American Capital Management Inc. cut its stake in Haemonetics Corporation (NYSE:HAE – Free Report) by 10.1% during the first quarter, according to its most recent 13F filing with the Securities and Exchange Commission. The firm owned 66,915 shares of the medical instruments supplier’s stock after selling 7,500 shares during the quarter. American Capital Management Inc. owned about 0.14% of Haemonetics worth $3,771,000 at the end of the most recent quarter.
A number of other institutional investors and hedge funds have also made changes to their positions in the stock. MIRAE ASSET GLOBAL ETFS HOLDINGS Ltd. lifted its stake in shares of Haemonetics by 3.4% during the 1st quarter. MIRAE ASSET GLOBAL ETFS HOLDINGS Ltd. now owns 29,541 shares of the medical instruments supplier’s stock worth $1,877,000 after purchasing an additional 971 shares during the last quarter. Caxton Associates LLP bought a new stake in Haemonetics during the first quarter valued at about $216,000. United Services Automobile Association purchased a new position in Haemonetics in the first quarter valued at about $212,000. Empowered Funds LLC grew its stake in Haemonetics by 9.1% in the first quarter. Empowered Funds LLC now owns 4,458 shares of the medical instruments supplier’s stock valued at $283,000 after purchasing an additional 372 shares during the last quarter. Finally, UBS AM A Distinct Business Unit of UBS Asset Management Americas LLC raised its holdings in Haemonetics by 6.2% in the first quarter. UBS AM A Distinct Business Unit of UBS Asset Management Americas LLC now owns 156,138 shares of the medical instruments supplier’s stock worth $9,923,000 after purchasing an additional 9,051 shares in the last quarter. 99.67% of the stock is currently owned by hedge funds and other institutional investors.
Haemonetics Stock Up 1.6% HAE stock opened at $80.06 on Tuesday. The firm has a 50 day moving average of $73.21 and a 200 day moving average of $66.04. The stock has a market capitalization of $3.64 billion, a PE ratio of 39.64, a price-to-earnings-growth ratio of 1.59 and a beta of 0.52. The company has a quick ratio of 1.87, a current ratio of 2.95 and a debt-to-equity ratio of 1.53. Haemonetics Corporation has a 52 week low of $47.31 and a 52 week high of $87.32.
Haemonetics (NYSE:HAE – Get Free Report) last released its earnings results on Thursday, May 7th. The medical instruments supplier reported $1.29 earnings per share for the quarter, topping the consensus estimate of $1.28 by $0.01. Haemonetics had a net margin of 7.29% and a return on equity of 27.30%. The company had revenue of $346.35 million for the quarter, compared to the consensus estimate of $336.83 million. During the same quarter in the previous year, the firm earned $1.24 EPS. Haemonetics’s revenue was up 4.8% compared to the same quarter last year. Haemonetics has set its FY 2027 guidance at 5.258-5.307 EPS. Sell-side analysts forecast that Haemonetics Corporation will post 5.21 earnings per share for the current year.
Analyst Upgrades and Downgrades Several analysts have commented on HAE shares. JPMorgan Chase & Co. decreased their price target on shares of Haemonetics from $74.00 to $62.00 and set a “neutral” rating for the company in a research report on Friday, May 8th. Bank of America raised shares of Haemonetics from a “neutral” rating to a “buy” rating and lifted their price objective for the stock from $72.00 to $80.00 in a research report on Friday, May 22nd. Weiss Ratings upgraded shares of Haemonetics from a “sell (d+)” rating to a “hold (c-)” rating in a research note on Thursday, June 25th. Mizuho increased their target price on shares of Haemonetics from $85.00 to $90.00 and gave the company an “outperform” rating in a research report on Wednesday, July 15th. Finally, Citigroup restated a “neutral” rating on shares of Haemonetics in a research note on Wednesday, July 8th. One analyst has rated the stock with a Strong Buy rating, six have issued a Buy rating and four have given a Hold rating to the company’s stock. Based on data from MarketBeat.com, the company presently has a consensus rating of “Moderate Buy” and an average price target of $78.89.
Read Our Latest Stock Report on Haemonetics
Haemonetics Profile (Free Report)
Haemonetics Corporation is a global provider of blood management solutions that support the collection, processing and transfusion of blood and blood products. The company’s offerings are designed to enhance patient safety and operational efficiency for blood centers, hospitals and plasma collection facilities. Haemonetics serves healthcare providers worldwide by delivering integrated systems, software and consumables that address critical needs throughout the continuum of blood management.
The company’s product portfolio includes automated apheresis and plasma collection systems, surgical blood salvage and coagulation monitoring devices, and pathogen reduction technologies.
