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UNITED THERAPEUTICS (UTHR)

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Earnings summaries and quarterly performance for UNITED THERAPEUTICS.

Recent press releases and 8-K filings for UTHR.

United Therapeutics Highlights Key Pipeline Developments and Strategic Initiatives at J.P. Morgan Healthcare Conference
UTHR
Product Launch
New Projects/Investments
  • United Therapeutics announced that its inhaled Tyvaso demonstrated dramatic improvement in forced vital capacity in the TETON 2 trial for Idiopathic Pulmonary Fibrosis (IPF) patients, with a 0.0001 p-value compared to placebo. A confirmatory TETON 1 trial is fully enrolled and expected to unblind in the first half of 2026, with regulatory filing planned for summer 2026 and potential FDA approval in 2027 for this 100,000-patient US market.
  • The company's next-generation "superprostacyclin," Ralinepag, is poised to become the most prescribed medicine for pulmonary hypertension (PAH), with its Phase 3 trial expected to unblind within the next three months (Q1 2026). Open-label extension data showed a sustained improvement of approximately 40 meters in six-minute walk distance over two years.
  • United Therapeutics is advancing its xenotransplantation platform, with the FDA having approved two clinical trials for xeno kidneys, and patients already enrolled. The company expects to complete trials and obtain approval for xeno kidneys and hearts before the end of this decade, supported by three production centers capable of supplying over 1,000 xenografts annually. Additionally, INDs for two more xenotransplant studies are anticipated in the first half of 2026.
2 days ago
United Therapeutics Highlights IPF, Superprostacyclin, and Xenotransplantation Progress
UTHR
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • United Therapeutics projects a significant revenue increase, potentially two to four times current levels, driven by the anticipated launch of Tyvaso for Idiopathic Pulmonary Fibrosis (IPF), which targets a 100,000-patient market in the U.S.. The confirmatory TETON 1 trial data for Tyvaso in IPF is expected in the first half of 2026, with an FDA filing planned for summer 2026 and approval anticipated in 2027.
  • The company also expects to unblind the Phase 3 trial for Ralinepag, a next-generation superprostacyclin for pulmonary hypertension, within the next three months (by April 2026), aiming for it to become the most prescribed medicine in the 50,000-patient U.S. pulmonary hypertension market.
  • United Therapeutics is progressing its xenotransplantation program, with two FDA-approved clinical trials for xeno kidneys already underway and plans to submit INDs for two more xeno-heart studies in the first half of 2026. The company has established three production centers capable of supplying over 1,000 xenografts annually upon FDA approval, which is expected before the end of this decade.
2 days ago
United Therapeutics Highlights IPF, Super-Prostacyclin, and Xenotransplantation Progress at J.P. Morgan Conference
UTHR
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • United Therapeutics announced dramatic improvement in forced vital capacity for its inhaled Tyvaso in the TETON 2 trial for Idiopathic Pulmonary Fibrosis (IPF), with a p-value of 0.0001. The company plans to file for FDA approval this summer for Tyvaso in IPF, anticipating approval next year, targeting a 100,000-patient market in the United States.
  • The company expects to unblind the Phase 3 trial for ralinepag, a next-generation super-prostacyclin, within the next three months. Open-label extension data for ralinepag showed a 40-meter improvement in six-minute walk distance, and it is projected to become the most prescribed medicine for pulmonary hypertension.
  • United Therapeutics is advancing its xenotransplantation program, with two FDA-approved clinical trials for xeno kidneys already enrolling patients. The company aims for FDA approval for an unlimited supply of transplantable kidneys and hearts before the end of the decade and has built three production centers capable of providing over 1,000 xenografts annually.
2 days ago
Liquidia Announces Preliminary Full-Year 2025 YUTREPIA Net Sales and Commercial Update
UTHR
Earnings
Product Launch
New Projects/Investments
  • Liquidia Corporation reported preliminary, unaudited YUTREPIA™ net product sales of approximately $90.1 million in the fourth quarter and $148.3 million for full-year 2025.
  • The company generated over $30 million of positive cash flow in Q4 2025 and held approximately $190.7 million in cash and cash equivalents as of December 31, 2025.
  • Since its June 2025 launch, YUTREPIA™ has received more than 2,800 unique patient prescriptions, with over 2,200 patients starting treatment by December 2025, demonstrating an 85% conversion rate from prescription to patient start.
  • Liquidia plans to expand its field sales team in 2026 and is advancing clinical programs for YUTREPIA and L606.
6 days ago
United Therapeutics Discusses Commercial Business, Pipeline, and Growth at Jefferies Conference
UTHR
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
  • United Therapeutics reported significant growth in total Tyvaso and Tyvaso DPI in its Q3 report, identifying them as key future growth drivers, particularly in PH-ILD.
  • The company projects achieving a quarterly revenue run rate of $1 billion by the end of 2027, primarily driven by the expansion and growth of its current commercial products.
