United Therapeutics Corporation

United Therapeutics Announces FDA Clearance to Proceed with Clinical Trial for Treprostinil-Iloprost SMI in Pulmonary Arterial Hypertension

United Therapeutics received FDA clearance under its IND to begin clinical testing of Treprostinil-Iloprost SMI, a first-of-its-kind use-as-needed combination inhaled therapy for pulmonary arterial hypertension. The phase 1 open-label single ascending dose study will assess safety, tolerability, and pharmacokinetics in healthy volunteers, with a phase 2 study in PAH patients anticipated in 2027 if results are positive. The candidate combines two prostacyclin analogues, treprostinil and iloprost, delivered via soft mist inhaler for as-needed symptom relief during acute flare-ups; it remains investigational and unapproved in any jurisdiction.

•4d ago

United Therapeutics Corporation Announces Additional $2 Billion Share Repurchase Authorization

United Therapeutics' board authorized a new share repurchase program of up to $2 billion, available through October 21, 2027. The company may execute via accelerated share repurchases, open market, or privately negotiated transactions, with no minimum purchase obligation and discretion to suspend at any time. An existing ASR entered into in September 2026, terminating in Q4 2026, runs separately and will not reduce the new authorization.

•10d ago

United Therapeutics Expands Organ Manufacturing Capabilities with Opening of Third Designated Pathogen-Free Xenograft Production Facility

United Therapeutics opened its third Designated Pathogen-Free xenograft production facility, in Houston, Texas, named for transplantation pioneers Dr. Bartley Griffith and Dr. Robert Montgomery. The biosecure facility is purpose-built to manufacture the company's xenokidneys and xenohearts, joining facilities in Virginia and Minnesota that are designed to enable commercial-scale production following potential FDA approval. Clinical trials remain underway: EXPAND (UKidney) and EXTEND (UThymoKidney) in end-stage renal disease, with the EXPRESS UHeart trial starting at a single center. All xeno-organ products are still investigational and not approved in any jurisdiction.

•12d ago

United Therapeutics Announces FDA Clearance to Proceed with SUMMIT Clinical Trial for Treprostinil SMI in PH-COPD

United Therapeutics received FDA clearance to proceed with the SUMMIT Phase 2 trial of treprostinil SMI (soft mist inhaler) in pulmonary hypertension associated with COPD. The 16-week, double-blind study will enroll approximately 40 patients, with secondary endpoints on exercise capacity and NT-proBNP; a Phase 3 registration study is planned for 2028 if results are successful. Management frames PH-COPD — estimated at 400,000-800,000 U.S. patients — as potentially 5-10x the size of the company's current approved markets, and treprostinil SMI could become the first FDA-approved therapy specifically for PH-COPD.

•13d ago

United Therapeutics Presents New Data at the CHEST 2026 Annual Meeting

United Therapeutics will present two oral and five poster presentations at the CHEST 2026 Annual Meeting (October 18-21, Phoenix) spanning its PAH, PH-ILD, and IPF portfolio. A pre-specified subgroup analysis of the phase 3 ADVANCE OUTCOMES study showed ralinepag reduced clinical worsening risk in PAH patients regardless of baseline risk criteria, and a post-hoc TETON-2 analysis showed nebulized treprostinil significantly reduced disease progression events in IPF patients. The FDA has accepted both the ralinepag NDA for PAH and the nebulized treprostinil sNDA for IPF; both assets remain investigational. Positive but incremental conference data that reinforces the pipeline ahead of pending FDA review decisions.

•19d ago

United Therapeutics Corporation Prevails in Patent Litigation Against Liquidia

A Delaware District Court found Liquidia infringes claims 1 and 14 of United Therapeutics' '327 patent covering inhaled treprostinil for PH-ILD, and rejected Liquidia's invalidity defense. United Therapeutics believes it is entitled to an order instructing the FDA to withdraw approval of Liquidia's Yutrepia NDA, which could remove Yutrepia from the U.S. market pending relabeled approval; it will also seek monetary damages, potentially a royalty on past Yutrepia sales. The ruling protects Tyvaso and Tyvaso DPI's PH-ILD franchise from its nearest competitor, with the parties due to submit an agreed form of final judgment within one week.

