he said. “The question I leave you with is, what if ivonescimab works really well?”

About Summit Therapeutics (NASDAQ:SMMT)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.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Summit announces updated HARMONi overall survival data and partners with Arcus to test ivonescimab in kidney cancer, expanding its late-stage development.

HAYWARD, Calif. & MIAMI--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer and inflammatory and autoimmune diseases, and Summit Therapeutics Inc. (Nasdaq: SMMT), a biopharmaceutical company focused on patient-friendly oncology therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical ne.

MIAMI--(BUSINESS WIRE)---- $SMMT--Summit Therapeutics Inc. (Nasdaq: SMMT) today announced results of an updated overall survival (OS) analysis from the global Phase III HARMONi clinical trial featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab. Ivonescimab plus platinum-doublet chemotherapy in this trial continues to show a positive OS trend and a consistent efficacy and safety profile in Asian and western patients when compared to chemotherapy alone. The HARMONi.

MIAMI--(BUSINESS WIRE)---- $SMMT--Summit Therapeutics Inc. (Nasdaq: SMMT) will host a conference call to announce its second quarter 2026 financial results and provide an update on operational progress on Thursday, July 23, 2026. The call is scheduled to take place at 4:30 p.m. EDT. The live and archived webcast can be accessed through the Investor Information section of the company's website, www.smmttx.com. About Summit Therapeutics Inc. Summit Therapeutics Inc. is a biopharmaceutical oncology company.

Summit Therapeutics Inc. (NASDAQ: SMMT) today announced it has signed an agreement with Toronto-based Biossil, Inc. for the sale of ridinilazole, an investigat

Summit Therapeutics is a highly volatile, single-asset company with a binary outcome. SMMT exhibits unusually concentrated ownership and heightened short interest, creating conditions for a short squeeze to take place. Recent pullbacks, driven by mixed market receptions to events do not fundamentally alter the investment narratives, present investors with an attractive entry point ahead of key catalysts.

An updated edition of the March 26, 2026, article.

The global oncology market is undergoing rapid transformation, driven by rising cancer incidence, aging population and ongoing scientific advances. According to the American Cancer Society, the United States alone is expected to see nearly 2.1 million new cancer cases and more than 626,000 deaths in 2026. Globally, growing exposure to lifestyle-related risk factors such as smoking, obesity and physical inactivity, along with demographic changes, is increasing cancer prevalence and supporting long-term growth in oncology healthcare spending.

At the same time, innovation is reshaping cancer care. Advances in immunotherapy, targeted treatments and personalized cancer vaccines have significantly broadened options beyond traditional chemotherapy and radiation. Immune-based approaches — including checkpoint inhibitors, CAR-T therapies, therapeutic vaccines and oncolytic viruses — are leveraging the body’s immune system to fight cancer more effectively. Meanwhile, targeted therapies are improving precision by addressing specific genetic and molecular abnormalities, while personalized vaccines are advancing individualized treatment strategies.

Emerging technologies such as genomic sequencing, artificial intelligence and machine learning are accelerating biomarker discovery, improving patient selection, and enabling earlier and more accurate diagnosis. Although a universal cure remains elusive, steady gains in survival rates and patient outcomes across multiple cancer types underscore the impact of these advances, particularly when paired with earlier detection and intervention.

Pharmaceutical companies continue to increase investment and strategic focus in oncology. Industry leaders such as Novartis (NVS - Free Report) , AstraZeneca (AZN - Free Report) , J&J (JNJ - Free Report) , Pfizer (PFE - Free Report) , AbbVie, Merck, Bristol Myers Squibb and Eli Lilly are expanding oncology pipelines with advanced modalities such as antibody-drug conjugates (ADCs), bispecific antibodies and next-generation immuno-oncology therapies. Smaller biotech firms also remain critical innovation drivers, often developing novel platforms and targets that support partnerships, licensing deals and M&A activity.

Backed by continuous innovation, supportive reimbursement trends and expanding treatment options, oncology remains one of the most resilient and attractive areas of the global healthcare sector for long-term investors.

