Acacia Pharma - FDA issues CRL for BARHEMSYS
Acacia Pharma has received a Complete Response Letter (CRL) from the FDA for lead asset BARHEMSYS (repurposed amisulpride) for the management of post-operative nausea and vomiting (PONV). The CRL comes as a surprise as it relates to deficiencies at the contract manufacturers responsible for producing the API. Importantly, we note that the FDA has not requested additional clinical data or trials for BARHEMSYS’s potential approval. We expect Acacia to work with its contract manufacturer and the FDA to discuss the exact requirements to resolve the agency’s concerns. At this point, Acacia expects a quick resolution and maintains a potential launch of BARHEMSYS for PONV rescue in H119. Our valuation is unchanged at €10.9/share.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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