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Apr 23 2020, 07:20 IST/BST
Amryt has closed enrolment in its AP101 Phase III trial for epidermolysis bullosa (EB). This decision was made in light of COVID-19 impacts on patient recruitment and given that the trial was already near full enrolment. Positively, the statistical impact from a modestly reduced patient size is expected to be immaterial. There is also increased clarity on timelines, which is encouraging against the COVID-19 backdrop - Amryt now expects results data in late Q3/early Q4. We still think regulatory approval and commercial launch of AP101, for which the commercial market opportunity is sizeable ($1bn+), are possible in 2021. FY 2019 results and a Q1 trading update are expected in early May.
Apr 23 2020, 07:20 IST/BST