With our thematic screens, you can easily spot stocks tied to trends shaping the future of investing. For those looking to gain exposure to the oncology space, companies such as Summit Therapeutics (SMMT - Free Report) , Verastem Oncology (VSTM - Free Report) and Xilio Therapeutics (XLO - Free Report) may be worth evaluating as part of a forward-looking portfolio strategy.

Explore 36 cutting-edge investment themes with Zacks Thematic Investing Screens and uncover your next big opportunity.

3 Cancer Stocks in FocusSummit Therapeutics’ lead pipeline candidate is ivonescimab, a dual PD-1/VEGF inhibitor that inhibits both the PD-1 pathway and the VEGF pathway at once. They are designed to overcome the limitations of single-target therapies like Keytruda. Summit in-licensed rights to develop and commercialize ivonescimab in most major global markets outside China from China-based Akeso in early 2023.

Summit Therapeutics is evaluating this drug in multiple late-stage studies across different settings in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Ivonescimab is currently approved only in China for two distinct NSCLC indications. 

For the NSCLC indication, the drug has already generated multiple positive phase III datasets. In January, the FDA accepted a biologics license application seeking approval of 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 BLA filing was based on encouraging results from the phase III HARMONi study. The FDA’s decision is expected on Nov. 14, 2026.

Per Summit Therapeutics, ivonescimab has the potential to replace PD-L1 inhibitors like Keytruda and Tevimbra as the next standard of care across multiple NSCLC settings. 

SMMT has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy)  stocks here.

Verastem Oncology is a precision oncology company focused on targeting key signaling pathways—particularly the RAS/MAPK pathway, which is affected in a large proportion of cancers.  Its novel combination regimen of avutometinib plus defactinib was approved by the FDA in early May 2025 for treating KRAS mutant recurrent low-grade serous ovarian cancer (LGSOC), a rare and distinct type of ovarian cancer. The approval was granted under the FDA’s accelerated approval pathway. It is commercialized in the U.S. market as an oral combination co-pack with the two prescription products, known as Avmapki Fakzynja Co-Pack. The launch is off to a strong start. The innovative combination therapy generated $30.9 million in sales in 2025 and $18.7 million in the first quarter of 2026.

Avmapki Fakzynja Co-Pack became the first and only FDA-approved treatment for the LGSOC indication. Per Verastem Oncology, the combo sets a new standard of care for women with recurrent LGSOC with a KRAS mutation.

The company is also evaluating avutometinib plus defactinib in combination studies in first-line metastatic pancreatic cancer, non-small cell lung cancer (NSCLC) and other RAS-driven tumors. The company recently initiated three phase II registration-directed studies on VS-7375, an oral, KRAS G12D (ON/OFF) inhibitor, in pancreatic, non-small cell lung, and colorectal cancers.

VSTM has a relatively active pipeline calendar through 2026 and 2027.

Verastem has a Zacks Rank #2.

Xilio Therapeutics has an exclusive license agreement with Gilead to develop and commercialize its investigational tumor-activated IL-12 inhibitor, efarindodekin alfa, as a monotherapy in a phase II study in patients with advanced solid tumors. 

Another key candidate in its pipeline is XTX501, a novel bispecific PD-1 / masked IL-2. For this candidate, Xilio plans to submit an investigational new drug (IND) application in mid-2026 to begin clinical studies. Xilio plans to begin a phase I study for XTX501 in the second half of 2026, subject to the FDA clearing the IND application. Xilio Therapeutics plans to initially evaluate XTX501 in NSCLC, with the goal of subsequently expanding development into additional solid tumor types, including those that are less responsive or resistant to PD-1–based therapies. The company sees XTX501 as a potential foundational “backbone” therapy.

In addition, Xilio is advancing a suite of preclinical “masked” T-cell engagers targeting tumor antigens such as PSMA, CLDN18.2 and STEAP1, with plans to enter clinical development by 2027, including a collaboration with AbbVie.

