Ionis cuts Tryngolza 2026 sales guidance, highlights Zanvastro launch and new Phase 3 wins
The company lowered Tryngolza product sales guidance to about $50 million while reporting positive Phase 3 results for sefaxersen and ulefnersen and a first Alexander disease launch.
Ionis Pharmaceuticals reported third quarter 2026 results on November 9, 2026, and cut its full-year guidance for Tryngolza (olezarsen) product sales. The company had previously guided to $100-110 million but now expects approximately $50 million, reflecting a more gradual launch ramp than anticipated as Ionis establishes a new treatment paradigm for people with sHTG.1 Tryngolza generated U.S. net product sales of $9 million and $41 million in the third quarter and nine months ended September 30, 2026, respectively.1
Outside the U.S., Ionis said it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for sHTG, paving the way to bring TRYNGOLZA to sHTG patients across Europe with a final approval decision expected in the fourth quarter of 2026.1
Zanvastro (zilganersen), approved for Alexander disease, saw its launch underway with first patients dosed with commercial drug1, and the company said it is commercializing outside the U.S. with Recordati, assuming approval.1
On the pipeline side, Ionis reported that its Phase 3 IMAgINATION study of sefaxersen in IgA nephropathy met its primary endpoint, demonstrating a clinically meaningful 43.1% reduction in proteinuria relative to placebo at week 37 (p<0.0001), with a safety profile consistent with previous data.1 Separately, the Ulefnersen Phase 3 study in patients with Fused in Sarcoma (FUS) Amyotrophic Lateral Sclerosis (ALS) met its primary endpoint (p=0.0005) and demonstrated a favorable safety and tolerability profile; data to be shared with health authorities.1
The company's partnered Phase 3 CARDIO-TTRansform study of eplontersen in transthyretin amyloid cardiomyopathy had mixed results: Although the study missed the primary composite endpoint in the overall population, eplontersen demonstrated nominal significance in the pre-specified monotherapy population and a favorable safety and tolerability profile.1
Ionis ended the quarter with cash, cash equivalents and short-term investments decreased to $1.9 billion, compared to $2.7 billion on December 31, 2025, primarily due to repayment of the 0% convertible notes on April 1, 2026 and cash used to fund operations.1 The company reaffirms its 2026 total revenue, including DAWNZERA product sales, operating loss and cash guidance based on its year-to-date results and fourth quarter outlook.1
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