Ionis Pharmaceuticals received FDA priority review for its antisense therapy olezarsen on February 26, 2026, setting a PDUFA target of June 30, 2026. The designation signals the agency’s view that olezarsen offers a significant therapeutic advance for patients with severe hypertriglyceridemia, a condition that can trigger life‑threatening pancreatitis.
Clinical data from the Phase 3 CORE and CORE2 trials show olezarsen reduces fasting triglycerides by 72 % and cuts acute pancreatitis events by 85 %. These results make it the first therapy to demonstrate a meaningful decline in pancreatitis risk for this patient population.
The priority review comes as Ionis is positioning olezarsen for a broad sHTG market. The company’s 2026 sales guidance of $800 million to $825 million reflects the expected commercial launch, while the drug’s approval would expand Ionis’s portfolio beyond TRYNGOLZA and DAWNZERA.
On February 25, 2026, Ionis reported its Q4 2025 earnings. Total revenue reached $203 million, beating the consensus estimate of $156 million but falling 10 % from the $227 million reported in Q4 2024. The decline was driven by a 12 % drop in revenue from the company’s core commercial products, offset by a 15 % increase in research‑and‑development revenue.
Earnings per share were –$1.41, missing the consensus estimate of –$1.33. The miss was largely attributable to higher operating expenses, including a $30 million one‑time restructuring charge related to the expansion of the olezarsen launch team.
Despite the EPS miss, the company’s guidance for 2026 remains unchanged, with revenue expected to grow roughly 20 % year over year. CFO Elizabeth L. Hougen noted that the guidance reflects continued investment in go‑to‑market activities for olezarsen and other upcoming launches.
Market reaction to the earnings was muted, with analysts citing the EPS miss and softer‑than‑expected guidance as key concerns. Morgan Stanley maintained an overweight rating and raised its price target to $95, while Stifel kept a hold rating with a $77 target.
CEO Brett P. Monia highlighted the significance of the FDA milestone, stating that the priority review “represents a significant step toward delivering the first‑ever treatment shown to reduce the risk of potentially life‑threatening acute pancreatitis attacks in people with sHTG.” He also emphasized that the company’s broader commercial strategy is on track to meet its 2026 revenue goals.
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