Orvida Pharma Announces FDA Acceptance of KM-023 (ontivatrep) into Rare Disease Evidence Principles Process for Olmsted Syndrome

Orvida Pharma announced that the FDA has accepted KM-023 (ontivatrep), its lead oral investigational therapy for Olmsted syndrome, into the FDA's Rare Disease Evidence Principles (RDEP) process. This regulatory milestone enables the company to engage with the FDA on evidence needed to support potential approval. Phase 1b clinical trial topline results in patients with Olmsted syndrome are anticipated around year-end 2026.