Novartis ADRs Fall 13% Premarket After Phase 3 HARBOR Miss
Key Facts
Novartis American depositary receipts (NVS) fell 13% in U.S. premarket trading on September 8, 2026, after the company said the Phase 3 HARBOR trial of del-desiran missed its primary endpoint.
HARBOR was a global, randomized and double-blind Phase 3 trial involving approximately 150 people with myotonic dystrophy type 1. The study ran for 54 weeks, with del-desiran or placebo administered every 8 weeks.
The primary endpoint was video hand opening time (vHOT), a measure of how the hand relaxes after contraction. The trial showed no statistically significant improvement over placebo, although Novartis observed evidence of clinical activity in secondary endpoints and exploratory analyses and said safety findings were generally consistent with earlier data.
The September 8, 2026 announcement was the second late-stage primary-endpoint miss in 4 days. On September 4, 2026, Novartis said the Phase 3 Lp(a)HORIZON trial of pelacarsen did not reduce cardiovascular-event risk versus placebo despite lowering lipoprotein(a) levels.
The selloff spread to neuromuscular-drug developers Dyne Therapeutics (DYN) and Sarepta Therapeutics (SRPT) in premarket trading. The reaction indicates that investors repriced development risk for similar therapies; it does not mean the two companies' own trials failed.
Novartis maintained its forecast for compound annual sales growth between 5% and 6% from 2025 to 2030. The company will analyze the full HARBOR dataset and engage health authorities before determining the appropriate development path for del-desiran.
Latest Updates · 3
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Update: Reports have identified the drug del-desiran as the catalyst for the decline, after it failed to meet primary endpoints in the Phase 3 HARBOR study. The trial was focused on treating myotonic dystrophy type 1, and its failure has intensified the negative sentiment surrounding the company's R&D pipeline.
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Update: Sector-wide pressure expanded as Amgen shares declined on Tuesday (September 8, 2026) following disappointing clinical trial results. This downturn contributed to a lower Dow Jones Industrial Average, further intensifying concerns regarding R&D productivity across the major pharmaceutical landscape.
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Update: Additional reports have identified the failed clinical trial as a study for a cholesterol-lowering drug targeting the Lp(a) protein to reduce cardiovascular risks. This specific setback represents a significant blow to the company's efforts to expand its cardiovascular portfolio, a key segment for its long-term revenue growth.