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—Expands BioCryst portfolio of targeted oral prophylactic therapy options to meet patients’ individual needs and preferences— 

—ORLADEYO is the first and only targeted oral prophylactic therapy with options for HAE patients aged 2 and above—

RESEARCH TRIANGLE PARK, N.C., Oct. 21, 2026 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for use of the oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in adults and adolescents aged 12 years and older. The new 150 mg ORLADEYO pellet formulation provides an alternative administration option for adults and adolescents who may have difficulty swallowing, prefer not to take a capsule or choose to remain on a pellet formulation beyond age 12. 

With this approval, prescribers can now provide their adult and adolescent patients with the option to take once-daily, orally administered ORLADEYO for prophylaxis to prevent attacks of HAE in either capsule or pellet formulation. The ORLADEYO pellet formulation 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.

“We are focused on advancing HAE attack prevention through a portfolio of therapies designed to support the diverse needs and preferences of patients,” said Charlie Gayer, President and Chief Executive Officer of BioCryst. “The approval of ORLADEYO pellets for adults and adolescents strengthens our ability to provide personalized treatment choice by offering the proven efficacy of ORLADEYO in a new formulation to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule. This milestone reflects our commitment to optimizing the management of HAE with proven therapies that help address the evolving needs of patients across the treatment landscape.”

ORLADEYO is the first and only targeted oral prophylactic therapy for patients with HAE aged 2 and above. A capsule formulation of ORLADEYO received 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 was approved by FDA for prophylactic therapy in pediatric patients in the U.S. with HAE aged 2 to <12 years.

Across two clinical studies, ORLADEYO capsules (150 mg) resulted in sustained attack prevention in patients 12 years and older with a mean attack-rate reduction of 91% at 96 weeks and an 88% reduction in rescue medication use 1​. ORLADEYO was safe and well tolerated in both trials. The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were gastrointestinal reactions and back pain. These gastrointestinal reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time, and typically self-resolved.

The FDA approval was based on chemistry, manufacturing, and controls information and data demonstrating the safety and tolerability of the ORLADEYO pellet formulation compared to ORLADEYO capsules.

BioCryst is committed to providing support every step of the way and offers Empower Patient Services, a single stop for all patient and HCP ORLADEYO needs. It combines a specialty pharmacy and patient support program with a dedicated team of experts who provide individualized and streamlined support navigating the insurance process, affordability, adherence, and related needs.

To download multimedia: https://www.globenewswire.com/NewsRoom/AttachmentNg/91e297e1-8672-4a7b-aa7a-ad4bfe93ea47

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.

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 oral pellet formulation of ORLADEYO for patients with HAE. 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 pellet formulation; the commercial viability of ORLADEYO oral pellets, including their ability to achieve market acceptance; 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; and the FDA 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.

Contact:

Investors:
[email protected]

Media:
[email protected]

1 Kiani-Alikhan S, Gower R, Craig T, et al. Once-daily oral berotralstat for long-term prophylaxis of hereditary angioedema: the open-label extension of the APeX-2 randomized trial. J Allergy Clin Immunol Pract. 2024;12(3):733-743.e10.

ORLADEYO® (berotralstat) oral pellets 150 mg BioCryst Pharmaceuticals, Inc.

Haemonetics Corporation (NYSE:HAE – Get Free Report)’s stock price hit a new 52-week high during trading on Wednesday. The company traded as high as $123.77 and last traded at $121.8850, with a volume of 829,190 shares trading hands. The stock had previously closed at $122.06.

Analysts Set New Price Targets HAE has been the subject of a number of analyst reports. Barrington Research boosted their price target on Haemonetics from $118.00 to $140.00 and gave the stock an “outperform” rating in a report on Friday, October 9th. JPMorgan Chase & Co. upped their price objective on Haemonetics from $62.00 to $86.00 and gave the company a “neutral” rating in a research report on Friday, August 7th. Raymond James Financial increased their price objective on Haemonetics from $105.00 to $125.00 and gave the company an “outperform” rating in a research note on Thursday, September 3rd. Robert W. Baird lifted their price objective on Haemonetics from $96.00 to $119.00 and gave the stock an “outperform” rating in a research report on Friday, August 21st. Finally, Wall Street Zen raised shares of Haemonetics from a “buy” rating to a “strong-buy” rating in a research note on Saturday, August 8th. One equities research 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. According to data from MarketBeat.com, the stock currently has a consensus rating of “Moderate Buy” and an average target price of $110.00.

