United Therapeutics Corporation UTHR
United Therapeutics Corporation (Nasdaq: UTHR) is a respiratory drug developer. Its lead program, Tyvaso DPI / Nebulized Tyvaso (treprostinil), is in Phase 3 for Pulmonary arterial hypertension (PAH) and PH-ILD. Its next catalyst on record is Nebulized Tyvaso: FDA decision on IPF sNDA (submitted June 2026) (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Nebulized Tyvaso — FDA decision on IPF sNDA (submitted June 2026) (date not stated). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Tyvaso DPI and Nebulized Tyvaso | PAH and PH-ILD (marketed) | small molecule | Approved |
| Remodulin, Orenitram, Adcirca, Unituxin | PAH (Remodulin, Orenitram, Adcirca); high-risk neuroblastoma (Unituxin) (all marketed) | small molecule | Approved |
| Nebulized Tyvaso sNDA | Idiopathic pulmonary fibrosis (TETON-1 and TETON-2 successful; sNDA submitted June 2026) | small molecule | Phase 3 |
| Ralinepag extended-release tablets | PAH (ADVANCE OUTCOMES successful March 2026; NDA submitted June 2026) | small molecule | Phase 3 |
| Nebulized Tyvaso TETON-PPF | Progressive pulmonary fibrosis (Phase 3 ongoing, target 698 patients) | small molecule | Phase 3 |
| Treprostinil SMI | PAH and PH-ILD (pivotal PK studies ongoing); PH-COPD (preparing Phase 2 IND) | device-combination | Phase 3 |
| UKidney (EXPAND, Phase 1/2/3) | End-stage renal disease xenotransplant | biologic-other | Phase 3 |
| UThymoKidney (EXTEND) | End-stage renal disease xenotransplant (IND cleared Aug 2025) | biologic-other | Phase 1 |
| UHeart (EXPRESS) | Advanced heart failure xenotransplant (IND cleared May 2026) | biologic-other | Phase 1 |
| miroliverELAP | Acute liver failure (Phase 1 complete; Phase 2 planned) | cell therapy | Phase 1 |
| Ralinepag DPI | PAH, PH-ILD, IPF, PPF (IND-enabling studies) | small molecule | Pre-clinical |
| THY-100 | Congenital athymia (preclinical; Thymmune acquired July 2026) | cell therapy | Pre-clinical |
Recent results and decisions
- Mar 30, 2026met Phase 3 TETON-1 met its primary endpoint, improving absolute FVC by 130.1 mL vs placebo at week 52 (p<0.0001); integrated TETON-1/2 FVC effect 111.8 mL.
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.
Filing - Mar 2, 2026met Phase 3 ADVANCE OUTCOMES met its primary endpoint, reducing risk of clinical worsening 55% vs placebo (HR 0.45, 95% CI 0.33-0.62, p<0.0001) in 687 PAH patients.
United Therapeutics Corporation today announced that its long-term pivotal phase 3 ADVANCE OUTCOMES study met its primary endpoint, with ralinepag reducing the risk of a clinical worsening event by 55% compared with placebo in patients with PAH (hazard ratio 0.45, 95% CI [0.33-0.62]; p<0.0001).
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
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The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.