other material
confidence high
sentiment negative
materiality 0.60
Theravance Biopharma Phase 4 PIFR-2 study of YUPELRI fails to meet primary endpoint vs Spiriva HandiHaler in severe COPD
Theravance Biopharma, Inc.
- PIFR-2 study did not show statistically significant difference on primary endpoint (change in trough FEV1 at Day 85) for YUPELRI vs Spiriva HandiHaler.
- Both arms demonstrated similar lung function improvement; YUPELRI safety and tolerability consistent with prior studies.
- Study enrolled adults with severe to very severe COPD (FEV1 <50% predicted) and suboptimal PIFR (<55 L/min).
- CEO Rick E Winningham noted growth opportunities ahead for YUPELRI, an important COPD maintenance option.