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

Core Insights - Ionis Pharmaceuticals is entering a pivotal phase in 2025, transitioning into a fully integrated commercial-stage biotechnology company with strong initial launches of TRYNGOLZA and DAWNZERA [1][4] Commercial Performance - TRYNGOLZA generated $108 million in its first year, with a 56% quarter-over-quarter revenue increase, leading to raised peak sales expectations for the combined FCS/sHTG opportunity to over $2 billion [5][10] - DAWNZERA is positioned as the first RNA-targeted medicine for hereditary angioedema (HAE) prevention, resonating well with physicians and patients [11] Product Launch and Pipeline - The FDA accepted Ionis' supplemental NDA for olezarsen in severe hypertriglyceridemia (sHTG) with a priority review and a PDUFA date of June 30, positioning the company for a launch at the end of June or early July [4][6] - Ionis anticipates three product approvals and launches in 2026, including olezarsen for sHTG, zilganersen for Alexander disease, and bepirovirsen for chronic hepatitis B [5][8] Market Opportunity - The sHTG market is significant, affecting over 3 million people in the U.S., with an estimated 1 million high-risk patients eligible for olezarsen [8] - The initial launch focus for sHTG will target high-risk patients with triglycerides above 500 and those above 880, based on feedback from medical specialists [12] Financial Guidance - The priority review for olezarsen is expected to accelerate market entry by four months, leading to improved financial guidance, which will be updated during the end-of-first-quarter earnings call [13] Neurology Pipeline - Ionis is advancing its neurology franchise with the upcoming launch of zilganersen for Alexander disease, supported by positive phase III data [14] - The phase III program for obinutersen in Angelman syndrome is ongoing, with enrollment expected to complete this year [15]