ADR Update: Waiting for the Roman results
Celyad’s Phase III CHART-1 study in cardiac regeneration missed its primary endpoint, but a clinically defined subgroup with 60% of patients saw a positive outcome, p=0.015. Celyad management believes data are robust enough to discuss submitting a conditional marketing authorization to the EMA for European approval. Data on the CHART-1 composite endpoint will be presented on 28 August 2016. The US Chart-2 trial with a new endpoint and EDV focus will run if partnered. On the basis of limited data, the indicative value has been revised from $96.8 to $35.2 per share.Celyad is engaged in engineered cell therapy treatments with clinical programs initially targeting indications in cardiovascular disease and oncology. Co. provides C-CATHez, an injection catheter that delivers bio therapeutic agents into the myocardium. Co.'s main product is C-Cure, which is in Phase III clinical trials for the treatment of chronic heart failure secondary to ischemic cardiomyopathy. Co.'s drug product candidates are autologous cell therapy treatments. In autologous procedures, a patient's cells are harvested, selected, reprogrammed and expanded, and then infused back into the same patient.
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