Edison Investment Research - Pharmaceuticals & healthcare - Acacia Pharma: Following guidance from the US FDA, Acacia Pharma has now outlined the regulatory pathway for its lead asset, BARHEMSYS, and plans to resubmit the new drug application (NDA) in Q319. This could enable a launch in H120 if approved by the FDA. Ongoing deficiencies with Acacia’s chosen contract manufacturing organisation (CMO), which led to two complete response letters (CRL), have resulted in the appointment of a new CMO. With increased visibility on the strategy, we have reintroduced our previously withdrawn forecasts and adjusted our launch timelines for BARHEMSYS in the US. We now forecast a launch in H120 (previously H119). We have also reduced our cost expectations in 2019 as Acacia delays its marketing operations. We now value Acacia at €631m.
ISIN: GB00BYWF9Y76
Original Article: Acacia Pharma (ACPH) - BARHEMSYS NDA refiling Q319, launch in Q120