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 plc has announced plans to redomicile its holding company from the UK to the US, aligning with its focus on US market operations. This change aims to enhance corporate flexibility and access to capital for its treatment, ridinilazole, targeting C. difficile infection. Under a court-approved scheme, existing shares will convert at a 5:1 ratio for new shares in Delaware-based 'New Summit.' Shareholder and court approvals are needed for this proposal, which will not affect UK operations in Oxford and Cambridge.
Summit Therapeutics plc announces the publication of Phase 2 clinical trial data for its antibiotic, ridinilazole, in the American Journal of Physiology – Gastrointestinal and Liver Physiology. The trial, which involved 100 patients, showed that ridinilazole preserved gut microbiome better than vancomycin, leading to a 60% reduction in C. difficile infection recurrence. Ridinilazole is designed to selectively target C. difficile while maintaining gut health, providing a stronger long-term clinical response.
Summit Therapeutics has appointed Michael Donaldson as its new Chief Financial Officer, effective immediately. Donaldson brings over 20 years of finance experience, especially in corporate finance. He previously held leadership positions at Goldfinch Bio and ARIAD Pharmaceuticals, contributing to significant acquisitions. The company's ongoing Phase 3 clinical trials for its antibiotic candidate, ridinilazole, hold promise for treating C. difficile infections. Summit aims to innovate in antibiotic development to improve patient outcomes while maintaining a focus on financial solutions.
Summit Therapeutics plc (NASDAQ: SMMT) reported its financial results for Q1 2020, highlighting a cash balance of $55.3 million as of March 31, down from $60.3 million at the end of 2019. The company posted a loss of $6.1 million, an improvement over the $6.9 million loss in Q1 2019. The Phase 3 Ri-CoDIFy clinical trials for ridinilazole have enrolled 291 patients as of May 31, 2020, though patient enrollment has been negatively affected by COVID-19 uncertainties, leading to the withdrawal of public commentary on trial completion timelines.
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