IONIS PHARMACEUTICALS INC

Ionis Pharmaceuticals announced that the U.S. FDA has approved TRYNGOLZA (olezarsen) as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG). The approval was based on positive Phase 3 CORE and CORE2 studies, which demonstrated up to 72% reduction in fasting triglyceride levels and up to 91% reduction in acute pancreatitis events. TRYNGOLZA, which is Ionis' first independent commercial launch in a prevalent condition, will be available in the U.S. in July.

Ionis Pharmaceuticals announced positive longer-term data from the open-label extension study (CORE-OLE) evaluating olezarsen in people with severe hypertriglyceridemia (sHTG). The data, presented at the National Lipid Association Scientific Sessions, showed mean hepatic fat fraction (HFF) levels returning toward baseline after 24 months of treatment with the 80 mg dose. Olezarsen maintained a favorable safety profile, and the study demonstrated high patient retention with over 90% of eligible patients remaining in the CORE-OLE.

Ionis Pharmaceuticals announced the appointment of Ludwig N. Hantson, Ph.D., a global biopharmaceutical leader with over 30 years of experience, to its Board of Directors, effective June 4, 2026. This strategic addition is expected to support the company's upcoming commercial launches and scaling operations. The company also noted the prior appointment of Peter N. Reikes and the retirement of two long-serving directors. Additionally, at its Annual Meeting, stockholders approved several proposals, including amendments to increase shares authorized under the 2011 Equity Incentive Plan by 9,500,000 and the 2000 Employee Stock Purchase Plan by 750,000.

Ionis Pharmaceuticals announced that its partner, GSK, reported positive pivotal Phase 3 data for bepirovirsen, an investigational antisense oligonucleotide for chronic hepatitis B (CHB). The B-Well 1 and B-Well 2 trials showed a statistically significant 19% functional cure rate in the overall study population and 26% in patients with lower viral activity, significantly outperforming the standard of care's less than 1% rate. Bepirovirsen is currently under priority review by the FDA and other global regulatory authorities, with first decisions anticipated in Q3 2026, positioning Ionis for potential future milestone payments and 10-12% tiered royalties on net sales.

IONIS PHARMACEUTICALS INC reported a significant increase in total revenue for Q1 2026, up 87% to $246.1 million, driven by strong product sales from TRYNGOLZA and DAWNZERA, and higher collaborative agreement revenue. The company also reduced its net loss by 37% to $(92.5) million, or $(0.56) per share. Key milestones were achieved with partners GSK, Otsuka, and Roche, contributing to research and development revenue.

Ionis Pharmaceuticals reported strong Q1 2026 financial results with total revenue increasing 87% to $246 million, driven by commercial success and $95 million in R&D milestone payments. The company increased its annual TRYNGOLZA peak net sales guidance for severe hypertriglyceridemia (sHTG) to over $3 billion. Key pipeline advancements include Priority Review acceptance for olezarsen in sHTG and zilganersen for Alexander disease, alongside positive Phase 3 data for bepirovirsen.

Ionis Pharmaceuticals announced additional positive results from the pivotal study of zilganersen in children and adults with Alexander disease (AxD). The study met its primary endpoint, demonstrating statistically significant and clinically meaningful stabilization of gait speed in individuals aged 5 and older at Week 61. Furthermore, new data indicated that zilganersen may improve gross motor function in younger children aged 2-4 years. These findings build on previously reported topline data and will be presented at the 2026 American Academy of Neurology annual meeting.