---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-082048"
form_type: "8-K"
ticker: "TBPH"
cik: "0001583107"
company_name: "Theravance Biopharma, Inc."
filed_at: "2025-08-25T23:59:59+00:00"
generated_at: "2026-05-17T10:13:18.432750+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Theravance Biopharma completes Phase 3 enrollment for ampreloxetine in nOH due to MSA; topline Q1 2026

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-25-082048
- form_type: 8-K
- ticker: TBPH
- cik: 0001583107
- company_name: Theravance Biopharma, Inc.
- filed_at: 2025-08-25T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1583107/000110465925082048/0001104659-25-082048-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1583107/000110465925082048/tm2524263d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-082048
- JSON: https://secwatch.observer/filing/0001104659-25-082048.json
- Plain text: https://secwatch.observer/filing/0001104659-25-082048.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.