•1mo ago

United Therapeutics Corporation Announces Accelerated Share Repurchase Agreement for Remainder of $2.0 Billion Authorization

United Therapeutics will enter into an accelerated share repurchase agreement with Citibank for approximately $477.6 million, using up the remainder of its previously announced $2.0 billion share repurchase authorization. Under the ASR terms, UTHR will pay Citi upfront on or around September 10, 2026 and receive an initial delivery of about 75% of the anticipated shares, with final settlement expected in the fourth quarter of 2026. UTHR had approximately 42.9 million shares outstanding as of September 4, 2026. CEO Martine Rothblatt said the market is not yet reflecting the scale of what United Therapeutics is positioned to achieve, and that completing the repurchase brings total capital returned to shareholders to $4 billion in approximately 2.5 years.

•1mo ago

United Therapeutics Corporation Announces FDA Acceptance of Supplemental New Drug Application for Nebulized Tyvaso® to Treat Idiopathic Pulmonary Fibrosis

The FDA accepted United Therapeutics' supplemental New Drug Application for nebulized Tyvaso (treprostinil) Inhalation Solution to treat idiopathic pulmonary fibrosis, with the agency's review anticipated to be complete in late April 2027. If approved, nebulized Tyvaso would become the first and only inhaled anti-fibrotic treatment for IPF, a disease the company estimates affects at least 100,000 people in the United States. The filing was based on the phase 3 TETON-1 and TETON-2 studies, whose combined analysis met the primary endpoint with a statistically significant 111.8 mL benefit in forced vital capacity versus placebo (p<0.0001), plus significance on most key secondary endpoints including clinical worsening, acute exacerbations, and quality-of-life measures. Both the FDA and the European Medicines Agency have granted orphan designation for treprostinil in IPF, and the drug remains investigational for this indication until a decision.

•1mo ago

United Therapeutics Presents Data at The European Society of Cardiology Congress 2026 and The European Respiratory Society International Congress 2026

United Therapeutics is presenting late-breaking data from its Phase 3 programs at the ESC and ERS congresses, highlighting positive outcomes for ralinepag and treprostinil. The ADVANCE OUTCOMES analysis showed ralinepag achieved clinical improvement in lower-risk PAH patients, while TETON data demonstrated nebulized treprostinil improved lung function and reduced clinical worsening in IPF patients. Interim ARTISAN data indicated improved right ventricular ejection fraction with early treprostinil titration, and the company confirmed NDAs for ralinepag and nebulized treprostinil were submitted in June 2026.

•2mo ago

United Therapeutics Corporation Announces FDA Filing Acceptance of New Drug Application for Ralinepag to Treat Pulmonary Arterial Hypertension

United Therapeutics announced that the FDA has accepted the New Drug Application for ralinepag to treat pulmonary arterial hypertension, with a Prescription Drug User Fee Act target action date of June 24, 2027. The filing acceptance is supported by data from the Phase 3 ADVANCE OUTCOMES study, where ralinepag achieved a statistically significant 55% reduction in the risk of clinical worsening compared to placebo. Chief Executive Officer Martine Rothblatt noted that the drug has the potential to offer a new, once-daily oral treatment that delayed disease progression and showed durability of effect over many years.

•2mo ago

United Therapeutics Corporation Announces Full Enrollment of the TETON-PPF Study of Inhaled Treprostinil for the Treatment of Progressive Pulmonary Fibrosis

United Therapeutics announced full enrollment of 754 patients in the TETON-PPF Phase 3 study evaluating inhaled Tyvaso for progressive pulmonary fibrosis (PPF). Topline data from the 52-week study is expected in the second half of 2027, with a supplemental NDA planned if successful. The rapid enrollment pace follows positive results from the TETON-1 and TETON-2 studies in idiopathic pulmonary fibrosis (IPF).

•2mo ago

United Therapeutics Corporation Announces ADVANCE OUTCOMES Study of Ralinepag Published in The Lancet

United Therapeutics announced that The Lancet published full results from the pivotal Phase 3 ADVANCE OUTCOMES study, which met its primary endpoint by reducing the risk of a clinical worsening event by 55% compared to placebo. The study demonstrated statistically significant improvements in key secondary endpoints, including a 24.3% reduction in NT-proBNP levels and a 20.4-meter improvement in six-minute walk distance at week 28. The company submitted a New Drug Application for ralinepag to the FDA in June 2026, targeting the drug as a once-daily oral prostacyclin receptor agonist for pulmonary arterial hypertension.

•3mo ago

United Therapeutics Corporation Announces Appointment of Victor Dzau to its Board of Directors

United Therapeutics appointed Dr. Victor Dzau to its Board of Directors effective July 22, 2026. Dr. Dzau brings extensive experience as the former President of the National Academy of Medicine and former Chancellor for Health Affairs at Duke University. His background in gene therapy, cardiac regeneration, and health policy is expected to support the company's mission to develop transplantable organs and treatments for rare diseases. CEO Martine Rothblatt noted that Dr. Dzau is uniquely capable of guiding the public benefit corporation, while the Board's Nominating Committee characterized the move as part of a concerted refreshment effort.

