United Therapeutics' ralinepag phase 3 meets primary endpoint; 55% risk reduction in PAH clinical worsening

UNITED THERAPEUTICS Corp

Ralinepag reduced risk of clinical worsening by 55% vs placebo (HR 0.45, p<0.0001) in phase 3 ADVANCE OUTCOMES study.
Statistically significant improvements in 6MWD, NT-proBNP, and 47% increased odds of clinical improvement at Week 28.
80% of patients on dual background therapy; safety consistent with prostacyclin class; no new signals.
Company plans to submit NDA to FDA by second half of 2026.
Full results to be presented at upcoming international conference.

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