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 demonstrated safety and tolerability while showing encouraging efficacy signals, including improvements in REVEAL risk score, functional class, quality of life, and early signs of reverse vascular remodeling and improved right heart function.
Read Cereno Scientific press release at this link
See also our previous articles about CS1 here