The European Medicines Agency (EMA) has approved Cereno Scientific’s Clinical Trial Application (CTA) for CS014, a novel HDAC inhibitor with epigenetic effects. CS014 targets thrombosis prevention and is expected to do so without increased risk of bleeding, a key limitation of currently approved antithrombotics. Management has communicated that the drug product has been shipped to the trial sites and work on patient recruitment has begun. The Phase I trial will assess the safety and tolerability of the drug in healthy volunteers. This will be the company’s second asset to enter the clinic after its lead asset, CS1. Following this regulatory milestone, we have updated our probability of approval from 5% to 7.5%, resulting in a lift to our valuation for Cereno to SEK2.54bn or SEK9.0/share, from SEK2.46bn or SEK8.8/share, previously.

Edison