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Aimmune Therapeutics says peanut allergy drug trial met primary endpoint, plans to file for FDA approval by year-end

The firm said of the 496 patients aged 4 to 17 years old who received treatment in the Phase III study, 67% of patients tolerated at least 600 mg of peanut protein with no more than mild symptoms, compared to 4% of placebo patients

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The Nasdaq-listed company said it plans to file for US FDA approval by the end of the year

Aimmune Therapeutics Inc. shares jumped over 10% in pre-market trading on Tuesday after the company said a late-stage trial for its AR101 peanut allergy drug met its primary endpoint.

The Nasdaq-listed company said it plans to file for Food and Drug Administration approval by the end of the year, and expects a filing in Europe in the first half of 2019.

Results of Phase III study

It said of the 496 patients aged 4 to 17 years old who received treatment in the Phase III 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 firm also added that about 50% of AR101 trial patients tolerated 1,000 mg of peanut protein, compared with 2% of placebo patients.

In pre-market New York trading, Aimmune shares were up 10.9% at US$37.20.

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