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) 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.
BETA Technologies (NYSE: BETA) and the Multistate Collaborative eIPP National Integration Complex completed the first electric conventional takeoff and landing (CTOL) aircraft flights under the U.S. DOT and FAA’s eVTOL Integration Pilot Program (eIPP), demonstrating Advanced Air Mobility operations in the National Airspace System.
The mission, run with Pennsylvania, Virginia, and Maryland aviation agencies, transported manufactured organs from United Therapeutics over about 275 nautical miles between airports in Virginia and Maryland. BETA reports over 160,000 nautical miles flown to date and charging infrastructure at 123 sites. The campaign is the first in a series of use cases expected to reach at least 26 states.
United Therapeutics (Nasdaq: UTHR) acquired preclinical biotech Thymmune Therapeutics, which develops scalable regenerative thymic cell therapies targeting post-transplant organ tolerance, immunodeficiencies, and autoimmune diseases. Thymmune’s lead iPSC-derived candidate THY-100 is in preclinical development for congenital athymia, an ultra-rare, life-threatening condition.
According to United Therapeutics, the deal includes $140 million in cash, subject to adjustments, plus up to $160 million in potential earn-out payments tied to clinical and regulatory milestones through 2031, strengthening its immunomodulatory and organ-transplant-focused pipeline.
United Therapeutics (Nasdaq: UTHR) received U.S. FDA premarket approval for its LungFX™ device, the first approved system for centralized ex vivo lung perfusion (EVLP) of donor lungs that otherwise cannot be placed for transplant.
LungFX supports reassessment of adult donor lungs, with total preservation time not intended to exceed 20 hours. Lung Bioengineering plans to add LungFX to its centralized EVLP services in 2027.
United Therapeutics (Nasdaq: UTHR) announced that Chief Financial Officer and Treasurer James Edgemond will present a company overview and update at the Jefferies Global Healthcare Conference in New York on Wednesday, June 3, 2026, from 12:45 to 1:15 p.m. EST.
The presentation will be available via live webcast and as an archived recording on the United Therapeutics investor relations website for 90 days.