Welcome to our dedicated page for Summit Therapeutics news (Ticker: SMMT), a resource for investors and traders seeking the latest updates and insights on Summit Therapeutics stock.
Summit Therapeutics Inc. develops oncology medicines led by ivonescimab, an investigational PD-1 / VEGF bispecific antibody in-licensed from Akeso. The company reports clinical and operational updates for ivonescimab programs in non-small cell lung cancer and colorectal cancer, including multiregional Phase III studies and data presentations from HARMONi trials.
Recurring Summit Therapeutics news also covers financial results, regulatory updates tied to the accepted Biologics License Application for ivonescimab in EGFR-mutated non-squamous NSCLC after tyrosine kinase inhibitor therapy, clinical trial collaborations, and equity-compensation actions under Nasdaq rules. Summit holds development and commercialization rights for ivonescimab across North America, South America, Europe, the Middle East, Africa, and Japan.
Summit Therapeutics (NASDAQ: SMMT) announced inducement option grants to 20 new employees totaling up to 257,368 shares of common stock. The awards were approved by the Compensation Committee and granted on January 26, 2026 under Nasdaq Listing Rule 5635(c)(4).
The options carry a 10-year term, an exercise price of $16.56 per share (Nasdaq closing price on January 26, 2026), and vest in equal annual installments over four years. Awards come from an equity pool reserved on January 22, 2025 and are subject to individual stock option agreements.
Summit Therapeutics (NASDAQ: SMMT) announced the U.S. FDA has accepted its Biologics License Application for ivonescimab plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC after prior 3rd‑generation EGFR TKI therapy.
The filing is based on the global Phase III HARMONi trial, and the FDA set a PDUFA goal date of November 14, 2026. The agency plans a complete review with mid‑cycle and wrap‑up meetings and proposed labeling, subject to no major deficiencies during review. An estimated ~14,000 U.S. patients are eligible annually in this post‑TKI setting.
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Summit Therapeutics (NASDAQ: SMMT) submitted a BLA to the U.S. FDA in Q4 2025 seeking approval of ivonescimab (a first‑in‑class bispecific antibody) plus chemotherapy for second‑line or later treatment of patients with EGFRm non‑squamous NSCLC. The submission is based on overall results from the global Phase III HARMONi trial. The company noted ~14,000 U.S. patients are eligible annually for this setting and reported approximately $710 million in cash, cash equivalents, and short‑term investments as of December 31, 2025 (preliminary, unaudited). If accepted, Summit anticipates an FDA decision by Q4 2026.
Summit Therapeutics (NASDAQ: SMMT) granted inducement stock options totaling up to 214,331 shares to 17 new employees, approved by the Compensation Committee. The awards were granted on January 6, 2026 as inducements under Nasdaq Listing Rule 5635(c)(4).
The options have a 10-year term, an exercise price of $18.66 per share (the Nasdaq closing price on January 6, 2026), and vest in equal annual installments over four years. The options were issued from an equity incentive pool reserved on January 22, 2025 and are subject to individual option agreements.
Summit Therapeutics (NASDAQ: SMMT) will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 12, 2026 at 9:45 AM PT. Robert W. Duggan, Chairman and Co-CEO, and Dr. Maky Zanganeh, President and Co-CEO, will deliver a corporate overview and provide an update on the development of the investigational bispecific antibody ivonescimab. The leadership team will also hold investor meetings during the conference. The live presentation will stream on the company website and an archived version will be posted after the event.
Summit Therapeutics (NASDAQ: SMMT) announced inducement option grants to nine new employees totaling up to 67,483 shares of common stock.
The awards were granted on December 2, 2025 under Nasdaq Listing Rule 5635(c)(4) and approved by the company’s Compensation Committee. Each option has a 10-year term and an exercise price of $17.25, the Nasdaq closing price on December 2, 2025. Options vest in equal annual installments over a four-year period and will be issued under stock option agreements from an equity pool reserved on January 22, 2025.
Summit (NASDAQ: SMMT) highlighted Phase III HARMONi-A results for partner Akeso showing ivonescimab plus chemotherapy improved overall survival vs chemotherapy alone in EGFR‑mutated NSCLC after EGFR‑TKI.
Key metrics: OS HR 0.74 (95% CI 0.58–0.95, p=0.019); median OS 16.8 months vs 14.1 months. Data cut-off April 2025; median follow‑up 32.5 months. Safety: treatment‑related discontinuations 11.2% vs 6.2%; TRAE deaths 0.6% in each arm. HARMONi global readouts previously showed PFS HR 0.52 and earlier OS analyses with HRs ~0.78–0.79.
Summit Therapeutics (NASDAQ: SMMT) will present at four investor conferences in November–December 2025. Summit leadership will host fireside chats and meet investors at: UBS Global Healthcare Conference in Palm Beach on Nov 10, 2025 at 3:30pm ET; Jefferies Global Healthcare Conference in London on Nov 18, 2025 at 3:30pm GMT (10:30am ET); Citi 2025 Global Healthcare Conference in Miami on Dec 2, 2025 at 10:30am ET; and Evercore Healthcare Conference in Miami on Dec 3, 2025 at 2:10pm ET. The fireside chats will be streamed live and archived on the company website www.smmttx.com.
Summit Therapeutics (NASDAQ: SMMT) said results from the Phase III HARMONi-A trial (sponsored by partner Akeso) will be presented at SITC 2025 on Nov 7, 2025 at 11:30am ET. HARMONi-A evaluated ivonescimab plus platinum-doublet chemotherapy versus placebo plus chemotherapy in EGFR‑mutated, locally advanced or metastatic non-squamous NSCLC after EGFR TKI failure.
The company reported HARMONi-A produced the first statistically significant overall survival (OS) benefit for an ivonescimab-containing regimen versus standard of care in a Phase III study. The single-region study was conducted in China, where >40,000 patients have received ivonescimab in clinical or commercial settings. Summit is sponsoring the multiregional HARMONi Phase III trial and plans a BLA submission based on the multiregional study; ivonescimab is not approved in Summit territories including the US and Europe.