Report

Acacia Pharma - BYFAVO receives FDA approval

The US FDA has approved BYFAVO (remimazolam) for injection, a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures in adult patients lasting 30 minutes or less. This is Acacia’s second asset approval this year following the US approval on 26 February of its lead asset, BARHEMSYS (amisulpride injection) for the management of PONV. 2020 is a transformative year for Acacia marking its evolution into an integrated hospital pharmaceutical company with strong development and commercialisation capabilities. BYFAVO broadens Acacia’s US commercial pipeline and will enable significant leverage of its commercial infrastructure in the US on launch. Timely launches and effective sales execution of both products is critical. Our revised valuation is €1.03bn.
Underlying
Acacia Pharma Group PLC

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).

Provider
Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Sean Conroy

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