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) will participate in three investor conferences in March 2026. Leadership will attend TD Cowen's Health Care Conference (Boston) on March 2, 2026 with a fireside chat at 2:30pm ET, Jefferies Conference (Miami) on March 10, 2026 for investor meetings, and Citizens Life Sciences Conference (Miami) on March 11, 2026 with a fireside chat at 2:15pm ET. Both fireside chats will be webcast live and archived on the company's website.
Summit Therapeutics (NASDAQ: SMMT) reported 2025 results and clinical progress on February 23, 2026. Key clinical milestones include FDA acceptance of a BLA with a PDUFA date of November 14, 2026, HARMONi-3 squamous cohort screening completed with an interim PFS analysis planned Q2 2026, and multiple collaborations (Revolution, GSK) initiating trials in 2026. Financially, cash and short-term investments were $713.4M at year-end 2025, GAAP net loss was $1,079.6M for 2025, and non-GAAP net loss was $347.2M.
Summit Therapeutics (NASDAQ: SMMT) will report fourth quarter and full year 2025 financial results and provide an operational update on February 23, 2026 after market close. The earnings conference call will be held at 4:30 PM ET with a live webcast and archived replay available on the company website.
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.
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.