CYPS317 / FibroBiologics - LARVOL DELTA

FibroBiologics…announced preclinical data from its CYPS317 program for psoriasis presented at the Society for Investigative Dermatology 2026 Annual Meeting (GlobeNewswire) - "In a chronic-relapsing psoriasis model, booster dosing of HDF spheroids sustained therapeutic efficacy and prevented splenomegaly, a marker of systemic immune burden. Additionally, CYPS317 demonstrated significant reductions in PASI scores, normalization of monocyte-to-lymphocyte ratios, and reduced splenic immune cell accumulation."

Preclinical • Psoriasis

FibroBiologics, Inc...announced the presentation of preclinical data from its CYPS317 program for psoriasis at the Society for Investigative Dermatology 2026 Annual Meeting taking place May 13-15, 2026, in Chicago, Illinois. (GlobeNewswire)

Preclinical • Immunology • Psoriasis

Upcoming Milestones:…Psoriasis (GlobeNewswire) - "Receive IND clearance for the treatment of psoriasis with CYPS317, the Company's fibroblast spheroid product candidate, in the first half of 2026."

IND • Psoriasis

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