Acacia Pharma updates on FDA talks post CRL

UK-based Acacia Pharma (Euronext: ACPH) today provided an update following receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration in respect of its New Drug Application (NDA) for Barhemsys (amisulpride injection) on October 5, 2018.

Acacia’s shares dipped 0.95% 6o 2.71 euros by close of trading today.

“Our discussions with FDA and our contract manufacturer over the past week have been productive and provided clarification on the steps needed to enable our NDA for Barhemsys to be approved. Our contract manufacturer is fully committed to working with Acacia Pharma to institute a corrective and preventative action plan that will rectify the deficiency identified as quickly as possible. We continue to plan for a launch in the first half of 2019,” said Dr Julian Gilbert, chief executive of Acacia Pharma.