(RTTNews) - The FDA's November calendar has more than a dozen PDUFA dates on the horizon, setting the stage for an eventful month in the regulatory landscape.

Biotech Stocks Facing FDA Decision In November 2026 

(RTTNews) - Lunit Inc. (328130.KQ) and Summit Therapeutics Inc. (SMMT) announced a research agreement to evaluate Lunit SCOPE IO, Lunit's AI-powered pathology platform, for tumour microenvironment analysis to support Summit's immuno-oncology development programs for ivonescimab.

Lunit And Summit Collaborate On AI-Powered Biomarker Discovery For Ivonescimab 

(RTTNews) - Akeso, Inc. (9926.HK) announced that its partner Summit Therapeutics (SMMT) has entered into a clinical trial collaboration with ECOG-ACRIN Cancer Research Group to evaluate Ivonescimab in a registration-enabling Phase II/III study in biliary tract cancer.

Akeso's Ivonescimab To Be Evaluated In Global Phase II/III Biliary Tract Cancer Trial 

(RTTNews) - Summit Therapeutics Inc. (SMMT) on Monday announced the closing of AstraZeneca's (AZN) $2 billion strategic equity investment, which will support accelerated development of ivonescimab, an investigational PD-1/VEGF bispecific antibody.

Summit Therapeutics Secures $2B Strategic Investment From AstraZeneca 

(RTTNews) - The week brought a fresh round of developments across the biotech and pharma landscape, with companies advancing new therapies through regulatory milestones, clinical studies, strategic deals and corporate activity. Key updates spanned oncology, rare diseases, cardiov

Weekly Buzz: EW, ABBV, MIRM Score FDA Wins, AZN, NVO Strike Deals; LLY, KOD Report Data 

(RTTNews) - Daiichi Sankyo (4568.TS) and AstraZeneca (AZN) have entered into a clinical trial collaboration agreement with Summit Therapeutics (SMMT) to evaluate Datroway (datopotamab deruxtecan) in combination with ivonescimab across multiple solid tumor types, expanding efforts

Daiichi Sankyo, AstraZeneca, Summit Partner On Datroway- Ivonescimab Cancer Studies 

Summit Therapeutics Inc., a biopharmaceutical company, focuses on discovery, development, and commercialization of patient, physician, caregiver, and societal friendly medicinal therapies. Its lead development candidate is ivonescimab, a bispecific antibody for immunotherapy through blockade of PD-1 with the anti-angiogenesis for the treatment of non-small lung cancer (NSCLC) and colorectal cancer (CRC). The company has also combined ivonescimab with chemotherapy, which is in phase III clinical trial for the patients with epidermal growth factor receptor, mutated, and locally advanced or metastatic non-squamous NSCLC; first-line metastatic NSCLC; and first-line unresectable metastatic CRC. It markets its products in the United states, Canada, Europe, Japan, Latin America, Middle East, and Africa. The company was founded in 2003 and is headquartered in Miami, Florida.

Summit Therapeutics Inc. News