Theravance Biopharma Shares CYPRESS Phase 3 Ampreloxetine Study Update

What Happened
On August 25, 2026, Theravance Biopharma announced and furnished a slide presentation (Exhibit 99.1) updating the Phase 3 CYPRESS Study (0197) of ampreloxetine in patients with symptomatic neurogenic orthostatic hypotension (nOH) associated with multiple system atrophy (MSA). The presentation includes post‑hoc analyses of CYPRESS data and information about the company’s interactions with the U.S. Food and Drug Administration regarding the ampreloxetine clinical development program. The presentation was furnished to the SEC (not “filed” under Section 18).

Key Details

• Presentation date filed: August 25, 2026; Exhibit 99.1 furnished with the Form 8-K.
• Study: Phase 3 CYPRESS Study (0197) of ampreloxetine for nOH associated with MSA; includes post‑hoc and exploratory analyses.
• Regulatory: Presentation includes details of interactions with the U.S. FDA about ampreloxetine’s development and potential regulatory path.
• Corporate context: The filing reiterates forward‑looking statement cautions and references a Definitive Proxy Statement filed Aug 21, 2026 in connection with a proposed transaction with Zymeworks Inc.

Why It Matters
This update gives investors the company’s current view of clinical and regulatory data for ampreloxetine—key drivers of the drug’s development value. Post‑hoc analyses are exploratory and the company notes they may not predict clinical benefit; FDA interactions described could affect whether additional trials are required. Separately, the ongoing proposed transaction with Zymeworks and related proxy materials remain material to shareholders.