United Therapeutics Q3 Revenue Hits Record $833 Million

United Therapeutics Corporation reported record quarterly revenue of $833 million for the third quarter of 2026, up 4% from a year earlier, as higher Tyvaso, Orenitram and Unituxin sales more than offset a decline in Remodulin. The pulmonary hypertension drugmaker also highlighted two FDA review decisions expected in 2027, extending the quarter’s focus beyond commercial growth to potential expansion of its product portfolio.

Tyvaso DPI and nebulized Tyvaso generated combined worldwide revenue of $504 million, a 5% year-over-year increase and a quarterly record. U.S. combined revenue rose 6% to $496 million. The company also reported record Tyvaso DPI referrals and commercial and total patient counts.

Orenitram revenue increased 11% to a record $145 million, marking the product’s 19th consecutive quarter of year-over-year revenue growth. Total patient numbers also reached a record. Unituxin revenue rose 9% to $52 million, including $50 million in the U.S.

Remodulin was the main commercial offset, with worldwide revenue declining 3% to $122 million. U.S. Remodulin revenue fell 2% to $109 million. Revenue from Adcirca and other products totaled $9 million.

United Therapeutics ended the period with $3.5 billion in cash, cash equivalents and marketable investments. Trailing-12-month operating cash flow was $1.4 billion. The company also announced a new $2 billion share repurchase authorization, though the presentation did not provide a timetable for purchases.

Regulatory reviews center on Tyvaso and ralinepag

The FDA accepted United Therapeutics’ supplemental new drug application for nebulized Tyvaso in idiopathic pulmonary fibrosis, with an April 26, 2027, target action date. The investigational indication is supported by the TETON-1 and TETON-2 trials, both of which met their primary endpoint measuring the change from baseline in absolute forced vital capacity at week 52.

An integrated analysis of the two studies showed a Hodges-Lehmann treatment effect estimate of 111.8 milliliters compared with placebo. The combined data also showed a 31% reduction in the risk of a clinical worsening event and a 48% reduction in the risk of an acute IPF exacerbation. United Therapeutics said nebulized Tyvaso was well tolerated, with a safety profile consistent with earlier inhaled treprostinil studies and known prostacyclin-related adverse events. The IPF use remains investigational and has not been approved by the FDA.

The company also completed enrollment in TETON-PPF, a global study of nebulized Tyvaso in progressive pulmonary fibrosis. The trial enrolled 754 patients, compared with a target of 698, and data are expected in the second half of 2027.

Separately, the FDA accepted the new drug application for ralinepag tablets in pulmonary arterial hypertension and set a June 24, 2027, target action date. The ADVANCE OUTCOMES study met its primary endpoint of time to clinical worsening and several additional endpoints, including NT-proBNP, six-minute walk distance and clinical improvement. The company reported no new safety signals, while noting adverse events consistent with the prostacyclin class. Ralinepag remains investigational.

United Therapeutics also received FDA clearance to proceed with the 40-patient Phase 2 SUMMIT study of treprostinil delivered through a soft mist inhaler in pulmonary hypertension associated with chronic obstructive pulmonary disease. Safety is the primary endpoint, with six-minute walk distance and NT-proBNP among the secondary measures. The FDA separately cleared a clinical trial of an as-needed treprostinil-iloprost soft mist inhaler in pulmonary arterial hypertension.

Organ programs remain a longer-term development focus

The company’s organ pipeline spans xenotransplantation, autologous and allogeneic regenerative medicine, and thymic immune restoration. Its EXPAND study of UKidney is ongoing, while the Phase 1 EXTEND study of UThymoKidney has been completed. Other programs include UHeart for advanced heart failure and regenerative approaches targeting end-stage kidney, liver and lung disease.

United Therapeutics cautioned that its expectations for revenue growth, clinical programs, manufacturing and field-force expansion, and organ-development efforts are forward-looking and subject to evolving risks. Regulatory acceptance does not ensure approval, and the timing and outcome of clinical studies and pipeline programs may differ materially from the company’s current expectations.