United Therapeutics' TETON-1 Tyvaso meets primary endpoint; FVC improvement 130.1 mL (p<0.0001)

UNITED THERAPEUTICS Corp

TETON-1 met primary endpoint: change in absolute FVC by 130.1 mL vs placebo (p<0.0001) at week 52.
Nebulized Tyvaso significantly reduced risk of clinical worsening; benefits seen across all subgroups.
Integrated analyses of TETON-1 and TETON-2 show statistically significant treatment effects on primary and most secondary endpoints.
Plan to submit sNDA to FDA by summer 2026 for priority review to add IPF indication for Tyvaso.
Safety profile consistent with prior Tyvaso studies; no new safety signals observed.

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