---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-100860"
form_type: "8-K"
ticker: "TBPH"
cik: "0001583107"
company_name: "Theravance Biopharma, Inc."
filed_at: "2026-08-25T20:52:55+00:00"
generated_at: "2026-08-25T20:54:14.698592+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Theravance's ampreloxetine misses primary endpoint in Phase 3 CYPRESS nOH/MSA study

## Summary
- Primary endpoint (OHSA composite change at week 8 of randomized withdrawal) not statistically significant; secondary endpoints showed similar trends.
- FDA in May 2026 said existing data won't support approval; Type C meeting requested to align on future pivotal trial design.
- Post hoc analysis (confirmed symptomatic nOH, n=47): average OHSA diff -1.06 (p=0.001), OHDAS -1.27 (p<0.001), OHQ -1.24 (p<0.001).
- Pressor effect confirmed via BP, heart rate, norepinephrine changes; safety consistent with prior studies, no worsening supine hypertension.
- Company previously announced acquisition by Zymeworks (June 29, 2026), subject to shareholder approval; deal context for this update.

## SEC filing metadata
- accession: 0001104659-26-100860
- form_type: 8-K
- ticker: TBPH
- cik: 0001583107
- company_name: Theravance Biopharma, Inc.
- filed_at: 2026-08-25T20:52:55+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1583107/000110465926100860/0001104659-26-100860-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1583107/000110465926100860/tm2623927d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-100860
- JSON: https://secwatch.observer/filing/0001104659-26-100860.json
- Plain text: https://secwatch.observer/filing/0001104659-26-100860.txt

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