BioCryst to Present New HAE Data from ORLADEYO® (berotralstat) and Navenibart at the 2026 European Academy of Allergy and Clinical Immunology Annual Meeting

RESEARCH TRIANGLE PARK, N.C., May 27, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present seven abstracts from its hereditary angioedema (HAE) portfolio at the Annual Meeting of the European Academy of Allergy and Clinical Immunology (EAACI) taking place in Istanbul, Turkey, from June 12-15, 2026.

Data include six abstracts featuring new clinical trial and real-world outcomes with ORLADEYO^® (berotralstat), the first and only targeted oral prophylactic therapy for patients with HAE aged 2 and older, and one abstract featuring clinical trial outcomes with navenibart, a long-acting, monoclonal antibody plasma kallikrein inhibitor being investigated for prophylaxis to prevent attacks of HAE.

BioCryst poster presentations include:

Real-World Patient Characterization, Prior Long-Term Prophylactic Prescribing Patterns, and Treatment Outcomes for Adults on Berotralstat with Hereditary Angioedema in Japan; poster D1.407; Friday, June 12, 12:00–13:00 p.m. (TRT)
Berotralstat Decreased HAE Attacks Treated with On-Demand Therapy or Utilising Professional Care in Paediatric Patients Aged 2 to <12 years: APeX-P Results Through 48 Weeks; poster D2.498; Saturday, June 13, 12:00–13:00 p.m. (TRT)
Reductions in Hereditary Angioedema Attacks among Patients with C1 Esterase Inhibitor Deficiency Who Switched from Another Long-Term Prophylaxis to Berotralstat; poster D2.360; Saturday, June 13, 12:00–13:00 p.m. (TRT)
Hereditary Angioedema Attack Rates among Patients with Normal C1 Esterase Inhibitor Before and After Switching from Another Long-Term Prophylaxis to Berotralstat; poster D2.357; Saturday, June 13, 12:00–13:00 p.m. (TRT)
Reductions in Healthcare Resource Utilization in Adolescents with Hereditary Angioedema on Berotralstat; poster D2.361; Saturday, June 13, 12:00–13:00 p.m. (TRT)
Clinical Outcomes with Navenibart According to Baseline Attack Rate, Body Mass Index, and Age: Results of the ALPHA-STAR Trial; poster D3.438; Sunday, June 14, 12:15–13:15 p.m. (TRT)
Hereditary Angioedema Attack Frequency and Severity According to Individuals Taking Berotralstat for Long-Term Prophylaxis; poster D3.324; Sunday, June 14, 12:15–13:15 p.m. (TRT)

Visit www.ORLADEYO.com for more information.

About ORLADEYO^® (berotralstat)
ORLADEYO^® (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older. One dose of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.

About navenibart
Navenibart is an investigational YTE-modified monoclonal antibody inhibitor of plasma kallikrein, an established and safe mechanism, currently being evaluated in clinical trials for long-term prevention of HAE attacks with potential best-in-class dosing every 3 or 6 months.

U.S. Indication and Important Safety Information

INDICATION
ORLADEYO^® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 2 years and older.

Limitations of use
The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or doses of ORLADEYO higher than the prescribed once-daily dose are not recommended due to the potential for QTc interval prolongation.

IMPORTANT SAFETY INFORMATION
An increase in QTc interval was observed in adults at dosages higher than 150 mg once daily and was concentration dependent.

The most common adverse reactions (≥10%) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.

In adult and pediatric patients aged 12 years and older with moderate or severe hepatic impairment (Child-Pugh B or C), the recommended dosage of ORLADEYO capsules is 110 mg once daily with food. In pediatric patients aged 2 to <12 years with moderate or severe hepatic impairment (Child-Pugh B or C), avoid use of ORLADEYO.

Berotralstat is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein. P-gp inducers may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. Avoid concomitant use of P-gp inducers with ORLADEYO.

ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. Concomitant use of ORLADEYO with CYP2D6 or CYP3A4 substrates can increase exposure of the CYP2D6 or CYP3A4 substrates and may increase the risk of adverse reactions associated with the substrates. If ORLADEYO is concomitantly used with CYP2D6 or CYP3A4 substrates where minimal increases in the concentration of the substrates may lead to serious adverse reactions, closely monitor or modify the dosage of the CYP2D6 or CYP3A4 substrate.

The safety and effectiveness of ORLADEYO in pediatric patients <2 years of age have not been established.

There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.

To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About BioCryst Pharmaceuticals
BioCryst is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (“HAE”) and other rare diseases, driven by its deep commitment to improving the lives of people living with these conditions. BioCryst has commercialized ORLADEYO^® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of potential first-in-class or best-in-class oral small-molecule and injectable protein therapeutics for a range of rare diseases. For more information, please visit www.biocryst.com or follow us on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding new clinical trial and real-world outcomes with respect to BioCryst’s HAE portfolio and the potential dosing profile and competitive positioning of navenibart. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: risks related to the development and interpretation of clinical and real-world data; BioCryst’s ability to successfully progress its development plans for navenibart; the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results; ongoing and future clinical development of product candidates, including navenibart, may take longer than expected and may not have positive results; the FDA or other applicable regulatory agencies may require additional studies beyond the studies planned for navenibart, may not provide regulatory clearances which may result in delay of planned clinical trials, may not review regulatory filings on our expected timeline, may impose certain restrictions, warnings, or other requirements, may impose a clinical hold, or may withhold, delay or withdraw market approval, may ultimately determine that there are deficiencies in the development program or execution thereof, may require additional information or studies, may disagree with our safety and efficacy conclusions, or may impose certain restrictions, warnings, or other requirements; and risks related to the expected dosing or best-in-class profile of navenibart. This list is not exclusive. To see a more comprehensive set of risks, please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in BioCryst’s forward-looking statements.

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