Xilio has a Zacks Rank #2

Key Takeaways SMMT filed ivonescimab's FDA application after phase III NSCLC data. The decision is expected in November.SMMT is enrolling patients in phase III NSCLC and CRC studies, with HARMONi-3 data expected in 2H 2026.SMMT expanded ivonescimab's development through collaborations with GSK, Pfizer and other partners. Summit Therapeutics (SMMT - Free Report) has emerged as one of the most closely watched oncology biotech companies following the rapid advancement of its lead cancer candidate, ivonescimab. Summit in-licensed rights to develop and commercialize ivonescimab in most major global markets outside China from China-based Akeso in early 2023.

Since in-licensing rights to ivonescimab, Summit Therapeutics has transformed from a small biotech player into a late-stage oncology company with a growing global development program centered around the candidate.

Ivonescimab is 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). Unlike currently marketed immuno-oncology therapies that target only the PD-1 pathway, ivonescimab simultaneously targets both PD-1 and VEGF, a differentiated mechanism that management believes could redefine the treatment landscape and emerge as the next standard of care in NSCLC.

Year to date, shares of SMMT have declined 0.1% compared with the industry’s 6.4% fall.

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Investor attention remains focused on the company’s expanding late-stage pipeline and upcoming regulatory milestones.

SMMT Rides on Ivonescimab’s Development ProgressBuilding on the success of the Akeso-sponsored studies in China, Summit Therapeutics is sponsoring multiple global and multi-regional clinical studies to support regulatory approvals in its licensed territories.

In May 2025, SMMT reported encouraging results from the phase III HARMONi study, which evaluated 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 study met one of its two primary endpoints — progression-free survival (PFS). Although the study did not meet the overall survival (OS) endpoint, the data showed a favorable trend toward OS. Based on these results, Summit Therapeutics submitted a biologics license application with the FDA in January 2026. A final decision on ivonescimab’s approval is expected by Nov. 14, 2026.

The company is currently enrolling patients in three late-stage studies on ivonescimab — two in NSCLC (HARMONi-3 and HARMONi-7) and one in CRC (HARMONi-GI3).

HARMONi-3 is evaluating ivonescimab against Merck’s (MRK - Free Report) blockbuster drug Keytruda, as first-line treatment for metastatic squamous and non-squamous NSCLC, while HARMONi-7 is evaluating ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. A data readout from the squamous cohort of the HARMONi-3 study is expected in the second half of 2026, which could be an important catalyst for the stock.

Enrollment in the non-squamous NSCLC cohort is expected to be completed by the end of second-quarter 2026, with PFS data anticipated in the first half of 2027.

Beyond lung cancer, Summit Therapeutics has expanded development into gastrointestinal cancers through the HARMONi-GI3 study, the company’s first late-stage study outside NSCLC. The study is evaluating the candidate in combination with chemotherapy against bevacizumab plus chemotherapy in first-line unresectable metastatic colorectal cancer.

Like HARMONi-GI3, Summit plans to start more late-stage studies on ivonescimab and intends to provide updates in the near future.

Strategic Collaborations Expand Development PotentialSummit Therapeutics expanded the potential of ivonescimab through a collaboration with drug giant GSK plc (GSK - Free Report) to evaluate the candidate in combination with GSK’s investigational B7-H3-targeting antibody drug conjugate, risvutatug rezetecan, across multiple solid tumors, including small cell lung cancer (SCLC). The company has partnered with GORTEC, MD Anderson Cancer Center, Pfizer and Revolution Medicines to accelerate ivonescimab’s preclinical and clinical development across several solid tumor indications beyond its current core development plan.

SMMT's Zacks Rank & EstimatesSummit Therapeutics currently has a Zacks Rank #2 (Buy). Over the past 30 days, estimates for SMMT’s 2026 loss per share have narrowed from $1.31 to $1.17, and 2027 estimates for loss per share have improved from $1.38 to $1.21.

Positive regulatory updates and the successful development of ivonescimab could support the further momentum for the stock in 2026.

