News

Committee supports broader Winrevair use for PAH in Europe

A committee of the European Medicines Agency (EMA) has recommended expanding the indication for Winrevair (sotatercept-csrk), Merck’s approved injection therapy for adults with pulmonary arterial hypertension (PAH). Winrevair was approved in the European Union last year. It is currently indicated for use in combination with…

New PAH therapy to target disease drivers in upcoming global trial

The U.S. Food and Drug Administration (FDA) has cleared Cereno Scientific’s request to launch a global Phase 2b trial of CS1, an oral therapy for people with pulmonary arterial hypertension (PAH). The company expects to begin enrolling patients in the second quarter of 2026, with top-line data anticipated…

Tiakis ready to advance tiprelestat to Phase 2 trial for PAH

Tiakis Biotech is set to advance its experimental therapy tiprelestat into a Phase 2 clinical trial for pulmonary arterial hypertension (PAH), after successfully finalizing the data package required for regulatory review. The planned study, dubbed ATHENA, will be led by Stanford University and will enroll about 90 patients…

ADM may offer new clues for protecting lungs in BPD-PH

Overproduction of the naturally occurring hormone adrenomedullin, or ADM, helped protect neonatal mice from experimental bronchopulmonary dysplasia (BPD) and related pulmonary hypertension (PH), a study reports. “These findings strongly support the potential of ADM therapy for infants with BPD-PH,” the researchers wrote in the study, “Adrenomedullin…

2 proteins could be targets for future CTEPH treatment: Study

Two proteins associated with the aggregation and activation of platelets may serve as biomarkers of chronic thromboembolic pulmonary hypertension (CTEPH) severity and progression, according to a study conducted in China. The proteins, PAD4 and NOX2, were elevated in platelets of people with CTEPH compared with healthy individuals, suggesting they may…

Merck plans Phase 3 Winrevair study after Phase 2 trial hits goal

Merck is planning a Phase 3 trial testing Winrevair (sotatercept-csrk) in people with combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF). CpcPH is a form of pulmonary hypertension due to left heart disease, marked by elevated blood pressure in the vessels…