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Celyad gets the USA label advantageous for one of its products

The Belgian biotechnology company Celyad, which develops cell therapies, announced Thursday it had obtained from the US Food and Drug accelerated authorization procedure for one of its products for the treatment of heart failure of ischemic origin.

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).

The status of expedited procedure granted by the FDA ( "fast-track") permits a treatment likely to respond to a unmet medical need to receive priority review recording.

In the case of treatment developed by Celyad, called C-Cure, the FDA considered "reduced mortality, hospitalizations and improving the quality of life of patients with chronic heart failure row ischemic cardiomyopathy (Editor's note: poor blood supply to the heart muscle), "observed in early clinical trials, the company said in a statement.

The group had obtained in December 2015 approval from the FDA to conduct product a pivotal Phase III study, the last step before a possible market, and is currently looking for one or more strategic partners to launch this test clinical.

"Although all of our resources are currently focused on the development of our platform in immuno-oncology, receive fast-track label for C-Cure highlights the quality of science and the strength of the results to 9 and 12 months generated" at previous trials, commented CEO Celyad Christian Homsy, said in the statement.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
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It now has over 1700 members who share their technical experience, scientific and regulatory.

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