Novartis AGNovartis's phase III HARBOR trial for del-desiran failed to meet primary endpoints, its third trial setback in a week.
Novartis shares fell 13% in premarket trading on Tuesday after its late-stage trial for the muscle-wasting drug del-desiran failed to meet primary endpoints, marking the company's third drug trial setback in a week and putting the stock on track for its worst trading day ever. The failure also dragged down other biotech stocks, with Dyne Therapeutics falling about 30%, Sarepta Therapeutics dropping 16%, and NewAmsterdam Pharma down 12%, as concerns spread across the sector. Novartis said its global phase III HARBOR study, testing del-desiran in patients with myotonic dystrophy type 1, did not demonstrate statistically significant improvement versus placebo on measurements of hand opening time. The company is evaluating the full dataset and will engage with health authorities to determine the next steps. Del-desiran is one of three antibody oligonucleotide conjugate therapies added to Novartis's neuromuscular pipeline through its roughly $12 billion acquisition of Avidity Biosciences last year. Despite the setback, Novartis maintains its 5-6% five-year sales CAGR guidance for 2025-2030.
Novartis AGNovartis's phase III HARBOR trial for del-desiran failed to meet primary endpoints, its third trial setback in a week.
Dyne Therapeutics IncDyne Therapeutics fell about 30% as the Novartis muscle-drug trial failure spread concerns across the biotech sector.
Sarepta Therapeutics IncSarepta Therapeutics dropped 16% amid sector-wide fallout from Novartis's failed del-desiran trial.
Del-desiran was one of three antibody oligonucleotide conjugate therapies acquired via Novartis's ~$12 billion Avidity Biosciences acquisition, so the trial failure undermines that pipeline asset.