BioCryst to Present New HAE Data from ORLADEYO® (berotralstat) and Navenibart at the 2026 American Academy of Allergy, Asthma & Immunology Annual Meeting

Rhea-AI Summary

BioCryst (NASDAQ:BCRX) will present nine HAE abstracts at the 2026 AAAAI Annual Meeting (Feb 27–Mar 2, 2026) including six on ORLADEYO (berotralstat) and three on navenibart.

Key data include pediatric interim APeX-P results in children 2 to <12 years and a late‑breaking ALPHA‑SOLAR interim showing sustained attack suppression with navenibart every 3 or 6 months.

Positive

• Nine abstracts across ORLADEYO and navenibart presented at AAAAI 2026
• Six ORLADEYO abstracts include pediatric interim APeX‑P data through 48 weeks
• Late‑breaking ALPHA‑SOLAR interim shows sustained HAE attack suppression with navenibart dosed every 3 or 6 months

Negative

• Interim data only for ALPHA‑SOLAR and APeX‑P, not final long‑term readouts

News Market Reaction

+4.43%

5 alerts

+4.43% News Effect

+$73M Valuation Impact

$1.71B Market Cap

0.4x Rel. Volume

On the day this news was published, BCRX gained 4.43%, reflecting a moderate positive market reaction. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $73M to the company's valuation, bringing the market cap to $1.71B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Total abstracts: 9 abstracts ORLADEYO abstracts: 6 abstracts Navenibart abstracts: 3 abstracts +5 more

8 metrics

Total abstracts 9 abstracts HAE portfolio presentations at 2026 AAAAI Annual Meeting

ORLADEYO abstracts 6 abstracts New clinical trial and real-world outcomes with ORLADEYO

Navenibart abstracts 3 abstracts New clinical trial outcomes with navenibart

Pediatric age range Aged 2 and older ORLADEYO prophylactic therapy indicated for HAE patients

Navenibart dosing interval Every 3 or 6 months ALPHA-SOLAR interim results dosing schedule

AAAAI meeting dates Feb 27–Mar 2, 2026 Conference timing for HAE data presentations

Poster session time 2:45–3:45 p.m. EST Friday, February 27, 2026 ORLADEYO and navenibart posters

Late-breaking session time 9:45–10:45 a.m. EST Sunday, March 1, 2026 ALPHA-SOLAR interim results poster

Market Reality Check

Price: $6.76 Vol: Volume 4,636,877 is broad...

normal vol

$6.76 Last Close

Volume Volume 4,636,877 is broadly in line with 20-day average 4,747,359 (relative volume 0.98). normal

Technical Shares at $6.55 are trading below the 200-day moving average of $8.18 and 42.09% under the 52-week high.

Peers on Argus

BCRX gained 3.97% while peers were mixed: BGM jumped 19.82%, HROW rose slightly,...

BCRX gained 3.97% while peers were mixed: BGM jumped 19.82%, HROW rose slightly, and AVDL, PAHC, AMPH declined. This pattern points to a stock‑specific move rather than a broad sector rotation.

Historical Context

5 past events · Latest: Feb 05 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 05	Earnings date notice	Neutral	-2.8%	Announcement of Q4 2025 earnings release date and conference call details.
Feb 05	Inducement grants	Neutral	-2.8%	Inducement stock options and RSUs granted to new employees under Nasdaq rules.
Jan 23	M&A acquisition	Positive	+0.6%	Completion of Astria Therapeutics acquisition, adding navenibart to HAE franchise.
Jan 12	Revenue update	Positive	-4.2%	Preliminary 2025 ORLADEYO revenue beat prior guidance with strong growth metrics.
Jan 06	Inducement grant	Neutral	+2.3%	RSU grant to a new hire as inducement equity with multi‑year vesting schedule.

Pattern Detected

Recent history shows mixed reactions, including a selloff after a strong ORLADEYO revenue beat and only modest upside on acquisition news, suggesting investors sometimes fade positive catalysts.

Recent Company History

Over the past months, BioCryst has focused on strengthening its hereditary angioedema franchise. On Jan 12, 2026, it reported preliminary $601M 2025 ORLADEYO revenue, up 37% year-over-year and above guidance, yet the stock fell. The company then moved to acquire Astria Therapeutics, adding navenibart to its HAE portfolio, financed partly through a new loan facility and share issuance. More recently, news has included inducement equity grants and an upcoming Q4 2025 earnings date. Today’s AAAAI data announcement fits this ongoing HAE-focused expansion.

Market Pulse Summary

This announcement highlights BioCryst’s effort to expand and diversify its hereditary angioedema por...

Analysis

This announcement highlights BioCryst’s effort to expand and diversify its hereditary angioedema portfolio, with 9 abstracts at AAAAI covering both ORLADEYO and navenibart. Recent history shows strong ORLADEYO revenue growth and the addition of navenibart via the Astria acquisition, reinforcing an HAE-focused strategy. Investors may watch for detailed efficacy and durability signals from ALPHA-STAR and ALPHA-SOLAR, as well as future revenue and expense trends, to gauge how effectively these scientific milestones translate into commercial performance.

