secwatch.observer — SEC 8-K summary
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Issuer:     Theravance Biopharma, Inc. (TBPH)
CIK:        0001583107
Form:       8-K
Filed at:   2025-08-25T23:59:59+00:00
Accession:  0001104659-25-082048
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1583107/000110465925082048/0001104659-25-082048-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1583107/000110465925082048/tm2524263d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-082048

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer