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Acacia Pharma

FDA issues CRL for BARHEMSYS

Update | Pharmaceutical & healthcare | 10 Oct 2018

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 EUR 10.9/share.

Acacia Pharma

Raising the BAR in PONV

Initiation | Pharmaceutical & healthcare | 07 Sep 2018

Acacia Pharma is focused on bringing antiemetic drugs to the US hospital setting for unmet needs in post-operative nausea and vomiting (PONV) and chemotherapy-induced nausea and vomiting (CINV). We expect FDA approval of Acacia’s lead product, BARHEMSYS (repurposed amisulpride), for the management of PONV by its 5 October 2018 PDUFA date. In the near term, Acacia will concentrate on the US commercial opportunity by expanding its sales and marketing infrastructure. We anticipate US launch of BARHEMSYS in Q219 for PONV ‘rescue treatment’ and expect broadening of use for PONV prophylaxis in subsequent years. We value Acacia Pharma at EUR 579m or EUR 10.9 per share.