Primary endpoint met: 83% attack rate reduction versus placebo (p<0.0001) in the first and only prophylaxis Phase 3 study in all three types of HAE87% attack rate reduction versus placebo observed in people with HAE Type 1 or Type 2All secondary efficacy endpoints met with statistical significanceWell-tolerated safety profile of deucrictibant XR demonstratedConference call and webcast today at 8:00 a.m. EDT
ZUG, Switzerland, Sept. 08, 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 angioedema (AE-BK), such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced statistically significant and clinically meaningful topline results of the CHAPTER-3 pivotal Phase 3 study evaluating deucrictibant extended-release (XR) tablet for the prevention of HAE attacks. The primary endpoint and all secondary efficacy endpoints were met with statistical significance. Data from the CHAPTER-3 study will serve as the basis for marketing authorization applications, which are planned to be submitted starting in the first half of 2027.
CHAPTER-3 Study Design and Results
The CHAPTER-3 (NCT06669754) global Phase 3, double-blind, placebo-controlled study evaluated orally administered deucrictibant XR tablet (40 mg, once daily) for the prevention of attacks in adolescents and adults with HAE. CHAPTER-3 is the first and only prophylaxis Phase 3 study to evaluate all three types of HAE, including people with HAE type 1, HAE type 2, or HAE with normal C1 inhibitor. The study randomized 85 participants from 21 countries in a 2:1 ratio to deucrictibant XR (N=55) or placebo (N=30) for 24 weeks of treatment.
Treatment with deucrictibant XR in participants with all types of HAE reduced the mean monthly attack rate by 83% (p<0.0001). Further analysis in the 80 participants with HAE Type 1 or Type 2 showed that the mean monthly attack rate was 87% lower in the deucrictibant XR group compared to placebo. Primary endpoint results were consistent across subgroups. All secondary efficacy endpoints, assessed sequentially under a multiplicity-control procedure, were also met with statistical significance. In CHAPTER-3, administration of deucrictibant XR resulted in early-onset protection within the first week, which was then sustained through the 24 weeks of study treatment. Robust reductions in attack rate from baseline and increases in the percentage of attack-free participants were observed in the deucrictibant-treated group.
In CHAPTER-3, deucrictibant XR was well tolerated with most treatment-emergent adverse events being mild or moderate. There were no treatment-related serious adverse events reported. One participant in each group discontinued treatment due to an adverse event.
Marc A. Riedl, M.D., M.S., Professor of Medicine, Clinical Director of the U.S. Hereditary Angioedema Association (HAEA) Angioedema Center at the University of California San Diego (UCSD), and principal investigator in the CHAPTER-3 study, commented, “Alongside the RAPIDe-3 data in the on-demand setting, these CHAPTER-3 results further confirm the value of targeting the bradykinin B2 receptor for both the prevention and treatment of attacks across all types of HAE. People living with HAE are seeking novel treatment options that offer improved disease control and health-related quality of life, with reduced treatment burden. If approved, the efficacy, tolerability, and convenient oral administration position deucrictibant XR as a potential important addition to HAE clinical practice, supporting individualized treatment strategies designed around shared decision making.”
Peng Lu, M.D., Ph.D., President of Pharvaris, stated, “People living with HAE have been waiting for a well-tolerated oral therapy with injectable-like efficacy; we believe deucrictibant XR can help address this unmet need. CHAPTER-3 showed statistically significant reductions in attack frequency, characterized by early and sustained protection, clinically meaningful improvements in health-related quality of life, and better HAE control. The successful study completion would not have been possible without the incredible contributions of the clinical study participants and their caregivers, the site investigators and staff, the HAE community, our study partners, and the Pharvaris team, to whom we are sincerely thankful.”
Dr. Lu continued, “With the ongoing regulatory review of the NDA of deucrictibant IR for on-demand treatment of HAE attacks and the planned submission of an NDA for deucrictibant XR for prevention of bradykinin-mediated angioedema attacks, we are focused on commercial preparation for two potential launches. Pharvaris aims to set a new standard in stakeholder engagement by delivering a best-in-class experience for the community, powered by our expertise and integrated capabilities across the deucrictibant portfolio.”
Berndt Modig, Chief Executive Officer of Pharvaris, added, “Pharvaris was founded on the vision of elevating the standard of care in HAE. Today represents a landmark moment for the company and the community as a whole: deucrictibant could be the first and only oral therapy to offer injectable-like efficacy and a well-tolerated profile in on-demand treatment and prophylaxis with our two unique formulations. Pharvaris now plans to redefine disease management by uniting on-demand treatment and long-term prophylaxis within a single therapeutic franchise. This encourages us to further leverage our deep scientific expertise to bring novel therapies to those living with bradykinin-mediated diseases with unmet medical needs, beyond angioedema.”
Pharvaris plans to present additional efficacy, safety, and participant experience data from the CHAPTER-3 study at upcoming medical congresses.
The CHAPTER-4 open-label long-term extension study of deucrictibant XR for the prophylaxis of HAE attacks is ongoing.
Topline data from Part 1 of CREAATE (NCT07266805), a global, pivotal Phase 3 study evaluating orally-administered deucrictibant XR for the prevention of AAE-C1INH attacks, are anticipated in the first quarter of 2027. Enrollment in CREAATE is ongoing and progressing as planned.
Pharvaris plans to submit a New Drug Application to the U.S. Food and Drug Administration for the prophylaxis of bradykinin-mediated angioedema attacks in the first half of 2027.
Conference Call
Pharvaris will host a live conference call and webcast to discuss the CHAPTER-3 study topline data in greater detail at 8:00 a.m. EDT today via a live webcast; presentation slides may be accessed on the “Events and Presentations” page of the Pharvaris investor relations website. Participants interested in asking a verbal question during the Q&A may do so in the live conference call. An archived replay will also be available on the website for 90 days following the event.
About Deucrictibant
Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, the European Commission, and Swissmedic.
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. For more information, visit https://pharvaris.com/.
