BioCryst Presents New HAE Data for ORLADEYO® and Navenibart at EAACI 2026

Key Takeaways

• On June 12, 2026, BioCryst released EAACI poster data covering ORLADEYO clinical and real-world evidence plus a navenibart ALPHA-STAR post hoc analysis.
• In APeX-P children aged 2 to <12 years, median on-demand attack rate fell from 0.691 to 0.169 attacks/month over 48 weeks of ORLADEYO versus a 12-week standard-of-care period.
• Professional-care HAE attacks fell from 22 during 12 weeks of standard care to 3 over 12 weeks of ORLADEYO, with zero such attacks in weeks 37–48 of the reported analysis.
• Navenibart ALPHA-STAR (NCT05695248; n=29) showed attack-rate reductions across baseline attack rate, BMI, and age subgroups; Phase 3 ALPHA-ORBIT is NCT06842823.

What did BioCryst disclose at EAACI 2026?

According to BioCryst’s June 12, 2026 GlobeNewswire release, multiple posters featured ORLADEYO real-world and clinical data alongside navenibart ALPHA-STAR subgroup results. An earlier May 27, 2026 wire had previewed seven HAE abstracts (six ORLADEYO, one navenibart) for the Istanbul meeting.

Chief Research and Development Officer Sandeep Menon said the package reinforces BioCryst’s commercial oral prophylaxis franchise while advancing a next-generation long-acting antibody approach. The company framed EAACI as a European specialist venue for both approved and investigational HAE assets.

How did pediatric ORLADEYO perform in APeX-P?

Poster D2.498 updated 48-week data from ongoing APeX-P, described as the largest long-term prophylaxis trial in pediatric HAE patients aged 2 to under 12 years on once-daily ORLADEYO. Participants (n=29) entered one of four body-weight cohorts after a 12-week standard-of-care (SOC) period.

• Median (range) adjusted HAE attack rate requiring on-demand treatment: 0.691 (0–5.03) attacks/month in the SOC period versus 0.169 (0–1.75) during 48 weeks of ORLADEYO.
• Attacks requiring professional care: 22 during 12 weeks of SOC versus 3 over 12 weeks of ORLADEYO, with a trend toward less intensive settings and 0 such attacks in weeks 37–48.
• BioCryst reported no significant safety concerns identified over the 48-week treatment period in this update.

These figures are sponsor-reported congress data, not a completed regulatory review of a new indication claim. Readers should treat them as open-label pediatric evidence pending fuller peer-reviewed publication.

What does the navenibart ALPHA-STAR subgroup analysis show?

Poster D3.438 presented a post hoc analysis of Phase 1b/2 ALPHA-STAR. Per ClinicalTrials.gov NCT05695248, ALPHA-STAR is a completed multicenter, dose-ranging, open-label study of navenibart (formerly STAR-0215) in adults with type I or II HAE; 29 participants received drug across single- and multiple-dose cohorts.

BioCryst said reductions in overall HAE attack rate were observed across subgroups defined by baseline attack rate, body mass index (BMI), and age, with fewer moderate or severe attacks and less on-demand medication use in the analyzed subgroups. The company reiterated prior ALPHA-STAR tolerability messaging: no severe or serious treatment-emergent adverse events in the earlier readout, with common events including headache, nasopharyngitis, and urinary tract infection, and few injection-site reactions.

BioCryst stated the analysis supports ongoing Phase 3 evaluation in ALPHA-ORBIT (NCT06842823). Navenibart is described as an investigational YTE-modified monoclonal antibody plasma kallikrein inhibitor with potential every-3- or every-6-month dosing; it is not approved.

How is ORLADEYO positioned in Europe?

ORLADEYO (berotralstat) is an oral plasma kallikrein inhibitor. The EMA Orladeyo EPAR states EU authorisation from 30 April 2021 for routine prevention of recurrent HAE attacks in patients aged 12 years and older, with a recommended 150 mg capsule once daily with food. In the main EU study cited by EMA, patients on 150 mg daily for 24 weeks had an average of 1.3 attacks per month versus 2.4 on placebo.

U.S. labeling described in BioCryst’s wire positions ORLADEYO for prophylaxis in adults and pediatric patients 2 years and older, with a limitation that it is not for acute attack treatment. EU and U.S. age ranges differ; analysts should not collapse them when comparing pediatric posters with the EU SmPC.

What real-world ORLADEYO posters were listed?

Beyond APeX-P, BioCryst listed real-world evidence posters on Japan adult characterisation and outcomes (D1.407), switches from other long-term prophylaxis in C1-INH deficiency (D2.360) and normal C1-INH HAE (D2.357), adolescent healthcare-resource utilisation (D2.361), and attack frequency/severity on berotralstat prophylaxis (D3.324). The company said those RWE packages show sustained attack reductions, lower resource use, and high patient satisfaction in routine practice, including switchers.

Real-world designs cannot match randomised controlled trial internal validity. Competitive intelligence teams should treat RWE as practice-facing signals, not pivotal efficacy replacements.

What remains unproven after EAACI 2026?

ALPHA-STAR subgroup findings are post hoc in a small open-label Phase 1b/2 sample; BioCryst itself noted limited generalisability. Phase 3 ALPHA-ORBIT outcomes are not yet reported in the June 12 release. APeX-P remains an ongoing open-label pediatric study; the 48-week attack-rate deltas are sponsor congress numbers, not independent adjudication summaries published here.

Navenibart dosing every 3 or 6 months remains a development hypothesis. No EAACI abstract in the cited wire establishes comparative superiority versus injectable kallikrein or factor XII pathway prophylactics head-to-head.

Related NovaPharma coverage

• European navenibart deal analysis
• BioCryst European navenibart licensing deal
• ORLADEYO real-world HAE evidence

Frequently Asked Questions

Primary Sources

1. BioCryst EAACI 2026 data — GlobeNewswire, June 12, 2026
2. EMA Orladeyo (berotralstat) EPAR
3. ALPHA-STAR — ClinicalTrials.gov NCT05695248
4. ALPHA-ORBIT — ClinicalTrials.gov NCT06842823