FDA declines approval of Macrilen, issuing CRL

6 November 2014

Canadian biopharma firm AEterna Zentaris (Nasdaq: AEZS) has received a Complete Response Letter from the US Food and Drug Administration for its New Drug Application for Macrilen (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (AGHD).

Based on its review, the FDA has determined that the NDA cannot be approved in its present form. The news sent AEterna’s shares into free fall, dropping 49.2% to $1.28 in pre-market trading.

The CRL mentions that the planned analysis of the company's pivotal trial did not meet its stated primary efficacy objective as agreed to in the Special Protocol Assessment agreement letter between AEterna and the FDA.

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