Policy & Regulation
Aimmune Stock Trading Halted; FDA Allergenic Products Advisory Committee Meeting to Discuss Palforzia for Peanut Allergy
18 September 2019 - - NASDAQ has halted trading of US-based biopharmaceutical company Aimmune Therapeutics, Inc.'s (NASDAQ: AIMT) common stock, the company said.

The US Food and Drug Administration Allergenic Products Advisory Committee this week held a meeting to discuss whether efficacy and safety data support licensure of Palforzia as a treatment to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut in patients four through 17 years of age with a confirmed diagnosis of peanut allergy.

Aimmune Therapeutics is a biopharmaceutical company developing oral treatments for potentially life-threatening food allergies.

The company's Characterized Oral Desensitization ImmunoTherapy (CODIT) approach is intended to provide meaningful levels of protection against allergic reactions resulting from exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens.

Aimmune's first, investigational, complex biologic product candidate, Palforzia (AR101), is being developed as a treatment to reduce the frequency and severity of adverse events following exposure to peanut.

The BLA for Palforzia is under review by the FDA, which granted Palforzia Breakthrough Therapy Designation in 2015 for the desensitization of peanut-allergic patients 4 to 17 years of age.

The European Medicines Agency is reviewing Aimmune's Marketing Authorization Application for Palforzia, which Aimmune submitted in June 2019.

Aimmune initiated a randomised phase 2 clinical trial of its second investigational, complex biologic product, AR201, for the treatment of egg allergy in August 2019.