RedHill Biopharma - TALICIA will dominate newsflow in H219
RedHill’s Q219 results released on 23 July 2019 described steady progress across its pipeline, with TALICIA the centre of attention as the PDUFA date (2 November 2019) approaches. Based on the data released, we assign a high likelihood of FDA approval due to the clean dataset from the Phase III trials. From a commercial perspective, RedHill also appears to be ready with a US team in operation since mid-2017. Although potential approval and launch of TALICIA will dominate H219 newsflow, other notable R&D developments include initiation of the pivotal Phase III trial with RHB-204 in NTM infections and a meeting with the FDA to discuss further development of RHB-104 in Crohn’s disease. Our valuation is virtually unchanged.
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