Welcome to our dedicated page for United Therapeutics news (Ticker: UTHR), a resource for investors and traders seeking the latest updates and insights on United Therapeutics stock.
United Therapeutics Corporation develops and markets therapies for rare cardiopulmonary and related diseases, with a pulmonary arterial hypertension franchise built around treprostinil products such as Tyvaso DPI, Tyvaso Inhalation Solution, Remodulin and Orenitram. News commonly covers product sales, quarterly results, clinical data for pulmonary hypertension, idiopathic pulmonary fibrosis and interstitial lung disease, and updates on ralinepag and the TETON program.
The company also reports developments in manufactured-organ and transplant-support technologies, including EVLP, xenotransplantation, and Miromatrix Medical programs such as miroliverELAP and mirokidney. Governance updates, board composition, share repurchase activity and its status as a public benefit corporation are recurring corporate themes.
United Therapeutics (UTHR) will use the remaining portion of its previously announced $2.0 billion share repurchase authorization through a new accelerated share repurchase (ASR) agreement with Citibank for approximately $477.6 million, announced on September 8, 2026.
The company previously executed ASR agreements totaling $1.5 billion in March 2026 and repurchased an additional $22.4 million of stock in open-market transactions in the third quarter of 2026. Under the new ASR, United Therapeutics will make an upfront payment of about $477.6 million on or around September 10, 2026 and initially receive shares equal to roughly 75% of the expected total, based on the September 8, 2026 closing price.
The final share count will be determined by the average daily volume-weighted average price of UTHR shares during the ASR term, less a discount, with settlement expected in the fourth quarter of 2026. As of September 4, 2026, the company had approximately 42.9 million shares outstanding.
United Therapeutics (UTHR) announced FDA acceptance of a supplemental New Drug Application (sNDA) for nebulized Tyvaso (treprostinil) Inhalation Solution to treat idiopathic pulmonary fibrosis (IPF), with the review expected to be completed in late April 2027. Nebulized Tyvaso is not approved for IPF and remains investigational for this indication.
The filing is supported by phase 3 TETON-1 and TETON-2 data, where combined analyses met the primary endpoint, showing a statistically significant improvement in absolute forced vital capacity (FVC) versus placebo by 111.8 mL from baseline to week 52 (Hodges-Lehmann estimate; 95% CI, 79.7–144.0 mL; p<0.0001). Most key secondary endpoints also reached statistical significance, including reduced risk of clinical worsening and acute IPF exacerbations, and improvements in percent predicted FVC, K-BILD quality of life scores, and DLCO. Both FDA and the European Medicines Agency have granted orphan designation for treprostinil in IPF, and an ongoing TETON program continues to evaluate long-term safety and use in related fibrotic lung diseases.
United Therapeutics (Nasdaq: UTHR) will participate in four investor conferences via fireside chats. CEO Martine Rothblatt will present at Wells Fargo’s 21st Annual Healthcare Conference on September 8, 2026, Cantor Global Healthcare on September 9, Morgan Stanley’s 24th Annual Global Healthcare Conference on September 14, and Bernstein’s 3rd Annual Healthcare Forum on September 23. All sessions will be webcast live on the company’s investor relations website, with archived recordings available for 90 days.
United Therapeutics (Nasdaq: UTHR) announced eight data presentations across its pulmonary hypertension and lung disease portfolio at the ESC Congress 2026 (Munich, August 28-31) and ERS Congress 2026 (Barcelona, September 5-9). Late-breaking and other presentations cover phase 3 ADVANCE OUTCOMES (ralinepag in PAH), the phase 3 TETON program (nebulized treprostinil in IPF), the ARTISAN study (parenteral treprostinil in PAH), and the PHINDER screening study in PH-ILD. According to United Therapeutics, analyses show clinical improvement and reduced clinical worsening in PAH with ralinepag, and improved lung function and fewer serious clinical worsening events with nebulized treprostinil in IPF. The company also highlights June 2026 FDA submissions for ralinepag in PAH and nebulized treprostinil in IPF, which both remain investigational.
United Therapeutics (Nasdaq: UTHR) announced that the U.S. FDA has accepted its New Drug Application for ralinepag, an investigational once-daily oral prostacyclin for treating pulmonary arterial hypertension (PAH). The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of June 24, 2027.
