Key Takeaways SMMT's FDA-accepted BLA seeks approval of ivonescimab plus chemo for NSCLC after third-generation EGFR-TKIs.SMMT faces Nov. 14, 2026, PDUFA date, with FDA planning mid- and late-cycle reviews and labeling talks.SMMT's BLA is backed by the phase III HARMONi data that met PFS, while OS missed but trended favorably.Summit Therapeutics (SMMT) announced that the FDA has accepted its biologics license application (BLA) seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, ...

I have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this space.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 wr ...

Summit Therapeutics (NASDAQ:SMMT) is one of the best large cap stocks under $100 with huge upside potential. On January 14, H.C. Wainwright analyst Mitchell Kapoor reaffirmed his optimistic outlook on Summit Therapeutics (NASDAQ:SMMT). He assigned a Buy rating to the stock with a $40 price target, resulting in an upside of nearly 143%. Copyright: dolgachov / 123RF Stock Photo Kapoor’s rating comes at the back of the company’s submission of Biologics License Application (BLA), relating to ivonescimab cl ...

Group 1: Stock Performance - Regencell Bioscience Holdings Limited (NASDAQ:RGC) slumped 42.08% this week [1] - Figma, Inc. (NYSE:FIG) fell 19.41% this week, with Morgan Stanley analyst lowering the price target from $65 to $48 [1] - Atlassian Corporation (NASDAQ:TEAM) decreased 19.82% this week, while BTIG analyst maintains a Buy rating with a $220 price target [1] - Trip.com Group Limited (NASDAQ:TCOM) fell 20.19% this week due to an investigation by China's SAMR for potential anti-monopoly violations [2] - DocuSign, Inc. (NASDAQ:DOCU) slumped 6.42% this week [2] - HubSpot, Inc. (NYSE:HUBS) decreased 16.56% this week after Morgan Stanley lowered its price target from $640 to $577 [2] - Intuit Inc. (NASDAQ:INTU) fell 14.38% this week, despite opening a new TurboTax flagship and pledging $100,000 to NYC public schools [3] - Nutanix, Inc. (NASDAQ:NTNX) fell 13.19% this week, with multiple analysts lowering their price forecasts [3] - Guidewire Software, Inc. (NYSE:GWRE) decreased 14.09% this week [3] - Summit Therapeutics Inc. (NASDAQ:SMMT) fell 14.09% this week [3]

Core Insights - Summit Therapeutics is poised for a transformative year in 2026, focusing on its lead asset, ivonescimab, which has shown promising results in clinical trials [1][2] Group 1: Clinical Development - Summit and its partner Akeso have completed four positive Phase III studies with ivonescimab, demonstrating its efficacy against PD-1 inhibitors and in settings where these inhibitors have failed [2] - The company believes ivonescimab holds a potential first mover status in the frontline treatment of multiple solid tumors, positioning it strongly in a market projected to exceed $100 billion annually [2] Group 2: Regulatory Progress - Summit submitted its Biologics License Application (BLA) to the FDA in Q4 2025, based on the favorable benefit-risk profile of ivonescimab demonstrated in the HARMONi study [3] - The submission is significant due to the high unmet medical need and limited treatment options available for patients in the relevant settings [3]

Summit Therapeutics FY Conference Summary Company Overview - **Company**: Summit Therapeutics (NasdaqGM:SMMT) - **Lead Asset**: Ivonescimab - **Co-CEOs**: Dr. Maky Zanganeh and Bob Duggan - **Employee Count**: Over 275 employees Industry Context - **Market Size**: The PD-1/VEGF market is estimated to exceed $100 billion annually [2][29] - **Checkpoint Inhibitor Market**: Expected to top $20 billion by 2028 for non-small cell lung cancer alone [29] Key Developments - **Phase III Studies**: Completed four positive Phase III studies for ivonescimab, both in China and globally [1][2] - **BLA Submission**: Submitted Biologics License Application (BLA) to the FDA in Q4 2025 based on positive results from the Harmony study [2][19] - **Clinical Trials**: Actively enrolling in three global Phase III trials: Harmony III, Harmony VII, and Harmony GI III [3][8] Clinical Trial Highlights - **Harmony Studies**: - **Harmony III**: Evaluating ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in frontline metastatic non-small cell lung cancer [10][11] - **Harmony VII**: Evaluating ivonescimab monotherapy against pembrolizumab monotherapy for high PD-L1 expression patients [11] - **Harmony GI III**: Evaluating ivonescimab plus chemotherapy in unresectable metastatic colorectal cancer [12] - **Positive Results**: All four Phase III trials have shown positive results, marking a significant achievement in the PD-1/VEGF class [5][20] Mechanism of Action - **Unique Design**: Ivonescimab is a bispecific antibody designed to improve safety and efficacy by targeting both PD-1 and VEGF [6][7] - **Binding Properties**: Demonstrates cooperative binding properties that enhance anti-tumor activity [6] Competitive Position - **First-Mover Advantage**: Ivonescimab holds a significant lead over competitors in the PD-1/VEGF space, with ongoing trials while others are still in early stages [9][13] - **Collaborations**: Partnerships with Akeso and other companies to expand clinical trials and data collection [8][14] Financial Position - **Cash Balance**: Raised $500 million in October 2025, bringing cash reserves to approximately $710 million, remaining debt-free [28] Future Outlook - **Regulatory Decisions**: Anticipated FDA decision on BLA submission by the end of 2026 [19][27] - **Pipeline Expansion**: Plans to introduce novel combinations and new Phase III studies in 2026 [26][27] Conclusion - **Transformative Year**: 2026 is expected to be pivotal for ivonescimab, with significant potential to impact cancer treatment and patient outcomes [29]

Financial Position - As of December 31, 2025, Summit Therapeutics Inc. reported a preliminary unaudited balance of cash, cash equivalents, and short-term investments of approximately $710 million[6] Regulatory Submissions - The company submitted a Biologics License Application to the U.S. FDA for ivonescimab in combination with chemotherapy for the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer[9] Clinical Collaborations - Summit Therapeutics announced a clinical trial collaboration with GSK to evaluate ivonescimab in combination with GSK's risvutatug rezetecan across multiple solid tumor settings, including small cell lung cancer[10]

Core Viewpoint - Summit Therapeutics Inc. has announced a clinical trial collaboration with GSK plc to evaluate ivonescimab, a novel PD-1/VEGF bispecific antibody, in combination with GSK's investigational B7-H3 targeting antibody drug conjugate, risvutatug rezetecan, across multiple solid tumor settings, including small cell lung cancer [1] Group 1 - The collaboration aims to explore new mechanisms of action in cancer treatment [1]

Core Viewpoint - Summit Therapeutics Inc. has submitted a Biologics License Application (BLA) to the U.S. FDA for ivonescimab, a first-in-class investigational bispecific antibody, aimed at treating patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer in combination with chemotherapy [1]. Group 1 - The BLA submission is a significant step for the company as it seeks regulatory approval for ivonescimab [1]. - Ivonescimab is positioned as a novel treatment option in the second-line or later treatment setting for specific lung cancer patients [1].

Core Viewpoint - Summit Therapeutics Inc. will participate in the 44th Annual J.P. Morgan Healthcare Conference, presenting a corporate overview and updates on organizational progress [1] Group 1 - The conference is scheduled for January 12, 2026, at 9:45 AM PT [1] - Robert W. Duggan and Dr. Maky Zanganeh will represent the company during the presentation [1]