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

Theravance Biopharma, Inc.

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.

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