Aimmune Therapeutics Inc. (NASDAQ:AIMT) reported that almost (97%) all of the 554 enrolled 4-49yo peanut-allergic Phase 3 PALISADE patients have completed the updosing phase which starts the 6 month countdown to topline pivotal data release (early Q1:18). Aimmune stated that powering is above initial expectations. At this point, Wedbush believes no additional news, such as amendments to the safety protocol, is a likely signal for trial success. Recall, in Phase 2, a majority of GI AEs occurred during the up-dosing phase and of the patients who transitioned and completed three months of maintenance treatment, 90% were able to successfully consume 600 mg of peanut protein (meeting the primary endpoint of PALISADE).
DBV Technologies has guided to the release of pivotal Phase 3 results for Viaskin peanut treatment of peanut allergies in the second half of 2017. The firm estimates results could be released in September or October, based on 12-month study duration (enrollment completion occurred late June 2016) and an additional 1-2 months of data cleanup and processing. Wedbush believes shares of AIMT are likely to be volatile around this event but it anticipates that efficacy is likely to be materially lower than AR101 based on past results.
Wedbush's price target is based on the sum of a 30% annual discount on its net peak annual sales estimate for each product and indication and applying a 1x-10x multiple depending on stage of development, then dividing by share count and rounding to the nearest dollar.