See Also Five stocks we like better than Haemonetics AirJoule’s Kubota Deal Is a Major Validation—But the Hard Part Comes Next Dividend Stocks May Be the Quiet Rotation Trade Investors Are Missing Now Refiner Stocks Are Near Record Highs—Can Iran-Driven Margins Keep Them There? Verizon May Be an AI Infrastructure Stock Hiding in Plain Sight Want to see what other hedge funds are holding HAE? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Haemonetics Corporation (NYSE:HAE – Free Report).
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CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year Full data to be presented at upcoming scientific congress , /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced positive top-line Phase 3b results evaluating ANDEMBRY® (garadacimab-gxii) in children aged 2 to 11 years with hereditary angioedema (HAE). ANDEMBRY is approved in over 40 countries for the prevention of HAE attacks in adult and pediatric patients aged 12 years and older.
In this multicenter, open-label Phase 3b study evaluating ANDEMBRY in people living with HAE aged 2 to 11 years, ANDEMBRY demonstrated a favorable safety and tolerability profile consistent with previous studies. Treatment response was observed across the study population, with the majority of participants remaining attack-free during the 12-month treatment period. Participants aged 6 to 11 years (n = 16) received 100 mg of ANDEMBRY once monthly, while participants aged 2 to 5 years (n = 6) received 100 mg of ANDEMBRY every two months.
ANDEMBRY is a monoclonal antibody that targets factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE. By acting at the top of the HAE cascade, ANDEMBRY prevents attacks and represents a novel long-term prophylactic strategy.
"The top-line results support our plans to seek an expanded pediatric indication for ANDEMBRY in children aged 2 to 11 years," said Dr. Bill Mezzanotte, Executive Vice President, Head of R&D, CSL. "We are excited to share the full study findings with the scientific and patient communities at an upcoming medical congress and remain committed to advancing treatment options for people living with hereditary angioedema."
CSL plans to begin submitting filings to health authorities in the first half of the company's fiscal year to support an expanded pediatric indication for ANDEMBRY in children aged 2 to 11 years. Full study results will be presented at an upcoming scientific congress and submitted for publication in a peer-reviewed journal.
About Hereditary Angioedema (HAE)
HAE is a rare and potentially life-threatening genetic condition that occurs in about 1 in 10,000 to 1 in 50,000 people. HAE is caused by deficient or dysfunctional C1 esterase inhibitor (C1INH), a protein in the blood that helps to control inflammation. Inadequate amounts of properly functioning C1INH can lead to the accumulation of fluid in body tissues, causing considerable swelling referred to as angioedema. HAE attacks can affect many parts of the body, including the face, abdomen, larynx, and extremities. Patients who have abdominal attacks of HAE can experience extreme pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in airway closure, asphyxiation and, if left untreated, death.
About ANDEMBRY
ANDEMBRY is a novel monoclonal antibody inhibiting factor XIIa (anti-FXIIa mAb) that has completed the Phase 3 pivotal study as a once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. It was discovered and optimized by scientists at CSL's Bio21-based research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. ANDEMBRY uniquely inhibits the plasma protein, FXIIa. FXII is the first protein activated in the HAE pathway, initiating the inflammatory bradykinin-producing kallikrein-kinin system. By targeting activated FXII (FXIIa), ANDEMBRY inhibits this cascade at the top as compared to other HAE therapies that target downstream mediators.
IMPORTANT SAFETY INFORMATION
What are the possible side effects of ANDEMBRY?
The most common side effects of ANDEMBRY include:
Redness, itchiness, and bruising (injection-site reactions) Stomach (abdominal) pain Runny or stuffy nose, sneezing, watery eyes (nasopharyngitis) What is ANDEMBRY?
ANDEMBRY® (garadacimab-gxii) injection, for subcutaneous use, is a prescription medication used to prevent attacks of hereditary angioedema (HAE) in people 12 years and older.
It is not known if ANDEMBRY is safe and effective in children under 12 years of age.
What should I tell my healthcare provider before using ANDEMBRY?
Before using ANDEMBRY, tell your healthcare provider about any medical condition you may have, especially if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if ANDEMBRY can harm your unborn baby or if ANDEMBRY passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while using ANDEMBRY.
Tell your healthcare provider about all medications you take, including prescription medicines, over-the-counter treatments, vitamins, and herbal supplements.
How should I use ANDEMBRY?
Use ANDEMBRY exactly as instructed by your healthcare provider. Detailed instructions for use can be found in the patient information section of the full prescribing information.
ANDEMBRY is given as an injection under your skin (subcutaneous) by you or a caregiver. Your healthcare provider should show you or your caregiver how to prepare and inject your dose of ANDEMBRY before you inject yourself for the first time. Do not try to inject ANDEMBRY unless you have been trained by your healthcare provider.
