Latest news with #HARMONi-2
Business Wire
25-04-2025
- Business
- Business Wire
Interim Overall Survival Analysis Requested from Chinese Health Authorities Shows a Clinically Meaningful, Positive Trend Favoring Ivonescimab Compared to Pembrolizumab in PD-L1 Positive Advanced NSCLC from HARMONi-2 Study Conducted by Akeso in China
MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) ('Summit,' 'we,' or the 'Company') today noted that Akeso, Inc. (Akeso, HKEX Code: announced that ivonescimab was approved by the Chinese Health Authorities, the National Medical Products Administration (NMPA), for a second indication based on the results of the Phase III clinical trial, HARMONi-2 or AK112-303. HARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression. HARMONi-2 is a single region, multi-center, Phase III study conducted in China sponsored by Akeso with all relevant data exclusively generated, managed, and analyzed by Akeso. As a part of the review of the supplemental marketing application submitted by Akeso seeking a label expansion of ivonescimab in China, the NMPA requested that Akeso perform an interim analysis of overall survival (OS). Akeso announced that the results of this interim overall survival analysis included a clinically meaningful hazard ratio of 0.777. The analysis was conducted at 39% data maturity, with a nominal alpha level of 0.0001. Last September, for the primary analysis for HARMONi-2, 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 monotherapy pembrolizumab, 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. 'We are pleased to see that a trial that was designed to test for progression-free survival as the sole primary endpoint demonstrates a clinically meaningful overall survival trend at just 39% data maturity,' added Robert W. Duggan, Chairman and Co-Chief Executive Officer and Dr. Maky Zanganeh, Co-Chief Executive Officer and President of Summit. 'The clinically meaningful overall survival trend underscores the opportunity of ivonescimab to represent a potential to be the next generation in PD-1 directed immunotherapy, and potentially make a significant difference in the lives of patients with lung cancer and prospectively other tumors.' Summit is currently enrolling patients in the HARMONi-7 study. HARMONi-7 is a multiregional Phase III clinical trial sponsored by Summit which is evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-7 is currently enrolling patients globally and is conducted with registrational intent for the United States and other regions within Summit's license territories. 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 in China and Australia, 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. 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 could 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. Ivonescimab's tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC, 2023). 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, SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: and is currently engaged in multiple Phase III clinical trials. Over 2,300 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3, and the Company has begun to activate clinical trial sites in the United States for HARMONi-7. HARMONi is a Phase III clinical trial which intends to evaluate 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 a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in HARMONi was completed in the second half of 2024, and top-line results are expected to be announced in the middle of this year. HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6. 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 non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression. 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 approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. About Summit Therapeutics 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 our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK. For more information, please visit and follow us 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., 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, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program ('ATM Program'), the expected proceeds and uses thereof, 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, 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" section of filings that the Company makes with the Securities and Exchange Commission. 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 trademarks of Summit Therapeutics Inc. Copyright 2025, Summit Therapeutics Inc. All Rights Reserved.
Yahoo
25-04-2025
- Business
- Yahoo
Interim Overall Survival Analysis Requested from Chinese Health Authorities Shows a Clinically Meaningful, Positive Trend Favoring Ivonescimab Compared to Pembrolizumab in PD-L1 Positive Advanced NSCLC from HARMONi-2 Study Conducted by Akeso in China
Interim Analysis of HARMONi-2 Shows an Overall Survival Hazard Ratio of 0.777 Favoring Ivonescimab at 39% Data Maturity, Implying a Potential Numerical 22% Reduction in the Risk of Death Compared to Pembrolizumab Ivonescimab Monotherapy Approved by NMPA in China for Front-Line PD-L1 Positive Advanced NSCLC MIAMI, April 25, 2025--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today noted that Akeso, Inc. (Akeso, HKEX Code: announced that ivonescimab was approved by the Chinese Health Authorities, the National Medical Products Administration (NMPA), for a second indication based on the results of the Phase III clinical trial, HARMONi-2 or AK112-303. HARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression. HARMONi-2 is a single region, multi-center, Phase III study conducted in China sponsored by Akeso with all relevant data exclusively generated, managed, and analyzed by Akeso. As a part of the review of the supplemental marketing application submitted by Akeso seeking a label expansion of ivonescimab in China, the NMPA requested that Akeso perform an interim analysis of overall survival (OS). Akeso announced that the results of this interim overall survival analysis included a clinically meaningful