Aimmune shares surge 10% on positive late-stage trial results for peanut allergy drug [MarketWatch]
AIMMUNE THERAPEUTICS (AIMT)
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Source: MarketWatch
Aimmune shares surge 10% on positive late-stage trial results for peanut allergy drug Aimmune Therapeutics Inc. AIMT, +6.42% shares rose 9.8% in premarket trade Tuesday after the company said a late-stage trial for its peanut allergy drug met its primary endpoint. The company plans to file for Food and Drug Administration approval by the end of the year, and file in Europe in the first half of 2019. Of the 496 patients ages 4 to 17 years old who received treatment in the phase 3 study, 67% of patients who took AR101 tolerated at least 600 mg of peanut protein with no more than mild symptoms, compared to 4% of placebo patients, the company said. The difference between response rates was 63%, and 53% at the lower bound of the 95% confidence interval, compared with a pre-specified success criterion of at least 15%, Aimmune said. About 50% of AR101 patients tolerated 1,000 mg of peanut protein, compared with 2% of placebo patients. Of the roughly 500 patients enrolled in the trial's pr
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