Every material Form 8-K IONIS PHARMACEUTICALS INC has filed with the SEC since September 23, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Ionis reported third quarter 2026 revenue of $243 million, up from $157 million a year earlier, and a narrower net loss of $110 million, compared with $129 million. The company lowered its 2026 TRYNGOLZA product sales guidance to about $50 million, from $100-110 million, citing a more gradual launch, and reaffirmed its total revenue, operating loss and cash guidance.
Third quarter 2026 total revenue was $243 million versus $157 million in the same period of 2025.
Basic and diluted net loss per share was $0.66, compared with $0.80 a year earlier.
2026 TRYNGOLZA product sales guidance was lowered from $100-110 million to about $50 million.
Total revenue guidance of $875-900 million and DAWNZERA product sales guidance of $110-120 million were unchanged.
Ionis partner Roche announced Phase 3 IMAgINATION data showing investigational sefaxersen achieved a statistically significant 43.1% reduction in proteinuria relative to placebo at 37 weeks in adults with IgA nephropathy. Roche plans to share the data with health authorities, and the filing says Ionis is eligible for regulatory and sales milestone payments and tiered royalties on net sales of sefaxersen.
Proteinuria reduction of 43.1% vs. placebo at 37 weeks (95% CI: 32.5 to 52.0; P<0.0001)
Treatment effect consistent across all prespecified subgroups; no new safety signals reported
Study enrolled 459 people and will continue as a blinded study to assess eGFR at week 105
Roche will share data with health authorities; Ionis may receive regulatory and sales milestone payments and royalties
The FDA approved Hibsago (bepirovirsen), developed by GSK under a 2019 license from Ionis, for chronic hepatitis B in adults without cirrhosis who have suppressed HBV DNA and HBsAg levels of 3,000 IU/ml or less. Ionis has received an upfront payment, license fee and development and regulatory milestone payments, and is eligible for additional milestones and tiered royalties of 10-12% on net sales.
Phase 3 B-Well trials showed a 19% functional cure rate (233 of 1,220) versus 0 of 614 in the placebo group, in adults with HBsAg of 3,000 IU/ml or less
Current standard of care alone typically achieves less than 1% functional cure after one year of treatment, according to the filing
The approval followed FDA priority review and Breakthrough Therapy Designation; the filing states about 1.7 million people in the U.S. have chronic hepatitis B
The label includes boxed warnings for on-treatment hepatic flares and thrombocytopenia
Ionis and partner Roche reported positive prespecified interim results from the ongoing Phase 3 IMAgINATION study of investigational sefaxersen in adults with primary IgA nephropathy. The study met its primary endpoint, with statistically significant and clinically meaningful reductions in proteinuria versus placebo at 37 weeks, and no new safety signals were identified. The results advance a candidate that Roche licensed from Ionis, and Ionis is eligible for regulatory and sales milestone payments and royalties under that agreement.
Primary endpoint met: statistically significant reduction in 24-hour urine protein-to-creatinine ratio versus placebo at 37 weeks
Study enrolled 459 people, randomized 1:1 to sefaxersen or placebo for 105 weeks
Safety and tolerability were consistent with previously reported data, with no new safety signals
The study continues as a blinded study to assess change in eGFR at week 105; interim data will be presented at an upcoming medical congress, date not given
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