The NDA is supported by the phase 3 ADVANCE OUTCOMES trial in 687 PAH patients, where ralinepag reduced the risk of clinical worsening by 55% versus placebo and improved key secondary endpoints, including NT-proBNP levels, six-minute walk distance, and odds of clinical improvement by 47%. According to United Therapeutics, benefits were consistent across subgroups, and the safety profile matched known prostacyclin-related adverse events with no new safety signals. Ralinepag remains investigational and is not approved for any indication.
United Therapeutics (Nasdaq: UTHR) announced full enrollment of its phase 3 TETON-PPF study evaluating nebulized Tyvaso (inhaled treprostinil) for progressive pulmonary fibrosis (PPF). The multinational, randomized, double-blind, placebo-controlled registration trial has enrolled 754 patients and will assess safety and efficacy over 52 weeks.
Patients receive Tyvaso or placebo four times daily, titrated from three to a target of 12 breaths. The primary endpoint is change in absolute forced vital capacity at week 52, with multiple lung function and clinical secondary endpoints. Full enrollment was reached in August 2026, with topline data expected in the second half of 2027. If successful, United Therapeutics plans to use the results to support an sNDA to add PPF to nebulized Tyvaso’s U.S. label; Tyvaso is currently not approved for PPF.
United Therapeutics (Nasdaq: UTHR) reported second quarter 2026 total revenues of $783.3 million, down 2% year-over-year from $798.6 million. Net income rose 8% to $333.0 million, with basic EPS up 14% to $7.82 and diluted EPS up 13% to $7.27.
Total Tyvaso revenues declined 4% to $452.6 million as an 18% drop in Nebulized Tyvaso to $126.0 million offset 4% growth in Tyvaso DPI to $326.6 million. Remodulin fell 6% to $126.3 million, while Orenitram and Unituxin grew 1% and 12%, respectively.
Cost of sales increased 14% to $99.5 million, including a $7.5 million inventory reserve related to a Tyvaso DPI commercial supply agreement. Research and development expenses rose 9% to $146.3 million. The effective tax rate fell to 11% from 24%, supporting net income growth.
According to the company, two NDAs were submitted for ralinepag tablets in PAH and Nebulized Tyvaso in IPF, with additional IND and NDA filings planned later in 2026. The company also executed $1.5 billion of accelerated share repurchases under a $2.0 billion buyback program, leaving $500 million authorized through March 9, 2027.
United Therapeutics (Nasdaq: UTHR) reported that the pivotal phase 3 ADVANCE OUTCOMES study of investigational ralinepag in pulmonary arterial hypertension met its primary endpoint. Ralinepag reduced the risk of first clinical worsening event by 55% versus placebo (hazard ratio 0.45; 95% CI 0.33–0.62; p<0.0001).
Key secondary endpoints also reached statistical significance, including a 24.3% NT-proBNP reduction over placebo (p=0.0013), a +20.4 m placebo-corrected six-minute walk distance improvement (p=0.0033), and a 47% higher odds of clinical improvement (p=0.015). No new safety signals were observed. United Therapeutics submitted a New Drug Application for ralinepag to the FDA in June 2026, and ralinepag remains investigational.
United Therapeutics (Nasdaq: UTHR) announced that its Board of Directors appointed Victor Dzau, M.D. to the Board on July 22, 2026. Dr. Dzau recently completed a 12-year term as President of the National Academy of Medicine and has held senior leadership roles at Duke University, Harvard, and Stanford.
In July 2026, he returned to Duke as James B. Duke Distinguished Professor of Medicine, Chancellor Emeritus for Health Affairs, and Director of the Mandel Center. According to United Therapeutics, Dr. Dzau’s scientific work contributed to ACE inhibitors, gene therapy for vascular disease, and cardiac regeneration research, and his appointment aligns with the company’s public benefit mission in rare diseases and transplantable organ alternatives.
United Therapeutics (Nasdaq: UTHR) will release its second quarter 2026 financial results on Wednesday, August 5, 2026, at approximately 6:30 a.m. Eastern Time. The company will host a public webcast at 9:00 a.m. Eastern Time, accessible via its investor relations events page, with a rebroadcast available for one year.