Please see full prescribing information for ANDEMBRY,
including patient information and instructions for use.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958.
About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a leading global biopharma company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 29,000+ people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSL.com/Vita.
, /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that the Company intends to publish first quarter fiscal year 2027 financial results at 6:00 am ET on Thursday, August 6, 2026. The Company will hold a conference call with investors and analysts to discuss results and answer questions at 8:00 am ET on August 6, 2026.
The call can be accessed via teleconference at: Q1 2027 Haemonetics Corporation Earnings Conference Call. Once registration is completed, participants will receive a dial-in number along with a personalized PIN to access the call. While not required, it is recommended that participants join 10 minutes prior to the event start.
A live webcast of the call can be accessed on Haemonetics' investor relations website. Webcast Link: https://edge.media-server.com/mmc/p/r8e9tnfy
A replay of the conference call and webcast will be available for one year beginning on August 6, 2026 at 11:00 am ET using the conference call webcast link provided in this press release.
ABOUT HAEMONETICS
Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our Apheresis business features proprietary technologies designed to enhance safety, yield, donor satisfaction and operational efficiency for plasma and blood collectors around the world. Our MedSurg business offers Blood Management Technologies to help inform treatment decisions and optimize the management of blood products, and Interventional Technologies, including advanced vascular closure systems and sensor-guided technologies, designed to drive procedural effectiveness and elevate the patient experience. To learn more about Haemonetics, visit www.haemonetics.com.
Investor Contacts
Olga Guyette, VP - Investor Relations & Treasury
David Trenk, Senior Manager - Investor Relations
(781) 356-9763
(203) 733-4987
[email protected]
[email protected]
Media Contact
Josh Gitelson, Senior Director - Global Communications
Key Takeaways Haemonetics' Plasma franchise returned to growth, with fiscal Q4 revenues rising 3% to $130 million. HAE's NexSys PCS system is seeing strong uptake and is expected to support future growth. Haemonetics faces concerns from $1.22B in long-term debt and intense manual and automated competition. Haemonetics Corporation’s (HAE - Free Report) impressive Plasma franchise is poised to drive growth in the upcoming quarters. The robust uptake of the NexSys PCS system bodes well for its long-term growth. However, a debt-burdened balance sheet and fierce competitive pressure remain concerns for HAE’s operations.
In the past year, this Zacks Rank #3 (Hold) company’s shares have lost 2.4% compared with the industry’s decline of 29.5%. The S&P 500 composite has grown 22.8% in the same time frame.
The global provider of blood and plasma supplies and services has a market capitalization of $2.82 billion. HAE beat on earnings in each of the trailing four quarters, delivering an average surprise of 6.6%.
Let us delve deeper.
Haemonetics’ Key UpsidesPotential Growth Drivers for the Plasma Franchise: Haemonetics’ Plasma business unit focuses on the collection of source plasma for pharmaceutical manufacturers using apheresis devices that only collect plasma. In fiscal 2025, Haemonetics signed new long-term agreements with BioLife and Grifols, reinforcing its continued close partnership and highlighting its ability to bring innovation to plasma collections.
In the fourth quarter of fiscal 2026, the Plasma franchise returned to growth with revenues of $130 million, up 3% on a reported basis and 13% on an organic basis (excluding CSL). Plasma momentum continued with growth driven by category leadership, differentiated innovation, and strong market fundamentals. Its share of U.S. plasma collections grew in the high single digits in fiscal 2026, along with double-digit growth in Europe.
NexSys PCS System Continues to Thrive: Haemonetics’ FDA-cleared, NexSys PCS (plasma collection system) is designed to increase plasma yield collections, improve productivity in customers’ centers, enhance the overall donor experience and provide safe and reliable collections that will become life-changing medicines for patients. Haemonetics received 510(k) clearance for the NexSys PCS Plasma Collection System with Persona PLUS technology. The company’s full transition from the PCS2 devices to the latest NexSys with Persona Technology should drive meaningful improvements in the upcoming quarters.
Image Source: Zacks Investment Research
Haemonetics’ Key DownsidesWeak Solvency: Haemonetics exited the fiscal fourth quarter with cash and cash equivalents of $245.4 million and short-term debt & current maturities of $5 million on its balance sheet. The long-term debt at the end of the fiscal fourth quarter was $1.22 billion, indicating a highly leveraged balance sheet. Debt-to-capital ratio was 50.2%, while times interest earned ratio was 5.5 at the quarter’s end, down 5.5 sequentially.
Competitive Landscape: Haemonetics operates in a very competitive environment, both for manual and automated systems. Slower-than-expected product adoption by customers, especially the American Red Cross, might reduce the company’s revenues and profit.