Encouraging Global Phase II Ivonescimab Data in First-Line Metastatic Colorectal Cancer Presented at ASCO 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) today presented new results from the AK112-206 trial (NCT05382442), a global, open-label, multicenter Phase II study in first-line metastatic colorectal cancer (mCRC) co-sponsored by Summit and Akeso, featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab. The data were presented today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

The presentation, entitled “Ivonescimab with Oxaliplatin + Fluorouracil + Leucovorin Calcium for Patients with Unresectable Metastatic Colorectal Cancer: A Phase 2 Study,” detailed interim results of the multiregional extension portion of the study evaluating ivonescimab combined with mFOLFOX6 chemotherapy in patients with unresectable microsatellite stable (MSS) mCRC who were previously untreated for metastatic disease. Patients (n=49) were randomized (1:1) to receive ivonescimab (10 or 20 mg/kg; n=24, n=25, respectively) plus mFOLFOX6 once every two weeks. The data cut-off for this analysis was March 31, 2026 (10 or 20 mg/kg median follow-up: 9.9 months, 9.8 months, respectively).

In this U.S.- and China-based Phase II cohort of treatment-naïve patients with mCRC, patients receiving ivonescimab in combination with standard-of-care doublet chemotherapy mFOLFOX6 demonstrated an objective response rate (ORR) of 70.8% across both arms in evaluable patients (n=48). This result is encouraging compared to historical performance of standard-of-care regimens combining bevacizumab with FOLFOX chemotherapy from prior studies. Treatment responses in the ivonescimab 20 mg/kg arm were more durable than in the ivonescimab 10 mg/kg arm, with a duration of response landmark estimate at 9 months of 79.1% vs. 41.5%, respectively. While progression-free survival (PFS) analysis is still immature in this study, the landmark 9-month PFS rate was 76.1% for those patients receiving 20 mg/kg of ivonescimab.

The safety profile of ivonescimab combined with chemotherapy in this study is comparable to rates observed in historical studies with chemotherapy and anti-VEGF antibodies. In total including both arms, 20.4% of patients experienced serious treatment-related adverse events (TRAEs) associated with either ivonescimab or chemotherapy. There were no ivonescimab-related deaths and one ivonescimab-related discontinuation, supporting the tolerability and ability to manage adverse events.

“In this expansion cohort of treatment-naïve patients with metastatic colorectal cancer, the addition of ivonescimab to mFOLFOX6 delivered deep and durable response rates that compare favorably to historical benchmarks seen with chemotherapy alone or in combination with anti-VEGF therapies,” said David Berz, M.D., Ph.D., medical oncologist, Founder of Valkyrie Clinical Trials and an investigator in the AK112-206 study. “While progression-free survival remains immature, the high proportion of patients who were progression-free at nine months is encouraging, and the safety profile was consistent with established standards of care. These results support the potential of this dual-targeted approach to improve outcomes in this difficult-to-treat population and warrant further investigation.”

Ivonescimab continues to demonstrate an acceptable and manageable safety profile with no new safety signals observed in this study. This was consistent with previous studies of ivonescimab, including Phase II data in mCRC, and evidencing the potential for a favorable benefit-risk profile for ivonescimab plus mFOLFOX6 in this setting. In this study, adverse events were manageable: all patients experienced at least one treatment-emergent adverse event (TEAE) related to either ivonescimab or chemotherapy with the most common events on both dosing arms being decreased neutrophil count, decreased white blood cell count, and anemia.

“Metastatic colorectal cancer remains a significant area of unmet need, where many patients continue to face limited durable treatment options,” said Allen S. Yang, M.D., Ph.D., Chief R&D Strategy Officer of Summit. “These data add to the growing body of evidence supporting the potential of ivonescimab as a differentiated PD-1 / VEGF bispecific, and we are committed to advancing its development across multiple tumor types where we believe it may meaningfully improve patient outcomes.”

Summit is currently conducting HARMONi-GI3 (NCT07228832), a global Phase III clinical trial evaluating ivonescimab in combination with mFOLFOX6 chemotherapy compared with bevacizumab plus mFOLFOX6 chemotherapy in patients with first-line unresectable mCRC. This study is featured at this year’s ASCO Annual Meeting in a Trials-in-Progress (TiP) presentation entitled, “A Randomized, Active-Controlled Phase 3 Study of Ivonescimab + FOLFOX Versus Bevacizumab + FOLFOX as First-Line Treatment of Metastatic Colorectal Cancer: HARMONi-GI3.”

