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United Therapeutics Corporation

5 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

MilestoneUTHRUnitedH2 2026

Ralinepag NDA submission for PAH, expected in the second half of 2026 (no exact date yet). A company milestone for United (Ralinepag for Pulmonary arterial hypertension): a step in the program rather than a decision or a data readout.

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Entry

Ralinepag NDA submission for PAH · Company milestone

Drug

Ralinepag

For

Pulmonary arterial hypertension

Stage

Phase 3 · the last stage before a drug can be approved

When

H2 2026 · the company gave a window, not a day

Source note

Company PR (May 17, 2026): intends to submit an NDA for ralinepag in PAH to FDA by the second half of 2026, after ADVANCE OUTCOMES met its primary endpoint (55% risk reduction in clinical worsening).

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Source: businesswire.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
UTHR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneUTHRUnitedQ4 2026

NDA submission for treprostinil SMI (soft mist inhaler) by year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for United (treprostinil SMI for PAH / pulmonary hypertension): a step in the program rather than a decision or a data readout.

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Entry

NDA submission for treprostinil SMI (soft mist inhaler) by year-end 2026 · Company milestone

Drug

treprostinil SMI

For

PAH / pulmonary hypertension

Stage

NDA

When

Q4 2026 · the company gave a window, not a day

Source note

Q2 2026 earnings release (Aug 5, 2026). Company guides 'planned filings later this year' / 'by the end of this year'; mapped to 2026-Q4 as outer bound.

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Source: ir.unither.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
UTHR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalUTHRUnited2027

United expects the FDA to decide on Tyvaso (nebulized treprostinil) for Idiopathic pulmonary fibrosis during 2027 (no exact date yet). An approval lets the company start selling it in that market.

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Entry

FDA action expected on Tyvaso IPF sNDA · Regulatory approval

Drug

Tyvaso (nebulized treprostinil)

For

Idiopathic pulmonary fibrosis

Stage

sNDA under review

When

2027 · the company gave a window, not a day

Source note

sNDA submitted June 2026 with priority review requested, based on positive TETON-1 and TETON-2. PDUFA date not yet publicly announced; company anticipates potential 2027 approval (launch possibly as early as Q1 2027).

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Source: seekingalpha.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
UTHR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalUTHRUnited2027

United expects the FDA to decide on ralinepag for pulmonary arterial hypertension during 2027 (no exact date yet). An approval lets the company start selling it in that market.

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Entry

Potential FDA approval of ralinepag tablets in PAH · Regulatory approval

Drug

ralinepag

For

pulmonary arterial hypertension

Stage

NDA under review

When

2027 · the company gave a window, not a day

Source note

Q2 2026 earnings release (Aug 5, 2026). NDA submitted June 2026; no PDUFA date disclosed yet (acceptance not yet announced as of Aug 21). Companion Tyvaso IPF 2027 approval already tracked.

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Source: ir.unither.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
UTHR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsUTHRUnitedH2 2027

United expects to report results from its Phase 3 study of Tyvaso (nebulized treprostinil) for Progressive pulmonary fibrosis in the second half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.

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Entry

TETON-PPF Phase 3 topline in progressive pulmonary fibrosis · Clinical trial results (readout / topline data)

Drug

Tyvaso (nebulized treprostinil)

For

Progressive pulmonary fibrosis

Stage

Phase 3 · the last stage before a drug can be approved

When

H2 2027 · the company gave a window, not a day

Source note

Company PR (Aug 17, 2026): TETON-PPF (754 patients) fully enrolled; topline data expected in the second half of 2027.

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Source: ir.unither.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
UTHR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Past catalysts

ApprovalUTHRUnitedJun 29, 2026

The FDA approved United’s LungFX (device) for Centralized ex vivo lung perfusion for donor lungs on Jun 29, 2026. The company can now sell it in that market.

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Entry

FDA approves LungFX device for centralized ex vivo lung perfusion · Regulatory approval

Drug

LungFX (device)

For

Centralized ex vivo lung perfusion for donor lungs

Stage

PMA / Approved

When

Jun 29, 2026

Source note

FDA granted premarket approval for the LungFX device, submitted by United Therapeutics subsidiary Lung Bioengineering, for centralized ex vivo lung perfusion of donor lungs that would not otherwise be used for transplant.

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Source: ir.unither.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
UTHR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ConferenceUTHRUnitedMay 18, 2026

United presented data on Tyvaso (treprostinil) inhalation solution for Idiopathic pulmonary fibrosis (IPF) at a medical meeting on May 18, 2026. The linked source has the details.

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Entry

TETON-1 full results published in NEJM and presented at ATS 2026 · Data presented at a medical meeting

Drug

Tyvaso (treprostinil) inhalation solution

For

Idiopathic pulmonary fibrosis (IPF)

Stage

Phase 3 · the last stage before a drug can be approved

When

May 18, 2026

Source note

NEJM published the full TETON-1 results plus combined TETON-1/TETON-2 analyses of nebulized Tyvaso in IPF, with a summary presented the same day at the ATS 2026 International Conference.

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Source: ir.unither.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
UTHR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ConferenceUTHRUnitedMay 17, 2026

United presented data on ralinepag for Pulmonary arterial hypertension (PAH) at a medical meeting on May 17, 2026. The linked source has the details.

More details

Entry

Full ADVANCE OUTCOMES ralinepag results presented at ATS 2026 · Data presented at a medical meeting

Drug

ralinepag

For

Pulmonary arterial hypertension (PAH)

Stage

Phase 3 · the last stage before a drug can be approved

When

May 17, 2026

Source note

United Therapeutics presented the full pivotal ADVANCE OUTCOMES dataset for once-daily oral ralinepag during the Breaking News clinical trial results session at the ATS 2026 International Conference in Orlando.

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Source: ir.unither.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
UTHR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsUTHRUnitedMar 30, 2026

United reported results from its Phase 3 study of Tyvaso (treprostinil) inhalation solution for Idiopathic pulmonary fibrosis (IPF) on Mar 30, 2026. The study met its main goal.

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Entry

Phase 3 TETON-1 met primary endpoint for Tyvaso in IPF (+130.1 mL FVC) · Clinical trial results (readout / topline data)

Drug

Tyvaso (treprostinil) inhalation solution

For

Idiopathic pulmonary fibrosis (IPF)

Stage

Phase 3 · the last stage before a drug can be approved

When

Mar 30, 2026

Source note

TETON-1 showed nebulized Tyvaso superior to placebo on change in absolute FVC by 130.1 mL at week 52 (p<0.0001), exceeding the treatment effect seen in TETON-2, and also hit statistical significance on reducing risk of clinical worsening.

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Source: ir.unither.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
UTHR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsUTHRUnitedMar 2, 2026

United reported results from its Phase 3 study of ralinepag for Pulmonary arterial hypertension (PAH) on Mar 2, 2026. The study met its main goal.

More details

Entry

Phase 3 ADVANCE OUTCOMES met primary endpoint: ralinepag cut worsening risk 55% · Clinical trial results (readout / topline data)

Drug

ralinepag

For

Pulmonary arterial hypertension (PAH)

Stage

Phase 3 · the last stage before a drug can be approved

When

Mar 2, 2026

Source note

The long-term pivotal Phase 3 ADVANCE OUTCOMES study met its primary endpoint, with oral ralinepag reducing the risk of a clinical worsening event by 55% versus placebo in pulmonary arterial hypertension (HR 0.45; p<0.0001).

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Source: ir.unither.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
UTHR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Things of Interest

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

No phase 2+ trials cached for this company.

Company news

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