HAE’s Estimate TrendThe Zacks Consensus Estimate for fiscal 2026 earnings has moved south 1 cent to $5.22 per share in the past 30 days.
The Zacks Consensus Estimate for fiscal 2026 revenues is pegged at $1.40 billion, which indicates a 4.9% decrease from the year-ago reported number.
Key PicksSome better-ranked stocks in the broader medical space are Globus Medical (GMED - Free Report) , Integra LifeSciences (IART - Free Report) and Phibro Animal Health (PAHC - Free Report) .
Globus Medical has an earnings yield of 5.5%, well ahead of the industry’s negative 3% yield. Its earnings surpassed estimates in each of the trailing four quarters, the average surprise being 26.3%. The company’s shares have rallied 43.8% against the industry’s 4.8% decline over the past year.
GMED carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Integra LifeSciences, carrying a Zacks Rank #2 at present, has an earnings yield of 16% against the industry’s negative 3% yield. Shares of the company have gained 22.8% compared with the industry’s 4.8% growth. IART’s earnings topped estimates in each of the trailing four quarters, the average surprise being 16.8%.
Phibro Animal Health, carrying a Zacks Rank #2 at present, has an earnings yield of 9.2% compared with the industry’s 2.8% yield. Shares of the company have climbed 43.1% against the industry’s 27.9% decline. PAHC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 16.3%.
On June 25, 2026, Haemonetics Corp (HAE) shares rose 6.5% today, bringing the current price to $77.62. The stock has experienced a 52-week range between $47.32
BioCryst Pharmaceuticals, Inc. is upgraded to Buy, reflecting strong execution in HAE and a compelling pipeline with Orladeyo and navenibart. BCRX targets $1.8bn in revenues and $1bn in cash by 2033, leveraging best-in-class efficacy and less frequent dosing for navenibart to challenge market incumbents. Recent Q1 results showed 11% YoY Orladeyo revenue growth, robust non-GAAP profitability, and reaffirmed 2026 guidance, suggesting valuation remains attractive.
, /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced the publication of a new study comparing its VASCADE MVP® XL vascular closure system with the VASCADE MVP® venous vascular closure system in the context of large‐bore venous access closure procedures. This study, "VASCADE MVP-XL Versus VASCADE MVP for Large-Bore Venous Access-Site Closure in Electrophysiology Procedures: A Single-Center Experience on Efficacy and Complications," was published earlier this week in the Journal of Cardiovascular Electrophysiology.
The retrospective, non‐randomized, observational single‐center cohort study included a total of 574 consecutive patients undergoing catheter ablation for atrial arrhythmia, or left atrial appendage closure procedures. The study included some procedures in which VASCADE MVP was used outside the scope of its approved indication, which is for use with 6-12F inner diameter procedural sheaths. Results demonstrated VASCADE MVP XL's superior performance in the context of these large‐bore venous access closure procedures, achieving higher procedural success, a more consistent safety profile, and efficient hemostasis without complications, including 0% bleeding complications.
In March 2026, the U.S. Food and Drug Administration (FDA) approved expanded labeling for the VASCADE MVP XL venous vascular closure system to include procedures using 10-14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths. With this label expansion, the VASCADE MVP XL system is approved for larger sheaths used in market-leading technologies for pulsed field ablation (PFA) to treat atrial fibrillation such as Boston Scientific's FARAPULSE® and left atrial appendage closure (LAAC) solutions, including Boston Scientific's WATCHMAN TruSteer®. VASCADE MVP XL is now the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD procedural sheaths.
FDA approval was supported by clinical evidence from the AMBULATE EXPAND trial, a multicenter, prospective, single-arm, pivotal trial designed to evaluate the safety and effectiveness in technologies using 17F maximum OD procedural sheaths. The study results were published in the Journal of Cardiovascular Electrophysiology in March 2026. Additionally, findings from a prospective ultrasound sub‑study involving 31 patients were published in Heart Rhythm O2 yesterday and will be presented at the Heart Rhythm Society's Heart Rhythm 2026 in Chicago on Saturday, April 25, 2026 from 12:00 – 2:00 p.m. CT. This study provided an imaging‑based assessment of the closure site and demonstrated encouraging early vascular findings in a high‑risk, fully anticoagulated population, offering further insight into vascular healing following VASCADE MVP XL deployment.
"The expanded indication for the VASCADE MVP® XL system supports the rapidly evolving electrophysiology landscape, including the adoption of next‑generation PFA and LAAC technologies and the growing number of concomitant procedures," said Jan Hartmann, M.D., Senior Vice President and Chief Medical Officer at Haemonetics. "By enabling reliable venous closure in large‑bore procedures, VASCADE MVP XL helps electrophysiology teams deliver safe, effective care across hospital‑based labs and increasingly time‑ and cost‑conscious outpatient settings, including ambulatory surgery centers."
