- Aimmune Therapeutics (NASDAQ:AIMT) is up 9% premarket on light volume in response to successful results from a European Phase 3 clinical trial, ARTEMIS, evaluating lead candidate AR101 for the treatment of peanut allergy.
- The study met the primary endpoint of a statistically significant proportion of AR101-treated patients who tolerated a 1 g dose of peanut protein in a blinded exit challenge at month 9 compared to placebo (p<0.00001).
- The median tolerated dose of peanut protein in the treatment group improved 100-fold (10 mg at baseline to 1,000 mg at exit).
- No new safety signals were reported.
- The company plans to file a marketing application in Europe mid-year. Its U.S. marketing application is currently under FDA review with an expected action date around January 2020.
- Management will host a conference call this morning at 8:30 am to discuss the results.