hazard ratio of 0.777. The analysis was conducted at 39% data maturity, with a nominal alpha level of 0.0001. Last September, for the primary analysis for HARMONi-2, 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 monotherapy pembrolizumab, 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. "We are pleased to see that a trial that was designed to test for progression-free survival as the sole primary endpoint demonstrates a clinically meaningful overall survival trend at just 39% data maturity," added Robert W. Duggan, Chairman and Co-Chief Executive Officer and Dr. Maky Zanganeh, Co-Chief Executive Officer and President of Summit. "The clinically meaningful overall survival trend underscores the opportunity of ivonescimab to represent a potential to be the next generation in PD-1 directed immunotherapy, and potentially make a significant difference in the lives of patients with lung cancer and prospectively other tumors." Summit is currently enrolling patients in the HARMONi-7 study. HARMONi-7 is a multiregional Phase III clinical trial sponsored by Summit which is evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-7 is currently enrolling patients globally and is conducted with registrational intent for the United States and other regions within Summit's license territories. 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 in China and Australia, 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. 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 could 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. Ivonescimab's tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, SITC, 2023). 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, SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: and is currently engaged in multiple Phase III clinical trials. Over 2,300 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3, and the Company has begun to activate clinical trial sites in the United States for HARMONi-7. HARMONi is a Phase III clinical trial which intends to evaluate 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 a 3rd generation EGFR TKI (e.g., osimertinib). Enrollment in HARMONi was completed in the second half of 2024, and top-line results are expected to be announced in the middle of this year. HARMONi-3 is a Phase III clinical trial which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC: HARMONi-A, HARMONi-2, and HARMONi-6. 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 non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression. 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 approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. About Summit Therapeutics 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 our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK. For more information, please visit and follow us 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., 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, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program ("ATM Program"), the expected proceeds and uses thereof, 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, 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" section of filings that the Company makes with the Securities and Exchange Commission. 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 trademarks of Summit Therapeutics Inc. Copyright 2025, Summit Therapeutics Inc. All Rights Reserved. View source version on Contacts Contact Summit Therapeutics: Dave GancarzChief Business & Strategy Officer Nathan LiaBraatenSenior Director, Investor Relations investors@ media@
Yahoo
25-04-2025
- Business
- Yahoo
Here's Why Summit Therapeutics Stock Soared 15% on Friday
Shares of Summit Therapeutics SMMT rose more than 15% on Friday after the analysts at Cantor Fitzgerald and Truist Securities maintained their positive outlook on the company. Both investment firms remain optimistic about Summit Therapeutics' lead pipeline drug, ivonescimab. This drug was developed in collaboration with China-based Akeso, which is also its original developer. Summit in-licensed the right to develop and market the drug in 2022 across several territories, including the United States and Europe. Cantor reportedly reiterated its Overweight rating on SMMT after an SEC filing revealed that the company's co-chief executive officer (co-CEO), Bob Duggan, exercised warrants to acquire nearly 4 million shares of the company. This transaction was executed about four years before the warrants expired at a strike price of $1.58 each. The analyst pointed out that this indicated a bullish signal for the stock. Another regulatory filing also revealed that the company's other co-CEO, Zanganeh Mahkam, procured a similar number of SMMT shares after exercising her warrants roughly four years in advance. The analysts at Truist also maintained their 'Buy' rating on Summit and a price target of $35 per share. Year to date, shares of Summit have surged 30% against the industry's 10% decline. Image Source: Zacks Investment Research The growing optimism around SMMT stock stems from the recently reported results from the HARMONi-2 study, whichevaluated ivonescimab against Merck's MRK blockbuster oncology drug Keytruda in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. Last year in May, Summit reported that the drug met its primary endpoint of progression-free survival (PFS), delivering statistically significant and clinically meaningful benefits. Updated results released in September further revealed that ivonescimab cut the risk of disease progression or death by nearly half compared to Keytruda. A clinically meaningful benefit of the drug was also seen across multiple clinical subgroups, including those with PD-L1 low and high expression, squamous and non-squamous histologies, and other high-risk patients. Based on the HARMONi-2 study results, we believe that ivonescimab could replace Keytruda as the next standard of care across multiple NSCLC settings. Unlike the Merck drug, which targets the PD-1 protein, the Summit drug is a first-in-class bispecific antibody that targets two