other material
confidence high
sentiment positive
materiality 0.70
Virios Therapeutics: FDA alignment on Phase 3 fibromyalgia and Phase 2 Long-COVID endpoint clarity
Dogwood Therapeutics, Inc.
- FDA agreed on Phase 3 program for IMC-1 (famciclovir/celecoxib) for fibromyalgia treatment.
- FDA accepted fatigue as primary endpoint and orthostatic intolerance as key secondary for IMC-2 Long-COVID Phase 2 study.
- Company provided unrestricted grant to Bateman Horne Center for placebo-controlled study of up to 60 LC patients on IMC-2.
- New international patent application filed for IMC-2 as treatment for Long-COVID and fatigue conditions.
- Company has capital to support operations into Q4 2024; exploring M&A opportunities.