About Colorectal Cancer
Colorectal cancer (CRC), which includes cancers of the colon and rectum, is the third most commonly diagnosed cancer worldwide and the second leading cause of cancer-related death, with approximately 1.9 million new cases and more than 900,000 deaths reported globally in 2022.1 In the U.S., CRC remains a significant health burden, with an estimated 158,850 new cases and 55,230 deaths projected in 2026.2 Prognosis is highly dependent on stage at diagnosis: while overall 5-year survival is approximately 65%, patients with metastatic disease have substantially poorer outcomes, with 5-year survival rates of approximately 13% for metastatic colon cancer and 18% for metastatic rectal cancer.2,3 These data underscore the urgent need for improved treatment options for patients with metastatic CRC (mCRC).

CRC is biologically heterogeneous, with tumors broadly classified based on microsatellite status. Approximately 80–85% of colorectal cancers are microsatellite stable (MSS), also referred to as mismatch repair–proficient (pMMR) tumors.4 MSS/pMMR colorectal tumors are typically characterized by lower tumor mutational burden and an immune-cold phenotype, with limited responsiveness to immune checkpoint inhibitors.5,6 In metastatic disease, they represent the overwhelming majority of cases, accounting for approximately 95% of tumors.5 As a result, most patients with mCRC are not eligible for currently approved immunotherapy monotherapies and are treated with chemotherapy-based regimens, often in combination with targeted therapies such as anti-VEGF and anti-EGFR agents.

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 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 this 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 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four 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 CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.

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.

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.

In addition, Akeso has recently 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 HARMONi-A, with a manageable safety profile in each study.

HARMONi-A was 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 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.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, 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.

References:

World Health Organization. Colorectal cancer fact sheet. February 13, 2026. Accessed May 19, 2026. National Cancer Institute, Surveillance, Epidemiology, and End Results (SEER) Program. Cancer Stat Facts: Colorectal Cancer. Accessed May 19, 2026. American Cancer Society. Survival Rates for Colorectal Cancer (based on SEER 2014–2020 data). January 13, 2026. Accessed May 19, 2026. Colorectal Cancer Alliance. Microsatellite Stability Biomarker (MSS). Accessed May 19, 2026. Lieu CH. The use of immunotherapy in metastatic microsatellite-stable colorectal cancer. Hematol Oncol. 2022;20(12). Han YJ, Shao CY, Yao Y, et al. Immunotherapy of microsatellite stable colorectal cancer: resistance mechanisms and treatment strategies. Postgrad Med J. 2024;100:373–381. 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 that 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260530544179/en/

Ivonescimab Plus Chemotherapy Reduced the Risk of Death by 34% Compared to Tislelizumab Plus Chemotherapy; Hazard Ratio 0.66

First Regimen to Achieve a Statistically Significant and Clinically Meaningful Overall Survival Benefit over an anti-PD-(L)1 Antibody Combined with Chemotherapy in a Phase III Clinical Trial in 1L NSCLC

Tolerable Safety Profile Consistent with Prior Clinical Trial Results

Simultaneous Publication of Latest Ivonescimab HARMONi-6 Results in The Lancet

Summit Conference Call to Be Held at 7:00 a.m. ET on Monday, June 1, 2026

MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) today announced positive overall survival (OS) results from the Phase III HARMONi-6 trial, conducted in China and sponsored by Summit’s partner Akeso, Inc. (HKEX Code: 9926.HK), will be presented today as part of the Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

The presentation is entitled “Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in previously untreated advanced squamous non-small cell lung cancer: Overall survival results of the phase 3 HARMONi-6 trial.” HARMONi-6 is evaluating ivonescimab in combination with platinum-based chemotherapy compared to tislelizumab, a PD-1 inhibitor, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression. HARMONi-6 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. The trial’s primary endpoint is progression-free survival (PFS), and OS is a key secondary endpoint.

