Merck reported Phase 2 CADENCE results showing WINREVAIR met the primary endpoint in adults with CpcPH-HFpEF. The company said the data support advancement into a registrational Phase 3 study.
Phase 3 trial results show seralutinib missed its primary endpoint in PAH but showed benefit in advanced disease subgroups. Meanwhile, Winrevair demonstrated significant reductions in pulmonary vascular resistance in heart failure-related pulmonary hypertension in a Phase 2 study.
Tenax Therapeutics is nearing completion of enrollment in its first Phase III trial for levosimendan in pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), with data expected in the second half of 2026. The company has already randomized more than 230 patients and has sufficient cash reserves to sustain operations into 2027. Management views PH-HFpEF as a multi-billion dollar opportunity affecting over 2 million patients in the U.S.