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) will host a conference call on Thursday, July 23, 2026, to announce its second quarter 2026 financial results and provide an update on operational progress. The call is scheduled for 4:30 p.m. EDT and will be available via live and archived webcast through the Investor Information section of the company’s website, www.smmttx.com.
Summit Therapeutics (NASDAQ: SMMT) signed an agreement to sell ridinilazole, its investigational Phase III precision antibiotic for C. difficile infection, to Toronto-based Biossil, an AI-native biopharma focused on late-stage programs in serious diseases.
Ridinilazole previously showed a higher observed Sustained Clinical Response than vancomycin in Summit’s Phase III Ri-CoDIFy trial but did not meet the prespecified primary endpoint for superiority. Earlier studies and Ri-CoDIFy indicated microbiome-sparing effects versus vancomycin. Under the agreement, Summit will receive $500,000 upfront, up to $104.5 million in regulatory and commercial milestones, and tiered royalties on net sales, while refocusing on its core oncology strategy and development of ivonescimab. Ridinilazole remains unapproved, and its safety and efficacy have not been evaluated by regulators such as the FDA.
Summit Therapeutics (Nasdaq:SMMT) has launched an underwritten public offering of $500 million in common stock, with a 30-day option for underwriters to purchase up to an additional $75 million. Completion, size, and terms of the offering remain subject to market and other conditions.
Summit plans to use net proceeds, with existing cash and cash equivalents, to fund research and development of its lead product candidate ivonescimab, and for working capital and general corporate purposes. The securities are offered under an effective Form S-3 shelf registration statement.
Summit Therapeutics (NASDAQ:SMMT) will participate in the 47th Annual Goldman Sachs Global Healthcare Conference in Miami on Monday, June 8, 2026. Management will hold a fireside chat at 10:00 AM ET, covering a corporate overview, recent progress, and development of its investigational bispecific antibody ivonescimab. A live and archived webcast will be available on the company’s website.
Summit Therapeutics (NASDAQ:SMMT) reported Phase III HARMONi-6 results for ivonescimab plus chemotherapy in 1L squamous NSCLC versus tislelizumab plus chemotherapy. Ivonescimab reduced risk of death by 34% (HR 0.66; 95% CI 0.50–0.87; p=0.0017), with 24‑month OS 64.7% vs 48.6% and median OS 27.89 vs 23.69 months.
Benefits were observed across PD-L1 subgroups. Safety was considered acceptable and consistent with prior studies, though treatment-related serious adverse events and Grade ≥3 hemorrhage were more frequent with ivonescimab. Results were presented at ASCO 2026 and simultaneously published in The Lancet.
Summit Therapeutics (NASDAQ:SMMT) reported interim global Phase II data for ivonescimab plus mFOLFOX6 in first-line unresectable metastatic colorectal cancer (MSS mCRC) at ASCO 2026.
Evaluable patients (n=48) showed 70.8% ORR and 100% DCR. The 20 mg/kg arm had a 9‑month DoR estimate of 79.1% and 9‑month PFS rate of 76.1%. Serious TRAEs occurred in 20.4% of patients; no ivonescimab-related deaths were reported.
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.