UNITED THERAPEUTICS Corp UTHR
UNITED THERAPEUTICS Corp (Nasdaq: UTHR) is a cardio-renal-metabolic drug developer. Its lead program, Ralinepag extended-release tablets, is in Phase 3 for Pulmonary arterial hypertension (PAH). Its next catalyst on record is Nebulized Tyvaso IPF: FDA action date (sNDA) (April 26, 2027).
Upcoming catalysts
- April 26, 2027Nebulized Tyvaso IPF — FDA action date (sNDA)
In September 2026, we were notified that the FDA had accepted our sNDA with a user fee goal date of April 26, 2027.
- June 24, 2027Ralinepag extended-release tablets — FDA action date (NDA)
In August 2026, we were notified that the FDA had accepted our NDA and established a user fee goal date of June 24, 2027.
Next further out: Nebulized Tyvaso PPF (TETON-PPF) — Topline data (H2 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Ralinepag extended-release tablets | PAH | small molecule | Phase 3 |
| Nebulized Tyvaso | Idiopathic pulmonary fibrosis (IPF) | small molecule | Phase 3 |
| Nebulized Tyvaso | Progressive pulmonary fibrosis (PPF) | small molecule | Phase 3 |
| Treprostinil SMI | PAH, PH-ILD | small molecule | Phase 3 |
| Treprostinil SMI | PH-COPD | small molecule | Phase 2 |
| miroliverELAP | Acute liver failure | cell therapy | Phase 2 |
| UKidney | End-stage renal disease | cell therapy | Phase 1 |
| UThymoKidney | End-stage renal disease | cell therapy | Phase 1 |
| UHeart | Advanced heart failure | cell therapy | Phase 1 |
| Treprostinil-Iloprost SMI | PAH (PRN use) | small molecule | Phase 1 |
| Ralinepag DPI | PH-ILD, IPF, PPF | small molecule | Pre-clinical |
| Tyvaso DPI | IPF, PPF | small molecule | 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
Other phase 3 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.