Aimmune down on safety concerns for peanut allergy therapy
Aimmune Therapeutics Inc. (NASDAQ:AIMT) was off $3.33 (11%) to $26.29 on Monday after the New England Journal of Medicine published full data from the Phase III PALISADE trial of the company's peanut allergy therapy AR101, including detailed safety showing a higher rate of rescue epinephrine use in the active arm vs. placebo arm. The move translates to a loss in market cap of over $195 million.
In February, Aimmune reported that AR101 met PALISADE's primary endpoint of a greater proportion of patients ages 4-17 who were able to tolerate a dose of at least 600 mg of peanut protein -- at least two peanuts according to Aimmune -- at the exit food challenge vs. placebo (67.2% vs. 4%, p<0.00001). Patients in the primary analysis group tolerated no more than 30 mg of peanut protein at baseline (see "Aimmune's Peanut Allergy Therapy Meets in Phase III")...
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