AIMT stock surged 16% in after-hours trading on January 31, 2020, after the company announced FDA approval for PALFORZIA.

Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, announced that the FDA approved PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. PALFORZIA is the first approved treatment for patients with peanut allergy. It’s an oral immunotherapy indicated including anaphylaxis, that may occur with exposure to peanuts. Maintenance and up-dosing could be continued in patients 4 years of age and older. PALFORZIA is to be used together with a peanut-avoidant diet. PALFORZIA is not indicated for the emergency treatment of allergic reactions.

PALFORZIA is a complex biologic drug used with a structured dosing approach that builds on a century of oral immunotherapy (OIT) research. With OIT, the particular allergenic proteins are ingested initially in very tiny quantities, followed by incrementally increasing amounts, resulting in the ability to mitigate allergic reactions to the allergen over time. PALFORZIA is a rigorously designed, pharmaceutical-grade OIT for peanut allergy with a well-defined allergen profile to guarantee that each and every dose, whether 0.5 mg (equivalent to 1/600th of a peanut) or 300 mg, has been prepared and analyzed for consistency.

“This is a defining moment for the peanut allergy community and for Aimmune Therapeutics, and we’re excited to bring the first FDA-approved treatment for peanut allergy to patients and their families,” said Jayson Dallas, M.D., President and CEO of Aimmune Therapeutics. “Our commercial field team is ready to begin engaging with allergists to help them prepare to safely integrate PALFORZIA in their practices and, with approval in hand, our payer staff can also immediately begin work to secure formulary access to PALFORZIA. We view this approval as just the start for Aimmune, and it underscores our continuing commitment to bringing innovative treatments to people with potentially life-threatening food allergies.”

“Peanut allergy carries an overwhelming psychosomatic burden that affects patients and their families daily – peanuts are everywhere, and the threat of a severe reaction related to an accidental peanut exposure dominates households’ daily lives,” said Lisa Gable, Chief Executive Officer, Food Allergy Research and Education (FARE). “The risk of accidental exposure is real, and we, as a community, have long awaited a choice beyond preventing peanuts alone. As one of the organizations that initially highlighted the need for an FDA-approved oral treatment approach to food allergy back in 2011, we are thrilled with today’s FDA approval of PALFORZIA as it fills a longstanding need in the treatment of peanut allergy.”

“Not only is PALFORZIA the first approved therapy for peanut allergy, but it is the first approved treatment for any food allergy,” said Daniel Adelman, M.D., Chief Medical Officer of Aimmune Therapeutics. “We truly appreciate the efforts of the allergy community that contributed to the evolution of PALFORZIA – including the more than 1,200 patients and their families who participated in our clinical trials, the research investigators and their staff, the advocacy community, and our dedicated employees – all of whom have helped us develop and deliver this first-of-its kind therapy.”

Peanut allergy is among the most common food allergies in the world, affecting more than 1.6 million children and teens in the United States alone. It can be a chronic and life-long condition, and reactions to peanuts can vary from mild to potentially life-threatening, with one in five peanut-allergic patients visiting emergency rooms each year due to accidental exposures.

“Peanut allergy is more prevalent now than ever before and is now a serious public health concern. The food allergy community has been eagerly anticipating an injectable treatment which may help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment choice to offer our patients that has demonstrated both the efficacy and safety to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, M.D., Associate Professor of Pediatrics and Medicine and Chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences. “With today’s approval of PALFORZIA, we could – for the first time – offer kids and teens with peanut allergy a proven medicine that employs a proven therapeutic approach.”

On January 23, 2020, Roth Capital analyst Zegbeh Jallah raised her price target for Aimmune to $50 from $45, primarily because she is bullish on Palforzia’s launch outlook. Jallah notes that the EMA’s approval of Palforzia is expected during the second half of 2020. She has a Buy rating on the shares.

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