First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects
This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology
The regulatory decision follows promising results from RIVER-81
The company gets access to Lonza’s clinically validated SYNtecan linker-payload platform as it prepares an IND filing for its acute myeloid leukemia therapy in 2027
Genome editing holds extraordinary promise for treating previously incurable genetic diseases
The upcoming multi-center, multinational Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and early signs of efficacy
The investigational new drug application with FDA was actually for NEOK002, an EGFR/MUC1-targeting antibody-drug conjugate aimed at solid tumors
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
The early-stage trial demonstrated an excellent safety profile alongside clinically meaningful improvements in visual acuity
The partnership initially will focus on cardiovascular and kidney diseases
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