TBPH Stock Plunges 26% on Failure of Late-Stage MSA Study

Shares of Theravance Biopharma TBPH plunged 26% after the company announced the failure of the late-stage CYPRESS study evaluating ampreloxetine, an investigational, once-daily norepinephrine reuptake inhibitor, for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA).

Consequently, TBPH has decided to wind down the ampreloxetine program.

More on TBPH’s Phase III CYPRESS Study

The phase III CYPRESS study was a registrational multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment.

Top-line data from the study showed that it failed to meet its primary endpoint in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. Secondary endpoints were also not statistically significant, despite demonstrating biological activity. However, ampreloxetine was well-tolerated and a favorable safety profile was observed.

TBPH will complete additional analyses of the CYPRESS dataset and phase III program, in consultation with external experts, to assess whether the data merits further regulatory discussion.

Following the setback, Theravance’s strategic review committee is accelerating a review of strategic options, including a potential sale of the company, with the objective of maximizing shareholder value.

Over the past year, TBPH’s shares have gained 43.6% against the industry’s 0.8% fall.

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TBPH Undertakes Organizational Restructuring

Besides the strategic review, the company announced a major organizational restructuring aimed at optimizing its cost structure and sharpening its focus on its commercial product, Yupelri. Theravance anticipates reducing its workforce by approximately 50% by shutting down the entire research and development division and cutting roughly 50% of general and administrative staff. These layoffs will take place over the next two quarters. The restructuring is expected to cut operating costs by approximately 60% relative to the company’s preliminary 2025 operating cost of $110 million.

The company anticipates realizing full annualized cost savings of approximately $70 million by the third quarter of 2026.

Combined with continued sales of Yupelri, these savings are projected to drive approximately $60–$70 million in annualized cash flow beginning in the third quarter of 2026.

TBPH Provides Preliminary Results

The company also announced preliminary results for fourth-quarter and full-year 2025 in the same press release.

Preliminary net sales of Yupelri in the United States were $70.6 million in the fourth quarter of 2025, up 6% year over year.

For full-year 2025, Yupelri sales are expected to be $266.6 million, up 12%, including a $25 million milestone from Viatris VRTS received in January 2026.

Theravance and Viatris have collaborated for the development and commercialization of Yupelri, a long-acting muscarinic antagonist (LAMA), as a once-daily, nebulized treatment of chronic obstructive pulmonary disease (COPD).

Additionally, the company received $50 million as a milestone payment on Trelegy from Royalty Pharma in February.

TBPH ended 2025 with approximately $326.5 million in cash and remained debt-free.

2026 Outlook

Theravance expects global net sales of Trelegy to reach approximately $3.51 billion in 2026, which would trigger an additional $100 million of milestone payments.

The company expects around $400 million in cash by the first quarter of 2026, along with the milestone payments for Trelegy and Yupelri.

TBPH’s Zacks Rank & Stocks to Consider

Theravance Biopharma currently has a Zacks Rank #3 (Hold).

Some top-ranked stocks in the biotech sector are Catalyst Pharmaceuticals CPRX, which currently sports a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals ANIP, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.54 to $2.59. CPRX shares have gained 9.2% over the past year.

Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.

Over the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $8.08 to $8.22 for 2026. Over the past year, shares of ANIP have surged 27.5%.

ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.