Forward Looking Statements
This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “estimate,” “may,” “could,” “should,” “would,” “will” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; the outcome of regulatory approvals, including the outcome of our NDA and MAA for the on-demand treatment of acute attacks of HAE; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, RAPIDe-3, CHAPTER-1, and CHAPTER-3 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as CREAATE; risks arising from epidemic diseases, which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and geopolitical conflicts; changes in regulations and customs, tariffs and trade barriers; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release.
Contact
Maggie Beller
Vice President, Head of Corporate and Investor Communications [email protected]
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/76d0e23d-eaa6-4b74-af0d-f870fc152ecc
Investors with an interest in Medical - Products stocks have likely encountered both GE HealthCare Technologies (GEHC - Free Report) and Haemonetics (HAE - Free Report) . But which of these two stocks is more attractive to value investors? We'll need to take a closer look to find out.
There are plenty of strategies for discovering value stocks, but we have found that pairing a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system produces the best returns. The Zacks Rank favors stocks with strong earnings estimate revision trends, and our Style Scores highlight companies with specific traits.
Currently, GE HealthCare Technologies has a Zacks Rank of #2 (Buy), while Haemonetics has a Zacks Rank of #3 (Hold). This means that GEHC's earnings estimate revision activity has been more impressive, so investors should feel comfortable with its improving analyst outlook. However, value investors will care about much more than just this.
Value investors analyze a variety of traditional, tried-and-true metrics to help find companies that they believe are undervalued at their current share price levels.
The Style Score Value grade factors in a variety of key fundamental metrics, including the popular P/E ratio, P/S ratio, earnings yield, cash flow per share, and a number of other key stats that are commonly used by value investors.
GEHC currently has a forward P/E ratio of 14.54, while HAE has a forward P/E of 19.67. We also note that GEHC has a PEG ratio of 2.07. This figure is similar to the commonly-used P/E ratio, with the PEG ratio also factoring in a company's expected earnings growth rate. HAE currently has a PEG ratio of 2.08.
Another notable valuation metric for GEHC is its P/B ratio of 2.95. The P/B is a method of comparing a stock's market value to its book value, which is defined as total assets minus total liabilities. By comparison, HAE has a P/B of 5.64.
Based on these metrics and many more, GEHC holds a Value grade of B, while HAE has a Value grade of C.
GEHC is currently sporting an improving earnings outlook, which makes it stick out in our Zacks Rank model. And, based on the above valuation metrics, we feel that GEHC is likely the superior value option right now.
— Expands availability of the first and only oral prophylactic therapy for patients with HAE ages 2 to <12 years in Japan —
RESEARCH TRIANGLE PARK, N.C., Aug. 25, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for once-daily ORLADEYO® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years.
“The approval of ORLADEYO for children in Japan marks an important step toward our goal of bringing a once-daily oral treatment to people living with HAE around the world,” said Charlie Gayer, President and Chief Executive Officer of BioCryst. “We’re proud to advance an oral prophylactic option in Japan that can help reduce treatment burden for children and provide greater convenience for families managing this lifelong disease.”
For children with HAE, treatment has traditionally required injections, creating additional burden for patients and caregivers. Developed with the unique administration needs of children in mind, the ORLADEYO granule formulation (known as pellet formulation in the U.S.) is sprinkle-like in appearance and size and can be poured directly into the mouth and swallowed immediately with water or milk, or sprinkled over a spoonful of soft, non-acidic food.
This approval is based on positive interim results from the APeX-P clinical trial, the largest trial of long-term prophylaxis (LTP) in pediatric patients with HAE, evaluating the pharmacokinetics, safety and efficacy of ORLADEYO in patients aged 2 to <12 years with HAE due to C1-inhibitor deficiency. Interim results from APeX-P presented at multiple allergy and immunology-focused congresses and published in the Annals of Allergy, Asthma & Immunology showed ORLADEYO was generally well tolerated, demonstrated a consistent safety profile across this age group, and resulted in early and sustained reductions in monthly attack rates with no new safety signals identified beyond those previously described in prior adult and adolescent trials. The most commonly reported treatment-emergent adverse event (TEAE) was nasopharyngitis.
BioCryst will launch ORLADEYO for children in Japan following completion of the Japanese National Health Insurance System (NHI) reimbursement pricing process. OrphanPacific, Inc. is BioCryst’s representative partner in Japan and holds the marketing authorization.
ORLADEYO is the first and only targeted oral prophylactic therapy for patients with HAE aged 2 and above. A capsule formulation of ORLADEYO received U.S. Food and Drug Administration (FDA) approval for prophylaxis to prevent HAE attacks in adult and pediatric patients 12 years and older in December 2020 and is now approved in more than 45 countries around the world. In December 2025, the oral pellet formulation of ORLADEYO (known as granule formulation in Japan) was approved by FDA for prophylactic therapy in pediatric patients in the U.S. with HAE aged 2 to <12 years.
Today’s milestone represents the second regulatory approval for ORLADEYO in Japan. The capsule formulation of ORLADEYO was approved in January 2021 by the MHLW in Japan for prophylactic treatment of HAE in adults and pediatric patients 12 years and older.
BioCryst has also filed its application for the use of ORLADEYO in patients with HAE aged 2 to <12 years with the European Medicines Agency and Health Canada. Additional regulatory filings are planned in other global territories.
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 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.
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 therapeutics for 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 the use of ORLADEYO for pediatric patients with HAE aged 2 to <12 years, including with respect to regulatory filings, commercialization and potential benefits. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s 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 its commercialization plans for ORLADEYO, including the once-daily oral granule formulation; the commercial viability of ORLADEYO oral granules; interim results of a clinical trial do not necessarily predict final results; risks related to government actions, including that decisions and other actions related to pricing and reimbursement 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; other applicable regulatory agencies may not approve ORLADEYO for use in pediatric patients with HAE aged 2 to <12 years within the timeframe expected, or at all, 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, may impose certain restrictions, warnings, or other requirements, may impose a clinical hold with respect to ORLADEYO, or may withhold or delay market approval for ORLADEYO; and once approved, the FDA, MHLW and other applicable regulatory agencies may withdraw market approval for ORLADEYO. This list is not exclusive. To see a more comprehensive list 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.
