Form 8-K

8-K — UNITED THERAPEUTICS Corp

Accession: 0001104659-26-036445

Filed: 2026-03-30

Period: 2026-03-30

CIK: 0001082554

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2610558d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2610558d1_ex99-1.htm)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15 (d) of

the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

March 30, 2026

United Therapeutics Corporation

(Exact Name of Registrant as Specified in

its Charter)

Delaware

000-26301

52-1984749

(State or Other

(Commission

(I.R.S. Employer

Jurisdiction of

File Number)

Identification Number)

Incorporation)

1000 Spring Street

Silver Spring, MD

20910

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including

area code: (301) 608-9292

Check the appropriate box below if the Form 8-K filing

is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities

Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange

Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under

the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under

the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant

to Section 12(b) of the Act:

Title of each class

Trading symbol(s)

Name of each exchange on which

registered

Common Stock, par value $0.01 per share

UTHR

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging

growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of

the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ¨

If an emerging

growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with

any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01. Other Events

On March 30, 2026, United Therapeutics Corporation

issued a press release announcing positive results of the TETON-1 clinical study of Tyvaso® (treprostinil)

Inhalation Solution in patients with idiopathic pulmonary fibrosis. The press release is attached as Exhibits 99.1 and is incorporated

herein by reference.

TYVASO is a registered trademark of United

Therapeutics Corporation.

Item 9.01. Exhibits

(d) Exhibits

Exhibit No.

Description of Exhibit

99.1

Press Release dated March 30, 2026

104

The cover page from this Current Report on Form 8-K, formatted in Inline XBRL

SIGNATURE

Pursuant to the requirements of the Securities

Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

UNITED THERAPEUTICS CORPORATION

Dated: March 30, 2026

By:

/s/ Paul A. Mahon

Name:

Paul A. Mahon

Title:

General Counsel

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2610558d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

United Therapeutics Corporation Announces TETON-1 Pivotal

Study of Tyvaso® Meets Primary Endpoint for Treatment of Idiopathic Pulmonary Fibrosis, Exceeding Impressive Treatment Effect Seen

in TETON-2

Nebulized Tyvaso® (treprostinil) Inhalation Solution demonstrated

superiority over placebo for the change in absolute forced vital capacity by 130.1 mL and reduced the risk of clinical worsening in

patients with idiopathic pulmonary fibrosis, with positive results observed across all subgroups

Integrated analyses of TETON-1 and TETON-2 showed

statistically significant treatment effects across the primary and most secondary efficacy endpoints, reinforcing the robustness of the

clinically meaningful results observed in each of the individual studies

Nebulized Tyvaso combines direct lung delivery with multimodal

activity across fibrotic, vascular, and inflammatory pathways that are not currently addressed by existing IPF therapies

United Therapeutics plans to seek priority review of a supplemental

New Drug Application to be submitted to the FDA by the end of this summer

SILVER SPRING, Md. and RESEARCH TRIANGLE

PARK, N.C., March 30, 2026 — United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation,

today announced that its TETON-1 study evaluating the use of nebulized Tyvaso for the treatment of idiopathic pulmonary

fibrosis (IPF) met its primary efficacy endpoint, demonstrating superiority over placebo for the change in absolute forced

vital capacity (FVC) by 130.1 mL (Hodges-Lehmann [H-L] estimate, 95% confidence interval [CI], 82.2 to 178.1 mL;

p <0.0001) from baseline to week 52.

Nebulized Tyvaso achieved statistical significance

for reducing the risk of clinical worsening and showed numerical improvement in other important secondary endpoints relative to placebo,

including time to first acute exacerbation of IPF and changes in percent predicted FVC, King’s Brief Interstitial Lung Disease

quality of life questionnaire (K-BILD) score, and diffusion capacity of lungs for carbon monoxide (DLCO).

Benefits of nebulized Tyvaso were observed

across all subgroups, such as use of background therapy (nintedanib, pirfenidone, or no background therapy), smoking status, and supplemental

oxygen use. Treatment with nebulized Tyvaso was well-tolerated, and the safety profile was consistent with previous Tyvaso studies and

known prostacyclin-related adverse events. No new safety signals were observed.

Integrated analyses of TETON-1 and

TETON-2 showed statistically significant treatment effects compared to placebo from baseline to week 52 for the primary endpoint

of change in absolute FVC by 111.8 mL (H-L estimate, 95% CI, 79.7 to 144.0; p <0.0001) and most secondary endpoints, including time

to first clinical worsening and first acute exacerbation of IPF and changes in percent predicted FVC, K-BILD score, and DLCO. Overall

survival at week 52 trended in favor of Tyvaso but did not meet statistical significance.

