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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.

Flare Therapeutics Presents Updated FX-909 Phase 1A Data in Urothelial Cancer
UTHR
New Projects/Investments
  • Flare Therapeutics announced updated Phase 1A clinical data for FX-909, a first-in-class orally bioavailable inhibitor of PPARG, in patients with locally-advanced or metastatic urothelial cancer.
  • The data, presented at the 2026 ASCO GU Cancers Symposium, showed antitumor activity in biomarker-defined PPARGhigh tumors, with 18 of 25 efficacy-evaluable patients demonstrating tumor regressions, including five confirmed partial responses and one complete response.
  • FX-909 exhibited an acceptable safety profile and meaningful clinical benefit, with five patients remaining on treatment at the data cut-off (November 10, 2025) for extended periods, including one for 12.7+ months.
  • Interim data from the ongoing Phase 1B expansion study for FX-909 is anticipated in mid-2026.
23 hours ago
United Therapeutics Reports Q4 2025 Results and Outlines Multiple Product Launches for 2027
UTHR
Earnings
Product Launch
Guidance Update
  • United Therapeutics reported Q4 2025 total revenue of $790 million, a 7% increase over Q4 2024, contributing to full-year 2025 total revenue exceeding $3 billion with 11% growth.
  • The company anticipates three significant commercial launches in 2027: Tresmi, a soft mist inhaler for PAH and ILD; a once-daily super prostacyclin for PAH; and an improved treatment for IPF.
  • Management reaffirmed its commitment to double-digit revenue growth and projects reaching a $4 billion revenue run rate by the end of 2027, independent of the new product contributions.
  • In its transplantation efforts, Zeno has 2 patients transplanted with full enrollment of a 6-patient cohort expected by summer 2026, targeting a commercial launch in 2030.
3 days ago
United Therapeutics Reports Record 2025 Revenue and Details Multiple Upcoming Product Launches
UTHR
Earnings
Product Launch
Guidance Update
  • United Therapeutics reported record-breaking revenue for full year 2025, surpassing $3 billion with 11% total revenue growth over 2024, and $790 million in Q4 2025, a 7% increase from Q4 2024.
  • The company anticipates three disease-transformative commercial launches in 2027: Tresmi, a soft mist inhaler for PAH and ILD (filing in 2026); a once-daily super prostacyclin for PAH (unblinding next week); and a new treatment for IPF (filing after TETON-1 unblinding next month, launch by June 2027).
  • Management reaffirmed its commitment to double-digit revenue growth and expects to achieve a $4 billion revenue run rate by the end of 2027, driven by existing products, with new launches projected to further accelerate growth.
  • In xenotransplantation, the Zeno clinical trial has 2 patients transplanted and is on schedule to fully enroll its 6-patient cohort by summer, targeting a commercial product launch in 2030.
3 days ago
United Therapeutics Reports Q4 2025 Results
UTHR
Earnings
New Projects/Investments
Revenue Acceleration/Inflection
  • United Therapeutics reported total revenue of $790 million for Q4 2025, representing a 7% increase year-over-year.
  • Tyvaso DPI/Nebulized Tyvaso revenue grew 12% year-over-year to $464 million, achieving its highest DPI revenue quarter and record DPI total patients.
  • The TETON-2 study for Nebulized Tyvaso in Idiopathic Pulmonary Fibrosis (IPF) met its primary endpoint, with data for the TETON-1 U.S. and Canada study expected in the first half of 2026.
  • Orenitram revenue increased 12% year-over-year to $121 million, marking its 16th consecutive quarter of year-over-year quarterly revenue growth.
3 days ago
United Therapeutics Reports Record 2025 Revenue, Prepares for Three Major Product Launches in 2027
UTHR
Earnings
Product Launch
Guidance Update
  • United Therapeutics achieved record-breaking revenue in full year 2025, surpassing $3 billion with 11% total revenue growth over 2024, and reported $790 million in total revenue for Q4 2025, a 7% increase from the prior year quarter.
  • The company anticipates three significant commercial launches in 2027: Tresmi (a soft mist inhaler for PAH and ILD), a once-daily super prostacyclin for PAH, and a new treatment for IPF, with regulatory filings for these products expected in 2026.
  • Management reaffirmed its commitment to double-digit revenue growth and projects reaching a $4 billion revenue run rate by the end of 2027, a target that does not rely on the contribution from the new product launches.
  • Progress is also being made in xenotransplantation, with two patients transplanted in the Zeno clinical trial and a commercial Zeno product projected for 2030, alongside expected FDA guidance in 2026 for the Miromatrix manufactured liver product.
3 days ago
United Therapeutics Reports Q4 and Full Year 2025 Financial Results
UTHR
Earnings
Share Buyback
Revenue Acceleration/Inflection
  • United Therapeutics Corporation reported record total revenues of $3.18 billion for the full year 2025, reflecting an 11% growth over 2024, with diluted earnings per share (EPS) of $27.86.
  • For the fourth quarter of 2025, total revenues were $790.2 million, and diluted EPS was $7.70.
  • Total Tyvaso revenues grew by 16% to $1,878.2 million for the full year 2025, primarily driven by Tyvaso DPI.
  • The company entered into accelerated share repurchase agreements totaling approximately $2.0 billion in August 2025 and March 2024.
3 days ago
United Therapeutics Reports Record Full Year 2025 Financial Results
UTHR
Earnings
Revenue Acceleration/Inflection
Share Buyback
  • United Therapeutics Corporation reported record total revenues of $3.18 billion for the full year 2025, representing an 11% increase over 2024, and $790.2 million for the fourth quarter of 2025.
  • Net income for the full year 2025 was $1,334.7 million, with diluted earnings per share of $27.86.
  • Total Tyvaso revenues grew by 16% to $1,878.2 million in 2025, primarily driven by Tyvaso DPI sales.
  • The company repurchased shares under accelerated share repurchase agreements totaling $2.0 billion, receiving 2,642,498 shares in 2025.
3 days ago
United Therapeutics Announces Positive Phase 1 Study Results for miroliver ELAP®
UTHR
New Projects/Investments
  • United Therapeutics (Nasdaq: UTHR) announced positive results from its phase 1 study of miroliver ELAP®, an external liver assist product for Acute Liver Failure (ALF) patients. This study was the world's first FDA-cleared clinical trial using a bioengineered liver.
  • The single-arm, open-label, safety study met its primary endpoint of survival during miroliver ELAP treatment, with no reports of unexpected serious adverse events attributable to the product over a 32-day follow-up period.
  • Based on these positive results, United Therapeutics will initiate a phase 2 study for miroliver ELAP.
  • miroliver ELAP addresses a critical unmet medical need, as approximately 30% of ALF patients die because they are ineligible for a liver transplant or a donated liver is not available.
  • Full study results are expected to be presented and published in the second half of 2026.
Jan 26, 2026, 12:00 PM
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.
Jan 12, 2026, 9:30 PM
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.
Jan 12, 2026, 9:30 PM