BioCryst Pharmaceuticals (BCRX) is evolving into a dual-product hereditary angioedema (HAE) franchise, targeting both oral and injectable prophylactic preferences. BCRX's ORLADEYO profit engine supports pipeline funding; Q2 2026 revenue reached $218.3M, with strong gross margins and positive cash flow independent of licensing receipts. The navenibart acquisition positions BCRX to capture injectable-preferring HAE patients, leveraging existing commercial infrastructure for operating leverage and customer retention.
Haemonetics is a medtech company that's increasingly generating more recurring revenues with plasma consumables. HAE also has MedSurg, which generates higher margins by selling technologies useful for cardiovascular procedures, for example. As such, these two segments give HAE a durable growth profile. And their recent agreement with CSL could expand on this potential.
Aurora Investment Counsel acquired a new stake in Haemonetics Corporation (NYSE:HAE – Free Report) during the second quarter, according to its most recent disclosure with the Securities and Exchange Commission (SEC). The firm acquired 25,501 shares of the medical instruments supplier’s stock, valued at approximately $1,913,000. Aurora Investment Counsel owned about 0.06% of Haemonetics as of its most recent filing with the Securities and Exchange Commission (SEC).
A number of other institutional investors have also recently bought and sold shares of the business. EverSource Wealth Advisors LLC grew its stake in shares of Haemonetics by 12.3% during the first quarter. EverSource Wealth Advisors LLC now owns 1,920 shares of the medical instruments supplier’s stock worth $108,000 after purchasing an additional 211 shares during the period. Quantinno Capital Management LP boosted its holdings in Haemonetics by 9.0% during the second quarter. Quantinno Capital Management LP now owns 3,492 shares of the medical instruments supplier’s stock worth $261,000 after buying an additional 289 shares during the last quarter. UMB Bank n.a. grew its position in shares of Haemonetics by 110.9% during the 4th quarter. UMB Bank n.a. now owns 582 shares of the medical instruments supplier’s stock worth $47,000 after buying an additional 306 shares during the period. Cardinal Capital Management grew its position in shares of Haemonetics by 1.5% during the 4th quarter. Cardinal Capital Management now owns 22,442 shares of the medical instruments supplier’s stock worth $1,799,000 after buying an additional 321 shares during the period. Finally, Kemnay Advisory Services Inc. acquired a new stake in shares of Haemonetics in the 4th quarter valued at approximately $26,000. Institutional investors and hedge funds own 99.67% of the company’s stock.
Analyst Upgrades and Downgrades HAE has been the topic of several recent analyst reports. Barrington Research lifted their price objective on shares of Haemonetics from $95.00 to $118.00 and gave the stock an “outperform” rating in a research note on Wednesday. Raymond James Financial reaffirmed an “outperform” rating and issued a $105.00 target price on shares of Haemonetics in a research note on Friday, August 7th. Robert W. Baird set a $96.00 target price on shares of Haemonetics in a report on Friday, August 7th. JPMorgan Chase & Co. lifted their price target on shares of Haemonetics from $62.00 to $86.00 and gave the stock a “neutral” rating in a research report on Friday, August 7th. Finally, Bank of America raised shares of Haemonetics from a “neutral” rating to a “buy” rating and boosted their price target for the company from $72.00 to $80.00 in a report on Friday, May 22nd. One analyst has rated the stock with a Strong Buy rating, six have given a Buy rating and four have given a Hold rating to the company’s stock. Based on data from MarketBeat.com, Haemonetics presently has an average rating of “Moderate Buy” and an average price target of $95.00.
View Our Latest Stock Report on Haemonetics Key Haemonetics News Here are the key news stories impacting Haemonetics this week:
Positive Sentiment: New CSL Plasma supply agreement: Haemonetics signed a non-exclusive agreement to supply CSL Plasma’s U.S. collection operations. The deal restores business with a major customer after a prior supply transition weighed on results, potentially improving revenue visibility and supporting the company’s plasma-collection franchise. Haemonetics reconnects with CSL in US plasma collection deal Positive Sentiment: Raised fiscal 2027 outlook and solid quarterly results: Haemonetics reported quarterly revenue of $339.4 million, up approximately 5.6% year over year, while adjusted EPS rose to $1.14 and exceeded consensus. Management raised its full-year reported revenue-growth forecast to 5%–8% from 4%–7%, with plasma revenue and adoption of Persona PLUS on the NexSys PCS platform providing momentum. Haemonetics Jumps as Investors Cheer Raised Fiscal 2027 Outlook Positive Sentiment: Analyst support: BTIG raised its price target from $96 to $110 and maintained a Buy rating, reinforcing bullish momentum. BTIG raises Haemonetics price target Haemonetics Trading Up 3.6% HAE opened at $108.39 on Thursday. The stock has a market capitalization of $4.93 billion, a P/E ratio of 53.14, a P/E/G ratio of 2.10 and a beta of 0.52. Haemonetics Corporation has a 12 month low of $47.31 and a 12 month high of $108.50. The firm’s fifty day simple moving average is $80.50 and its 200 day simple moving average is $67.90. The company has a current ratio of 3.08, a quick ratio of 1.91 and a debt-to-equity ratio of 1.40.
Haemonetics (NYSE:HAE – Get Free Report) last released its earnings results on Thursday, August 6th. The medical instruments supplier reported $1.14 earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of $1.08 by $0.06. The firm had revenue of $339.38 million during the quarter, compared to analysts’ expectations of $327.86 million. Haemonetics had a return on equity of 27.55% and a net margin of 7.12%.The company’s revenue was up 5.5% on a year-over-year basis. During the same quarter in the prior year, the company earned $1.10 EPS. As a group, research analysts anticipate that Haemonetics Corporation will post 5.28 EPS for the current fiscal year.
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.