Read Our Latest Stock Report on HAE

Haemonetics Price Performance The company has a market capitalization of $5.53 billion, a PE ratio of 59.63, a PEG ratio of 2.42 and a beta of 0.61. The company has a current ratio of 3.08, a quick ratio of 1.91 and a debt-to-equity ratio of 1.40. The company’s 50 day moving average price is $104.90 and its 200-day moving average price is $81.38. Haemonetics (NYSE:HAE – Get Free Report) last released its quarterly earnings data on Thursday, August 6th. The medical instruments supplier reported $1.14 EPS for the quarter, topping analysts’ consensus estimates of $1.08 by $0.06. The company had revenue of $339.38 million for the quarter, compared to the consensus estimate of $327.86 million. Haemonetics had a return on equity of 27.55% and a net margin of 7.12%. The company’s quarterly revenue was up 5.5% compared to the same quarter last year. During the same period last year, the business posted $1.10 EPS. On average, sell-side analysts forecast that Haemonetics Corporation will post 5.29 earnings per share for the current fiscal year.

Institutional Investors Weigh In On Haemonetics Several institutional investors have recently bought and sold shares of the business. Nierenberg Investment Management Company LLC purchased a new position in Haemonetics in the second quarter valued at about $1,971,000. Rice Hall James & Associates LLC purchased a new stake in shares of Haemonetics in the second quarter worth about $3,828,000. Renaissance Technologies LLC acquired a new stake in shares of Haemonetics in the first quarter valued at about $2,435,000. Quantinno Capital Management LP grew its stake in shares of Haemonetics by 438.0% in the first quarter. Quantinno Capital Management LP now owns 30,708 shares of the medical instruments supplier’s stock valued at $1,731,000 after buying an additional 25,000 shares in the last quarter. Finally, Aurora Investment Counsel acquired a new stake in shares of Haemonetics in the second quarter valued at about $1,913,000. 99.67% of the stock is currently owned by hedge funds and other institutional investors.

Haemonetics Company Profile (Get Free Report)

Haemonetics Corporation (NYSE: HAE) is a medical technology company that develops and supplies products and software for blood management. Its solutions are used to collect, process, manage and analyze blood and blood components, helping healthcare providers and blood and plasma collection organizations improve the availability, safety and efficiency of transfusion-related care.

The company’s portfolio includes plasma and blood component collection systems, disposable collection and processing kits, surgical blood recovery and autotransfusion systems, and technologies used to assess coagulation and hemostasis.

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Key Takeaways Haemonetics shares surged 149.3% in a year, defying the industry's 26.8% decline amid MedSurg growth.
HAE's MedSurg revenues rose 6% to $148.1 million in fiscal Q1 2027, aided by Blood Management growth.
HAE's NexSys PCS upgrades support growth, but competition and unfavorable currency trends pose risks.

Haemonetics Corporation’s (HAE - Free Report) impressive MedSurg business 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, fierce competitive pressure and unfavorable foreign exchange remain concerns for HAE’s operations. 

In the past year, this Zacks Rank #3 (Hold) company’s shares have gained 149.3% against the industry’s decline of 26.8%. The S&P 500 composite has grown 18% 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 5.97%.

Let us delve deeper.

Haemonetics’ Key UpsidesMedSurg Growth Broadens: Haemonetics’ MedSurg business is supported by Blood Management Technologies and Interventional Technologies, giving the company multiple avenues for growth. Recent acquisitions expanded the portfolio through Vivasure Medical, Attune Medical and OpSens, adding vascular closure, esophageal protection and sensor-guided technologies.

In the first quarter of fiscal 2027, MedSurg revenues increased 6.0% on a reported basis and 5.9% organically to $148.1 million. Blood Management Technologies grew 8.1% organically, with double-digit growth in Hemostasis and Transfusion Management partly offset by slower Cell Salvage capital upgrades. Transfusion Management continued to benefit from software implementations and faster customer activations, expanding the recurring revenue base.