Key Terms

hereditary angioedema, monoclonal antibody, plasma kallikrein inhibitor, prophylaxis, +4 more

8 terms

hereditary angioedema medical

"present nine abstracts from its hereditary angioedema (HAE) portfolio at the 2026"

A rare inherited disorder that causes sudden, painful swelling under the skin or in internal tissues, including the airway, because a natural blood‑control protein is missing or not working. Attacks can be unpredictable and sometimes life‑threatening, so people often need ongoing medication or emergency treatment. For investors, hereditary angioedema represents a niche but stable market for specialized therapies, diagnostics, and emergency care solutions.

monoclonal antibody medical

"navenibart, a long-acting, monoclonal antibody plasma kallikrein inhibitor being"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

plasma kallikrein inhibitor medical

"monoclonal antibody plasma kallikrein inhibitor being investigated for prophylaxis"

A plasma kallikrein inhibitor is a drug that blocks a specific blood protein (plasma kallikrein) involved in processes like swelling, inflammation, and leaking blood vessels; think of it as turning off a faucet that fuels sudden internal swelling. For investors, these drugs matter because their ability to prevent or treat conditions driven by that protein — and their safety, regulatory approval, and market alternatives — strongly affect potential sales, development costs, and competitive value.

prophylaxis medical

"inhibitor being investigated for prophylaxis to prevent attacks of HAE."

Prophylaxis is a medical prevention strategy — a drug, vaccine, device, or procedure given to stop a disease or condition before it starts. For investors, prophylactic products matter because they can create steady, large markets and reduce long‑term healthcare costs; regulatory approval or broader adoption can change demand forecasts much like a new safety feature that becomes standard across an entire industry.

open-label medical

"interim results of the long-term, open-label ALPHA-SOLAR trial showing sustained"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

real-world evidence medical

"Impact of Berotralstat on Hereditary Angioedema Attack Rates ... Real-World Evidence"

Real-world evidence is information gathered from everyday sources like patient records, insurance claims, or everyday experiences, rather than controlled experiments or clinical trials. It helps investors understand how products or policies perform in real life, providing a more complete picture of their effectiveness and value beyond official tests. This type of evidence can influence decision-making by offering insights based on actual, everyday outcomes.

long-acting medical

"navenibart, a long-acting, monoclonal antibody plasma kallikrein inhibitor"

A long-acting product is a drug or treatment designed to work for an extended period after a single dose, reducing how often it must be taken or administered. For investors, longer-lasting therapies can increase patient convenience and adherence, lower treatment costs over time, and create competitive advantages or pricing power—similar to a single charge lasting days instead of hours—potentially boosting market demand and revenue predictability.

late-breaking abstract technical

"The breadth of data to be presented at AAAAI, including a late-breaking abstract,"

A late-breaking abstract is a short summary of new clinical or scientific data submitted and accepted for presentation at a medical or scientific conference after the usual submission deadline. Investors watch these because they often contain fresh, potentially market-moving results—like seeing the final score of a game released just before kickoff—so they can change expectations about a drug’s safety, effectiveness, or commercial prospects.

AI-generated analysis. Not financial advice.

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.

BCRXW

Contact:

Investors:
investorrelations@biocryst.com 

Media:
media@biocryst.com 

FAQ

What HAE data will BioCryst (BCRX) present at AAAAI 2026?

BioCryst will present nine abstracts on HAE, six for ORLADEYO and three for navenibart. According to BioCryst, presentations include pediatric APeX‑P interim data and a late‑breaking ALPHA‑SOLAR interim on long‑term navenibart efficacy.

What did the ALPHA‑SOLAR interim results for navenibart show for BCRX?

The ALPHA‑SOLAR interim showed sustained, robust suppression of HAE attacks with navenibart every 3 or 6 months. According to BioCryst, this was presented as a late‑breaking abstract at AAAAI 2026.

What pediatric ORLADEYO (berotralstat) data will BCRX share at the meeting?

BioCryst will present interim APeX‑P data showing reductions in moderate and severe attacks and symptomatic days in children aged 2 to less than 12 years through 48 weeks. According to BioCryst, this is an interim analysis.

When and where will BioCryst present its AAAAI 2026 posters for BCRX?

BioCryst will present several posters on Friday, February 27, 2026, 2:45–3:45 p.m. EST, Level 2, Hall E, and a late‑breaking abstract on Sunday, March 1, 2026, 9:45–10:45 a.m. EST. According to BioCryst, details are in the JACI supplement.

How should investors interpret the BCRX ALPHA‑SOLAR and APeX‑P findings?

These are interim clinical and real‑world data indicating efficacy signals but not final outcomes. According to BioCryst, the presentations report sustained attack reductions and real‑world ORLADEYO results, requiring confirmation in final analyses.