Quarterly Sales (Approved)
November 2020 (Est)
Amp Volatility Score
Catalyst Info & Data Links
TITLE: Quarterly Sales AR101 (Palforzia) in Peanut Allergy (FDA-approved drug)
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
November 2020 (Est)
06-2020: PALISADE Follow-On Study (ARC004): Longer-Term Outcomes With AR101 Oral Immunotherapy for Peanut Allergy (European Academy of Allergy and Clinical Immunology (EAACI))
2018: AR101 oral immunotherapy for peanut allergy. New England Journal of Medicine, 379(21), 1991-2001.
2018: Efficacy and safety of AR101 in oral immunotherapy for peanut allergy: results of ARC001, a randomized, double-blind, placebo-controlled phase 2 clinical trial. The Journal of Allergy and Clinical Immunology: In Practice, 6(2), 476-485.
Viaskin™ (by DBV Technologies)
+15 million Americans have food allergies
+1.7 million children are believed to have a peanut allergy (In the U.S. alone)
MECHANISM OF ACTION/ RATIONALE
Although OIT is the most widely studied route of administration for food allergen immunotherapy, the precise mechanism of action underlying allergen desensitization is not fully understood. At least 2 temporally overlapping processes appear to be involved with AR101 treatment: 1) acute desensitization occurring over a period of weeks to months, and 2) immunomodulation occurring over a period of months to years.
The administration of gradually increasing amounts of allergen to allergic individuals during initial dose escalation results in the degranulation of mast cells and basophils bearing antigen-specific IgE bound to FcεR1, which in turn can result in allergy symptoms. The controlled release of mediators of inflammation by mast cells and basophils renders these cells temporarily refractory to subsequent antigen-mediated activation and granule release, leading to a state of acute desensitization. Desensitization is maintained by continued dosing with daily exposure during the up-dosing and maintenance periods.
Source - Sponsor Briefing Document/Allerginic Product Advisory Committee
Updated by HC
AIMT, AR101 (Palforzia), Peanut Allergy
Prior Data (click to view full image)
Trial Design / Revenue (click to view full image)
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