other material
confidence high
sentiment negative
materiality 0.85
FibroGen's pamrevlumab fails Phase 3 DMD study in non-ambulatory patients; primary endpoint not met
KYNTRA BIO, INC.
- Phase 3 LELANTOS-1 study of pamrevlumab in non-ambulatory DMD patients did not meet primary endpoint (PUL 2.0 score at week 52).
- Pamrevlumab was generally safe and well tolerated; most adverse events were mild or moderate.
- Topline results from LELANTOS-2 Phase 3 study in ambulatory DMD patients expected in Q3 2023.
- CEO Enrique Conterno expressed disappointment and thanked patients, caregivers, and investigators.