Q3 2026 Recap: Allergy News and Updates

Allergy and immunology regulatory activity accelerated from July through September 2026. The US Food & Drug Administration (FDA) extended Ryaltris (olopatadine/mometasone) to children aged 6 to 11 years with seasonal allergic rhinitis, accepted marketing applications for lonvo-z and oral deucrictibant in hereditary angioedema (HAE), and granted Fast Track designation to Aravax's PVX108 for peanut allergy.

Aquestive resubmitted its Anaphylm New Drug Application (NDA), and a WAO Delphi panel endorsed ED05-based precautionary allergen labeling. HCPLive features examined Palforzia's discontinuation, the delayed allergic toll of wildfire smoke, and why anaphylaxis guidelines lag behind epinephrine nasal spray.

Explore this quarter's top allergy news, FDA updates, clinical trial data, and expert insights below.

FDA Ryaltris Pediatric Approval in Allergic Rhinitis

FDA Approves Ryaltris for Children Aged 6 to 11 With Seasonal Allergic Rhinitis

The FDA expanded the approval of Ryaltris (olopatadine hydrochloride and mometasone furoate; Glenmark Pharmaceuticals) nasal spray to include seasonal allergic rhinitis in children aged 6 to 11 years, the company announced July 21, 2026. The fixed-dose antihistamine and corticosteroid combination was first approved in 2022 for patients aged ≥ 12 years.

Approval was supported by a phase 3, randomized, double-blind, placebo-controlled trial of 446 children, in which 1 spray per nostril twice daily improved nasal symptoms vs placebo over 14 days and was well tolerated. The most common adverse reactions were dysgeusia, epistaxis, and nasal discomfort.

Lonvo-z and Deucrictibant HAE New Drug Applications Accepted by FDA

Lonvo-z BLA Accepted by FDA With Priority Review for HAE

The FDA accepted the Biologics License Application for lonvoguran ziclumeran (lonvo-z; Intellia Therapeutics) with priority review for HAE in patients aged ≥16 years, setting a PDUFA date of March 10, 2027. If approved, the one-time CRISPR/Cas9 therapy targeting KLKB1 would be the first in vivo gene-editing treatment for HAE, and the FDA does not currently plan an advisory committee.

In the phase 3 HAELO trial, a single 50 mg dose reduced mean monthly attacks by 87% vs placebo. Overall, 62% of treated patients remained attack-free and therapy-free through 6 months vs 11% with placebo, and all adverse events were mild or moderate.

Read more: What CRISPR Gene Therapy Means for HAE: FAQ on This 1-Time Treatment

FDA Accepts NDA for Oral Deucrictibant for HAE Attacks

The FDA accepted Pharvaris' NDA for deucrictibant immediate-release capsules, an oral bradykinin B2 receptor antagonist for on-demand treatment of HAE attacks, with a PDUFA date of April 23, 2027. If approved, it would become the first oral agent in its class for acute HAE attacks.

The phase 3 RAPIDe-3 trial, which enrolled patients aged ≥ 12 years, including those with normal C1 inhibitor levels, met its primary endpoint and all 11 secondary efficacy endpoints. Median time to onset of symptom relief was 1.28 hours, and median time to complete attack resolution was 11.95 hours.

PVX108 Fast Track

Aravax's PVX108 Receives FDA Fast Track Designation for Peanut Allergy

The FDA granted Fast Track designation to PVX108 (Aravax), an investigational peptide immunotherapy for peanut allergy, on August 3, 2026. Built from 7 short synthetic fragments of the major peanut allergen, PVX108 contains no whole allergen or extract and is administered intradermally once monthly without dose escalation.

In the phase 1 AVX-001 trial of 67 peanut-allergic adults, no serious adverse events occurred, and mild injection site reactions were the only event more frequent than with placebo. Exploratory analyses showed peanut-reactive T cells shifting toward tolerance, and topline phase 2 data are expected later in 2026.

Anaphylm NDA Resubmission

Aquestive Resubmits Anaphylm NDA for Anaphylaxis Treatment

Aquestive Therapeutics resubmitted its NDA for Anaphylm (dibutepinephrine) sublingual film, a needle-free epinephrine prodrug for type I allergic reactions including anaphylaxis, on September 17, 2026. The resubmission responds to a January 30, 2026 Complete Response Letter (CRL) requesting a packaging-focused human factors study and a confirmatory pharmacokinetic study.

Revised packaging cut median pouch-opening time from 17 seconds to 3 seconds, and no protocol-defined use errors occurred in the self-administration arm. The FDA has not yet classified the resubmission or set a review timeline.

Read more: Anaphylm Is Back at the FDA: A Clinician FAQ on Needle-Free Epinephrine

WAO Delphi Consensus on Precautionary Allergen Labeling

WAO Delphi Consensus Endorses ED05-Based Allergen Labelling

A World Allergy Organization (WAO) ACT-UP! e-Delphi panel of 35 experts across 21 countries reached consensus on 33 of 35 statements on precautionary allergen labeling. The panel recommended "may contain" warnings apply only when a mandatory risk assessment shows unintended allergen presence exceeding an action level based on ED05 reference doses, the amount estimated to trigger objective reactions in ≤5% of allergic individuals.

Panelists rejected a fixed 5 ppm cutoff, while 10 ppm failed to reach consensus. "May contain X" emerged as the preferred wording, and 97% agreed free-from labels should mean no detectable allergen.

Palforzia Discontinuation, Wildfire Smoke, and Neffy Guideline Gap

Palforzia Discontinued, Ending the Only FDA-Approved Peanut OIT Option

Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp), the first and only FDA-approved oral immunotherapy (OIT) for peanut allergy, was discontinued as of July 31, 2026. Stallergenes Greer said the withdrawal was unrelated to safety, quality, or efficacy. HCPLive spoke to experts on what this discontinuation means for the allergy field.

How Wildfire Smoke Triggers Allergic Disease Long After It Clears

Smoke from Canadian wildfires blanketed the East Coast and Midwest in summer 2026, and emerging research suggests its allergic toll can outlast the haze. HCPLive spoke with environmental health experts on wildfire smoke’s impact on allergies.

Watch our dynamic video: Wildfire Smoke's Hidden Toll on Patients with Allergies

Epinephrine Nasal Spray Available, but Anaphylaxis Guidelines Lag

Epinephrine nasal spray (neffy) received FDA approval on August 9, 2024, but formal anaphylaxis practice parameters have not yet incorporated it. HCPLive spoke with allergists on how to counsel patients about epinephrine nasal spray before anaphylaxis guidelines catch up.