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March 2026 allergy news: FDA label updates, mastocytosis NDA, and promising data for peanut patch, remibrutinib, and CRSwNP biologics.
March 2026 brought a wave of regulatory updates and emerging therapeutic data across the allergy and immunology space, spanning anaphylaxis management, food allergy desensitization, hereditary angioedema (HAE), systemic mastocytosis, and chronic rhinosinusitis with nasal polyps (CRSwNP). Several developments centered on improving access to emergency therapies and accelerating disease-modifying approaches for IgE-mediated allergy and mast cell–driven conditions. Key updates from the month highlighted advances in noninvasive treatment options, RNA-based therapeutics, and targeted inhibitors with rapid onset of action.
This month in review spotlights the top 6 allergy news stories in March.
The US Food and Drug Administration (FDA) removed the minimum age requirement for 1 mg epinephrine nasal spray, allowing use in any patient weighing ≥ 33 lbs (15 kg). Previously, pediatric use was limited to those aged ≥ 4 years despite weight-based dosing alignment. The updated labeling now bases dosing solely on weight, expanding access to needle-free epinephrine for younger children at risk for anaphylaxis.
The revision also included practical updates, such as guidance for accidental sniffing after administration, allowances for freeze-thaw use, and expanded storage parameters, including temperature excursions up to 122°F. These changes aim to improve real-world usability in settings such as schools and childcare. Approximately 25% of children within the eligible weight range had previously been excluded due to age criteria, underscoring the clinical significance of the labeling change.
The FDA granted Fast Track designation to Argo Biopharmaceutical’s BW-20805, an investigational small interfering RNA (siRNA) therapy targeting the kallikrein pathway for prophylaxis of HAE. Early phase 2 findings suggest potential sustained suppression of disease activity, though investigators emphasized the preliminary nature of the data and the need for longer follow-up.
The ongoing phase 2 trial is expected to be completed in 2026, with plans for a global phase 3 study thereafter. The designation reflects the therapy’s potential as a long-acting treatment option in a disease requiring ongoing prophylaxis.
Related: BW-20805 Reduces HAE Attacks in Phase 2 Trial, With Markus Magerl, MD
The FDA accepted the new drug application (NDA) for Cogent Biosciences’ bezuclastinib in adults with non-advanced systemic mastocytosis and assigned a PDUFA target action date of December 30, 2026. The agency indicated no planned advisory committee meeting and identified no major review issues at acceptance.
The submission is supported by data from the SUMMIT trial evaluating the selective KIT inhibitor (KIT D816V) in patients with mast cell–driven symptoms. The regulatory milestone signals potential progress toward a targeted oral therapy for a population with limited treatment options.
Phase 3 VITESSE trial data demonstrated strong desensitization outcomes with the VIASKIN peanut patch (VP250), an epicutaneous immunotherapy delivering 250 µg peanut protein. Among peanut-allergic children aged 4–7 years, 82.8% receiving VP250 increased their eliciting dose compared with 48% on placebo over 12 months.
The trial met its primary endpoint, with significantly greater responder rates in treated patients across baseline eliciting dose strata (46.3% vs 14.7% and 43.1% vs 14.6%, respectively; P <.001). Additionally, 60% of participants improved by ≥ 2 dose levels during food challenge testing versus 23.4% on placebo. Investigators highlighted the patch’s noninvasive design and potential for improved adherence compared with oral immunotherapy.
“It's fantastic data to show that epicutaneous immunotherapy, [at] such a low dose, works to desensitize the vast majority of patients to a level that I think will protect them clinically from allergic reactions,” David Fleischer, MD, professor of pediatrics at Children’s Hospital Colorado, told HCPLive.
Phase 2 data presented at the 2026 AAAAI Annual Meeting demonstrated rapid desensitization with remibrutinib, a Bruton’s tyrosine kinase inhibitor. After only 1 week of treatment, 88% of adults with IgE-mediated peanut allergy tolerated a previously reactive dose during oral food challenge. The therapy was well tolerated, with no serious adverse events reported.
Across dose groups, 4 weeks of therapy produced estimated response rates ranging from 0.41 to 0.84, all exceeding placebo. In an interview, Robert Wood, MD, from Johns Hopkins Children's Center, said that the speed of remibrutinib may open up the possibility of the treatment to be used intermittently instead of continuously.
At AAAAI 2026, HCPLive spoke with Joseph Han, MD, from Old Dominion University, on late-breaking phase 2 VIBRANT data demonstrating that verekitug, a thymic stromal lymphopoietin (TSLP) receptor–blocking therapy, reduced the need for surgery and improved outcomes in severe chronic rhinosinusitis with nasal polyps. Quarterly treatment reduced surgical need by 76% compared with baseline expectations, highlighting the biologic’s potential in severe disease management.
Han emphasized that targeting upstream epithelial cytokines such as TSLP may offer broader anti-inflammatory control compared with downstream biologics, supporting ongoing development in CRSwNP.
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