Interventional Technologies returned to growth, increasing 2.8% organically as Vascular Closure grew in the low double digits. VASCADE MVP and MVP XL benefited from renewed U.S. momentum, broader utilization and the expanded MVP XL indication for sheaths up to 17F outer diameter. 

NexSys PCS Platform Continues to Advance: Haemonetics’ FDA-cleared NexSys PCS plasma collection system is designed to increase plasma yield, improve center productivity, enhance the donor experience and support safe, reliable collections. The bi-directionally connected NexSys PCS with NexLynk DMS has historically reduced donor door-to-door time by an average of 16 minutes. 

Persona Technology further strengthens the platform’s value proposition. Persona PLUS, the latest firmware-based enhancement, is delivering yield improvements above 5% versus earlier Persona offerings and can be deployed without replacing devices. Adoption accelerated in the first quarter of fiscal 2027 and is progressing ahead of schedule. Continued upgrades can deepen customer integration and support higher-value recurring disposable revenues. 

Image Source: Zacks Investment Research

What Ails HAE Stock?Competitive Risks Remain: Haemonetics operates in a 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. 

Foreign Exchange Can Affect Earnings: Haemonetics generates a meaningful share of sales outside the United States and conducts international business in local currencies, including the Japanese yen, euro and Chinese yuan. In the first quarter of fiscal 2027, management said earnings growth was achieved despite unfavorable foreign exchange. Full-year fiscal 2027 guidance assumes a 0-1% currency impact to reported revenues. Currency movements can therefore continue to create volatility in translated sales and earnings. 

HAE’s Estimate TrendThe Zacks Consensus Estimate for fiscal 2026 earnings has remained unchanged at $5.29 per share in the past 30 days.

The Zacks Consensus Estimate for fiscal 2026 revenues is pegged at $1.41 billion, which indicates a 5.9% increase from the year-ago reported number.

Key PicksSome better-ranked stocks in the broader medical space are Phibro Animal Health (PAHC - Free Report) , Abbott (ABT - Free Report) and Globus Medical (GMED - Free Report) .

Phibro Animal Health has an earnings yield of 9.3% compared with the industry’s 2.7% yield. Shares of the company have increased 2.6% against the industry’s 27.9% decline over the past year. PAHC’s earnings outpaced estimates in each of the trailing four quarters, the average surprise being 18.4%. 

PAHC sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Abbott, carrying a Zacks Rank #2 (Buy) at present, has an earnings yield of 5.6% compared with the industry’s 2.6% yield. Its earnings beat estimates in each of the trailing four quarters, the average surprise being 0.8%. ABT shares have plunged 22.5% compared with the industry’s 27.9% decline over the past year.

Globus Medical, currently carrying a Zacks Rank #2, has an earnings yield of 6.8% against the industry’s negative 1.7% yield. Its earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 27.9%. GMED shares have rallied 32.6% compared with the industry’s 7.3% growth over the past year.

Haemonetics (HAE) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

On October 08, 2026, Haemonetics Corp HAE shares experienced a significant rise of 17.5%, bringing the current price to $119.47. The stock has seen remarkable performance over the past year, trading between a 52-week low of $48.17 and a high of $121.00.

GF Value™ verdict: Current price is $119.47, which is 38.3% above the GF Value of $86.40, indicating that the stock is overvalued. GF Score™ of 80/100 suggests a strong overall performance, reflecting good fundamentals. Notable signal: Insider activity shows that insiders bought $0.1 million worth of shares over the past 12 months, with no selling activity. Is HAE Overvalued or Undervalued? The current price of Haemonetics Corp at $119.47 is significantly higher than its GF Value™ estimate of $86.40. This indicates that the stock is approximately 38.3% overvalued, according to GuruFocus' proprietary intrinsic value assessment. The GF Value™ is derived from a combination of historical trading multiples, past business growth, and future performance estimates, providing a comprehensive view of what the stock should be worth based on its fundamentals.