Clinical data related to the VASCADE MVP XL system will be presented and discussed at HRS 2026, as part of a Haemonetics‑sponsored Rhythm Theater session entitled Efficient Workflows for AF Ablation: New Technologies and Sites of Service, scheduled for Saturday, April 25, 2026, at 10:30 a.m. CT.
About Haemonetics
Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components. To learn more about Haemonetics, visit www.haemonetics.com.
Cautionary Statement Regarding Forward-Looking Information
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for the operation of Haemonetics, including statements regarding potential benefits associated with the expanded labeling of the VASCADE MVP XL venous vascular closure system and Haemonetics' plans or objectives related to the commercialization of such product enhancement. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics' current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, product quality; market acceptance; the effect of economic and political conditions; and the impact of competitive products and pricing. These and other factors are identified and described in more detail in Haemonetics' periodic reports and other filings with the U.S. Securities and Exchange Commission. Haemonetics does not undertake to update these forward-looking statements.
Investor Contacts:
Olga Guyette, Vice President-Investor Relations & Treasury
, /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that Chris Simon, President and CEO, will participate in a fireside chat with investors at the Bank of America 2026 Healthcare Conference on Tuesday, May 12, 2026 at 8:00 a.m. PT.
The public may access a live webcast of the fireside chat at Haemonetics' Investor Relations website or at the following link: https://bofa.veracast.com/webcasts/bofa/healthcare2026/75d0U1.cfm.
A replay of the recorded webcast will become accessible within 24 hours after the event and will be available for one year on Haemonetics' Investor Relations website.
ABOUT HAEMONETICS
Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components. To learn more about Haemonetics, visit www.haemonetics.com.
Investor Contacts:
Olga Guyette, Vice President-Investor Relations & Treasury
Financial release and supplemental presentation accessible online
, /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that financial results for its fourth quarter fiscal year 2026, which ended March 28, 2026, are available on the Company's Investor Relations website at www.haemonetics.com.
The Company will host a conference call and webcast with investors and analysts to discuss and answer questions about the results at 8:00 a.m. ET on May 7, 2026.
Conference Call and Webcast Information:
Registration: Click here to register. Upon registration, participants will receive dial-in details and a personalized PIN. While not required, joining 10 minutes prior to the event start time is recommended. Live webcast: Access here or through the Investor Relations section of the Haemonetics website. A replay of the conference call and webcast will be available beginning at 11:00 a.m. ET on May 7, 2026 and will remain accessible for one year via the webcast link above.
Earnings Materials:
Haemonetics has also posted the following materials on its Investor Relations website, which will be referenced during the conference call and webcast:
Fourth Quarter Fiscal 2026 Earnings Release Fourth Quarter Fiscal 2026 Supplemental Earnings Presentation ABOUT HAEMONETICS
Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components. To learn more about Haemonetics, visit www.haemonetics.com.
Haemonetics (HAE) came out with quarterly earnings of $1.29 per share, beating the Zacks Consensus Estimate of $1.28 per share. This compares to earnings of $1.24 per share a year ago.
Although the revenue and EPS for Haemonetics (HAE) give a sense of how its business performed in the quarter ended March 2026, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.
Matson was the top performer as container shipping rates strengthened amid supply chain disruptions and management executed on operational efficiency initiatives. Revolve Group sold off as the online fashion retailer faced softer consumer demand and lower discretionary spending. We added to Haemonetics Corporation following recent share price volatility.
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Key Takeaways HAE topped Q4 adjusted EPS and revenue estimates; shares gained 1.4% after results. Haemonetics' gross margin slid to 57.2% as COGS rose 7.7%, swinging to a $23.0M operating loss. HAE guided FY27 revenue growth of 4-7% and said adjusted EPS should rise roughly in line with revenues. Haemonetics Corporation (HAE - Free Report) delivered fourth-quarter fiscal 2026 adjusted earnings of $1.29 per share, up 4.0% year over year. The figure beat the Zacks Consensus Estimate by 1.0%.
On a GAAP basis, loss per share was 44 cents compared to earnings of of $1.17 per share in the prior-year quarter.
HAE posted adjusted earnings per share of $4.96 for fiscal 2026, up from $4.57 in fiscal 2025.
HAE’s RevenuesRevenues rose 4.8% from the year-ago period’s level to $346.35 million, topping the Zacks Consensus Estimate by 2.4%.
For fiscal 2026, the company generated total revenues of $1.33 billion, down 2.0% from the prior-year figure.
