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Grifols, S.A. - GRFS STOCK NEWS

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Grifols, S.A. (NASDAQ: GRFS) is a leading global healthcare company headquartered in Barcelona, Spain, with a legacy of over 75 years dedicated to improving the health and well-being of people around the world. As a vertically integrated plasma derivative producer, Grifols collects plasma and manufactures life-saving plasma-derived therapies. The company’s commitment to innovation and patient care has established it as a benchmark in the plasma collection market and transfusion medicine.

Grifols operates through three main business divisions:

  • Bioscience: This division encompasses all plasma-related activities including research, development, collection, production, and sales of plasma-derived therapies. The acquisition of Talecris in 2011 and Biotest in 2022 significantly expanded the product portfolio, with the biopharma business contributing 84% of sales in 2023.
  • Diagnostic: Providing innovative solutions for safe transfusions, therapy monitoring, and the detection of infectious and autoimmune diseases, this division focuses on research and novel technologies to enhance treatment outcomes and laboratory efficiency.
  • Hospital: Specializing in non-biological pharmaceutical products, the Hospital division meets the diverse needs of healthcare facilities worldwide.

Grifols' latest advancements include the successful phase 4 trial of XEMBIFY® for primary immunodeficiencies, showing non-inferiority in Ig levels with biweekly dosing compared to weekly dosing. Additionally, the phase 2 trial of ABvac40, a potential Alzheimer’s vaccine, demonstrated a robust immune response and some cognitive benefits in patients with early-stage Alzheimer’s disease.

With a global presence in more than 100 countries, Grifols continues to grow its network of plasma donation centers, boasting over 390 locations across North America, Europe, Africa, the Middle East, and China. The company's economic impact in its core countries of operation was EUR 9.6 billion in 2022, generating 193,000 jobs including indirect and induced employment.

Grifols' class A shares are listed on the Spanish Stock Exchange as part of the Ibex-35 (MCE:GRF), while non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and the U.S. NASDAQ through ADRs (NASDAQ:GRFS).

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Biotest, a Grifols Group company, has projected USD 1 billion in U.S. sales of its FDA-approved intravenous immunoglobulin, Yimmugo®, over the next seven years. Expected to launch in Q1 2025, Yimmugo will be distributed by Kedrion in the U.S. This marks Grifols' expansion in the U.S. market for immunodeficiency treatments, leveraging its existing portfolio and new proteins like fibrinogen and trimodulin, both in late-stage development. Yimmugo is the first Biotest product from their new FDA-certified facility in Germany, enhancing Grifols' strategy to meet rising demand for immunoglobulins.

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Grifols has completed the sale of a 20% equity stake in Shanghai RAAS (SRAAS) to Haier Group for RMB 12.5 billion (EUR 1.6 billion). The strategic alliance aims to enhance China's healthcare system through synergies between Grifols' plasma and diagnostic expertise and Haier's healthcare solutions portfolio. Grifols retains a 6.58% stake in SRAAS and a seat on the Board of Directors. The exclusive albumin distribution agreement between Grifols and SRAAS is extended for 10 years, with an option to prolong it to 2044. Proceeds from the sale will be used by Grifols to reduce debt. The collaboration seeks to capitalize on China's growing demand for albumin and expand their footprint in life sciences, clinical medicine, and biotechnology.

The transaction has received regulatory approvals and compliance confirmation from the Shenzhen Stock Exchange. Grifols and SRAAS have worked together for four years, during which the Chinese hemoderivatives market has seen double-digit growth.

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Grifols announced that its subsidiary Biotest has received FDA approval for Yimmugo®, an innovative intravenous immunoglobulin (Ig) to treat primary immunodeficiencies (PID). This approval marks Yimmugo as the first U.S.-approved medicine in Biotest’s portfolio, produced at their FDA-certified facility in Germany. Already approved in Europe, Yimmugo’s U.S. launch is expected in the latter half of 2024. The approval is anticipated to bolster Grifols' revenue and support its growth strategy. Additionally, Biotest has two more plasma proteins in late-stage development aimed at U.S. and other markets.

