Aeterna Zentaris leaps on planned growth hormone drug NDA

Canada-based Aeterna Zentaris’ (TSX: AEZS) saw its shares rise as much as 14% in pore-market trading today, after it announced that, following its meeting with the US Food and Drug Administration on March 29, 2017, the company intends to file a New Drug Application (NDA) seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD).

In November 2014, Aeterna Zentaris received a Complete Response Letter from the FDA, saying the agency determined that the NDA cannot be approved in its present form.

Moreover, as recently as January this year, the biopharmaceutical group announced top-line results from a confirmatory trial of Macrilen, a synthetic small molecule and ghrelin agonist. The data showed macimorelin did not achieve equivalence to the insulin tolerance test (ITT) in the diagnosis of growth hormone deficiency in adults (AGHD).