Strength across the company’s core platforms stood out, with organic revenue growth of 4.5% and organic growth excluding CSL impacts of 8.6%, helping offset continued softness in interventional technologies.
Following the earnings announcement, HAE’s shares rose 1.4% last Friday.
HAE’s Q4 Segmental Details At Plasma, revenues totaled $130.3 million, up 2.8% year over year (up 1.8% on an organic basis). Organic growth, excluding CSL impacts, was 12.7%, reflecting continued momentum in the franchise.
Revenues at Blood Center increased 0.7% to $56.4 million (up 5.5% on an organic basis). The segment’s organic performance reflected the benefit of portfolio-adjusted growth.
Hospital revenues rose 8.0% to $159.6 million (up 6.5% organically).
HAE’s Margin AnalysisIn the fourth quarter of fiscal 2026, gross profit increased 2.7% to $198.2 million. Gross margin contracted 120 basis points (bps) year over year to 57.2% as cost of goods sold rose 7.7% to $148.1 million.
Selling, general and administrative expenses increased 5.6% to $121.8 million, while research and development expenses declined 9.2% to $14.4 million. Total operating expenses jumped 81.8% to $221.2 million, driving an operating loss of $23.0 million compared to operating income of $71.3 million in the prior-year quarter.
Haemonetics Financial Position Haemonetics ended fiscal 2026 with $245.4 million in cash and cash equivalents compared to $306.8 million at the end of fiscal 2025.
Cumulative net cash flow at the end of fiscal fourth-quarter 2026 was $293.2 million compared with $181.7 million a year ago.
Haemonetics Corporation Price, Consensus and EPS SurpriseHAE’s Fiscal 2027 Guidance Management expects reported revenue growth of 4-7%, including an estimated 53rd-week impact of roughly 2% and a currency impact of 0-1%. Organic revenue growth is projected at 3-6%, with approximately mid-single-digit growth expected in both Plasma and Hospital and a mid-single-digit decline anticipated in Blood Center. The Zacks Consensus Estimate for fiscal 2027 revenues is pegged at $1.41 billion.
Adjusted earnings per diluted share are expected to grow in line with revenues. The Zacks Consensus Estimate is pegged at $5.30.
Our TakeHaemonetics ended the fiscal fourth quarter with better-than-expected results, wherein both earnings and revenues surpassed estimates.
Strong fiscal fourth-quarter performance was largely driven by core platforms, with outperformance in Plasma and Blood Management Technologies businesses. The company completed the four-year long-range plan, having built a more diversified, sustainable and durable business. With a strengthened competitive position and focus on disciplined execution, it has momentum for fiscal 2027 and beyond.
The contraction of gross margin in the quarter does not bode well.
HAE’s Zacks Rank & Key Picks Haemonetics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Alcon (ALC - Free Report) , Intuitive Surgical (ISRG - Free Report) and Phibro Animal Health (PAHC - Free Report) .
Alcon, currently carrying a Zacks Rank #2 (Buy), reported a fourth-quarter 2025 EPS of 78 cents, which missed the Zacks Consensus Estimate by 0.8%. Revenues of $2.70 billion missed the Zacks Consensus Estimate by 0.2%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
ALC has an earnings yield of 2.5% compared to the industry’s negative 1.6% yield. The company’s earnings surpassed estimates in two of the trailing four quarters and missed in the other two, the average surprise being 1.11%.
Intuitive Surgical, carrying a Zacks Rank #2 at present, posted a first-quarter 2026 adjusted EPS of $2.50, which exceeded the Zacks Consensus Estimate by 20.2%. Revenues of $2.77 billion topped the Zacks Consensus Estimate by 6.2%.
ISRG has an earnings yield of 2.1% in contrast to the industry’s negative yield of 0.9%. The company’s earnings outpaced estimates in each of the trailing four quarters, the average surprise being 16.82%.
Phibro Animal Health, carrying a Zacks Rank #2 at present, posted a second-quarter fiscal 2026 adjusted EPS of 87 cents, which outpaced the Zacks Consensus Estimate by 27.01%. Revenues of $373.9 million outperformed the Zacks Consensus Estimate by 4.72%.
PAHC has an estimated long-term earnings growth rate of 21.5% compared with the industry’s 12.1% growth. The company’s earnings outpaced estimates in each of the trailing four quarters, the average surprise being 20.15%.
Investors in Haemonetics Corporation (HAE - Free Report) need to pay close attention to the stock based on moves in the options market lately. That is because the June 18, 2026 $40.00 Call had some of the highest implied volatility of all equity options today.
What is Implied Volatility?Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could also mean there is an event coming up soon that may cause a big rally or a huge sell-off. However, implied volatility is only one piece of the puzzle when putting together an options trading strategy.
