Acacia Pharma - BARHEMSYS round three PDUFA date
Acacia has announced that the FDA has accepted the resubmitted NDA for key asset BARHEMSYS for post-operative nausea and vomiting (PONV). As expected, the FDA has categorised it as a Class 2 resubmission and set a PDUFA date of 26 February 2020. Prompt launch execution will be critical once approved, and Acacia’s US sales team is positioning itself for launch in H120. Managing cash burn during the intervening period is essential as we forecast that Acacia will need to raise c £40m in H120 (following potential approval) to fund operations, with additional future funding dependent on sales execution. We retain our previous forecasts (GBP denominated) and valuation of €631m.Acacia Pharma Group Plc. Acacia Pharma Group PLC is a United Kingdom-based company specialized in the pharmaceutical industry. The pharmaceutical group focuses on the development and commercialization of new nausea and vomiting treatments for surgical and cancer patients. Its pipeline includes BAREMIS, an intravenous formulation of amisulpride, which is a selective dopamine antagonist that has completed phase 3 clinical development for the prophylaxis and treatment of Postoperative nausea and vomiting (PONV), and APD403, which is based on the selective dopamine antagonist amisulpride and it is being developed as an intravenous injection for cancer patients to be administered immediately before chemotherapy to prevent acute chemotherapy-induced nausea & vomiting ( CINV).
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