BioCryst to Present New HAE Data from ORLADEYO® (berotralstat) and Navenibart at the 2026 American Academy of Allergy, Asthma & Immunology Annual Meeting
MWN-AI** Summary
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) has announced an upcoming presentation of nine abstracts related to its hereditary angioedema (HAE) portfolio at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, scheduled for February 27-March 2, 2026. This significant event will feature new clinical trial and real-world data on BioCryst's ORLADEYO® (berotralstat), the first oral prophylactic therapy designed for individuals aged two and older suffering from HAE. Additionally, findings on navenibart, an emerging monoclonal antibody plasma kallikrein inhibitor aimed at preventing HAE attacks, will also be presented.
Among the highlights is a late-breaking presentation of interim results from the ALPHA-SOLAR trial, showcasing the long-term efficacy of navenibart with a dosing schedule of either every three or six months. Charlie Gayer, CEO of BioCryst, emphasized the company's commitment to developing diverse treatment options tailored to the needs of patients and their healthcare teams.
The abstracts will encompass various aspects of treatment impacts, notably including a pediatric-focused study indicating that ORLADEYO effectively decreases moderate and severe attack rates in children aged 2 to 12 over a 48-week period. Other data will explore medication routines, real-world attack rate reductions, and healthcare utilization before and after initiating treatment with berotralstat.
In total, BioCryst will present eight posters on February 27 and unveil the late-breaking abstract on March 1, 2026. The findings underscore BioCryst’s robust commitment to addressing the complexities of HAE and align with its broader strategy in pharmaceutical innovation aimed at improving patient care.
For more information on BioCryst’s initiatives and updates, individuals can visit www.biocryst.com.
MWN-AI** Analysis
BioCryst Pharmaceuticals (Nasdaq: BCRX) is poised to attract significant investor interest following its presentation of key data on ORLADEYO® (berotralstat) and navenibart at the upcoming 2026 AAAAI Annual Meeting. As the first oral therapy for prophylaxis against hereditary angioedema (HAE), the efficacy and real-world outcomes reported from those studies could strengthen ORLADEYO's market position, particularly for pediatric indications.
The company will showcase critical clinical trial results highlighting ORLADEYO’s capability to significantly reduce both the frequency of HAE attacks and the associated healthcare resource utilization, particularly in younger populations. This pediatric-focused data could attract not only patients but also healthcare providers and payers, potentially increasing acceptance and prescribing rates.
In addition to ORLADEYO, the information regarding navenibart, a long-acting monoclonal antibody, is crucial. With interim results showcasing robust attack suppression when administered every three or six months, the data could address a significant unmet need for long-term prophylactic treatments in HAE, setting navenibart on a path to potentially outperform competing therapies.
Investors should closely watch the market's reaction to BioCryst's presentations, especially the late-breaking abstract on navenibart's sustained efficacy. Positive outcomes could lead to a surge in stock price, given that the competitive landscape for rare disease therapies is often determined by clinical efficacy and differentiated dosing schedules.
However, despite the promising data, investors should remain cautious due to inherent clinical trial uncertainties and regulatory hurdles. A comprehensive review of data and market comparisons against competitors should guide investment decisions. Overall, BioCryst represents a compelling opportunity with its innovative approach to treating HAE, yet it is imperative to consider the potential risks involved in such biotech investments.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
RESEARCH TRIANGLE PARK, N.C., Feb. 11, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present nine abstracts from its hereditary angioedema (HAE) portfolio at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting taking place in Philadelphia from February 27-March 2, 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 three abstracts featuring new clinical trial outcomes with navenibart, a long-acting, monoclonal antibody plasma kallikrein inhibitor being investigated for prophylaxis to prevent attacks of HAE. These data include a late-breaking presentation highlighting positive interim results of the long-term, open-label ALPHA-SOLAR trial showing sustained, robust HAE attack suppression with navenibart administered every 3 or 6 months.
