IONS changes
Pick any two versions below to diff them.
- Price
- $44.12 → $44.27(+0.3%)
- Thesis
- The market lowered its view of Ionis's pipeline after two large partnered heart trials failed in 2026. On July 9, 2026, AstraZeneca's eplontersen trial in transthyretin amyloid cardiomyopathy missed its primary endpoint. On September 4, 2026, Novartis said that pelacarsen lowered Lp(a) but did not reduce cardiovascular events in the HORIZON trial. Both trials were possible sources of large royalties. Investors now value Ionis mostly on its own launches, which are still small: TRYNGOLZA sales were $5 million in Q2 2026 after a price cut, and Ionis still has an operating loss. The market doubts that TRYNGOLZA can reach the multi-billion-dollar potential that management sees in severe hypertriglyceridemia, which the FDA approved in June 2026. For the gap to close, four things must be true. TRYNGOLZA sales must grow fast from Q3 2026 in severe hypertriglyceridemia, with the EU decision for this use expected in 2027Q4 2026. DAWNZERA must reach its 2026 guidance of $110 million to $120 million of sales. GSK must win approval for bepirovirsen in chronic hepatitis B, with an FDA target date of October 26, 2026, and Roche must file sefaxersen in IgA nephropathy after the positive Phase 3 interim data of September 2026. Ionis must stay on its path to cash flow breakeven in 2028. The bepirovirsen decision and the Q3 2026 report, expected at the end of October 2026, give the first evidence. If the launches grow, the gap can close over the next four to eight quarters. If TRYNGOLZA grows slowly, the market can keep a low value on the pipeline.
- Checkpoints
- Oct 26, 2026: FDA decision on GSK's bepirovirsen in chronic hepatitis B. Pending. Watch: FDA approval on time passes; a rejection or a long delay fails. Oct 29, 2026 (estimate): Q3 2026 results: first quarter of the TRYNGOLZA sHTG launch. Pending. Watch: Fast growth in TRYNGOLZA sales after the June approval and DAWNZERA on track for $110 million to $120 million pass; flat TRYNGOLZA sales or a cut to 2026 guidance fail. Q4 2026 (estimate): EU decision on TRYNGOLZA in severe hypertriglyceridemia. Pending. Watch: European Commission approval in Q4 2026 passes; a delay into 2027 or a rejection fails. Feb 2027 (estimate): Full-year 2026 results and 2027 outlook. Pending. Watch: A 2027 outlook with strong growth in product sales and a clear path to cash flow breakeven in 2028 passes; a later breakeven or slow launch growth fails.
- Recent events
- 2026-10-16: The CHMP of the European Medicines Agency recommended the extension of the EU approval of TRYNGOLZA to adults with severe hypertriglyceridemia and triglycerides of 880 mg/dL or more. Ionis expects the European Commission decision in Q4 2026, earlier than it had planned. Ionis works with its partner Sobi on TRYNGOLZA in Europe. 2026-09-23: Ionis and Roche said that sefaxersen met its primary endpoint at a prespecified interim analysis of the Phase 3 IMAgINATION study in IgA nephropathy, with a significant reduction in proteinuria at 37 weeks. The study continues to measure kidney function at week 105. 2026-09-22: Ionis and its partner Otsuka said that ulefnersen met the primary endpoint of the Phase 3 FUSION study in FUS-ALS, a rare genetic form of ALS (p=0.0005). The companies plan to discuss fast approval paths with the FDA and other regulators. Otsuka holds the license, and Ionis can receive milestone payments and royalties. 2026-09-04: Novartis said that its Phase 3 Lp(a)HORIZON trial of pelacarsen did not meet its primary endpoint of fewer cardiovascular events, although pelacarsen lowered Lp(a) as in earlier studies. Ionis discovered pelacarsen and earns royalties from Novartis, and it sold part of these royalties to Royalty Pharma in 2023. 2026-09-03: The FDA approved ZANVASTRO (zilganersen) as the first disease-modifying treatment for Alexander disease, an ultra-rare neurological disorder. Ionis received a Priority Review Voucher with the approval. This is its first independent launch in neurology. 2026-07-29: Ionis reported Q2 2026 results. Revenue was $268 million, and the loss from operations was $102 million. TRYNGOLZA sales were $5 million, after a lower net price from April 1, 2026, and DAWNZERA sales were $26 million. Cash and short-term investments were $2.1 billion. Ionis said it is on track for its 2026 guidance and for cash flow breakeven in 2028. 2026-07-09: Ionis and AstraZeneca said that the Phase 3 CARDIO-TTRansform trial of eplontersen in transthyretin amyloid cardiomyopathy missed its primary endpoint of cardiovascular death and recurrent cardiovascular events. A prespecified subgroup on eplontersen alone showed a nominally significant result. 2026-06-24: The FDA approved TRYNGOLZA to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia. This is Ionis's first independent launch in a common condition. 2026-05-28: GSK reported that bepirovirsen gave a functional cure rate of 19% in chronic hepatitis B in the pivotal B-Well studies, against 0% with standard of care. In Q2 2026, Ionis and GSK amended their agreement, with higher milestones and royalty terms that exclude China, Hong Kong and Macau.