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

Tiakis Biotech has received positive scientific advice from the US Food and Drug Administration (FDA) for a planned Phase 2 ATHENA clinical trial of tiprelestat in pulmonary arterial hypertension. The therapy has been granted orphan designation in the U.S. and in Europe for pulmonary arterial hypertension. Dr. Roham Zamanian, Professor of Medicine at Stanford University and

CS1 is a HDAC, Histone Deacetylase inhibitor, that works through epigenetic modulation and is being developed by Cereno Scientific as a disease modifying treatment for pulmonary arterial hypertension. CS1 targets the root cause of the disease, aiming to reverse the pathological vascular remodeling of the small lung arteries. The Phase IIa trial evaluated the safety,