Core Viewpoint - The Portnoy Law Firm has initiated an investigation into Summit Therapeutics Inc. for potential securities fraud, following significant stock price declines related to clinical trial results [2][4]. Group 1: Investigation Details - The investigation is focused on possible violations of federal securities laws concerning Summit Therapeutics [4]. - A class action may be filed on behalf of investors affected by the alleged fraud [2]. Group 2: Clinical Trial Results - On May 30, 2025, Summit announced topline results from the Phase III clinical trial of ivonescimab, which showed that patients treated with ivonescimab and chemotherapy were 48% less likely to progress or die compared to those receiving chemotherapy alone [4]. - Despite the initial results, the drug did not demonstrate a statistically significant difference in overall survival, leading to a stock price drop of $7.99 per share, or 30.5%, closing at $18.22 on the same day [4]. - On September 7, 2025, additional data revealed weaker results for ivonescimab in North American and European patients, causing a further decline of $6.54 per share, or 25.15%, to close at $19.45 on September 8, 2025 [4].

Core Viewpoint - Summit Therapeutics Inc. is facing a class action lawsuit due to allegations of making false and misleading statements regarding its Pinnacle Study of poziotinib, impacting investors who purchased securities during the specified Class Period [3]. Group 1: Class Action Details - The class action represents investors who bought securities between March 17, 2022, and September 22, 2022, with a deadline of September 24, 2025, to file a lead plaintiff motion [1]. - Investors are encouraged to contact the Portnoy Law Firm for a complimentary case evaluation and to discuss their legal rights [2]. Group 2: Allegations Against Summit - The complaint alleges that Summit's public statements regarding the results of its Pinnacle Study were materially false and misleading, leading to investor damages when the truth was revealed [3].

Core Insights - Summit Therapeutics' shares dropped 25% following the final analysis of the HARMONi study, which evaluated the investigational antibody ivonescimab in non-small cell lung cancer (NSCLC) patients, revealing significant differences in progression-free survival (PFS) between Asian and Western patients [1][6][8] Study Results - The HARMONi study focused on patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed after EGFR-TKI treatment, assessing PFS and overall survival (OS) as primary endpoints [2] - The initial analysis indicated a 48% reduction in disease progression risk with ivonescimab plus chemotherapy compared to chemotherapy alone, but the final analysis showed a 45% risk reduction in Asian patients versus 33% in Western patients [3][8] - For the OS endpoint, the study showed a 21% reduction in death risk, but results were not statistically significant, with a more favorable trend observed in Western patients [4] Collaboration and Market Rights - Summit is developing ivonescimab in collaboration with Akeso, having acquired exclusive rights to market the drug in the US, Canada, Europe, and Japan, while Akeso retains rights in China where the drug is already approved for two NSCLC indications [5] Investor Sentiment - The stock decline reflects investor disappointment over the unexpected PFS gap and the lack of a clear OS benefit, which the FDA has indicated is necessary for marketing authorization in the US [6][8] Year-to-Date Performance - Year-to-date, Summit's stock has increased by 9%, compared to a 12% growth in the industry [7] Competitive Landscape - Summit's ivonescimab is positioned as a potential replacement for PD-(L)1 inhibitors in NSCLC treatment, being a first-in-class bispecific antibody targeting both PD-1 and VEGF, which may offer advantages over existing therapies [12] - The company is conducting additional late-stage studies for ivonescimab in various NSCLC settings [13] - The bispecific antibody market is competitive, with other companies like BioNTech, Bristol Myers, Pfizer, and Merck developing similar candidates, but Summit is currently ahead in clinical development [14][16]

Core Points - The conference call is hosted by Summit Therapeutics, indicating an update on the company's current status and future strategies [1] Group 1 - The call is led by Dave Gancarz, who holds the position of Chief Business and Strategy Officer [1]

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Summit Therapeutics (NasdaqGM:SMMT) Update / Briefing September 08, 2025 08:00 AM ET Company ParticipantsDave Gancarz - Chief Business & Strategy OfficerH. Jack West - VP - Clinical DevelopmentYigal Nochomovitz - DirectorSalveen Richter - Biotechnology Equity ResearchGreg Wiessner - Biotech Equity Research AssociateCory Kasimov - Senior Managing DirectorManmeet Soni - COO & CFOMohit Bansal - MD & Co-Head - Therapeutics ResearchNone - ExecutiveDaina Graybosch - Senior MD - Immuno-OncologyClara Dong - VP - Eq ...