Given that the stock is deemed significantly overvalued, there exists a risk for potential investors. Buying at inflated valuations can lead to disappointing returns if the market corrects itself to reflect more realistic pricing. Even though Haemonetics has shown robust growth and strong fundamentals, the current valuation raises concerns regarding a margin of safety for new investors.

How Does HAE's Valuation Compare to Its History? Metric Current Historical P/E (TTM) 58.3x 35.7x Forward P/E 22.5x N/A Currently, Haemonetics Corp's P/E ratio stands at 58.3x, which is 63% above its 5-year median of 35.7x. The forward P/E ratio of 22.5x suggests that while future earnings may be expected to improve, the current valuation remains high compared to historical levels. This P/E analysis aligns with the GF Value™ verdict, reinforcing the notion that the stock is overvalued based on its historical pricing patterns.

What Does HAE's GF Score™ Tell Us? The GF Score™ assesses various aspects of a company's fundamentals, including financial strength, profitability, growth, valuation, and momentum. Haemonetics Corp has a GF Score™ of 80/100, indicating strong overall performance, but with some areas that warrant caution.

Metric Rating GF Score™ 80 Financial Strength 5/10 Profitability 8/10 Growth 8/10 Valuation 6/10 Momentum 3/10 Haemonetics Corp's strongest areas are its profitability and growth, both rated at 8/10, indicating a solid ability to generate earnings and expand. However, the momentum rank at 3/10 suggests that the stock may not be experiencing strong upward price movement, which could be a concern for short-term investors. The valuation rank of 6/10 confirms that while the company has good fundamentals, its current high valuation poses a risk.

What Are Gurus and Insiders Doing with HAE? Currently, 7 gurus hold shares of Haemonetics Corp, with 5 increasing their positions and 2 trimming their holdings in recent quarters. This suggests a generally positive sentiment among institutional investors, indicating their belief in the company's long-term potential. Additionally, insider activity shows that insiders purchased $0.1 million worth of shares over the past year, and notably, there were no sales. This buying behavior by insiders may reflect their confidence in the company's prospects.

Such patterns of insider buying, combined with the active participation of institutional investors, can serve as a positive signal for potential investors, indicating that informed parties believe in the company's future performance despite its current overvaluation.

What This Means for Investors In summary, Haemonetics Corp is currently overvalued based on the GF Value™ estimate. With a significant premium over its intrinsic value and a high P/E ratio compared to its historical levels, potential investors should approach with caution. While the company has strong fundamentals, including good profitability and growth, the elevated valuation presents risks. For more detailed insights, you can visit the Haemonetics Corp HAE stock page and explore the GF Value™ page for a deeper understanding.

Frequently Asked Questions What is HAE's GF Score™?

Haemonetics Corp has a GF Score™ of 80/100, indicating a strong overall performance based on various fundamental factors.

Is HAE overvalued or undervalued?

According to the GF Value™, HAE is currently overvalued, with a price of $119.47 compared to its intrinsic value of $86.40.

What is HAE's P/E ratio?

HAE's P/E ratio is 58.3x, which is significantly higher than its 5-year median of 35.7x, indicating a higher valuation than 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].

Disclosures I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.

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ZUG, Switzerland, Oct. 05, 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 that insights from a Pharvaris-funded analysis of the multinational Adelphi Real World HAE Disease Specific Programme™ (DSP) dataset evaluating how HAE is managed in clinical practice have been published in Advances in Therapy.

The analysis evaluated real-world patterns of HAE disease management including frequency, severity, and characteristics of HAE attacks; use of long-term prophylaxis (LTP) and on-demand treatment (ODT); patient and physician decision-making around treating or not treating attacks; treatment adherence and reasons for suboptimal adherence; and patient and physician perspectives on treatment satisfaction and unmet needs.