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On August 18, 2026, Haemonetics Corp
HAE +15.93% 85
shares rose 15.9%, bringing the current price to $104.65. This performance reflects a significant 52-week range, with a low of $47.32 and a high of $106.67, highlighting the stock's volatility and recent upward momentum.
GF Value™ verdict: Current price of $104.65 is 22.8% above the GF Value™ of $85.22.GF Score™ is 85/100, indicating a strong overall rating.Notable signal: Insiders have bought $0.1M in stock over the past 12 months, with no selling activity.Is HAE Overvalued or Undervalued?According to the GF Value™, Haemonetics Corp is currently overvalued, with its market price of $104.65 exceeding the fair value estimate of $85.22 by 22.8%. This overvaluation suggests a lack of margin of safety for potential investors, indicating that the stock may be trading at a premium in relation to its intrinsic value. GF Value™ is GuruFocus' proprietary intrinsic-value estimate, which is derived from various factors including historical trading multiples, past business growth, and future performance projections. Given this context, the GF Valuation label identifies HAE as modestly overvalued, which poses a risk for investors looking for solid entry points.
The risk associated with investing in an overvalued stock like HAE includes the potential for price corrections if market sentiment shifts or if the company fails to meet growth expectations. Therefore, while the company's performance over the past year shows significant growth—up 97%—the elevated price level raises concerns about sustainability.
How Does HAE's Valuation Compare to Its History?MetricCurrentHistoricalP/E (TTM)51.3x35.8xForward P/E19.8xN/AHaemonetics Corp's current P/E ratio of 51.3x is significantly higher than its 5-year median P/E of 35.8x, suggesting that the stock is trading at a higher valuation compared to its historical levels. The forward P/E of 19.8x indicates that analysts expect a decline in valuation multiples in the future, which aligns with the GF Value™ verdict of being overvalued. This P/E analysis reinforces concerns about HAE's current pricing versus historical standards.
What Does HAE's GF Score™ Tell Us?The GF Score™ measures a company's financial strength, profitability, growth potential, valuation, and momentum to provide an overall rating. Haemonetics Corp has a GF Score™ of 85/100, which signifies strong performance in several key areas, particularly in profitability and growth. The strongest sub-ranks are in Profitability and Growth, each rated 8/10, indicating that the company has been effective in generating profits and is expected to continue growing. However, the Financial Strength rank of 5/10 suggests that there may be some areas for improvement in its balance sheet.
MetricRatingGF Score™85Financial Strength5/10Profitability8/10Growth8/10Valuation7/10Momentum6/10The overall scores indicate that while HAE demonstrates strong profitability and growth potential, its financial strength may be a concern, particularly given the stock's current valuation levels. The valuation rank of 7/10 suggests that there is room for caution as well, especially when considering the GF Value™ assessment of overvaluation.
What Are Gurus and Insiders Doing with HAE?Currently, seven gurus hold positions in Haemonetics Corp, with five of them having added to their stakes and two trimming their holdings in recent quarters. This indicates a generally positive sentiment among institutional investors, which can be a reassuring factor for potential investors. Insider activity also supports this sentiment, as insiders have purchased $0.1M worth of shares over the past year without any selling activity, suggesting confidence in the company's future prospects.
This pattern of buying among insiders and the majority of gurus indicates a level of commitment to the company, which can be interpreted as a positive signal. However, the fact that some gurus have reduced their positions may also warrant attention, as it could reflect differing views on the stock's valuation or future performance.
What This Means for InvestorsIn conclusion, based on the GF Value™, Haemonetics Corp appears to be overvalued at its current price of $104.65, given the fair value estimate of $85.22. This situation presents a risk for investors in terms of potential price corrections if the stock does not meet growth expectations. While the strong GF Score™ indicates solid fundamentals and insider confidence, the overvaluation raises caution regarding entry points. For more detailed insights, visit the Haemonetics Corp
HAE +15.93% 85
stock page for comprehensive analysis.
Frequently Asked QuestionsWhat is HAE's GF Score™?
HAE's GF Score™ is 85/100, which indicates strong performance across various metrics, particularly in profitability and growth.
Is HAE overvalued or undervalued?
HAE is currently overvalued, with a market price that is 22.8% higher than the GF Value™ estimate.
What is HAE's P/E ratio?
HAE has a P/E (TTM) of 51.3x, which is significantly above its 5-year median P/E of 35.8x, indicating a higher valuation compared to its historical levels.
This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected].
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Stock to Watch: Haemonetics (HAE - Free Report) Haemonetics Corporation provides blood management solutions to customers encompassing blood and plasma collectors, hospitals and health care providers globally. The company’s portfolio of integrated devices, information management, and consulting services offers blood management solutions for each facet of the blood supply chain, helping better clinical outcomes. Blood and its components (plasma, platelets, and red cells) have several vital and frequently life-saving clinical applications.
HAE is a #3 (Hold) on the Zacks Rank, with a VGM Score of A.
Momentum investors should take note of this Medical stock. HAE has a Momentum Style Score of B, and shares are up 15.5% over the past four weeks.
For fiscal 2027, six analysts revised their earnings estimate upwards in the last 60 days, and the Zacks Consensus Estimate has increased $0.06 to $5.28 per share. HAE boasts an average earnings surprise of +6%.
With a solid Zacks Rank and top-tier Momentum and VGM Style Scores, HAE should be on investors' short list.
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Investors can count on the Zacks Rank's success, with #1 (Strong Buy) stocks producing an unmatched +23.94% average annual return since 1988, more than double the S&P 500's performance. But the model rates a large number of stocks, and there are over 200 companies with a Strong Buy rank, plus another 600 with a #2 (Buy) rank, on any given day.
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Stock to Watch: Haemonetics (HAE - Free Report) Haemonetics Corporation provides blood management solutions to customers encompassing blood and plasma collectors, hospitals and health care providers globally. The company’s portfolio of integrated devices, information management, and consulting services offers blood management solutions for each facet of the blood supply chain, helping better clinical outcomes. Blood and its components (plasma, platelets, and red cells) have several vital and frequently life-saving clinical applications.
HAE is a #3 (Hold) on the Zacks Rank, with a VGM Score of A.
