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FDA updates, phase 3 CRISPR data in HAE, and emerging food allergy prevention strategies defined allergy and immunology news in April 2026.
April 2026 featured key updates in allergy, immunology, and rare disease, including FDA regulatory changes, phase 3 gene therapy results, and advances in prevention research. The FDA removed the age restriction for ARS Pharmaceuticals’ epinephrine nasal spray (neffy), shifting to weight-based pediatric use in younger patients. In hereditary angioedema (HAE), Intellia Therapeutics’ CRISPR-based lonvoguran ziclumeran (lonvo-z) delivered a large reduction in attack rates in the phase 3 HAELO trial.
Here, the HCPLive editorial team highlighted the top 5 allergy news stories in April 2026.
The FDA removed the age restriction for ARS Pharmaceuticals' epinephrine nasal spray (neffy), shifting to weight-based labeling for patients ≥ 33 pounds, expanding pediatric access. Nicole Chase, MD (St. Paul Allergy & Asthma; University of Minnesota Medical School), noted the update aligns with epinephrine auto-injector practice and may improve real-world adherence.
FDA labeling also clarifies the administration technique, storage conditions, and safety considerations, including the importance of avoiding inhalation during dosing. Chase emphasized that intranasal epinephrine use may reduce needle anxiety and support earlier treatment of anaphylaxis. She highlighted potential benefits in school and camp settings, improved storage flexibility, and longer shelf life versus injectables, improving epinephrine access and adherence.
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
In the phase 3 HAELO trial, CRISPR-based therapy lonvoguran ziclumeran (lonvo-z) reduced hereditary angioedema (HAE) attack rates by 87% versus placebo. Lead investigator Aleena Banerji, MD (Massachusetts General Hospital; Harvard Medical School), reported a mean monthly attack rate of 0.26 vs. 2.10, and 62% of patients are attack-free on prophylaxis. Banerji highlighted durable, one-time treatment potential.
The in vivo CRISPR/Cas9 therapy targets KLKB1 to reduce kallikrein activity and bradykinin production. Safety was generally mild, with infusion reactions, headache, and fatigue. Intellia Therapeutics has initiated a rolling BLA submission with a possible US launch in 2027.
Related: Single-Dose Lonvoguran Ziclumeran Cuts HAE Attacks by 87% in Phase 3 Trial
Recent evidence suggests food allergy may be modifiable in early life through immune tolerance, microbiome shifts, and early allergen exposure. The LEAP trial demonstrated an approximately 80% peanut allergy risk reduction with early introduction, followed by population declines after guideline adoption. Very low-dose oral immunotherapy research led by Julie E. M. Upton, MD, showed increased tolerated peanut doses in allergic toddlers.
ACTIVATE trial data presented by Jose Clemente, PhD (Icahn School of Medicine at Mount Sinai), explored vaginal seeding effects on the infant microbiome. Additional studies from Susanne Brix-Pedersen and Jamie Blum, PhD (Salk Institute) highlight bifidobacteria-driven immune protection and dietary epitope-based tolerance mechanisms, respectively.
Related: The Early-Life Window: Can Food Allergy Be Prevented Before It Begins?
Phase 2 RAPIDe-1 trial data show oral deucrictibant, a bradykinin B₂ receptor antagonist, significantly reduced hereditary angioedema (HAE) attack severity within 4 hours compared with placebo. Investigators Marc A. Riedl, MD (University of California San Diego), and Emel Aygören-Pürsün, MD (Goethe University Frankfurt), reported least squares mean reductions in VAS-3 scores of −15.02 (20 mg) and −16.28 (30 mg), both P < .0001. Median time to symptom relief was 2.5–2.7 hours versus 8 hours with placebo.
Most attacks achieved near-complete resolution and reduced rescue therapy use. Safety was similar to placebo, supporting further evaluation as a rapid, oral on-demand HAE treatment option.
A phase 1/2 randomized trial of jack jumper ant venom immunotherapy (VIT) showed that a lower 25 mcg maintenance dose achieved similar protection to the standard 50 mcg dose, with 85% of participants tolerating a sting challenge at 12 months. Adriana Le Thanh-Thao, MBBS (Royal Hobart Hospital Jack Jumper Allergy Program), reported no significant efficacy difference between dosing groups. However, lower dosing showed more systemic reactions, while greater dosing reduced treatment-related reactions. Delta-inulin (Advax) increased IgG4 responses but did not improve clinical outcomes.
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