AFT Pharmaceuticals - Further studies for Maxigesic IV’s US nod

AFT Pharmaceuticals announced that, along with partner Hyloris Pharmaceuticals, the company will initiate additional studies to address the FDA queries (raised in July 2022) related to Maxigesic IV’s packaging. The new studies, which aim to generate incremental data on extractable and leachable compounds from the packaging, are expected to commence before end-CY22 with targeted completion by CY23. The company will file for FDA registration after submitting its response. Maxigesic IV has already launched in 10 countries and was out-licensed to Hikma Pharmaceuticals in the United States in April 2021 for up to NZ$18.8m in total proceeds. We anticipate the incremental launches (including 20 launches planned in Australia) in the second half of the year will offset this delay and we maintain our estimates.