It also boasts a Value Style Score of B thanks to attractive valuation metrics like a forward P/E ratio of 17.21; value investors should take notice.
Six analysts revised their earnings estimate upwards in the last 60 days for fiscal 2027. The Zacks Consensus Estimate has increased $0.06 to $5.28 per share. HAE boasts an average earnings surprise of +6%.
With a solid Zacks Rank and top-tier Value and VGM Style Scores, HAE should be on investors' short list.
Key Takeaways HAE beat Q1 earnings and revenue estimates as organic sales rose 5.9%, led by Plasma growth of 8.2%. Haemonetics' Plasma growth was supported by share gains, collection trends and Persona PLUS rollout. HAE raised fiscal 2027 reported revenue growth guidance to 5-8% and organic growth to 4-7%. Haemonetics Corporation (HAE - Free Report) posted first-quarter fiscal 2027 adjusted earnings of $1.14 per share, up 3.6% year over year. The figure beat the Zacks Consensus Estimate by 6.5%.
On a GAAP basis, earnings per share were 72 cents compared with 70 cents in the prior-year quarter.
Revenues increased 5.6% year over year to $339.4 million and beat the Zacks Consensus Estimate by 3.5%. Organic revenues rose 5.9%, with Plasma delivering particularly strong 8.2% organic growth.
Following the earnings announcement, HAE’s shares rose 0.4% last Friday.
HAE’s Apheresis Business Builds MomentumApheresis revenues totaled $191.3 million, up 5.3% on a reported basis and 6.0% organically. Plasma revenues increased 7.2% to $155.5 million, while organic growth reached 8.2%, supported by share gains, strong collection trends and the Persona PLUS rollout.
Management said U.S. customer collections rose in the high-single to low-double digits. Persona PLUS adoption was ahead of schedule, with early adopters achieving yield improvements of more than 5% versus earlier Persona offerings. Other Apheresis revenues declined 2.4% to $35.8 million, reflecting portfolio optimization and order timing.
Haemonetics’ MedSurg Growth BroadensMedSurg revenues rose 6.0% to $148.1 million, with organic growth of 5.9%. Blood Management Technologies revenues advanced 8.6% to $88.1 million and 8.1% organically, benefiting from double-digit growth in Hemostasis and Transfusion Management, partly offset by slower Cell Salvage capital upgrades.
Interventional Technologies revenues increased 2.5% to $59.9 million and 2.8% organically. Vascular Closure grew in the low double digits, aided by improving procedure trends, stronger commercial execution and broader use of the VASCADE MVP XL system. Management also cited growing adoption across large-bore venous closure procedures.
HAE’s Margin AnalysisIn the first quarter of fiscal 2027, gross profit increased 5.5% year over year to $202.8 million. Gross margin remained flat at 59.8% as cost of goods sold rose 5.8% to $136.6 million.
Selling, general and administrative expenses increased 7.4% to $118.9 million, while research and development expenses declined 0.4% to $16.2 million. Total operating expenses rose 5.0% to $145.3 million. Operating income increased 6.7% to $57.5 million from $53.9 million in the prior-year quarter, while operating margin expanded 10 basis points to 16.9%.
Haemonetics Strengthens Cash GenerationCash flow from operating activities reached $52.3 million, up $34.9 million from the prior-year quarter’s level. Free cash flow climbed to $39.1 million from $2.5 million, aided by favorable working-capital movements and lower non-cash equipment transfers, partly offset by higher capital expenditures.
Haemonetics ended the quarter with $223.4 million in cash and cash equivalents and total debt of about $1.17 billion. During the quarter, the company repaid $50 million on its revolving credit facility and repaid another $50 million after quarter-end, reducing the outstanding revolver balance to $200 million.
HAE Raises Fiscal 2027 Revenue OutlookManagement raised fiscal 2027 reported revenue growth guidance to 5-8% from 4-7%. Organic revenue growth is now projected to be 4-7%, up from the prior 3-6% guidance, while the expected impact from the 53rd week remains roughly 2%. The Zacks Consensus Estimate for fiscal 2027 revenues is pegged at $1.41 billion.
Adjusted earnings per share are expected to grow in line with revenues. The Zacks Consensus Estimate is pegged at $5.28.
Our TakeHaemonetics ended the fiscal first quarter with both earnings and revenues surpassing estimates. Broad-based growth across the company’s core platforms supported the quarterly performance. HAE’s operating margin expansion looks encouraging.
With a strengthened competitive position and focus on disciplined execution, it has momentum for fiscal 2027 and beyond. Additionally, the raised full-year guidance bodes well for the company.
HAE’s Zacks Rank & Key Picks Haemonetics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Intuitive Surgical (ISRG - Free Report) , Quest Diagnostics (DGX - Free Report) and Medpace (MEDP - Free Report) .
Intuitive Surgical, carrying a Zacks Rank #2 (Buy) at present, reported second-quarter 2026 adjusted EPS of $2.80, which surpassed the Zacks Consensus Estimate by 12.9%. Revenues of $2.89 billion beat the Zacks Consensus Estimate by 3.1%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
ISRG has an earnings yield of 3.1% compared to the industry’s negative 3% yield. The company beat earnings estimates in each of the trailing four quarters, the average surprise being 16.53%.
Quest Diagnostics, carrying a Zacks Rank #2 at present, posted second-quarter 2026 adjusted EPS of $3.12, which outpaced the Zacks Consensus Estimate by 11%. Revenues of $3.04 billion topped the Zacks Consensus Estimate by 2.1%.
DGX has an earnings yield of 4.7%, almost in line with the industry’s yield. The company’s earnings outpaced estimates in each of the trailing four quarters, the average surprise being 5.77%.
Medpace, carrying a Zacks Rank #2 at present, posted second-quarter 2026 adjusted EPS of $4.25, which beat the Zacks Consensus Estimate by 4.17%. Revenues of $707.3 million outperformed the consensus mark by 1.12%.