“The breadth of data to be presented at AAAAI, including a late-breaking abstract, reflect the continued evolution of our strategy to expand and diversify our HAE portfolio in ways that matter to patients and their care teams,” said Charlie Gayer, Chief Executive Officer of BioCryst. “From advancing programs like navenibart to the launch of an expanded pediatric indication for ORLADEYO, we are focused on delivering meaningful treatment options that align with individual patient needs, preferences, and lifestyles, supported by rigorous and innovative clinical evidence.”
BioCryst will present the following eight posters on Friday, February 27, 2026, from 2:45 – 3:45 p.m. ?EST? at the Convention Center, Level 2, Hall E:
- Oral Berotralstat Reduces the Rate of Moderate and Severe Attacks and Percentage of Days with HAE Symptoms Over 48 Weeks in Children Aged 2 to Less Than 12 Years: Interim Data from APeX-P; Poster #114
- Medication Routines Among Patients with Hereditary Angioedema; Poster #071
- Impact of Berotralstat on Hereditary Angioedema Attack Rates in Patients with C1-Inhibitor Deficiency: Real-World Evidence Stratified by Prior Long-Term Prophylaxis; Poster #042
- Real-World Attack Rate Reductions After Berotralstat Initiation Among Patients with Hereditary Angioedema with Normal C1-Inhibitor Stratified by Prior Long-?Term Prophylaxis; Poster #047
- Reductions in Healthcare Resource Utilization Among Patients with Hereditary Angioedema with C1-Inhibitor Deficiency Following the Initiation of Berotralstat; Poster #046
- Impact of Berotralstat on Healthcare Resource Utilization in Patients with Hereditary Angioedema with Normal C1-Inhibitor; Poster #004
- Navenibart Demonstrates Durable Efficacy and Tolerability Across Biological Sexes: Subgroup Analysis from the ALPHA-STAR Trial; Poster #L060
- Navenibart Delays Time to First Attack in Hereditary Angioedema: Results from ALPHA-STAR; Poster #L041
BioCryst will present the following late-breaking abstract on Sunday, March 1, 2026, from 9:45 – 10:45 a.m. EST at the Convention Center, Level 2, Hall E:
- Long-Term, Sustained, Robust Hereditary Angioedema Attack Suppression with Navenibart Administered Every 3 and 6 Months: ALPHA-SOLAR Interim Results; Poster #L59
The abstracts are available to view in an online supplement to The Journal of Allergy and Clinical Immunology (JACI) at jacionline.org.
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 BioCryst’s expectations relating to its HAE portfolio. 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: BioCryst’s ability to successfully implement or maintain its commercialization plans for ORLADEYO; 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; risks related to government actions, including that decisions and other actions may not be taken when expected or at all, or that the outcomes of such decisions and other actions may not be in line with BioCryst’s current expectations; ongoing and future clinical development of product candidates, including navenibart, may take longer than expected and may not have positive results; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates, including navenibart, as expected; the FDA or other applicable regulatory agencies may require additional studies beyond the studies planned for products and product candidates, 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 on products and product candidates, may impose a clinical hold with respect to product candidates, or may withhold, delay or withdraw market approval for products and product candidates, 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; product candidates, if approved, may not achieve market acceptance; BioCryst’s ability to successfully commercialize its products and product candidates. 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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Contact:
Investors:
investorrelations@biocryst.com
Media:
media@biocryst.com
FAQ**
How might the success of the abstracts presented by BioCryst Pharmaceuticals Inc. (BCRX) at the AAAAI Annual Meeting impact the company's stock performance in 2026 and beyond?
What potential market growth opportunities could arise for BioCryst Pharmaceuticals Inc. (BCRX) with its expanded pediatric indication for ORLADEYO®?
Considering the clinical evidence presented, how could the introduction of navenibart enhance BioCryst Pharmaceuticals Inc. (BCRX)'s competitive positioning in the HAE treatment market?
What risks should investors consider regarding BioCryst Pharmaceuticals Inc. (BCRX) as it advances its clinical trials for navenibart, especially in light of regulatory uncertainties?
**MWN-AI FAQ is based on asking OpenAI questions about BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX).
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