“By incorporating both physician-reported clinical data and patient-reported experiences, this analysis provides a comprehensive view of how hereditary angioedema is managed in routine clinical practice,” said Peng Lu, M.D., Ph.D., President of Pharvaris. “Early diagnosis and effective treatment remain critical, yet this real-world analysis highlights remaining gaps between guideline-recommended care and the actual experience of people with HAE. Addressing these gaps may help improve treatment outcomes, enhance patient satisfaction, and optimize overall disease management. These findings highlight the importance of understanding how treatment decisions are made in real-world settings and the barriers that may still limit alignment with clinical guidelines. At Pharvaris, we are committed to supporting the HAE community by leveraging insights to inform decisions and to identify solutions that may further inform medical care and address the practical and clinical needs of patients and physicians in everyday practice.”

Study Insights
The analysis identified gaps that currently persist between guideline-recommended care and real-world practice. Patient satisfaction with treatment and the decision to change treatment were mostly driven by ease of portability, route of administration, perceived efficacy, and the odds of experiencing adverse events. In addition, treatment burden—particularly related to route of administration, convenience, and integration into daily life—continues to impact patient behavior and satisfaction.

With regards to on-demand treatment of attacks, a substantial proportion of patients do not treat all HAE attacks, most commonly because attacks are perceived as not severe enough to use treatments patients perceive being associated with increased burden. Other reasons included the lack of availability of therapy and pain associated with injectable treatments. With regards to LTP treatment satisfaction, daily oral treatment was preferred over biweekly or monthly injections. These findings highlight ongoing unmet needs and suggest that real-world factors, including patient preferences and treatment usability, play a critical role in treatment outcomes.

Study Details
The analysis used data from the Adelphi Real World HAE DSP, a cross-sectional, retrospective survey conducted between January 2023 and January 2024 across the United States, Europe, and Japan. The study included 225 physicians, who completed record-based assessments for 1,131 patients with HAE, as well as 279 patients who provided direct, self-reported insights through questionnaires. This dual approach enabled comparison of physician-reported clinical data with patient-reported experiences, offering a comprehensive view of real-world HAE management. The survey captured both clinical characteristics and patient perspectives, including treatment behaviors and quality-of-life impact. Although the HAE treatment landscape has evolved between the time of the survey and present, the findings from the study are still considered actual.

The full publication can be found here: https://link.springer.com/article/10.1007/s12325-026-03790-2

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.

Femasys (NASDAQ:FEMY – Get Free Report) and Haemonetics (NYSE:HAE – Get Free Report) are both healthcare companies, but which is the superior stock? We will compare the two businesses based on the strength of their risk, earnings, analyst recommendations, institutional ownership, profitability, dividends and valuation.

Risk and Volatility Femasys has a beta of -2.07, indicating that its stock price is 307% less volatile than the S&P 500. Comparatively, Haemonetics has a beta of 0.54, indicating that its stock price is 46% less volatile than the S&P 500.

Valuation & Earnings This table compares Femasys and Haemonetics”s gross revenue, earnings per share (EPS) and valuation.

Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Femasys $2.29 million 7.65 -$18.63 million ($3.53) -0.59 Haemonetics $1.33 billion 3.61 $97.31 million $2.04 51.86 Haemonetics has higher revenue and earnings than Femasys. Femasys is trading at a lower price-to-earnings ratio than Haemonetics, indicating that it is currently the more affordable of the two stocks.

Profitability This table compares Femasys and Haemonetics’ net margins, return on equity and return on assets.

Net Margins Return on Equity Return on Assets Femasys -534.36% -225.97% -74.68% Haemonetics 7.12% 27.55% 9.65% Analyst Recommendations This is a summary of recent recommendations for Femasys and Haemonetics, as provided by MarketBeat.com.

Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Femasys 1 0 3 0 2.50 Haemonetics 0 4 6 1 2.73 Femasys presently has a consensus target price of $50.00, indicating a potential upside of 2,292.34%. Haemonetics has a consensus target price of $99.78, indicating a potential downside of 5.69%. Given Femasys’ higher probable upside, analysts clearly believe Femasys is more favorable than Haemonetics.

Insider & Institutional Ownership 65.3% of Femasys shares are owned by institutional investors. Comparatively, 99.7% of Haemonetics shares are owned by institutional investors. 7.7% of Femasys shares are owned by insiders. Comparatively, 2.1% of Haemonetics shares are owned by insiders. Strong institutional ownership is an indication that endowments, large money managers and hedge funds believe a company will outperform the market over the long term.

