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The HARBOR study failure is Novartis's second major late-stage trial setback in days and its third pipeline blow in a week
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Novartis announced Tuesday that its experimental drug del-desiran failed to beat placebo in a late-stage trial for myotonic dystrophy type 1, sending the company's stock down roughly 9% and on course for one of its worst trading days on record.
The global Phase III HARBOR study, which enrolled approximately 150 patients with the progressive muscle-wasting disease and ran for 54 weeks, came up short of statistical significance on its primary endpoint — video hand opening time — the company said. Secondary endpoints and exploratory analyses showed some evidence of clinical activity, and Novartis said it will evaluate the full dataset and engage with health authorities to determine a development path.
