other_material
confidence high
sentiment positive
materiality 0.60
Theravance Biopharma completes Phase 3 enrollment for ampreloxetine in nOH due to MSA; topline Q1 2026
Theravance Biopharma, Inc.
- Enrollment completed in open-label portion of pivotal Phase 3 CYPRESS study (NCT05696717) for nOH due to MSA.
- Expected topline results in Q1 2026; if positive, plans for expedited NDA submission and priority FDA review.
- Ampreloxetine has Orphan Drug Designation in the U.S.; addresses ~40,000 patients with symptomatic nOH due to MSA.
- Primary endpoint is change in OHSA composite score from randomized-withdrawal baseline to Week 8.
item 8.01item 9.01