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Based in Belgium, Sequana Medical develops products to treat diuretic-resistant fluid overload, a frequent complication of liver disease and HF. Its proprietary alfapump and DSR approaches aim to provide significant clinical and quality-of-life benefits in these fluid overload conditions.
Sequana in October 2022 reported positive efficacy data from its POSEIDON North American registration study for the alfapump in recurrent and refractory ascites, and it expects to submit a US Premarket Approval application in H223, with US approval expected in 2024. Following encouraging data including sustained improvements in diuretic response from its Phase IIa SAHARA DSR study in HF patients with persistent congestion, the company plans to start the MOJAVE US Phase I/IIa study in H123 using its second-generation product (DSR 2.0) in a similar patient population. It has recently successfully dosed the first patient with DSR 2.0 in a Canadian Phase I study (YUKON).
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Sequana’s alfapump and Direct Sodium Removal (DSR) platforms are being advanced as long-term treatments for diuretic-resistant fluid overload related to liver disease, malignant ascites and heart failure (HF). The alfapump removes localised excess fluid build-up in the peritoneal cavity, and it is being advanced for treating fluid overload (ascites) resulting from liver disease including non-alcoholic steatohepatitis. Sequana’s larger opportunity lies within its DSR programme for chronic HF patients with persistent congestion.
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