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FDA epinephrine updates, phase 3 HAE data on lonvo-z, and new food allergy prevention research from April through June 2026.
Allergy news accelerated this quarter, with major regulatory, clinical trial, and research developments reshaping care. The US Food & Drug Administration (FDA) expanded epinephrine nasal spray (neffy) access via weight-based dosing, while phase 3 HAELO data positioned lonvoguran ziclumeran (lonvo-z) as a potential one-time CRISPR therapy for hereditary angioedema, cutting attack rates by 87%.
Experts also weighed in on an expanding HAE treatment landscape, including sebetralstat (Ekterly) and investigational RNA therapy BW-20805. Moreover, emerging research examined whether food allergy could be prevented before sensitization, from early peanut introduction to microbiome-modulating strategies. Explore this quarter's top allergy news, KOL insights, and clinical trial updates below.
The FDA removed the minimum age requirement for neffy (epinephrine nasal spray), shifting eligibility to weight-based criteria for patients ≥33 lbs. Nicole Chase, MD, from St. Paul Allergy & Asthma, University of Minnesota Medical School, explained the update mirrors existing epinephrine auto-injector dosing standards.
ARS Pharmaceuticals will provide free carrying cases starting this summer. The label update also clarifies temperature tolerance (freezing to 122°F) and proper administration technique to avoid sniffing during dosing. Chase noted the change may improve treatment adherence and reduce needle anxiety, encouraging earlier epinephrine use during allergic reactions and anaphylaxis management.
Related: Weight-Based Dosing Informs Age Removal for Epinephrine Nasal Spray, With Nicole Chase, MD
FDA Removes Age Requirement for Epinephrine Nasal Spray, Now Based on Weight Alone
A single dose of lonvoguran ziclumeran (lonvo-z; Intellia Therapeutics) reduced HAE attack rates 87% versus placebo in phase 3 HAELO data, Aleena Banerji, MD (Harvard/MGH), reported. The CRISPR/Cas9 therapy targets KLKB1 to cut kallikrein and bradykinin production, requiring no ongoing treatment.
Secondary data presented at EAACI 2026 showed 91% fewer moderate/severe attacks and 89% fewer attacks needing on-demand treatment, with zero non-responders. Only mild-to-moderate TEAEs occurred, with no liver toxicity.
A rolling BLA began in April, with a US launch anticipated in H1 2027.
Related: HAELO Phase 3: Lonvo-z Secondary Endpoints, QoL Data Detailed at EAACI
Three HAE experts detailed a rapidly evolving treatment landscape to HCPLive. Updated guidelines now recommend sebetralstat (Ekterly) as first-line acute treatment, with Mauro Cancian, MD, noting KONFIDENT data showing a 4-minute median time to treatment. Investigational RNA therapy BW-20805 showed 80% of patients attack-free post-dose, per Markus Magerl, MD, with prekallikrein levels dropping 90-97%. Lonvoguran ziclumeran (lonvo-z), Intellia's one-time CRISPR therapy, cut attack rates by 87% in phase 3 data.
Related: The Early-Life Window: Can Food Allergy Be Prevented Before It Begins?
Three recent studies explore food allergy prevention before sensitization. Nicole Chase, MD, cited research showing very low-dose oral immunotherapy (30 mg peanut protein) improved tolerance in allergic toddlers by 18 months, while LEAP trial follow-up data showed a 27% real-world decline in peanut allergy since 2015 guidelines.
New microbiome research is driving prevention momentum: the ACTIVATE trial linked vaginal seeding to reduced sensitization in cesarean-born infants; a Nature Microbiology study tied early bifidobacteria colonization to lower IgE; and a Science Immunology study identified dietary epitopes driving oral tolerance—though prevention remains clinically premature.