•3mo ago

United Therapeutics Corporation Acquires Thymmune Therapeutics

United Therapeutics acquired Thymmune Therapeutics for $140 million in cash, with an additional $160 million in potential earn-outs contingent on clinical milestones through 2031. The transaction adds Thymmune's proprietary iPSC-derived thymic cell platform to UTHR's portfolio, complementing the existing UThymoKidney program aimed at transplant tolerance. Thymmune's lead candidate, THY-100, is in preclinical development for congenital athymia, a life-threatening condition in infants born without a functional thymus.

•4mo ago

United Therapeutics Corporation Announces TETON-1 Study of Tyvaso Published in The New England Journal of Medicine and Presented at ATS 2026

United Therapeutics announced that the pivotal TETON-1 Phase 3 study of nebulized Tyvaso for idiopathic pulmonary fibrosis (IPF) met its primary endpoint, showing statistically significant preservation of lung function (FVC) versus placebo. The results, published in The New England Journal of Medicine, also showed a 33% reduction in the risk of clinical worsening. Combined analysis with TETON-2 confirmed these benefits and showed a 48% reduction in acute IPF exacerbations. The company plans to submit a supplemental New Drug Application to the FDA by the end of summer 2026 to add IPF to Tyvaso’s label, seeking priority review for this major new indication.

•5mo ago

United Therapeutics Corporation Announces ADVANCE OUTCOMES Study of Ralinepag Presented at ATS 2026

United Therapeutics announced that its pivotal Phase 3 ADVANCE OUTCOMES study for ralinepag met its primary endpoint, showing a 55% reduction in the risk of clinical worsening in PAH patients. The drug also achieved statistical significance for key secondary endpoints, including a 24.3% reduction in NT-proBNP levels and a 20.4-meter improvement in six-minute walk distance. United Therapeutics plans to submit a New Drug Application for ralinepag to the FDA by the second half of 2026, positioning it as the first once-daily oral prostacyclin receptor agonist for PAH.

•5mo ago

United Therapeutics Corporation Announces FDA Clearance to Proceed with UHeart Xenotransplantation Clinical Trial

United Therapeutics received FDA clearance to begin the EXPRESS clinical trial for UHeart, a gene-edited pig heart intended for human transplantation. The study is designed as a seamless Phase 1/2/3 trial, starting with an initial cohort of two participants at a single center. Data from the first recipient will be reviewed by the FDA before the second transplant proceeds. UHeart features 10 genetic edits—six human genes added and four porcine genes inactivated—to reduce rejection risk. The company intends to use data from this trial to support a Biologics License Application (BLA) for regulatory approval.

•5mo ago

Varda Space Industries and United Therapeutics Collaborate to Advance Microgravity-Enabled Treatments for Rare Pulmonary Disease

United Therapeutics and Varda Space Industries have entered into a collaboration to explore the use of microgravity for developing improved formulations of treatments for rare pulmonary diseases. The collaboration will leverage Varda's orbital manufacturing and reentry platform to process small molecule medicines in microgravity, aiming to enhance stability, bioavailability, and delivery methods. United Therapeutics, known for its focus on rare diseases, sees this partnership as a potential breakthrough in clinical development, with the first compounds likely targeting life-threatening pulmonary diseases.

•5mo ago

United Therapeutics Corporation Reports First Quarter 2026 Financial Results

United Therapeutics reported Q1 2026 revenue of $781.5 million, down 2% year-over-year, with net income decreasing 15% to $274.9 million. The company announced a $2.0 billion share repurchase authorization, with $1.5 billion already executed via ASR agreements, leaving $500 million available. Management highlighted positive clinical results from the ADVANCE OUTCOMES and TETON-1 studies and expressed commitment to returning to sequential quarterly revenue growth.

•5mo ago

MannKind Announces Ralinepag Dry Powder Inhalation (DPI) Program to be Pursued for Pulmonary Hypertension and Fibrotic Lung Diseases

MannKind is advancing a dry powder inhalation formulation of ralinepag for partner United Therapeutics, which recently reported positive Phase 3 data for the oral version of the drug. United Therapeutics made a $5 million payment to support the program, with MannKind eligible to receive up to $35 million in development milestones and 10% royalties on net sales. The collaboration targets pulmonary arterial hypertension and fibrotic lung diseases, with a Phase 1 study planned to assess dosing and pharmacokinetics.

•5mo ago