The trial results will be presented by Dr. Shun Lu, MD, PhD, Chief of Shanghai Lung Cancer Center at Shanghai Chest Hospital, Professor of Medicine at Shanghai Jiaotong University, and associate editor for the Journal of Thoracic Oncology.

In major markets globally, first-line therapy for patients with advanced NSCLC without driver mutations is most commonly a PD-1 inhibitor plus platinum-based chemotherapy. Prior to HARMONi-6, there were no known Phase III clinical trials in advanced NSCLC which have shown a statistically significant and clinically meaningful improvement in OS when compared to PD-(L)1 inhibitor therapy in combination with chemotherapy in a head-to-head setting. Examples of PD-(L)1 inhibitors include pembrolizumab, nivolumab, tislelizumab, and atezolizumab.

Clinically Meaningful Efficacy

In the HARMONi-6 planned interim analysis of OS, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement when compared to tislelizumab in combination with chemotherapy, with a hazard ratio (HR) of 0.66 (95% CI: 0.50, 0.87; p=0.0017). A clinically meaningful benefit was demonstrated across clinical subgroups, including those with either PD-L1 negative or positive expression. OS rates at 24 months were 64.7% for those patients receiving ivonescimab plus chemotherapy compared to 48.6% for those receiving tislelizumab plus chemotherapy. Median follow-up time of the current data cut was 21.4 months.

HARMONi-6 ITT (n=532):

Median Follow-up: 21.36 mos.

Ivonescimab + Chemo

(n=266)

Tislelizumab + Chemo

(n=266)

Median OS

27.89 mos.

(95% CI: 27.89, NE)

23.69 mos.

(95% CI: 20.11, NE)

24-Month OS Rates

64.7%

48.6%

OS Stratified HR

0.66

(95% CI: 0.50, 0.87; p= 0.0017)

mos.: months; NE: not established

“For the first time, a Phase III clinical study has demonstrated a statistically significant overall survival benefit in front-line driver-mutation-negative non-small cell lung cancer compared to anti-PD-1 therapy in combination with chemotherapy,” said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. “While this represents another study where ivonescimab has demonstrated a significant OS benefit, these data represent the answer to the question regarding ivonescimab and its ability to translate PFS benefits into the extension of lives for patients with cancer in the front-line setting compared to immunotherapy-based regimens.”

The HARMONi-6 study met its primary endpoint as announced in April 2025, showing a statistically significant and clinically meaningful improvement in PFS. Detailed results for efficacy and safety were presented at the European Society of Medical Oncology 2025 Congress (ESMO 2025) last October and published in The Lancet simultaneously.

Safety Profile

In this analysis, ivonescimab continued to demonstrate an acceptable and manageable safety profile in the HARMONi-6 study, which was consistent with previous Phase III studies of ivonescimab plus chemotherapy. No additional safety signals were noted in the HARMONi-6 study in this current data cut compared to the previous data cut presented.

Treatment-related serious adverse events occurred in 41.4% of patients receiving ivonescimab in combination with chemotherapy and 34.3% of patients receiving tislelizumab in combination with chemotherapy. Most of the possibly VEGF-related adverse events occurring in the ivonescimab-plus-chemotherapy arm were classified as Grade 1 or 2; Grade 3 or higher hemorrhage events were observed in 2.6% of patients in the ivonescimab-plus-chemotherapy arm compared to 0.8% of patients in the tislelizumab-plus-chemotherapy arm in this study. Treatment-related adverse events (TRAEs) leading to discontinuation in this study occurred in 5.3% of patients receiving ivonescimab plus chemotherapy compared to 4.5% for those receiving tislelizumab plus chemotherapy.

In squamous NSCLC, VEGF-A monoclonal antibodies have had limited clinical development based on historical data demonstrating significant risks of toxicity, including life-threatening hemorrhage and other bleeding complications. The results of this study further validate the unique mechanism of action of ivonescimab, including apparent key differences as compared to historical clinical studies where an anti-PD-1 monoclonal antibody and an anti-VEGF monoclonal antibody were administered separately.

