
Q2 2026 Recap: Allergy News & Updates
Key Takeaways
- FDA updated neffy labeling to weight-based eligibility ≥33 lb, clarified storage (freezing–122°F) and technique, and ARS will supply free carrying cases to support adherence.
- Phase 3 HAELO showed single-dose CRISPR/Cas9 lonvo-z (KLKB1 editing) reduced HAE attacks 87% vs placebo, with 0 non-responders and no liver toxicity; rolling BLA underway.
FDA epinephrine updates, phase 3 HAE data on lonvo-z, and new food allergy prevention research from April through June 2026.
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.
FDA Neffy Label Update
FDA Removes Age Restriction for Epinephrine Nasal Spray, With Nicole Chase, MD
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:
Lonvo-z Phase 3 HAELO Data
Single-Dose Lonvo-z Cuts HAE Attacks by 87% in Phase 3 Trial, With Aleena Banerji, MD
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:
HAE Treatment & Food Allergy Prevention
HAE in 2026: New Therapies, Updated Guidelines, the Case for Early Treatment
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.
Can Food Allergy Be Prevented Before It Begins? A Look At 3 Recent Studies
Related:
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.















































