  • Following positive TETON 2 clinical study results for idiopathic pulmonary fibrosis (IPF), which showed a 96 ml benefit (placebo-adjusted difference on FVC), the company sees a multi-billion dollar opportunity and plans to meet with the FDA by the end of 2025 to discuss regulatory strategy.
  • The Advanced Outcomes trial for Ralinepag, a once-a-day oral prostacyclin, is expected to read out in the first half of 2026, with the potential for higher potency and efficacy than existing treatments.
  • United Therapeutics has initiated its xenotransplantation program, successfully completing a first transplant of a kidney into a human in the EXPAND clinical trial, with plans to expand to lung and heart transplants.
Nov 18, 2025, 12:00 PM
United Therapeutics Outlines Growth Trajectory and Pipeline Progress at Jefferies Conference
UTHR
Guidance Update
New Projects/Investments
Legal Proceedings
  • United Therapeutics projects a quarterly revenue run rate of $1 billion by the end of 2027, primarily driven by the growth of its existing commercial business, including Tyvaso and Tyvaso DPI.
  • The Teton 2 clinical study for Idiopathic Pulmonary Fibrosis (IPF) showed a 96 milliliter benefit on FVC, with Teton 1 expected to unblind in H1 2026; both trials are required for FDA approval, targeting a multi-billion dollar market opportunity.
  • The company is confident in the continued growth of its Tyvaso DPI product, which achieved 22%-23% growth in Q3, despite ongoing litigation and competition from Utrepia.
  • United Therapeutics is advancing its pipeline with Rilendipag, a once-daily oral prostacyclin, with clinical trial results expected in H1 2026, and has initiated xenotransplantation with the first kidney transplant in the EXPAND clinical trial.
Nov 18, 2025, 12:00 PM
United Therapeutics Provides Business Update and Future Outlook at Jefferies Conference
UTHR
Guidance Update
Product Launch
New Projects/Investments
  • United Therapeutics anticipates achieving a $1 billion quarterly revenue run rate by the end of 2027, predominantly from its current commercial products.
  • Tyvaso DPI demonstrated 22%-23% growth in Q3, and the company maintains confidence in its continued growth despite market competition and ongoing litigation.
  • The Teton 2 study for Idiopathic Pulmonary Fibrosis (IPF) showed a 96 milliliter benefit on FVC, with Teton 1 data expected in H1 2026 for this multi-billion dollar market.
  • The company expects Rilendipag (oral once-daily prostacyclin) clinical trial results in H1 2026, aiming for superior potency and efficacy.
  • The first kidney transplant in the xenotransplantation EXPAND clinical trial has been completed, with plans to expand to lung and heart transplants.
Nov 18, 2025, 12:00 PM
United Therapeutics Discusses Q3 Growth, $4 Billion Revenue Target, and Pipeline Milestones at UBS Conference
UTHR
Guidance Update
Product Launch
New Projects/Investments
  • United Therapeutics reported double-digit year-over-year growth in its Tyvaso franchise for Q3 2025 and announced the first transplant of its U-Kidney under a clinical trial.
  • The company expressed confidence in reaching a $4 billion revenue run rate by the end of 2027, supported by the positive TETON-2 clinical trial data for IPF, which was described as the "best IPF study ever conducted".
  • Key upcoming data readouts include the TETON-1 trial for IPF and the ralinepag outcomes study, both anticipated in the first half of 2026.
  • United Therapeutics plans to introduce higher-dose Tyvaso cartridges (80, 96, and 112 micrograms) in the coming months, and noted that competitor Yutrepia's launch is expanding the overall PAH and PH-ILD markets rather than materially impacting Tyvaso's growth.
Nov 10, 2025, 2:30 PM
United Therapeutics Discusses Q3 Performance, Pipeline Progress, and 2027 Revenue Target
UTHR
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
  • United Therapeutics reported double-digit year-over-year growth in its Tyvaso franchise for the third quarter.
  • The company announced positive results from its TETON-2 clinical trial for IPF, described as the "best IPF study ever conducted," and anticipates TETON-1 results in the first half of 2026.
  • United Therapeutics is confident in achieving a $4 billion run rate by the end of 2027, partly driven by the clarity gained from the TETON-2 IPF trial.
  • Key pipeline updates include the recent first U-Kidney transplant under its clinical trial (the first clinical IND for a xeno organ) and expected outcomes study results for ralinepag in the first half of 2026.
Nov 10, 2025, 2:30 PM
UTHR Highlights Q3 Growth, Key Clinical Milestones, and 2027 Revenue Target
UTHR
Guidance Update
New Projects/Investments
  • United Therapeutics reported double-digit year-over-year growth in its Tyvaso franchise for the third quarter.
  • The company announced positive results from the TETON-2 clinical trial for IPF in September, describing it as the "best IPF study ever conducted".
  • United Therapeutics expects to achieve a $4 billion revenue run rate by the end of 2027, driven by the clarity gained from the TETON-2 trial in IPF.
  • The first transplant of its U-Kidney under a clinical trial was announced last week, marking the first clinical IND for a xeno organ. The study will involve a first cohort of six patients, followed by a second cohort of 44 or more patients.
  • Upcoming pipeline milestones include results from the ralinepag outcomes study and the TETON-1 trial for IPF, both anticipated in the first half of 2026.
Nov 10, 2025, 2:30 PM