Edison Investment Research - AFT Pharmaceuticals (AFT) AFT Pharmaceuticals - Maxigesic IV closer to FDA approval

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Edison Investment Research

Sean Conroy

AFT Pharmaceuticals - Maxigesic IV closer to FDA approval

AFT Pharmaceuticals has announced that the US FDA has allocated a Prescription Drug User Fee Act (PDUFA) date for Maxigesic IV, an intravenous form of its flagship pain relief medicine. The PDUFA date is expected to be the last step in the FDA review process and has been set for 17 October 2023. It follows submission of additional requested data in April 2023 in response to the complete response letter (CRL) received from the FDA in July 2022 (related to queries about certain extractable and leachable compounds present in Maxigesic IV’s packaging) following the 2021 New Drug Application. The IV formulation is registered in 43 countries and has been launched in more than 19 (including the key markets of Germany, France and Italy), but the US is expected to be a key high-margin market. We note that Maxigesic IV was out-licensed to Hikma Pharmaceuticals in the US in 2021 for up to NZ$18.8m in proceeds.

02/05/2023 1 EN

Underlying

AFT Pharmaceuticals

AFT Pharmaceuticals is engaged in the distribution of pharmaceutical products and the development of pharmaceutical intellectual property.

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NZAFTE0001S4 NZX New Zealand

Provider

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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AFT Pharmaceuticals - Maxigesic IV closer to FDA approval

AFT Pharmaceuticals - H125 profitability weighed down by one-offs

AFT Pharmaceuticals - Maxigesic IV reaches the Chinese shores

AFT Pharmaceuticals - Hikma partnership expands to include Combogesic

Accsys Technologies - Upgrading guidance for the full year

Topps Tiles - Market outperformance again in FY24

Nabaltec - Resilience and margin expansion

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