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

Corsair Pharma will present preclinical data on their TRX-248 transdermal patch at the Pulmonary Hypertension Professional Network Symposium (PHPPN), Sept 18-20, 2025. The once-daily patch delivers treprostinil for pulmonary arterial hypertension treatment. These data provide additional support for the clinical program which is currently in a first-in-human Phase 1 study. The transdermal patch has the

Cereno Scientific announced on August 26, 2025 that the US Food and Drug Administration (FDA) has granted Fast Track designation to CS1, its lead drug candidate for treating pulmonary arterial hypertension (PAH). This designation accelerates development and regulatory review for treatments addressing serious conditions with high unmet medical need. In a Phase IIa trial, it

Gossamer Bio, Inc. today announced enrollment completion for the ongoing, global registrational Phase 3 PROSERA Study evaluating seralutinib in Functional Class II and III pulmonary arterial hypertension patients. Gossamer Bio and the Chiesi Group are jointly developing seralutinib under a global collaboration agreement. See also our previous article about the PROSERA study at this link

The investigational drug CS1 aims to reverse the pathological vascular remodeling of the small pulmonary arteries. A successful Phase IIa trial was concluded in 2024 (see our article here). Insights into the long-term use of CS1 are being gathered in an expanded access program with 10 patients from the Phase IIa trial. Preparations are currently

Gossamer Bio, Inc. presented clinical and preclinical data related to its investigational drug seralutinib at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress that took place January 29th through February 1st in Rio de Janeiro, Brazil. Of particular interest the data on sustained benefit of seralutinib over nearly 1.5 years, and the evidence, from preclinical

Merck/MSD announced today that the Phase 3 HYPERION trial on pulmonary arterial hypertension patients (Group 1 World Health Organisation) in functional class II-III was suspended. Patients in the study will be offered the option of receiving WINREVAIR through the Phase 3 SOTERIA open-label extension study. Findings from the HYPERION study will be available later this