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TAKHZYRO Solution for Injection in 2 mL Pre-Filled Pen is Now Approved to Facilitate Subcutaneous Administration in Adolescent (Aged 12 Years and Above) and Adult Patients with HAE.1 The Pre-Filled Pen Option is Designed to Allow for An Individualized Treatment Approach for Adolescent and Adult HAE Patients. In the EU, TAKHZYRO is Approved for Routine Prevention of Recurrent HAE Attacks in Patients Aged 2 Years and Older.1 ZURICH , Feb. 24, 2025 /PRNewswire/ -- Takeda (TSE: 4502) (NYSE: TAK) announced today that the EMA has approved an additional 2 mL pre-filled pen option for TAKHZYRO® (lanadelumab) for subcutaneous administration in adolescents (aged 12 years and above) and adult patients with Hereditary Angioedema (HAE).1 The additional subcutaneous administration option expands Takeda's offering in this space, showing dedication to the HAE community while providing individualized treatment options to support patients with a life-threatening disease, by helping to reduce HAE burden

prnewswire.com 2025 Feb 24
HAE Stock News Image - prnewswire.com

ANDEMBRY® is a first-in-class monoclonal antibody treatment that inhibits activated Factor XII (FXIIa), the initiating factor in the HAE pathway, and offers the first pre-filled pen presentation enabling once-monthly subcutaneous administration The approval is based on the results of the international pivotal Phase 3 VANGUARD trial, which included HAE patients from Japan CSL is dedicated to improving the lives of those with HAE – a community that we have proudly supported for more than 40 years TOKYO , Feb. 20, 2025 /PRNewswire/ -- CSL Behring K.K. (Headquarters: Minato-ku, Tokyo; President and Representative Director: Izumi Yoshida) today announced that it has received manufacturing and marketing approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for ANDEMBRY® (garadacimab) Subcutaneous (S.C.

prnewswire.com 2025 Feb 20
HAE Stock News Image - seekingalpha.com

Astria Therapeutics' strong cash position and efficient spending provide a financial runway through mid-2027, reducing dilution risk and supporting pivotal trials for navenibart and STAR-0310. Navenibart, targeting hereditary angioedema, shows promising Phase 1b/2 data with a 90-95% reduction in attack rates, positioning it as a potential best-in-class treatment. STAR-0310, aimed at atopic dermatitis, leverages OX40 inhibition and YTE half-life extension technology, though it faces stiff competition and must prove differentiation.

seekingalpha.com 2025 Feb 17
HAE Stock News Image - prnewswire.com

- ANDEMBRY®, the first and only once-monthly treatment targeting factor XIIa to prevent attacks in HAE patients, inhibits plasma protein factor XIIa, which initiates the cascade of events leading to angioedema at various sites of the body- ANDEMBRY reinforces CSL's decades-long commitment to delivering innovative treatment modalities to the HAE community and comes with a convenient patient-centric pre-filled pen (auto-injector) enabling subcutaneous self-injection- Supported by the Phase 3 VANGUARD trial, this marks the third regulatory approval for ANDEMBRY, which was also recently approved by Australia's Therapeutic Goods Administration (TGA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in January MARBURG, Germany, Feb. 13, 2025 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced that the European Commission (EC) has approved ANDEMBRY® (garadacimab), the first and only once-monthly treatment targeting factor XIIa to

prnewswire.com 2025 Feb 13
HAE Stock News Image - zacks.com

Haemonetics' third-quarter fiscal 2025 results reflect the positive effects of the company's long-range plan with meaningful earnings growth and margin expansion.

zacks.com 2025 Feb 07
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Haemonetics Corporation (NYSE:HAE ) Q3 2025 Earnings Conference Call February 6, 2025 8:30 AM ET Company Participants Olga Guyette - Vice President, Investor Relations and Treasury Christopher Simon - President and Chief Executive Officer James D'Arecca - EVP and Chief Financial Officer Conference Call Participants Anthony Petrone - Mizuho Financial Group Marie Thibault - BTIG David Turkaly - Citizens JMP Andrew Cooper - Raymond James Mike Matson - Needham & Company Craig Bijou - Bank of America Securities Michael Petusky - Barrington Research Larry Solow - CJS Securities Operator Good day, and welcome to the Haemonetics Third Quarter Fiscal Year 2025 Conference Call and Webcast. At this time, all participants are in a listen-only-mod.

seekingalpha.com 2025 Feb 06
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Although the revenue and EPS for Haemonetics (HAE) give a sense of how its business performed in the quarter ended December 2024, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.

zacks.com 2025 Feb 06
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Haemonetics (HAE) came out with quarterly earnings of $1.19 per share, in line with the Zacks Consensus Estimate. This compares to earnings of $1.04 per share a year ago.

zacks.com 2025 Feb 06
HAE Stock News Image - prnewswire.com

Financial release accessible online BOSTON , Feb. 6, 2025 /PRNewswire/ -- Haemonetics Corporation (NYSE: HAE) announced that financial results for its third quarter fiscal year 2025, which ended December 28, 2024, are available on its Investor Relations website. 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.

prnewswire.com 2025 Feb 06
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Wondering how to pick strong, market-beating stocks for your investment portfolio? Look no further than the Zacks Style Scores.

zacks.com 2025 Jan 24
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