“The unprecedented results of TETON-1,

which surpassed even the overwhelmingly positive results of TETON-2, represent a profound step forward for people living with

IPF, a devastating disease with few treatment options. We remain sincerely grateful to the patients, caregivers, and investigators who

made this trial possible,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics.

“In the past seven months, our three pivotal studies, TETON-1, TETON-2, and the ADVANCE OUTCOMES study of

ralinepag, met their primary endpoints with p-values <0.0001, an inflection point heralding a new era of even greater growth for United

Therapeutics. These consecutive accomplishments were produced by our culture of innovation and our commitment to multiple shots on goal

to advance treatments for rare cardiopulmonary and respiratory diseases.”

“IPF is a progressive, life-limiting

disease for which existing treatments provide only modest benefit and are often accompanied by significant side effects. TETON-1

reinforces what was shown in TETON-2, with both studies demonstrating clinically meaningful treatment outcomes in IPF patients

with or without background anti-fibrotic therapy. Together, both studies demonstrated not only better preservation of lung function,

but also preservation of quality of life, as well as reduced disease worsening and reduced acute IPF exacerbations. These findings have

the potential to fundamentally shift our approach to IPF management and could be a game changer,” said Steven D. Nathan,

M.D., Schar Chair, Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital and Chair of the TETON Steering

Committee.

“The TETON program has achieved

statistical significance in endpoints that have never been attained in other IPF clinical trials. These results provide a compelling

body of evidence for nebulized Tyvaso’s differentiated direct lung delivery combined with multimodal activity across fibrotic,

vascular, and inflammatory pathways that are not currently addressed by existing therapies,” said Peter Smith, Pharm.D.,

Senior Vice President, Product Development at United Therapeutics and the lead for the global TETON program.

United Therapeutics plans to seek priority review of a supplemental

New Drug Application, to be submitted to the U.S. Food and Drug Administration (FDA) by the end of this summer, to add IPF to

the labeled indications for nebulized Tyvaso based on data from the TETON-1 and TETON-2 studies. Both the FDA and the European

Medicines Agency have granted orphan designation for treprostinil to treat IPF.

Additional TETON-1 study

results and data from the integrated analyses of TETON-1 and TETON-2 will be presented at the American Thoracic Society

Annual Meeting in Orlando in May 2026. Full results of the TETON-2 study were recently published in the New England Journal

of Medicine and are available online at NEJM.org.

TETON Clinical Program

A post-hoc analysis of the INCREASE

study in patients with pulmonary hypertension associated with interstitial lung disease suggested that nebulized Tyvaso was associated

with a significant improvement in FVC, laying the foundation for the TETON clinical program to evaluate the use of nebulized Tyvaso

in IPF and progressive pulmonary fibrosis (PPF). TETON-1 enrolled patients with IPF in the United States and Canada,

and TETON-2 enrolled patients with IPF outside the United States and Canada. TETON-PPF is

evaluating the use of nebulized Tyvaso in PPF in patients globally, and enrollment is ongoing.

TETON-1 Study Design

The TETON-1 study (NCT04708782)

was a 598-patient, multicenter, randomized, double-blind, placebo-controlled phase 3 registration study evaluating the safety and efficacy

of nebulized Tyvaso in patients with IPF over a 52-week period at sites in the United States and Canada. The study reached

full enrollment in January 2025.

The primary endpoint of the study was the

change in absolute FVC from baseline to week 52. Secondary endpoints included: (1) time to clinical worsening; (2) time to

first acute exacerbation of IPF; (3) overall survival at week 52; (4) change in percent predicted FVC from baseline to week

52; (5) change in the K-BILD questionnaire from baseline to week 52; and (6) change in DLCO from baseline to week 52.

Safety assessments included the development

of adverse events, serious adverse events, vital signs, clinical laboratory parameters, and electrocardiogram parameters.

Eligible patients completing

the TETON-1 study could enroll in the TETON-OLE study (NCT04905693), an ongoing open-label

extension study to evaluate the long-term safety and tolerability of nebulized Tyvaso in patients with fibrotic lung disease.

