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.
Gossamer Bio's seralutinib narrowly missed its primary endpoint in the Phase 3 PROSERA study for pulmonary arterial hypertension, achieving a p-value of 0.0320 versus the prespecified threshold of 0.025, though showing stronger results in intermediate- and high-risk patients.
PTC Therapeutics withdrew its resubmitted new drug application for Translarna in Duchenne muscular dystrophy after the FDA indicated the data was unlikely to meet the threshold for substantial evidence of effectiveness, marking the third unsuccessful US approval attempt.