What do the Analysts Think?Clearly, options traders are pricing in a big move for Haemonetics, but what is the fundamental picture for the company? Currently, Haemonetics is a Zacks Rank #3 (Hold) in the Medical - Products industry that ranks in the Bottom 39% of our Zacks Industry Rank. Over the last 60 days, no analyst has increased his earnings estimate for the current quarter, while two have dropped their estimates. The net effect has taken our Zacks Consensus Estimate for the current quarter from $1.19 per shareto $1.10 in that period.
Given the way analysts feel about Haemonetics right now, this huge implied volatility could mean there’s a trade developing. Oftentimes, options traders look for options with high levels of implied volatility to sell premium. This is a strategy many seasoned traders use because it captures decay. At expiration, the hope for these traders is that the underlying stock does not move as much as originally expected.
On May 21, 2026, Haemonetics Corp (HAE) shares rose 4.0%, bringing the current price to $61.94. The stock has fluctuated significantly over the past year, with
May 27, 2026 07:00 ET | Source: BioCryst Pharmaceuticals, Inc.
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.
[url="]KalVista Pharmaceuticals[/url], Inc. (Nasdaq: KALV) today announced new data highlighting the burden of injectable on-demand treatment in children aged
, /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that Chris Simon, President and CEO, will participate in a fireside chat with investors at the Goldman Sachs 47th Annual Global Healthcare Conference on Monday, June 8, 2026 at 4:00 p.m. ET.
The public may access a live webcast of the fireside chat at Haemonetics' Investor Relations website or at the following link:
https://event.webcasts.com/starthere.jsp?ei=1766065&tp_key=0b16b4b62d&tp_special=8
A replay of the recorded webcast will become accessible 12 hours after the event and will be available for 90 days on Haemonetics' Investor Relations website.
ABOUT HAEMONETICS
Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Our innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components. To learn more about Haemonetics, visit www.haemonetics.com.
Investor Contacts:
Olga Guyette, Vice President-Investor Relations & Treasury
BOSTON, June 5, 2026 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced an update to its reportable segment structure to better align external financial reporting with how the Company manages its business and allocates resources. Under the new structure, Haemonetics will transition from three reportable segments to two.
ZUG, Switzerland, June 11, 2026 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced the annual general meeting of shareholders will take place on Friday, June 26, 2026, at 16:00 CEST (10:00 a.m. EDT).
All relevant documents and information relating to the annual general meeting, including the notice and agenda for the annual general meeting, are or will be made available in the “Investors” section of Pharvaris’ website under “Events & Presentations”. The documents will also be made available on the SEC’s website at www.sec.gov. Shareholders who wish to attend the meeting should register as described in the notice and agenda for the annual general meeting.
About Pharvaris
Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs in bradykinin-mediated conditions, including all types of bradykinin-mediated angioedema. Pharvaris’ aspiration is to offer therapies with injectable-like efficacy™, a well-tolerated profile, and the convenience of oral administration to prevent and treat bradykinin-mediated angioedema attacks. By delivering on this aspiration, Pharvaris aims to provide a new standard of care in bradykinin-mediated angioedema. Pharvaris is preparing marketing authorization applications for deucrictibant immediate-release capsule as an on-demand treatment of HAE attacks, and a global pivotal Phase 3 study of deucrictibant extended-release tablet for the prevention of HAE attacks (CHAPTER-3) is ongoing with topline data anticipated in the third quarter of 2026. In addition, CREAATE is an ongoing Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. For more information, visit https://pharvaris.com/.
— Growing body of ORLADEYO® clinical data and real-world evidence demonstrates consistent reductions in HAE attack burden and healthcare utilization across diverse patient populations
— New post hoc analysis of Phase 1b/2 ALPHA-STAR study of investigational navenibart demonstrates consistent reductions in HAE attack rates across patient subgroups, supporting ongoing Phase 3 evaluation as a potential long-acting therapeutic option for the broad HAE population
RESEARCH TRIANGLE PARK, N.C., June 12, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new clinical data and real-world evidence for ORLADEYO® (berotralstat), the first and only targeted oral prophylactic therapy for patients with hereditary angioedema (HAE) aged 2 and older, in addition to new data from the Phase 1b/2 multicenter, dose-ranging, open-label ALPHA-STAR study of navenibart, an investigational, long-acting, monoclonal antibody plasma kallikrein inhibitor for prophylaxis to prevent attacks of HAE. These data will be featured across multiple poster presentations during the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Turkey, from June 12-15.