HARMONi-6 Clinical Trial Results Published in The Lancet

The Lancet simultaneously published these findings in a manuscript titled, “Ivonescimab plus Chemotherapy for Squamous Non-small-cell Lung Cancer.”

“A heartfelt congratulations to our partner, Akeso, for their continuing, tremendous efforts to make a significant difference in the lives of patients with cancer,” said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. “The decision we made in December 2022 to enter into a partnership specifically with Akeso and accelerate the global clinical development plan of this potentially landscape-changing compound in ivonescimab is further validated with these groundbreaking results for patients facing high unmet medical needs. We look forward to continuing this positive momentum.”

Conference Call

Summit will host a conference call and live webcast to discuss recent updates related to ivonescimab, including data released at ASCO, on Monday, June 1, 2026, at 7:00 a.m. ET. Conference call and webcast information is accessible through the company’s website, www.smmttx.com. An archived edition of the webcast will be available on the website later in the day on Monday.

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 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 this 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 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four 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 CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3.

HARMONi is a Phase III clinical trial is 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.

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.

In addition, Akeso has recently 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, and a manageable safety profile in each study.

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.

Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, 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 that 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.

For most of the past three decades, U.S.-listed biotech companies were fair proxies for homemade American science. But now, that assumption is fraying. By one estimate from investment bank Jefferies, roughly a third of the industry's licensing spending in 2025 went toward drugs and candidates that originated in China, where lower costs and faster regulators have turned its labs into a firehose of ready-to-license molecules and programs.

In antibody-drug conjugates (ADCs) -- an increasingly sophisticated class of targeted therapies -- Chinese biotechs now supply close to 90% of global licensing activity. The question is, when you buy a U.S. biotech stock whose most promising programs were invented elsewhere, by another company, what are you actually holding?

In some cases, the answer to that question might contain an unpleasant surprise for investors, which is why this trend of importing innovation is also an emerging risk worth understanding.

Image source: Getty Images.

It's dangerous to bet that American biotechs will replicate foreign results Summit Therapeutics (SMMT +2.57%) is a biotech with an investment thesis that's almost entirely dependent on the success of ivonescimab, an antibody therapy for various cancers that it licensed from China's Akeso in 2022, paying $500 million up front and low-double-digit royalties on sales. Summit didn't discover the molecule; it bought the right to sell it in the U.S., Europe, and Japan.

In May 2025, according to the first peek, investors were given data from ivonescimab's global phase 3 trial for patients with previously treated, EGFR-mutated non-small cell lung cancer (NSCLC). Treatment with ivonescimab plus chemotherapy led to an impressive 48% gain in progression-free survival (PFS). But the data for overall survival (how long patients lived) did not pass the threshold for statistical significance.

Today's Change

(

2.57

%) $

0.34

Current Price

$

13.38

After the full trial data were presented later in the year, there was another, even larger issue: The cohorts of patients from Western countries saw only a 33% reduction in the risk of progression or death, versus a 45% reduction in Chinese patients, with the Western group's benefit not being statistically significant. And that's precisely the kind of discrepancy that regulators at the U.S. Food and Drug Administration (FDA) are likely to take issue with before they decide whether to approve ivonescimab, slated for mid-November of this year.

Similarly, shortly before that readout, an FDA panel ruled that a largely Asian data set supporting another cancer drug was inapplicable to U.S. patients, a precedent that now shadows every China-heavy trial and, by extension, nearly all trials of candidates licensed from China. Summit filed with the FDA for a narrower second-line use indication in early 2026, giving up some of its grander ambitions for ivonescimab.

Investors who bet that Akeso's data would be easy for Summit to replicate, leading to a low-risk, easy approval process for ivonescimab in the U.S., have not fared well. The biotech's stock is down 35% in the last 12 months. This emerging risk contributed to that decline, alongside a broadly weak biotech market and ivonescimab's survival shortfall.

Big pharma is vulnerable, too This risk applies to major pharma companies and stocks as well.