About IPF

Idiopathic pulmonary fibrosis, or IPF, is

a scarring disease of the lungs of an unknown (idiopathic) cause and is the most common of the idiopathic interstitial pneumonias. IPF

is characterized by the progressive loss of the ability of the lungs to transfer oxygen into the blood, ultimately resulting in respiratory

failure and death. While the precise causes of IPF remain unknown, IPF rarely presents before age 50 and can be associated with

cigarette smoking and certain genetic dispositions. In addition, some evidence suggests that gastroesophageal reflux (acid reflux, or

heartburn), certain viral infections, air pollution, and workplace exposures may be risk factors for IPF. IPF is estimated to affect

between 0.33 and 4.51 people per 10,000 persons worldwide. Further, United Therapeutics estimates there are over 100,000 IPF patients

in the United States.

About Tyvaso® (treprostinil) Inhalation

Solution

INDICATION

TYVASO (treprostinil) Inhalation Solution

is a prostacyclin mimetic indicated for the treatment of:

· Pulmonary

arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with TYVASO

establishing effectiveness predominately included patients with NYHA Functional Class III

symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective

tissue diseases (33%).

The effects diminish over the minimum recommended

dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

While there are long-term data on use of

treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of

an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor. The controlled clinical experience with

TYVASO was limited to 12 weeks in duration.

· Pulmonary

hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise

ability. The study with TYVASO establishing effectiveness predominately included patients

with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic

pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO

Group 3 connective tissue disease (22%).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

TYVASO is a pulmonary and systemic vasodilator.

In patients with low systemic arterial pressure, TYVASO may produce symptomatic hypotension.

TYVASO inhibits platelet aggregation and

increases the risk of bleeding.

Co-administration of a cytochrome P450 (CYP)

2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a

CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events

associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness.

Like other inhaled prostaglandins, TYVASO

may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity,

are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during

treatment with TYVASO.

DRUG INTERACTIONS/SPECIFIC POPULATIONS

The concomitant use of TYVASO with diuretics,

antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.

Human pharmacokinetic studies with an oral

formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor,

gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin,

decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors

or inducers of CYP2C8.

Limited case reports of treprostinil use

in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension

is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk,

the effects on the breastfed infant, or the effects on milk production.

Safety and effectiveness in pediatric patients

have not been established.

Across clinical studies used to establish

the effectiveness of TYVASO in patients with PAH and PH ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment

effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly

patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or

other drug therapy.

ADVERSE REACTIONS

Pulmonary Arterial Hypertension (WHO Group

In a 12-week, placebo-controlled study (TRIUMPH

I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with

TYVASO in ≥4% of PAH patients and more than 3% greater than placebo were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal

pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%). In addition, adverse reactions occurring

in ≥4% of patients were dizziness and diarrhea.

Pulmonary Hypertension Associated with ILD

(WHO Group 3)

In a 16-week, placebo-controlled study (INCREASE)

of 326 patients with PH-ILD (WHO Group 3), adverse reactions with TYVASO were similar to the experience in studies of PAH.

Please see Full Prescribing Information for

TYVASO, the TD-300 TYVASO® Inhalation System Instructions for Use manual, and additional information at www.TYVASOHCP.com

or call 1 844 UNITHER (1-844-864-8437).

About United Therapeutics

Founded by CEO Martine Rothblatt to discover a cure for her daughter's

life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers

alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs,

we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit

corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value,

and operate with sustainable practices that protect the future we are working to build. Visit us at www.unither.com and follow

us on LinkedIn, Facebook, and Instagram.

Forward-Looking Statements

Statements included in this press release that are not historical

in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking

statements include, among others, statements regarding the timing and outcome of our planned regulatory submission to the FDA to seek

approval to add IPF to the labeled indications for nebulized Tyvaso, including our plan to seek priority review; our expectations concerning

the potential benefits of nebulized Tyvaso for IPF patients, including the possibility that the results of the TETON-1 and TETON-2

studies could fundamentally shift the approach to IPF management; our belief that the results of the TETON-1, TETON-2,

and ADVANCE OUTCOMES studies will lead to a new era of growth for United Therapeutics; statements regarding our ongoing TETON-PPF

study of nebulized Tyvaso in patients with PPF; and our goals of expanding the supply of transplantable organs, developing practical

technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking

statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities

and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking

statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents

filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q,

and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform

Act of 1995 for forward-looking statements. We are providing this information as of March 30, 2026, and assume no obligation to

update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

TYVASO is a registered trademark of United Therapeutics Corporation.

For Further Information Contact:

Investor Inquiries

https://ir.unither.com/contact-ir

Media Inquiries

communications@unither.com

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-Section 425

+ Details

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