Summit Therapeutics WCLC Update Call September 8, 2025 8:00am ET Forward Looking Statement 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 p ...

Core Insights - The Phase III HARMONi trial data for ivonescimab plus chemotherapy shows an improving overall survival (OS) trend with a nominal p-value of 0.0332 compared to chemotherapy alone, particularly in North American patients with an OS hazard ratio (HR) of 0.70 [1][4][6] Group 1: Trial Overview - HARMONi trial evaluated ivonescimab plus platinum-doublet chemotherapy against placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who progressed after third-generation EGFR TKI treatment [2][18] - The trial's primary endpoints were progression-free survival (PFS) and overall survival (OS), with previous PD-1 monoclonal antibodies failing to show benefits in similar settings [2] Group 2: Efficacy Results - In the primary analysis, ivonescimab plus chemotherapy showed a median OS of 16.8 months versus 14.0 months for placebo plus chemotherapy, with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057) [4][6] - Longer-term follow-up analysis indicated a median OS of 17.0 months for ivonescimab compared to 14.0 months for placebo in Western patients, with an improved hazard ratio of 0.84 [6][7] - The overall response rate was higher in the ivonescimab arm at 45% compared to 34% in the placebo arm, with a median duration of response of 7.6 months versus 4.2 months [10] Group 3: Safety Profile - Ivonescimab plus chemotherapy demonstrated a manageable safety profile, with 7.3% of patients discontinuing due to treatment-related adverse events (TRAEs) compared to 5.0% in the placebo group [12][13] - The most common TRAEs included anemia and decreases in white blood cell counts, with less than 1% experiencing Grade 3 or higher hemorrhage events [12][13] Group 4: Future Developments - Summit Therapeutics plans to host a conference call on September 8, 2025, to discuss the ivonescimab data presented at the WCLC 2025 [14][30] - The company is engaged in multiple Phase III clinical trials for ivonescimab, including HARMONi-2 and HARMONi-6, which are expected to further evaluate its efficacy [19][20]

Core Viewpoint - H.C. Wainwright has raised the target price for Summit Therapeutics Inc. (SMMT.US) from $44 to $50 while maintaining a "Buy" rating, indicating a positive outlook for the company [1] Company Overview - Summit Therapeutics is a biopharmaceutical company focused on the research and commercialization of innovative therapies aimed at addressing significant unmet medical needs [1] - The company's current clinical development projects primarily target Clostridium difficile infection (CDI) [1] Market Position - The report highlights that now is an opportune time to invest in Summit, as it serves as a partner for CanSino Biologics (09926) in the U.S. market, providing a unique advantage [1] Clinical Data - The report mentions that CanSino's ivonescimab Phase III study HARMONi-A data validates clinical results in China, demonstrating its efficacy superior to Keytruda [1]

Group 1 - H.C. Wainwright raised the target price for Summit Therapeutics Inc. from $44 to $50 while maintaining a "Buy" rating [1] - The report highlights that the phase III study HARMONi-A data from Kangfang Biotech validates clinical results in China, demonstrating efficacy superior to Keytruda [1] - Summit Therapeutics is positioned as a unique partner for Kangfang Biotech in the U.S. market, presenting a favorable opportunity for investment [1] Group 2 - Summit Therapeutics is a biopharmaceutical company focused on developing and commercializing innovative therapies for serious unmet medical needs [1] - The company's current clinical development projects primarily target Clostridium difficile infection (CDI) [1] - Summit's products emphasize benefits for patients, families, healthcare providers, and society, aiming to extend life and improve quality of life [1]