MEDP has a historical five-year earnings growth rate of 30.5% compared with the industry’s 5.6% growth. In the trailing four quarters, the company delivered an average earnings beat of 10.16%.
Have you looked into how Haemonetics (HAE - Free Report) performed internationally during the quarter ending June 2026? Considering the widespread global presence of this provider blood management systems for health care providers and blood collectors, examining the trends in international revenues is essential for assessing its financial resilience and prospects for growth.
The global economy today is deeply interlinked, making a company's engagement with international markets a critical factor in determining its financial success and growth path. It has become essential for investors to comprehend how much a company relies on these foreign markets, as this understanding reveals the firm's potential for consistent earnings, its capacity to harness different economic cycles, and its overall growth prospects.
Being present in foreign markets serves as protection against local economic declines and helps benefit from more rapidly expanding economies. Yet, such expansion also introduces challenges related to currency fluctuations, geopolitical uncertainties and varied market behaviors.
While analyzing HAE's performance for the last quarter, we found some intriguing trends in revenues from its overseas segments that Wall Street analysts commonly model and monitor.
The recent quarter saw the company's total revenue reaching $339.38 million, marking an improvement of 5.6% from the prior-year quarter. Next, we'll examine the breakdown of HAE's revenue from abroad to comprehend the significance of its international presence.
Trends in HAE's Revenue from International MarketsOf the total revenue, $45.53 million came from Europe during the last fiscal quarter, accounting for 13.4%. This represented a surprise of +1.54% as analysts had expected the region to contribute $44.84 million to the total revenue. In comparison, the region contributed $52.9 million, or 15.3%, and $40.88 million, or 12.7%, to total revenue in the previous and year-ago quarters, respectively.
During the quarter, Other International contributed $2.99 million in revenue, making up 0.9% of the total revenue. When compared to the consensus estimate of $2.81 million, this meant a surprise of +6.26%. Looking back, Other International contributed $3.11 million, or 0.9%, in the previous quarter, and $2.81 million, or 0.9%, in the same quarter of the previous year.
Japan accounted for 3.8% of the company's total revenue during the quarter, translating to $12.86 million. Revenues from this region represented a surprise of -9.58%, with Wall Street analysts collectively expecting $14.22 million. When compared to the preceding quarter and the same quarter in the previous year, Japan contributed $18.4 million (5.3%) and $13.65 million (4.3%) to the total revenue, respectively.
Revenue Forecasts for the International MarketsIt is projected by analysts on Wall Street that Haemonetics will post revenues of $344.82 million for the ongoing fiscal quarter, an increase of 5.4% from the year-ago quarter. The expected contributions from Europe, Other International and Japan to this revenue are 12.8%, 0.8%, and 5%, translating into $44.07 million, $2.65 million, and $17.17 million, respectively.
For the full year, the company is expected to generate $1.41 billion in total revenue, up 5.8% from the previous year. Revenues from Europe, Other International and Japan are expected to constitute 12.9% ($182.19 million), 0.9% ($12.51 million) and 4.8% ($67.42 million) of the total, respectively.
Wrapping UpThe dependency of Haemonetics on global markets for its revenues presents a mix of potential gains and hazards. Thus, monitoring the trends in its overseas revenues can be a key indicator for predicting the firm's future performance.
In a world where international interdependencies and geopolitical conflicts are ever-increasing, Wall Street analysts closely monitor these trends for companies having international presence to adjust their earnings forecasts. Of course, there are several other factors, including a company's standing within its home borders, that influence analysts' earnings forecasts.
At Zacks, a company's changing earnings outlook is given considerable attention due to its proven, strong influence on a stock's price performance in the near term. The connection here is straightforward and positive: when earnings estimates are revised upward, the stock price generally follows suit, increasing as well.
The Zacks Rank, our proprietary stock rating tool, comes with an externally validated impressive track record. It effectively utilizes shifts in earnings projections to act as a dependable barometer for forecasting short-term stock price trends.
At the moment, Haemonetics has a Zacks Rank #3 (Hold), signifying that its performance may align with the overall market trend in the upcoming period. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> .
A Look at Haemonetics' Recent Stock Price PerformanceThe stock has increased by 12.6% over the past month compared to the 2.5% increase of the Zacks S&P 500 composite. Meanwhile, the Zacks Medical sector, which includes Haemonetics,has increased 3.3% during this time frame. Over the past three months, the company's shares have experienced a gain of 51.2% relative to the S&P 500's 5.1% increase. Throughout this period, the sector overall has witnessed a 12.9% increase.
Haemonetics NYSE: HAE reported a stronger start to fiscal 2027, with first-quarter revenue rising 6% year over year to $339 million and adjusted diluted earnings per share increasing 4% to $1.14. The company raised its full-year revenue outlook, citing broad-based growth across its MedSurg and apheresis businesses, while maintaining a disciplined stance on assumptions for the remainder of the year.
Chief Executive Officer Chris Simon said the quarter reflected investments in the company’s portfolio, operating model and commercial execution. “All three of our core platforms contributed to our performance this quarter,” Simon said, pointing to plasma, blood management technologies and interventional technologies.
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MedSurg Growth Led by Blood Management and Vascular Closure MedSurg revenue increased 6% on both a reported and organic basis to $148 million. Blood management technologies grew 8% organically, driven by double-digit growth in hemostasis and transfusion management, partly offset by slower cell salvage capital upgrades.
Hemostasis management posted mid-teens disposable growth as utilization increased across the installed base and the company gained share, according to Simon. He said demand for the HN cartridge supported the expansion of viscoelastic testing applications. The TEG business has grown at an average annual rate of 15% over the past five years, he said, with disposable products accounting for roughly 85% of TEG revenue.
Transfusion management also benefited from software implementations and faster customer activations, which the company said are expanding its recurring revenue base.
Interventional technologies returned to organic growth of 3%, led by low-double-digit growth in vascular closure. Simon said VASCADE MVP and VASCADE MVP XL gained momentum in the U.S., while electrophysiology helped offset softness in peripheral and coronary procedures and esophageal cooling.
