Sequana Medical FIRST LOOK: 100 day meeting shifts alfapump PMA approval to 1Q25 launch timing unchanged
Sequana announced the agreed outcome of the day 100 meeting with the FDA following receipt of the day 90 letter in relation to the PMA submission for the alfapump in liver ascites. The FDA requested additional work related to non-clinical aspects, and Sequana now expects FDA approval before end of 1Q25 (previously 3Q24). While the shift in the timing for PMA approval (1Q25 vs. 3Q24) is not ideal, timeline for US commercial launch remains unchanged (2H25). We note that the FDA was satisfied with the clinical and safety profile of the alfapump, and based on our conversations with management we believe the requests are manageable. We reiterate our BUY rating and € 6 TPSequana Medical NV. Sequana Medical NV is a Belgium-based company, which manufactures medical devices. The Company focuses mainly on the development of treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders. Sequana Medical NV provides alfapump, which is an implantable, programmable, wireless-charged and battery-powered system that is CE-marking for the management of refractory ascites due to liver cirrhosis and malignant ascites. Over 650 alfapump systems have been implanted. Apart from the Alfapump, the Company also aims to develop a direct sodium removal (DSR) therapy, which is a propriety approach to the treatment of volume overload in heart failure.
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