Belgian biotech company Celyad, which is developing cellular therapies, announced Thursday it has obtained from the US drug agency an accelerated authorization procedure for one of its products for the treatment of ischemic heart failure.
The title of the listed company jumped in Brussels in the wake of 6,53 39,74% in euros on Euronext to 11H00 (09H00 GMT).
FDA fast-track status allows treatment that meets an unmet medical need to benefit from a priority registration review.
In the case of the treatment developed by Celyad, dubbed C-Cure, the FDA took into account "the reduction in mortality, the number of hospitalizations and the improvement of the quality of life of patients suffering from consecutive chronic heart failure." ischemic cardiomyopathy (note: poor blood circulation of the heart muscle) ", observed in the first clinical trials, the company said in a statement.
In December, 2015 received FDA approval to conduct a pivotal Phase III study, the final step before commercialization, and is currently seeking one or more strategic partners to launch this trial. clinical.
"Although all of our resources are currently focused on the development of our immuno-oncology platform, receiving the fast-track label for C-Cure underscores the quality of science and the strength of 9 and 12 generated month results" previous tests, commented the general manager of Celyad Christian Homsy, quoted in the release.