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AIMT

Aimmune

08:09
11/28/16
11/28
08:09
11/28/16
08:09

Aimmune announces global enrollment completion of phase 3 AR101 PALISADE trial

Aimmune Therapeutics announced it has completed global enrollment of its Phase 3 PALISADE trial of AR101 for the treatment of peanut allergy, with the total randomized to the trial expected to be approximately 540 patients. AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. Aimmune continues to expect topline data from PALISADE in 4Q17, followed by regulatory submissions for marketing approval of AR101 in 2018 in both the U.S. and Europe. The company announced completion of North American enrollment in PALISADE in September, ahead of schedule and above target enrollment. Aimmune also announced ARTEMIS, a new dedicated European clinical trial of AR101 in peanut-allergic children and adolescents. ARTEMIS is designed to expand the data available on the efficacy profile of AR101 by exploring a higher level of protection after a shorter treatment period in a broader group of patients than in PALISADE. The primary efficacy endpoint in this new trial will be tolerating a cumulative amount of 2,043 mg of peanut protein in an exit double-blind, placebo-controlled food challenge after approximately nine months of treatment with AR101. ARTEMIS is a randomized, double-blind, placebo-controlled trial in peanut-allergic children and adolescents ages 4-17. The inclusion criteria for the trial will allow for baseline toleration of a cumulative amount not exceeding 144 mg of peanut protein in an entry DBPCFC. Patients will undergo approximately six months of up-dosing and then three months of maintenance therapy at 300 mg of AR101 per day, followed by an exit DBPCFC. Aimmune expects ARTEMIS to enroll between 120 and 160 patients at multiple sites in Europe, beginning in mid-2017.

  • 29

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    Dec

AIMT Aimmune

06/28/16
PIPR
06/28/16
NO CHANGE
Target $38
PIPR
Overweight
Piper reiterates Overweight on Aimmune after management meetings
After hosting meetings with management, Piper Jaffray analyst Charles Duncan reiterates an Overweight rating on Aimmune Therapeutics (AIMT) with a $38 price target. The stock closed yesterday down 44c to $11.01 and is down over 40% year-to-date. No matter how the Phase II data is dissected, Aimmune's AR101 appears to produce a higher response rate in about 50% less time than DBV Technologies' (DBVT) Viaskin, Duncan tells investors in a research note. He believes investors may be overlooking future potential drivers of competitive advantage for AR101.
08/23/16
PIPR
08/23/16
NO CHANGE
PIPR
Aimmune data positive, says Piper Jaffray
Piper Jaffray analyst Charles Duncan says that a study of Aimmune's OIT in very young children with peanut allergies indicates that it provides "clinically meaningful protection and perhaps even a disease modifying effect." The analyst says that the drug demonstrated "unexpectedly good" tolerability, and he believes that the data indicates that the drug could be differentiated versus the current standard of care. He keeps a $38 price target and Overweight rating on the stock.
09/21/16
PIPR
09/21/16
NO CHANGE
Target $38
PIPR
Overweight
Aimmune enrollment completion a 'big positive,' says Piper Jaffray
Piper Jaffray analyst Charles Duncan calls Aimmune Therapeutics' announcement yesterday that it completed North American enrollment of 350 patients in its Phase III PALISADE trial of AR101 as a "big positive." The faster than expected timelike "speaks to the unmet need in peanut allergy across the differentiated, broad patient population enrolled in PALISADE, Duncan tells investors in a research note. The analyst reiterates an Overweight rating on the shares with a $38 price target.
09/26/16
JMPS
09/26/16
INITIATION
Target $30
JMPS
Outperform
Aimmune initiated with an Outperform at JMP Securities
JMP Securities analyst Liisa Bayko initiated Aimmune with an Outperform and a $30 price target. The analyst is confident that AR101 Phase 3 data will show meaningful desensitization to peanuts in allergic children and adults and we will be paying close attention to safety and any discontinuations and projects $1.4B in sales by 2028.

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