Summary Haemonetics beats Femasys on 12 of the 15 factors compared between the two stocks.

About Femasys (Get Free Report)

Femasys Inc., a biomedical company, develops therapeutic and diagnostic solutions to address unmet women healthcare needs worldwide. The company provides FemVue saline-air device, a contrast-generating product in the United States, Canada, Japan, and Hong Kong; FemCath, a cornual balloon catheter, a single intrauterine directional delivery product that allows for selective evaluation of an individual fallopian tube; and FemCerv, a biopsy device for endocervical curettage, which can be used to sample cervical cells and tissue circumferentially with sample containment within the device to minimize contamination. It also develops permanent birth control solutions, such as FemBloc and FemChec; FemaSeed, an artificial insemination solution; and FemEMB, a product candidate for endometrial sampling in support of uterine cancer detection testing. The company offers its products to reproductive endocrinologists for infertility products, obstetrics-gynecological physicians, related healthcare professionals, and women's healthcare provider organizations. Femasys Inc. was incorporated in 2004 and is headquartered in Suwanee, Georgia.

About Haemonetics (Get Free Report)

Haemonetics Corporation, a healthcare company, provides suite of medical products and solutions in the United States and internationally. The company offers automated plasma collection systems, donor management software, and supporting software solutions including NexSys PCS and PCS2 plasmapheresis equipment and related disposables and solutions, as well as integrated information technology platforms for plasma customers to manage their donors, operations, and supply chain; and NexLynk DMS donor management system and Donor360 app. It also provides automated blood component and manual whole blood collection systems, such as MCS brand apheresis equipment to collect specific blood components from the donor; disposable whole blood collection and component storage sets; SafeTrace Tx blood bank information system; and BloodTrack blood management software, a suite of blood management and bedside transfusion solutions that combines software with hardware components, as well as an extension of the hospital's blood bank information system. In addition, the company offers hospital products comprising TEG and HAS hemostasis analyzer systems that provide a comprehensive assessment of a patient's overall hemostasis; and TEG Manager software, which connects various TEG analyzers throughout the hospital, providing clinicians remote access to active and historical test results that inform treatment decisions. Further, it provides Cell Saver Elite +, an autologous blood recovery system for cardiovascular, orthopedic, trauma, transplant, vascular, obstetrical, and gynecological surgeries; and VASCADE products comprising VASCADE and VASCADE MVP, a technology platform which offers catheter-based delivery system and leverages the natural clot-inducing properties of collagen. The company sells its products through direct sales force, independent distributors, and sales representatives. Haemonetics Corporation was founded in 1971 and is headquartered in Boston, Massachusetts.

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Investors interested in stocks from the Medical - Products sector have probably already heard of Phibro Animal Health (PAHC - Free Report) and Haemonetics (HAE - Free Report) . But which of these two stocks presents investors with the better value opportunity right now? Let's take a closer look.

We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. The Zacks Rank is a proven strategy that targets companies with positive earnings estimate revision trends, while our Style Scores work to grade companies based on specific traits.

Right now, Phibro Animal Health is sporting a Zacks Rank of #2 (Buy), while Haemonetics has a Zacks Rank of #3 (Hold). The Zacks Rank favors stocks that have recently seen positive revisions to their earnings estimates, so investors should rest assured that PAHC has an improving earnings outlook. But this is only part of the picture for value investors.

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.

Our Value category grades stocks based on a number of key metrics, including the tried-and-true P/E ratio, the P/S ratio, earnings yield, and cash flow per share, as well as a variety of other fundamentals that value investors frequently use.

PAHC currently has a forward P/E ratio of 10.06, while HAE has a forward P/E of 20.36. We also note that PAHC has a PEG ratio of 1.02. This metric is used similarly to the famous P/E ratio, but the PEG ratio also takes into account the stock's expected earnings growth rate. HAE currently has a PEG ratio of 2.15.

Another notable valuation metric for PAHC is its P/B ratio of 3.62. Investors use the P/B ratio to look at a stock's market value versus its book value, which is defined as total assets minus total liabilities. By comparison, HAE has a P/B of 5.84.

