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.
GT Biopharma (NASDAQ: GTBP) dosed the first patient on May 14, 2026 in a Phase 1 basket trial of GTB-5550, a B7-H3-targeted NK cell engager using subcutaneous dosing. FDA cleared the IND in February 2026. GT Biopharma reported about US$9 million cash as of March 31, 2026, expected to fund operations through Q4 2026, with initial Phase 1 updates anticipated in 2H 2026. The program advances amid broad B7-H3 activity, including GSK’s B7-H3 antibody-drug conjugate and IDEAYA’s bispecific ADC.
Summit Therapeutics (NASDAQ: SMMT) reported Q1 2026 results and clinical progress for ivonescimab (SMT112), a bispecific PD‑1/VEGF antibody. Key items: HARMONi‑6 overall survival to be presented in the ASCO 2026 Plenary Session; PDUFA date Nov 14, 2026 for a BLA in EGFR‑mutated non‑squamous NSCLC; $598.7M cash and short‑term investments at Mar 31, 2026.
Q1 GAAP net loss was $189.4M; non‑GAAP net loss was $116.6M. Multiple global Phase III trials and clinical collaborations continue to enroll.
Summit Therapeutics (NASDAQ: SMMT) will present three posters on ivonescimab at ELCC 2026 on March 27. Updated Phase III HARMONi data show intracranial PFS of 10.1 months vs 6.5 months in patients with baseline brain metastases (HR 0.53; nominal p=0.0068).
HARMONi also showed intracranial PFS benefit in patients without baseline CNS metastases (15.7 vs 11.6 months; HR 0.72; nominal p=0.0172). No new safety signals were identified. HARMONi-2 quality-of-life and comparator data versus pembrolizumab (China) will also be presented.
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.
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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.