proteins, namely PD-1 and VEGF. We believe this dual mechanism differentiates ivonescimab from currently available therapies for solid tumors as there is a potentially higher expression of both these proteins in tumor tissue compared to the normal tissues in the body. Analysts at Truist are optimistic about the overall survival (OS) data from the HARMONI-2 study, expected later this year. OS is considered to be the 'gold standard' for measuring the clinical benefits of a cancer drug. Currently, ivonescimab is only approved in China to treat patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR-TKI. This approval, received last year in May, is based on data from the late-stage HARMONi-A study, which showed that treatment with the drug achieved the primary endpoint of PFS when compared to placebo. Summit is currently conducting two late-stage studies on the drug in separate NSCLC settings, with data from one study expected in mid-2025. SMMT is also likely to start a third-late study evaluating the drug in a separate NSCLC setting later this year. Developing bispecific antibodies that target two proteins, namely PD-1 and VEGF, has been one of the lucrative areas in the treatment of cancer of late. Companies like BioNTech BNTX and Instil Bio TIL are also developing their respective PD-1/VEGF-targeting antibody candidates, namely BNT327 and AXN-2510. Despite the competition, we believe Summit enjoys the advantage of being ahead in clinical development over the BioNTech and Instil Bio therapies. The BNTX and TIL candidates are still at least a couple of years away from reaching the same clinical development position as SMMT. In November, Merck signed a deal with China-based LaNova Medicines for the latter's LM-299, which is also based on the same mechanism as ivonescimab. Merck intends to advance the drug's clinical development 'with speed and rigor for patients in need.' Summit Therapeutics PLC price | Summit Therapeutics PLC Quote Summit currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Merck & Co., Inc. (MRK) : Free Stock Analysis Report Summit Therapeutics PLC (SMMT) : Free Stock Analysis Report Instil Bio, Inc. (TIL) : Free Stock Analysis Report BioNTech SE Sponsored ADR (BNTX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
25-04-2025
- Business
- Yahoo
Why Summit Therapeutics Rocketed Double-Digits Today
Shares of lung cancer biotech Summit Therapeutics (NASDAQ: SMMT) rocketed 14.7% on Wednesday as of 1:45 p.m. ET. The markets were broadly up today on a potential easing of trade tensions with China. That should be a positive for Summit, as its main partner for its current lung cancer drug trials is Chinese biotech Akeso (OTC: AKES.F). Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. Continue » But the real reason for the market-beating performance today was more good news regarding a phase III trial for Summit's breakthrough drug, ivonescimab. Summit disclosed some preliminary results of its HARMONi-6 trial, conducted in partnership with Akeso. In the trial, Summit's antibody drug ivonescimab was administered along with platinum-based chemotherapy against the current standard of care, tislelizumab, which is made by BeiGene (NASDAQ: BGNE), in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). The trial showed ivonescimab delivered a "statistically significant improvement" in patients meeting the primary endpoint, which was progression-free survival, for patients with both positive and negative PD-L1 press release said the full data set would be disclosed in a presentation later this year. The positive trial comes on top of last year's groundbreaking HARMONi-2 trial in which ivonescimab topped Keytruda in a study where both drugs were administered as a monotherapy for patients with NSCLC. The consistent outperformance in multiple forms of administration against multiple existing standards of care is certainly very bullish for Summit, whose stock is nearly all the way back to an all-time high first touched last September, just after the HARMONi-2 trial data came in. All in all, ivonescimab seems well on its way to becoming a blockbuster drug for lung cancer, displacing the existing standards of care along with it. So, it's perhaps no wonder that BeiGene's stock was actually down a bit today; even the broader markets staged a big rally. Before you buy stock in Summit Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Summit Therapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $561,046!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $606,106!* Now, it's worth noting Stock Advisor's total average return is 811% — a market-crushing outperformance compared to 153% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of April 21, 2025 Billy Duberstein and/or his clients have no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Summit Therapeutics. The Motley Fool has a disclosure policy. Why Summit Therapeutics Rocketed Double-Digits Today was originally published by The Motley Fool Sign in to access your portfolio
Yahoo
11-04-2025
- Business
- Yahoo
Summit co-CEO option exercise ‘quite bullish,' says Cantor Fitzgerald
Cantor Fitzgerald views Bob Duggan's, Summit Therapeutics (SMMT) co-CEO and Chairman, stock option exercise 'quite unusual' and 'quite bullish' for the shares. Duggan' exercised warrants to purchase 4M shares of Summit at $1.58 approximately four years before their expiration, the analyst tells investors in a research note. Cantor has an Overweight rating on Summit Therapeutics. The stock in midday trading is up 9%, or $1.66, to $19.89. Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on SMMT: Disclaimer & DisclosureReport an Issue Expert says Summit's HARMONi-2 study could beat expectations, says Truist Optimistic Buy Rating for Summit Therapeutics Driven by Promising HARMONi-2 Trial and Favorable Regulatory Pathway in China Promising Potential of Ivonescimab in Oncology: A Buy Recommendation for Summit Therapeutics Moleculin, CNS, Global-e, Tenet, Summit: Trending by Analysts Summit Therapeutics upgraded to Buy from Neutral at Citi Sign in to access your portfolio
