secwatch.observer — SEC 8-K summary
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Issuer:     Theravance Biopharma, Inc. (TBPH)
CIK:        0001583107
Form:       8-K
Filed at:   2026-08-25T20:52:55+00:00
Accession:  0001104659-26-100860
Event type: other_material
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1583107/000110465926100860/0001104659-26-100860-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1583107/000110465926100860/tm2623927d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-100860

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