4 Allergy Headlines You Missed in September 2026

September brought regulatory momentum and pivotal trial data in hereditary angioedema (HAE) and anaphylaxis. On the HAE front, the US Food & Drug Administration (FDA) accepted Intellia Therapeutics' Biologics License Application (BLA) for lonvoguran ziclumeran (lonvo-z) with priority review, moving the 1-time CRISPR gene-editing therapy for HAE closer to market. Pharvaris reported that oral deucrictibant extended-release (XR) met its primary endpoint in the phase 3 CHAPTER-3 prophylaxis study.

In anaphylaxis, Aquestive Therapeutics resubmitted its New Drug Application (NDA) for Anaphylm (dibutepinephrine) sublingual film after addressing an FDA Complete Response Letter (CRL). Beyond the pipeline, HCPLive also published a piece on the link between wildfire smoke and allergies. Here are 4 allergy headlines you may have missed.

Hereditary Angioedema Pipeline Advances on 2 Fronts

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

The FDA accepted the BLA for lonvo-z (Intellia Therapeutics) and granted priority review for HAE in patients aged ≥ 16 years, setting a Prescription Drug User Fee Act (PDUFA) target action date of March 10, 2027. In the phase 3 HAELO trial, a single 50 mg infusion reduced mean monthly attacks by 87% versus placebo, and 62% of treated patients remained attack-free and therapy-free through 6 months. The FDA does not currently plan to convene an advisory committee.

Lonvo-z inactivates the KLKB1 gene to permanently lower plasma kallikrein activity. If approved, lonvo-z would become the first in vivo CRISPR-based therapy for HAE.

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

Deucrictibant XR Meets Primary Endpoint in HAE Prophylaxis

Pharvaris’ once-daily oral deucrictibant XR 40 mg reduced the mean monthly HAE attack rate by 83% versus placebo (P <.0001) in the phase 3 CHAPTER-3 study, with an 87% reduction among participants with HAE type 1 or type 2. CHAPTER-3 is the first phase 3 prophylaxis program to evaluate all 3 HAE types, including HAE with normal C1 inhibitor. Protection was evident within the first week and sustained through 24 weeks, with no treatment-related serious adverse events.

Pharvaris plans to begin submitting marketing applications for deucrictibant XR in the first half of 2027, while its NDA for on-demand deucrictibant immediate-release remains under FDA review.

Needle-Free Epinephrine Returns to the FDA

Aquestive Resubmits Anaphylm NDA for Anaphylaxis Treatment

Aquestive Therapeutics resubmitted its NDA for Anaphylm (dibutepinephrine), a sublingual film epinephrine prodrug for type I allergic reactions including anaphylaxis, following a January 30, 2026, CRL. The FDA had requested a human factors study on packaging and administration plus a confirmatory pharmacokinetic study. Redesigned packaging cut median pouch-opening time from 17 seconds to 3 seconds, with no protocol-defined use errors in the self-administration arm.

David B.K. Golden, MD, CM, lead author of the 2023 Anaphylaxis Practice Parameter and a member of Aquestive's Scientific Advisory Board, noted that a pocket-sized, needle-free option could ease barriers to carrying and using epinephrine. 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

How Wildfire Smoke Triggers Allergic Disease Long After It Clears

Canadian wildfire smoke pushed air quality to unhealthy and hazardous levels across the East Coast and Midwest, and emerging research suggests its allergic toll can persist after the haze lifts. A longitudinal study led by Jim Blando, PhD, of Old Dominion University, found delayed declines in peak flow among patients with allergies and asthma at a clinic near the Great Dismal Swamp National Wildlife Refuge.

Wynne Armand, MD, of Massachusetts General Hospital, discussed how smoke may prime allergic responses and drive eczema flares, along with protective steps clinicians can share with patients during smoke events. Investigators caution that wildfire-specific data remain limited compared with the broader urban air pollution literature.

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