The company attributed vascular closure performance to a stabilizing pulse field ablation, or PFA, market; investments in sales and marketing; and the expanded indication for VASCADE MVP XL for use with outer diameters up to 17 French. Simon said PFA penetration in atrial fibrillation procedures is now estimated at 80% to 85%, supporting an access-site market growth rate of approximately 6% to 7%.
Haemonetics also highlighted a real-world Emory University study involving more than 1,600 patients using VASCADE MVP XL in large-bore sheath procedures. The study showed rapid hemostasis, more than 92% same-day discharge and what the company described as an excellent safety profile.
Plasma Revenue Advances as Persona PLUS Rollout Accelerates Apheresis revenue rose 5% on a reported basis and 6% organically to $191 million. Plasma revenue grew 8% organically, supported by double-digit global disposable growth, customer share gains, collection activity and the rollout of Persona PLUS.
Simon said U.S. customer collections increased in the high-single-digit to low-double-digit range, including favorable ordering patterns. North American disposables rose in the mid-20% range during the quarter, while European sales increased by double digits.
Persona PLUS is a firmware upgrade designed to improve plasma yield, center productivity and cost per liter. The rollout is ahead of schedule, Simon said, and early adopters have achieved yield gains exceeding 5% compared with earlier Persona offerings. The company said it is converting 30 to 40 collection centers per week, while its guidance only includes contracted deployments with committed implementation timelines.
Other apheresis revenue declined 3% organically, which management attributed to portfolio optimization and order timing. Haemonetics raised its fiscal 2027 apheresis revenue outlook to low- to mid-single-digit growth, though it retained its assumption that underlying collection volume will grow 0% to 2% for the year.
Margins, Cash Flow and Capital Allocation First-quarter gross margin was 60.4%, down 40 basis points from the prior-year period. Chief Financial Officer James D’Arecca said the comparison was affected by approximately $14 million of upfront software license revenue recognized in the first quarter of fiscal 2026, which added about 200 basis points to the prior-year gross-margin result. Excluding that benefit, the company said adjusted gross margin expanded through product mix, pricing, Persona PLUS adoption and manufacturing execution.
Operating expenses rose 7% to $126 million, reflecting higher personnel costs, self-insured benefit plans, the Vivasure Medical acquisition and freight expense. Adjusted operating margin was 23.4%, down 70 basis points year over year, though management said it expanded after accounting for the prior-year software benefit.
D’Arecca reaffirmed the company’s expectation for 50 to 100 basis points of adjusted operating-margin expansion in fiscal 2027. He said the company expects to offset external cost pressures through revenue growth, product mix, Persona PLUS, productivity initiatives and tariff recovery.
Operating cash flow reached $52 million, about three times the prior-year level. Free-cash-flow conversion was 75% of adjusted net income in the first quarter and 106% over the trailing 12 months. Haemonetics repaid $50 million on its revolving credit facility during the quarter and another $50 million after quarter-end. Cash totaled $223 million at quarter-end, while net leverage was about 2.69 times EBITDA under its credit agreement. The company reaffirmed its fiscal 2027 free-cash-flow conversion target of approximately 80% of adjusted net income. Management said it currently prioritizes organic growth investments and debt reduction, while retaining flexibility for opportunistic share repurchases. Haemonetics has $325 million remaining under its share repurchase authorization after buying back $100 million of stock last year, according to Simon.
Raised Revenue Outlook Haemonetics raised fiscal 2027 reported revenue growth guidance to 5% to 8% and organic revenue growth guidance to 4% to 7%. D’Arecca said adjusted earnings per share is expected to grow broadly in line with the increased reported revenue outlook.
Management said the higher outlook incorporates first-quarter outperformance, while assumptions for the remaining three quarters are largely unchanged. The company’s guidance is adjusted for the impact of a 53rd week and excludes foreign exchange effects and the exit of its Liquid Solutions business when measuring organic growth.
Simon also said Haemonetics expects a potential Japanese approval for the VASCADE MVP XL label expansion later in the fiscal year, although it has not included related benefits in its forecast. The company is also in discussions with the U.S. Food and Drug Administration regarding PerQseal Elite and has included launch costs, but not potential revenue, in its plans.
About Haemonetics (NYSE:HAE)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.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Haemonetics (HAE - Free Report) came out with quarterly earnings of $1.14 per share, beating the Zacks Consensus Estimate of $1.07 per share. This compares to earnings of $1.1 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of +6.54%. A quarter ago, it was expected that this provider blood management systems for health care providers and blood collectors would post earnings of $1.28 per share when it actually produced earnings of $1.29, delivering a surprise of +0.78%.
Over the last four quarters, the company has surpassed consensus EPS estimates four times.
Haemonetics, which belongs to the Zacks Medical - Products industry, posted revenues of $339.38 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 3.49%. This compares to year-ago revenues of $321.39 million. The company has topped consensus revenue estimates four times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Haemonetics shares have added about 4.3% since the beginning of the year versus the S&P 500's gain of 12.8%.
What's Next for Haemonetics?While Haemonetics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Haemonetics was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.30 on $343.02 million in revenues for the coming quarter and $5.21 on $1.4 billion in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Products is currently in the bottom 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
One other stock from the same industry, Phibro Animal Health (PAHC - Free Report) , is yet to report results for the quarter ended June 2026.
This maker of animal health products and nutritional supplements is expected to post quarterly earnings of $0.72 per share in its upcoming report, which represents a year-over-year change of +26.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Phibro Animal Health's revenues are expected to be $366.14 million, down 3.3% from the year-ago quarter.
Financial release and supplemental presentation accessible online
, /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that financial results for its first quarter fiscal year 2027, which ended June 27, 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 August 6, 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 August 6, 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:
First Quarter Fiscal 2027 Earnings Release First Quarter Fiscal 2027 Supplemental Earnings Presentation 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.
