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. (NASDAQ: SMMT) is a biopharmaceutical oncology company whose news flow is closely tied to the development of its lead investigational therapy, ivonescimab (SMT112 in Summit’s territories). Ivonescimab is described by the company as a potential first-in-class bispecific antibody targeting PD-1 and VEGF in a single molecule, and it is being evaluated in multiple Phase III clinical trials in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
News about Summit frequently covers clinical milestones for ivonescimab, including updates from the global Phase III HARMONi trial in EGFR-mutated NSCLC after third-generation EGFR TKI therapy, as well as HARMONi-3 and HARMONi-7 in first-line metastatic NSCLC and HARMONi-GI3 in first-line unresectable metastatic CRC. Company announcements have highlighted progression-free survival and overall survival data, hazard ratios, response rates, and safety profiles, along with presentations at major conferences such as the World Conference on Lung Cancer, SITC, and ESMO.
Investors following SMMT news will also see regulatory and corporate updates, including Summit’s submission of a Biologics License Application to the U.S. FDA for ivonescimab plus chemotherapy in EGFR-mutated NSCLC, Fast Track designation for the HARMONi setting, and summaries of Akeso’s HARMONi-A trial in China, which demonstrated a statistically significant overall survival benefit for ivonescimab plus chemotherapy versus chemotherapy alone.
Additional news items cover financing activities such as private placements and at-the-market offerings, inducement stock option grants under Nasdaq Listing Rule 5635(c)(4), and collaboration announcements. Notably, Summit has reported a clinical trial collaboration with GSK plc to evaluate ivonescimab in combination with GSK’s investigational B7-H3-targeting antibody-drug conjugate, risvutatug rezetecan (GSK’227), across multiple solid tumor settings including small cell lung cancer.
For readers tracking SMMT, the news stream provides insight into Summit’s late-stage oncology pipeline, regulatory interactions, capital-raising efforts, and partnerships that shape the company’s development path.
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.
Summary not available.
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.
Summit Therapeutics (NASDAQ: SMMT) completed a private placement raising approximately $500 million by selling about 26.68 million common shares at $18.74 per share on October 21, 2025.
Insiders and related parties invested $282 million (including $272 million from named executives and employees and $10 million from Akeso). Summit said it intends to use net proceeds to advance clinical development of ivonescimab and for working capital and general corporate purposes.
The shares were sold in an unregistered transaction and Summit agreed to file an SEC registration statement to register resale of the shares.
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