For instance, Merck (MRK +2.75%) has leaned hard on Chinese innovation, including with a seven-drug deal with Kelun-Biotech worth $175 million up front and up to $9.3 billion in milestones. It hasn't experienced any of the same problems as Summit did, at least not yet.

Still, this problem is not a passing phase; China's latest five-year plan, approved in 2026, names biotechnology a "frontier" priority. The supply of licensable assets will only grow from here. Many of the U.S. biopharmas that rely on those assets will satisfy the FDA that their candidates are safe and effective. Others will hit the same wall Summit did: Global populations and the way clinical trial sites operate from one country to the next vary enough that some mismatches are inevitable.

The best way for investors to protect themselves is to ask where a company's value comes from before buying any shares. A business that discovers, develops, and manufactures its own drugs deserves a richer valuation than a stack of licensed-in bets because the licensee carries extra risks related to royalties going to the originator and whether foreign data clears the FDA.

That doesn't make Summit or its peers uninvestable, but it does mean that many clinical-stage stocks will look cheap because someone else has built most of their underlying value, which can be problematic.

Shares of Summit Therapeutics PLC (SMMT - Free Report) have gained 8.8% over the past four weeks to close the last trading session at $17.54, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $29.31 indicates a potential upside of 67.1%.

The mean estimate comprises 15 short-term price targets with a standard deviation of $12.01. While the lowest estimate of $7.70 indicates a 56.1% decline from the current price level, the most optimistic analyst expects the stock to surge 156.6% to reach $45.00. It's very important to note the standard deviation here, as it helps understand the variability of the estimates. The smaller the standard deviation, the greater the agreement among analysts.

While the consensus price target is a much-coveted metric for investors, solely banking on this metric to make an investment decision may not be wise at all. That's because the ability and unbiasedness of analysts in setting price targets have long been questionable.

However, an impressive consensus price target is not the only factor that indicates a potential upside in SMMT. This view is strengthened by the agreement among analysts that the company will report better earnings than what they estimated earlier. Though a positive trend in earnings estimate revisions doesn't give any idea as to how much the stock could surge, it has proven effective in predicting an upside.

Price, Consensus and EPS Surprise

Here's What You Should Know About Analysts' Price TargetsAccording to researchers at several universities across the globe, a price target is one of many pieces of information about a stock that misleads investors far more often than it guides. In fact, empirical research shows that price targets set by several analysts, irrespective of the extent of agreement, rarely indicate where the price of a stock could actually be heading.

While Wall Street analysts have deep knowledge of a company's fundamentals and the sensitivity of its business to economic and industry issues, many of them tend to set overly optimistic price targets. Are you wondering why?

They usually do that to drum up interest in shares of companies that their firms either have existing business relationships with or are looking to be associated with. In other words, business incentives of firms covering a stock often result in inflated price targets set by analysts.

However, a tight clustering of price targets, which is represented by a low standard deviation, indicates that analysts have a high degree of agreement about the direction and magnitude of a stock's price movement. While that doesn't necessarily mean the stock will hit the average price target, it could be a good starting point for further research aimed at identifying the potential fundamental driving forces.

That said, while investors should not entirely ignore price targets, making an investment decision solely based on them could lead to disappointing ROI. So, price targets should always be treated with a high degree of skepticism.

Why SMMT Could Witness a Solid UpsideAnalysts' growing optimism over the company's earnings prospects, as indicated by strong agreement among them in revising EPS estimates higher, could be a legitimate reason to expect an upside in the stock. That's because empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.

For the current year, four estimates have moved higher over the last 30 days compared to no negative revision. As a result, the Zacks Consensus Estimate has increased 10.4%.

Moreover, SMMT currently has a Zacks Rank #2 (Buy), which means it is in the top 20% of more than 4,000 stocks that we rank based on four factors related to earnings estimates. Given an impressive externally-audited track record, this is a more conclusive indication of the stock's potential upside in the near term. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> .

Therefore, while the consensus price target may not be a reliable indicator of how much SMMT could gain, the direction of price movement it implies does appear to be a good guide.