Novartis faces dual trial setbacks as pelacarsen and del-desiran miss endpoints

  • Pelacarsen missed the Lp(a)HORIZON cardiovascular-events endpoint, while del-desiran missed HARBOR’s primary DM1 endpoint.
  • The pelacarsen trial enrolled more than 8,000 patients, and HARBOR studied approximately 150 people over 54 weeks.
  • Novartis will present full pelacarsen results at a medical congress and review HARBOR data with health authorities.

Novartis reported two significant clinical setbacks: pelacarsen failed to significantly reduce cardiovascular events in the late-stage Lp(a)HORIZON trial despite lowering lipoprotein(a), or Lp(a), and del-desiran failed to show a statistically significant improvement versus placebo on the primary endpoint of the Phase III HARBOR study in myotonic dystrophy type 1 (DM1). The pelacarsen result sent Novartis shares down about 3%, with market listings showing declines of 3.2%, 3.3% and 3.61%, while the del-desiran announcement followed another more than 3% share decline. Novartis said HARBOR showed evidence of clinical activity in secondary endpoints and exploratory analyses, with safety generally consistent with earlier data, and it will review the full dataset with health authorities. The company reaffirmed its forecast for 5-6% compound annual sales growth from 2025 through 2030.

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