CYPS317 / FibroBiologics - LARVOL DELTA

FibroBiologics…announced the filing of a Phase 1/2 Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) seeking regulatory clearance to initiate clinical trials of CYPS317, an investigational allogeneic fibroblast spheroid-based therapy for the treatment of moderate to severe psoriasis (GlobeNewswire) - "FibroBiologics is pursuing a development program for CYPS317 with the goal of advancing first-in-human clinical trials following FDA review of the IND filing. The IND submission includes comprehensive preclinical pharmacology, safety, and manufacturing data supporting the therapeutic’s mechanism of action, durability of effect, and safety profile."

First-in-human • IND • New P1/2 trial • Psoriasis

FibroBiologics Reports Third Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Milestones:...(i) Complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317, FibroBiologics’ fibroblast spheroid product candidate, and submit IND; (ii) Complete pre-clinical IND-enabling studies for the treatment of multiple sclerosis with CYMS101, FibroBiologics’ fibroblast spheroid product candidate, and submit IND."

IND • Preclinical • Multiple Sclerosis • Psoriasis