“Together, these data reinforce the strength of our HAE portfolio, demonstrating consistent real-world impact for children and adults living with HAE today, while advancing next-generation treatment approaches to further improve outcomes, address ongoing clinical unmet need, and align with patient treatment preferences,” said Sandeep Menon, Chief Research and Development Officer of BioCryst.
New HAE Portfolio Clinical Data
Updated analysis of 48-week data from the ongoing APeX-P study, the largest trial of long-term prophylaxis (LTP) in pediatric patients with HAE, evaluating once-daily ORLADEYO in HAE patients aged 2 to <12 years will be featured in a poster presentation (Poster D2.498).
Analysis of 48-week trial data showed that treatment with ORLADEYO was associated with early and sustained reductions in rate and number of HAE attacks requiring on-demand treatment and professional care, with results as follows:
The median (range) adjusted HAE attack rate requiring on-demand treatment decreased from 0.691 attacks/month (0-5.03) during the 12-week standard of care (SOC) period to 0.169 attacks/month (0-1.75) during the 48-week ORLADEYO treatment period.The number of HAE attacks requiring professional care decreased from 22 during the 12-week SOC period to 3 over 12 weeks of ORLADEYO treatment; this was sustained throughout the treatment period, with a trended decrease in level of professional care required from emergency department or urgent care treatment to physicians’ office, and further reduction to 0 attacks during Week 37-48.No significant safety concerns were identified over the 48-week treatment period.
Additionally, a new post hoc analysis of the Phase 1b/2 ALPHA-STAR study of navenibart evaluating clinical outcomes across patient subgroups defined by baseline attack rate, body mass index (BMI), and age will be featured as a poster presentation (Poster D3.438).
The analysis demonstrated that investigational navenibart consistently reduced HAE attacks, with results as follows:
Reductions in overall HAE attack rate were observed across subgroups defined by baseline attack rate, BMI, and age.Following treatment, reductions in clinically relevant HAE outcomes were observed across analyzed subgroups, including reductions in moderate or severe attacks, and in baseline attack rate subgroup analyses, and reduced on-demand medication use. Reductions in the number of moderate or severe attacks were also observed with treatment across all BMI subgroups. Navenibart was previously shown to be well tolerated with no severe or serious treatment-emergent adverse events (TEAEs) reported and few injection site reactions. The most common TEAEs were headache, nasopharyngitis, and urinary tract infection. Together with the primary findings from Phase 1b/2 ALPHA-STAR, this analysis supports the ongoing Phase 3 evaluation of navenibart in the ALPHA-ORBIT trial as a potential long-acting therapeutic option for the broad HAE population.
Real-World Impact of ORLADEYO
Through a comprehensive real-world evidence (RWE) generation program, BioCryst continues its commitment to generating meaningful, practice-informing research to demonstrate the value of long-term prophylaxis with ORLADEYO in routine clinical practice across the diverse HAE patient community. In addition to clinical data generated in clinical trials, RWE across multiple studies demonstrated ORLADEYO’s ability to achieve sustained reductions in HAE burden. Benefits were observed in adolescent and adult patients, including those switching to ORLADEYO from other LTP therapies, and translated into fewer HAE attacks, reduced healthcare resource utilization, and high patient satisfaction.
This RWE will be presented in the following posters:
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)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)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 APeX-P
APeX-P is an ongoing, open-label study evaluating the pharmacokinetics, safety, and efficacy of ORLADEYO in patients aged 2 to <12 years with HAE due to C1-inhibitor deficiency. Before ORLADEYO initiation, patients received SOC for 12 weeks. The rates of HAE attacks requiring on-demand treatment and number of attacks requiring professional care were compared between 12 weeks of SOC and 48 weeks of ORLADEYO treatment. Participants (n=29) were placed in one of four cohorts by body weight at baseline.
About ALPHA-STAR
ALPHA-STAR is a Phase 1b/2, multicenter, dose-ranging, proof-of-concept, open-label trial that assessed the safety and clinical activity of single- and multiple-dose navenibart in adults aged 18 years and older with HAE due to C1-inhibitor deficiency. Eligible participants were those who experienced at least two HAE attacks during the 8-week trial run-in period. Participants (n=29) were placed in three navenibart dose cohorts and were pooled for the purpose of this post hoc analysis. Post hoc outcomes included the overall change from baseline in monthly HAE attack rate, the rate of attacks treated with on-demand medication, and the rate of moderate or severe attacks. Outcome measures were assessed for 6 months after the last dose. Due to small sample size and short-term study design, these data may not fully represent the broader population of patients with HAE.
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 data, real-world outcomes and expectations with respect to BioCryst’s HAE portfolio and the potential dosing profile, competitive positioning, and expectations for 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 implement or maintain its commercialization plans for ORLADEYO and successfully commercialize future products; 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.
