Welcome to our dedicated page for CAPISTRANO BANCORP news (Ticker: CRNO), a resource for investors and traders seeking the latest updates and insights on CAPISTRANO BANCORP stock.
Cereno Scientific AB (Nasdaq First North: CRNO B) is a clinical-stage biotechnology company developing disease-modifying therapies for rare cardiovascular and pulmonary diseases, with a focus on epigenetic modulation through histone deacetylase (HDAC) inhibition and prostacyclin (IP) receptor agonism. The news flow around Cereno Scientific highlights progress across its pipeline, including clinical milestones, regulatory interactions and scientific publications.
Investors and observers following CRNO-related news can expect updates on the company’s lead candidate CS1, an orally administered HDAC inhibitor in Phase II development for pulmonary arterial hypertension (PAH). Recent announcements have covered submission and FDA clearance of a global Phase IIb trial protocol, details of the planned randomized, placebo-controlled study design, and regulatory designations such as Orphan Drug Designation in the U.S. and EU and Fast Track status from the U.S. FDA.
News coverage also includes developments for CS014, a next-generation HDAC inhibitor and novel chemical entity. Cereno Scientific has reported completion of a Phase I trial with a favorable safety and tolerability profile and has highlighted peer-reviewed publication of non-clinical data showing antithrombotic efficacy without increased bleeding risk and potential disease-modifying effects in thrombotic and fibrosis-driven diseases.
Additional updates may feature preclinical progress for CS585, the company’s oral, highly potent and selective prostacyclin (IP) receptor agonist, as well as corporate and partnering activities. Cereno Scientific regularly communicates its participation in major life science events, such as JPM Week and the Biotech Showcase, where it engages with investors, pharmaceutical companies and other stakeholders. For users tracking CRNO, this news page offers a centralized view of clinical trial announcements, regulatory milestones, scientific publications and corporate developments related to Cereno Scientific’s rare cardiopulmonary disease pipeline.
Cereno Scientific (NASDAQ First North: B) reported initial 12-month Expanded Access Program (EAP) learnings for lead candidate CS1 in pulmonary arterial hypertension (PAH). The EAP enrolled 10 patients; CS1 was well tolerated with no unexpected safety concerns or deaths, and no discontinuations reported as related to CS1.
Six of ten patients completed 12 months; two discontinued after atrial fibrillation events assessed as not related, one withdrew consent and one was lost to follow-up. Phase IIa (25 patients, 3 months) met primary safety and tolerability endpoint with no drug-related serious adverse events. Phase IIb enrollment anticipated June 2026; further EAP analyses due Q2 2026.
Cereno Scientific (NASDAQ: B) received Swedish Medical Products Agency approval to start a Phase I pharmacokinetic study of CS014, designed using FDA pre-IND feedback. The open-label, randomized, two-period crossover trial in 14 healthy adults compares seven-day repeat dosing of CS014 versus valproic acid to characterize total and unbound plasma concentrations at steady state.
The company says a successful PK study could remove the need for additional nonclinical safety work and a Phase IIa trial, supporting a capital-efficient path toward a planned Phase II study in PH-ILD in Q1 2027. Results are expected mid-2026.
Cereno Scientific (NASDAQ First North: B) is broadening the development focus of its orally administered HDAC inhibitor CS014 to pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company completed a Phase I study and plans a Phase II program aimed to start in Q1 2027. The shift intends to target a patient population with high unmet need and align CS014 with combined fibrotic and pulmonary vascular pathology to strengthen clinical and strategic positioning.
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.