The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has recommended expanding WINREVAIR™ (sotatercept) approval for pulmonary arterial hypertension (PAH) treatment to include World Health Organisation (WHO) Functional Class II, III, and IV patients (previously only II-III). The recommendation is based on the Phase 3 ZENITH trial, which showed a 76% reduction in risk

The Food and Drug Administration (FDA)’s recent clearance for a Cereno Scientific Phase IIb trial on CS1 builds on the favourable safety, tolerability and encouraging disease-modifying signals observed in the Phase IIa study. CS1, an HDACi that acts through epigenetic modulation, has also been granted Orphan Drug Designation and Fast Track designation in the US. The

CM5480 is an experimental therapy being developed by Calcimedica, a US clinical-stage biopharmaceutical company. The findings of a new study titled “Combination of Orai1 inhibitor CM5480 with specific therapy mitigates pulmonary hypertension and its cardiac dysfunction” reveals that CM5480 was helpful in rat models when used on its own and provided additional benefits when combined

Cereno Scientific has submitted the clinical trial protocol for the planned global Phase IIb trial of its lead drug candidate CS1 to the U.S. Food and Drug Administration (FDA). CS1 is an oral histone deacetylase inhibitor (HDACi) intended as a disease-modifying therapy for pulmonary arterial hypertension (PAH), working through epigenetic modulation to target underlying mechanisms