Ionis Pharmaceuticals CEO Teases Late-June Olezarsen Launch After FDA Priority Review Acceptance

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Ionis Pharmaceuticals (NASDAQ:IONS) CEO Brett Monia told investors astatine Oppenheimer’s 36th Annual Healthcare Life Sciences Conference that the institution received FDA acceptance of its supplemental NDA for olezarsen successful terrible hypertriglyceridemia (sHTG), including precedence reappraisal and a June 30 PDUFA date. Monia said the timing positions the institution to motorboat “at the extremity of June, aboriginal July,” and helium characterized the reappraisal determination arsenic a favorable astonishment that accelerates the company’s introduction into the sHTG market.

Monia said Ionis has been preparing nether the presumption that a precedence reappraisal could occur, and the institution is present moving guardant with commercialized plans aligned to a summertime motorboat window. He noted that Ionis’ existing beingness successful the triglyceride diligent and doc assemblage done its familial chylomicronemia syndrome (FCS) motorboat has helped physique credibility with clinicians who besides negociate sHTG patients.

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Ionis has hired its afloat U.S. tract squad to enactment the anticipated launch, which Monia said totals “about 200 oregon so” representatives. He besides said commercialized proviso is successful spot and that aesculapian affairs has been educating clinicians astir terrible hypertriglyceridemia successful beforehand of the expanded label.

Monia described 2025 arsenic a “pivotal” and “transformational” play successful which Ionis became a afloat integrated commercial-stage biotechnology company. He pointed to 2 autarkic launches that began past year—TRYNGOLZA for FCS and DAWNZERA for hereditary angioedema (HAE) prophylaxis—and said some were disconnected to a beardown start.