Swedish drug development company Cereno Scientific AB (Nasdaq First North: CRNO B) announced on Tuesday that the US Food and Drug Administration has granted Fast Track designation to its lead program, CS1, for the treatment of pulmonary arterial hypertension (PAH).

The decision highlights CS1's potential as a differentiated treatment for PAH, a rare and progressive cardiovascular disease where safer and disease-modifying therapies remain limited. Fast Track designation provides closer engagement with the FDA, eligibility for rolling review, potential priority review, and is intended to accelerate development for this serious condition where safer therapies are urgently needed.

CS1 is an oral HDAC inhibitor with a novel epigenetic mechanism of action. In a completed Phase IIa trial, it met its primary endpoint of safety and tolerability while also showing encouraging efficacy signals, including improvements in risk score, functional class, quality of life, and early indicators of vascular and cardiac remodelling. A global Phase IIb study is currently in preparation.