Aimmune Therapeutics Inc.
www.aimmune.com
Latest From Aimmune Therapeutics Inc.
Finance Watch: BioNTech, Vir Launch IPOs But Take US Offerings To Market At A Discount
US FDA AdComm Win For Aimmune’s Palforzia Bodes Well For DBV’s Peanut Allergy Patch
Aimmune’s oral immunotherapy seems destined to come to market with a strict REMS, though analysts do not expect this will impact adoption. DBV is awaiting word on whether the FDA will review its second attempt at a BLA submission for Viaskin Peanut.
Aimmune’s Palforzia Gains US FDA Panel Nod But Faces REMS Restrictions
The agency’s plan to require a Risk Evaluation and Mitigation Strategy aimed at systemic allergic reactions with the peanut allergy immunotherapy did not go far enough, advisory committee members said, pushing for additional measures to be folded into the program.
Aimmune’s Peanut Allergy Immunotherapy Brings Safety Concerns To US FDA Panel
Palforzia was associated with a higher rate of adverse events, systemic allergic reactions, eosinophilic esophagitis and epinephrine use in controlled clinical trials; Allergenic Products Advisory Committee will weigh approval for patients ages 4-17 years with confirmed peanut allergy diagnosis.
Company Information
- Industry
- Biotechnology
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Pharmaceuticals
- Vaccines
- Therapeutic Areas
- Immune Disorders
- Alias(es)
- Allergen Research Corp.
- Ownership
- Public
- Headquarters
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Worldwide
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North America
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USA
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USA
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North America
- Parent & Subsidiaries
- Aimmune Therapeutics Inc.
- Senior Management
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Jayson Dallas, Pres. & CEO
Eric Bjerkholt, CFO
Jeffrey H Knapp, PhD, COO
Daniel C Adelman, MD, CMO
Mary Rozenman, PhD, SVP, Corp. Dev. & Strategy - Contact Info
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Aimmune Therapeutics Inc.
Phone: (650) 614-5220
8000 Marina Blvd.
Ste. 300
Brisbane, CA 94005
USA
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