Pharvaris is positioned to build a vertically integrated HAE franchise with deucrictibant in both immediate-release (IR) and extended-release (XR) forms. PHVS's NDA for deucrictibant IR was accepted by the FDA, with a PDUFA date set for April 23, 2027, following strong Phase 3 RAPIDe-3 results. The CHAPTER-3 Phase 3 data for deucrictibant XR, expected Q3 2026, is the pivotal catalyst determining PHVS's potential as an end-to-end HAE platform.
, /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions designed to improve patient outcomes, today announced publication of a study providing new evidence supporting the safety and efficacy of Haemonetics' VASCADE MVP® XL venous vascular closure system in large-bore sheath procedures. The retrospective cohort study represents the largest reported cohort using the VASCADE MVP XL system to date.
Conducted at Emory University and funded by a grant from Haemonetics, the single center retrospective study by an experienced user evaluated real-world outcomes in 1,623 patients who received the VASCADE MVP XL system following large bore (maximum 17F outer diameter (OD) sheaths) venous access electrophysiology procedures, including pulsed field ablation (PFA) for Atrial Fibrillation (AF), left atrial appendage closure (LAAC) or concomitant procedures. Results demonstrated that the VASCADE MVP XL system achieved rapid hemostasis (median 2 minutes), a 92.5% same-day discharge rate with a median time to discharge of 3.5 hours, and a strong safety profile with 1.2% overall vascular complications with no surgical interventions required.
"With real-world clinical evidence from a large and diverse patient population, we continue to demonstrate the VASCADE MVP XL system's consistent performance in large-bore venous closure," said Ken Crowley, Vice President and General Manager, Interventional Technologies at Haemonetics. "As physicians seek innovative closure technologies to help improve clinical outcomes and patient experiences across PFA, LAAC and concomitant procedures, VASCADE MVP XL is providing electrophysiology teams with a safe, reliable and effective solution delivering rapid hemostasis and enabling same-day discharge."
The study's corresponding author, David B. De Lurgio, M.D., Medical Director of Electrophysiology at Emory Saint Joseph's Hospital and professor of medicine at Emory University School of Medicine said, "What is particularly notable is that same-day discharge was consistently achieved, even with sheaths larger than historically used in device-based closure. With more than 1,600 patients in this cohort, the findings provide additional real-world evidence across a broad range of patients and procedures, including those with higher comorbidities in LAAC and concomitant cases."
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 OD procedural sheaths. The VASCADE MVP XL system is approved for vascular closure following procedures using market-leading technologies for PFA to treat atrial fibrillation such as Abbott's Volt® PFA System, Boston Scientific's FARAPULSE® and Medtronic's Sphere-9® catheter, and LAAC solutions, including Boston Scientific's WATCHMAN TruSteer®. FDA approval was supported by clinical evidence from the AMBULATE EXPAND trial, demonstrating that the VASCADE MVP XL system achieved rapid hemostasis with no complications and enabled same day discharge.1 VASCADE MVP XL is the only extravascular venous closure system clinically proven in electrophysiology procedures using up to 17F OD procedural sheaths.
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.
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. 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.
1 See Instruction for Use (IFU 4911) for complete details and safety information.
Investor Contacts:
Olga Guyette, Vice President-Investor Relations & Treasury
The market expects Haemonetics (HAE - Free Report) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.
The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 6. On the other hand, if they miss, the stock may move lower.
While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.
Zacks Consensus EstimateThis provider blood management systems for health care providers and blood collectors is expected to post quarterly earnings of $1.07 per share in its upcoming report, which represents a year-over-year change of -2.7%.
Revenues are expected to be $327.95 million, up 2% from the year-ago quarter.
Estimate Revisions TrendThe consensus EPS estimate for the quarter has been revised 0.15% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.
Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts.
Price, Consensus and EPS Surprise
Earnings WhisperEstimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).
The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.
Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.
A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.
Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).
How Have the Numbers Shaped Up for Haemonetics?For Haemonetics, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -4.67%.
On the other hand, the stock currently carries a Zacks Rank of #4.
So, this combination makes it difficult to conclusively predict that Haemonetics will beat the consensus EPS estimate.
Does Earnings Surprise History Hold Any Clue?Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.
For the last reported quarter, it was expected that Haemonetics would post earnings of $1.28 per share when it actually produced earnings of $1.29, delivering a surprise of +0.78%.
Over the last four quarters, the company has beaten consensus EPS estimates four times.
Bottom LineAn earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.
That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.
Haemonetics doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.
Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar.
, /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, announced today that Martin Madaus has been elected to the Company's Board of Directors, effective July 24, 2026.
Dr. Madaus brings more than 30 years of leadership experience in the diagnostics and life sciences tools industries, having helped drive corporate strategy, commercial growth and operational transformation as both a chief executive officer and a board member. He currently serves as Senior Operating Executive at The Carlyle Group, where since 2019 he has advised on healthcare investments and portfolio company performance. Previously, Dr. Madaus served as Chairman and Chief Executive Officer of Ortho Clinical Diagnostics, Inc. (now QuidelOrtho Corporation), a global provider of in vitro diagnostics, where he led the company's business turnaround following its carve-out from Johnson & Johnson. Earlier, as Chairman, President and Chief Executive Officer of Millipore Corporation, he led the company's transformation into a leading life sciences company, culminating in its acquisition by Merck KGaA in 2010. Before Millipore, Dr. Madaus served as President and Chief Executive Officer of Roche Diagnostics North America.
In addition to his executive leadership experience, Dr. Madaus is an active board leader and currently serves as Chair of the Board of Repligen Corporation and as a member of the board of directors of Azenta, Inc. He holds a Doctor of Veterinary Medicine from the University of Munich in Germany and a Ph.D. in Veterinary Medicine from the Veterinary School of Hanover in Germany.
"Martin has built and transformed some of the world's leading healthcare companies and brings deep operational, commercial and strategic leadership experience to our Board," said Ellen Zane, Chair of Haemonetics' Board of Directors. "His track record of leading complex global organizations, driving operational excellence and creating shareholder value will be invaluable as Haemonetics continues to execute its strategy, expand its leadership across attractive end markets and deliver long-term value for patients, customers and shareholders."
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, Vice President-Investor Relations & Treasury
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.