These metrics, and several others, help PAHC earn a Value grade of A, while HAE has been given a Value grade of C.

PAHC sticks out from HAE in both our Zacks Rank and Style Scores models, so value investors will likely feel that PAHC is the better option right now.

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

 | Source: BioCryst Pharmaceuticals, Inc.

— 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.

Contact:

Investors:
[email protected]

Media:
[email protected]

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.

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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Each stock is assigned a rating of A, B, C, D, or F based on their value, growth, and momentum characteristics. Just like in school, an A is better than a B, a B is better than a C, and so on -- that means the better the score, the better chance the stock will outperform.

The Style Scores are broken down into four categories:

Value ScoreValue investors love finding good stocks at good prices, especially before the broader market catches on to a stock's true value. Utilizing ratios like P/E, PEG, Price/Sales, Price/Cash Flow, and many other multiples, the Value Style Score identifies the most attractive and most discounted stocks.

Growth ScoreGrowth investors are more concerned with a stock's future prospects, and the overall financial health and strength of a company. Thus, the Growth Style Score analyzes characteristics like projected and historic earnings, sales, and cash flow to find stocks that will see sustainable growth over time.

Momentum ScoreMomentum trading is all about taking advantage of upward or downward trends in a stock's price or earnings outlook, and these investors live by the saying "the trend is your friend." The Momentum Style Score can pinpoint good times to build a position in a stock, using factors like one-week price change and the monthly percentage change in earnings estimates.

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How Style Scores Work with the Zacks Rank A proprietary stock-rating model, the Zacks Rank utilizes the power of earnings estimate revisions, or changes to a company's earnings outlook, to help investors create a successful portfolio.

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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To have the best chance of big returns, you'll want to always consider stocks with a Zacks Rank #1 or #2 that also have Style Scores of A or B, which will give you the highest probability of success. If you're looking at stocks with a #3 (Hold) rank, it's important they have Scores of A or B as well to ensure as much upside potential as possible.

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Thus, the more stocks you own with a #1 or #2 Rank and Scores of A or B, the better.

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.

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 Corporation (HAE) Q1 2027 Earnings Call Transcript

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.

Investor Contacts:
Olga Guyette, Vice President-Investor Relations & Treasury       
(781) 356-9763                                                                           
[email protected]                                              

David Trenk, Sr. Manager-Investor Relations
(203) 733-4987
[email protected]

Media Contact:
Josh Gitelson, Sr. Director-Global Communications
(781) 356-9776
[email protected]

SOURCE Haemonetics Corporation

, /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

David Trenk, Sr. Manager-Investor Relations

(781) 356-9763

(203) 733-4987

[email protected]

[email protected]

Media Contact:

Josh Gitelson, Sr. Director-Global Communications

(781) 356-9776

[email protected]

SOURCE Haemonetics Corporation

, /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

(781) 356-9763

[email protected]

David Trenk, Sr. Manager-Investor Relations

(203) 733-4987

[email protected]

Media Contact:

Josh Gitelson, Sr. Director-Global Communications

(781) 356-9776

[email protected]

SOURCE Haemonetics Corporation

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.

For more information about CSL, visit CSL.com.

Media Contacts
Etanjalie Ayala
Mobile: +1 610 297 1069
Email: [email protected] 

Bernadette Murdoch
Mobile: +61 449 950 745
Email: [email protected] 

Investors Contact
Bernard Ronchi
Mobile: +61 3 9389 3470
Email: [email protected] 

ANDEMBRY is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. ANDEMBRY® is a registered trademark of CSL Behring GmbH.

©2026 CSL Behring LLC. USA-AND-0594-JUL26

SOURCE CSL

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%.

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.

Resources Investor Relations Journalists Agencies Client Login Send a Release News Products Contact

, /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

David Trenk, Manager-Investor Relations

(781) 356-9763

(203) 733-4987

[email protected] 

[email protected] 

Media Contact: 

Josh Gitelson, Sr. Director-Global Communications

(781) 356-9776

[email protected] 

SOURCE Haemonetics Corporation

Also from this source

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.

Haemonetics Corporation (HAE) Q4 2026 Earnings Call Transcript