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AIMT

Aimmune

16:02
06/12/17
06/12
16:02
06/12/17
16:02

Aimmune says over 97% of patients in PALISADE trial completed up-dosing

Aimmune Therapeutics announced that, in the ongoing Phase 3 PALISADE trial of AR101, more than 97% of patients currently on study have completed up-dosing. AR101 is Aimmune's proprietary, investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. PALISADE is a double-blind, placebo-controlled trial designed to investigate the efficacy and safety of AR101 in peanut-allergic children, adolescents, and adults. A total of 554 peanut-allergic patients, ages 4-49, were randomized to receive either AR101 or placebo for approximately six months of up-dosing followed by six months of maintenance therapy. Aimmune remains blinded to data from the trial. Based on observations of aggregated data to date, Aimmune expects that the percentage of patients completing the entire study will be well ahead of the powering calculations behind the study design. With the vast majority of patients now successfully through up-dosing in PALISADE, Aimmune estimates that final study visits will be completed around year-end 2017, and that topline data will be available in the first quarter of 2018.

AIMT Aimmune

03/22/17
PIPR
03/22/17
NO CHANGE
Target $38
PIPR
Overweight
Piper sees Aimmune as having regulatory advantage over DBV
After hosting investor meetings with management, Piper Jaffray analyst Charles Duncan keeps an Overweight rating on Aimmune (AIMT) with a $38 price target. While regulatory visibility will increase in the next 12 months, investors today should focus on response rates for the single highest tolerated dose, or how much peanut can an allergic person tolerate in a single exposure, Duncan tells investors in a research note. The analyst sees Aimmune's AR101 as having generated "uniquely impressive results" on the two key efficacy measures relative to DBV Technologies (DBVT), including both response rates and size of highest tolerated dose. He believes investors may be overlooking catalysts for Aimmune, including up-dosing progress from the PALISADE trial prior to Phase III results around year-end.
02/17/17
PIPR
02/17/17
NO CHANGE
Target $40
PIPR
Overweight
Piper sees Aimmune trial changes as reducing clinical risk
Piper Jaffray analyst Charles Duncan believes the Phase III change announced yesterday by Aimmune Therapeutics (AIMT) reduces clinical risk for the trial read-out, while still addressing a broad group of children and teens more broadly relative to Aimmune's "mindshare competitor" DBV Technologies (DBVT). The PALISADE Phase III primary analysis and initial BLA application will now include ages 4-17, but exclude adult patients, Duncan tells investors in a research note. Following the news, the analyst still believes Aimmune's AR101 will be approved and used in some of adult patients, but points out another trial may be required. He pushed his first AR101 sales estimate in adults back by two years to 2021 in the U.S. market and 2020 to 2022 in the E.U. market. Duncan keeps an Overweight rating on Aimmune with a $40 price target.
12/21/16
PIPR
12/21/16
NO CHANGE
PIPR
Piper lays out top BioPharma picks for 2017
Piper Jaffray analysts laid out their top BioPharma picks for 2017. Analyst Richard Purkiss favors Pfizer (PFE) and Eli Lilly (LLY) as his top large pharma picks. Analyst Joshua Schimmer calls Gilead (GILD) and Alexion (ALXN) his top large cap picks. Analyst David Amsellem names Horizon Pharma (HZNP) his top specialty pharma pick. Piper's other top Biopharma picks for 2017 include ACADIA (ACAD), Aimmune (AIMT), Akorn (AKRX), Alnylam (ALNY), Axovant Sciences (AXON), Cara Therapeutics (CARA), CoLucid Pharmaceuticals (CLCD), Eale Pharmaceuticals (EGRX), Exelixis (EXEL), Ionis Pharmaceuticals (IONS), Mallinckrodt (MNK), Neurocrine (NBIX), Nektar (NKTR), Otonomy (OTIC), Reata Pharmaceuticals (RETA), Rigel Pharmaceuticals (RIGL), Ignyta (RXDX), Theravance Biopharma (TBPH), Versartis (VSAR) and Voyager Therapeutics (VYGR). The analysts look for recent momentum in BioPharma to continue in 2017. They believe innovation and potentially repatriation should lead to increased merger activity.
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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