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Cereno Scientific (NASDAQ First North: B) announced a peer-reviewed publication (Journal of Thrombosis and Haemostasis) on CS014, a novel HDAC inhibitor engineered to improve upon valproic acid by reducing hepatotoxic 4-ene metabolite formation while preserving HDAC activity. The manuscript reports potent antithrombotic effects across small artery, large artery and large vein models achieved at doses that preserve normal coagulation and bleeding time. Cereno also reported positive Phase I safety and tolerability at exposures predicted to support efficacy and said it is preparing for Phase II with initial focus on idiopathic pulmonary fibrosis.
Cereno Scientific (Nasdaq First North: B) will attend JPM Week 2026 in San Francisco and participate at the Biotech Showcase from January 12–18, 2026, with Biotech Showcase sessions running January 12–14, 2026.
The company said it will hold investor and partner meetings throughout the week to discuss progress across its HDAC inhibitor portfolio, including advancement of lead candidate CS1 toward a global Phase IIb trial in PAH and Phase I data supporting CS014 moving into Phase II. Investors can request meetings via the Biotech Showcase partnering platform or by emailing business.development@cerenoscientific.com. For IR contact, use tove.bergenholt@cerenoscientific.com or phone +46 73-236 62 46.
Cereno Scientific (B) announced that the U.S. FDA cleared initiation of its global Phase IIb trial of lead candidate CS1 for pulmonary arterial hypertension (PAH).
The randomized, double-blind, placebo-controlled, dose-finding study will enroll ~126 patients across ~65 sites in 10–12 countries, run 60 weeks total, and evaluate PVR by right-heart catheterization and 6-minute walk distance at Week 36. CS1 holds Orphan Drug and Fast Track designations. First patient in is planned for Q2 2026, with top-line data anticipated around Q4 2028 subject to enrollment timelines.
Cereno Scientific (B) submitted the clinical trial protocol for a planned global Phase IIb study of CS1 in pulmonary arterial hypertension (PAH) to the U.S. FDA on Nov 10, 2025. The submission follows FDA Type C meeting feedback and aims to advance CS1—an oral HDAC inhibitor that targets PAH via epigenetic modulation—after Phase IIa showed favorable safety, tolerability and encouraging efficacy signals (reverse vascular remodeling, improved right heart function, better patient quality of life). The Phase IIb is designed as a global, multicenter, placebo-controlled trial run with an international CRO. Cereno expects the FDA's standard 30-day review and plans to start the trial in H1 2026.
