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Acacia Pharma has announced that the FDA has accepted its revised New Drug Application (NDA) for BARHEMSYS and classified it as a Class 2 resubmission. In the revised NDA, Acacia, along with its manufacturing partner, has addressed the deficiencies identified in the 5 October Complete Response Letter (CRL). As this is a Class 2 resubmission (with a six-month total review time), the FDA has now set a Prescription Drug User Fee Act (PDUFA) goal of reviewing and acting on it, of no later than 5 May 2019. Acacia continues to expect to launch BARHEMSYS in H119. We retain our valuation of Acacia at €602m or €11.3/share.

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