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 (Nasdaq: UTHR) received FDA clearance to proceed with a phase 1 clinical trial of Treprostinil-Iloprost SMI.
The open-label, single ascending dose study will evaluate safety, tolerability and pharmacokinetics—how the drug moves through the body—in healthy volunteers. The investigational inhaled therapy combines treprostinil and iloprost and is intended for as-needed relief of pulmonary arterial hypertension (PAH) symptom flare-ups between maintenance doses. United Therapeutics anticipates starting a phase 2 study in PAH patients in 2027, assuming a successful phase 1 outcome.
United Therapeutics (UTHR) authorized a new share repurchase program for up to $2 billion, available through October 21, 2027.
Repurchases may use accelerated programs, open market transactions, privately negotiated transactions or other means. The authorization requires no minimum purchase and leaves purchases to the company’s discretion. An ongoing accelerated share repurchase transaction, entered into in September 2026 under the prior authorization, will not reduce the new program’s capacity. That transaction is scheduled to terminate in the fourth quarter of 2026, subject to earlier termination or extension under its terms.
United Therapeutics (UTHR) will report its third quarter 2026 financial results before market open on November 4, 2026. The release is scheduled for approximately 6:30 a.m. Eastern Time, followed by a public webcast at 9:00 a.m. Eastern Time. A webcast replay will remain available on the company's investor relations website for one year.
United Therapeutics (UTHR) opened its third pathogen-controlled xenograft production facility in Houston, expanding its manufacturing infrastructure for pig-derived kidneys and hearts.
The Houston facility and the Stewartville, Minnesota facility opened in August 2026 are designed to scale commercial production following product approval. The first facility, opened in Christiansburg, Virginia in 2024, produces organs for ongoing clinical trials.
The company is advancing trials intended to support U.S. approval applications for UKidney, UThymoKidney and UHeart. The kidney studies involve patients with end-stage renal disease; the heart study involves advanced heart failure. The heart study will start at one center, with expansion dependent on supportive initial data.
United Therapeutics (Nasdaq: UTHR) received FDA clearance to proceed with SUMMIT, a phase 2 trial of treprostinil delivered by soft mist inhaler.
The 16-week, double-blind study will evaluate safety and tolerability in approximately 40 patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). Secondary endpoints assess exercise capacity and NT-proBNP, a heart-failure biomarker. Eligible participants can enter an open-label extension to assess longer-term outcomes.
United Therapeutics anticipates starting a phase 3 registration study in 2028, assuming SUMMIT succeeds. It also plans development for pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. Treprostinil SMI is not approved in any jurisdiction for any indication.
Liquidia (LQDA) entered a global settlement with United Therapeutics resolving all six pending lawsuits and preserving uninterrupted YUTREPIA access for PAH patients. Net payments total $380.7 million: $175 million to United Therapeutics within 30 business days, two $72.7 million installments due by January 31 and April 30, 2027, and $60.3 million to other parties in October 2026.
Liquidia agreed not to appeal the ruling that two patent claims covering treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) were valid and infringed. It submitted a supplement to remove PH-ILD from YUTREPIA’s label and stopped promotion for that indication. Preliminary, unaudited Q3 2026 YUTREPIA net product sales were $222.7 million; cash and equivalents totaled $396.1 million at September 30. Liquidia plans to continue its YUTREPIA and L606 clinical programs and has ended commercial support for Treprostinil Injection.
United Therapeutics (Nasdaq: UTHR) will present new clinical analyses at the CHEST Annual Meeting, taking place October 18–21, 2026, in Phoenix.
A pre-specified subgroup analysis of phase 3 ADVANCE OUTCOMES showed ralinepag reduced clinical worsening risk in pulmonary arterial hypertension, regardless of baseline noninvasive low-risk criteria met. A post-hoc analysis, conducted after the study, of phase 3 TETON-2 showed nebulized treprostinil significantly reduced the risk of multiple disease progression events versus placebo in idiopathic pulmonary fibrosis. The FDA accepted applications for ralinepag in pulmonary arterial hypertension and nebulized treprostinil in idiopathic pulmonary fibrosis; both remain investigational for these uses.
United Therapeutics (UTHR) won a Delaware federal court ruling that Liquidia infringes two patent claims by marketing Yutrepia for PH-ILD.
The court found infringement of claims 1 and 14 of U.S. Patent No. 11,826,327 and concluded Liquidia failed to prove them invalid. The patent covers inhaled treprostinil treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics believes it is entitled to an order directing FDA withdrawal of Yutrepia approval and intends to seek damages for past infringement. Such an order, if granted, may remove Yutrepia from the U.S. market until FDA can approve labeling without PH-ILD.
The parties have one week to submit an agreed final judgment; disputed scope would require a court ruling. United Therapeutics sells Tyvaso and Tyvaso DPI, both approved for PH-ILD, and offers patient access programs.
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.