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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.

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