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Grifols, S.A. has filed its 2023 Annual Report on Form 20-F with the SEC, offering insights into its governance practices and financial performance. The company, a prominent player in the healthcare sector specializing in plasma-derived medicines, aims to provide transparency to investors through this filing.
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Grifols commemorates five decades of producing life-altering plasma-derived medications for patients at its primary facility in Clayton, North Carolina. The establishment of the Clayton site in 2011 propelled Grifols to become a prominent player in the plasma industry, fostering continuous business expansion. The flagship Grifols campus epitomizes the company's dominance in plasma therapeutics, generating significant positive impact on patient care and medical advancements.
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Grifols announces CE mark for Procleix ArboPlex Assay, a test to detect major arboviruses in blood donors, enhancing transfusion safety. The test addresses a significant public health concern due to the spread of arboviruses like dengue and Zika. Grifols aims to improve donor screening efficiency and safety with this innovative solution.
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Grifols announces positive results from Biotest's phase 3 clinical trial for fibrinogen concentrate BT524, showing efficacy in treating acquired fibrinogen deficiency. The regulatory approval process in Europe and the United States is set to begin in Q4 2024, potentially tapping into an USD 800 million market. Grifols' robust innovation strategy is highlighted, balancing internal and external investments to build a diversified portfolio.
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Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS) completes Cohort 1 of Phase 1/2 study evaluating Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15%, a potential breakthrough treatment for alpha1-antitrypsin deficiency. The study aims to demonstrate the effectiveness of a subcutaneous approach compared to intravenous therapy, offering patients the convenience of administering medication from home. This milestone has significant implications for alpha-1 patients, potentially revolutionizing the management of AAT deficiency.
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Healthcare software and services company Bloodbuy has entered into an agreement with Cerus Corporation to offer Pathogen Reduced Cryoprecipitated Fibrinogen Complex (IFC) on its online marketplace. IFC is a pathogen reduced blood component for fibrinogen supplementation with a 5-day post-thaw shelf life. The agreement aims to enhance patient outcomes and address inventory challenges in hospitals and blood centers.
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Araclon Biotech announced positive results from its Phase 2 trial of ABvac40, an active vaccine for the treatment of early-stage Alzheimer's disease. The trial met primary endpoints, confirming the vaccine's safety, tolerability, and robust immune response against the Aβ40 peptide. ABvac40 also showed a 38% reduction in disease progression compared to placebo, as measured by the Mini-Mental State Examination score. The vaccine's unique design targets the C-terminal end of the Aβ40 peptide, potentially preventing harmful reactions and immune triggers. The prevalence of Alzheimer's disease is expected to double by 2050 in the U.S. alone.
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FAQ

What does Grifols, S.A. specialize in?

Grifols specializes in the collection of plasma and the manufacturing of plasma-derived therapies. It also provides diagnostic solutions and non-biological pharmaceutical products.

Where is Grifols headquartered?

Grifols is headquartered in Barcelona, Spain.

What are the main business divisions of Grifols?

Grifols operates through three main divisions: Bioscience, Diagnostic, and Hospital.

What recent advancements has Grifols made?

Recent advancements include the phase 4 trial of XEMBIFY® for primary immunodeficiencies and the phase 2 trial of ABvac40 for early-stage Alzheimer’s disease.

What is Grifols' market presence?

Grifols has a global presence in more than 100 countries and operates over 390 plasma donation centers.

How has Grifols impacted the economy?

In 2022, Grifols' economic impact was EUR 9.6 billion, generating 193,000 jobs including indirect and induced employment.

Where are Grifols' shares listed?

Grifols' class A shares are listed on the Spanish Stock Exchange as part of the Ibex-35 (MCE:GRF). Non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the NASDAQ through ADRs (NASDAQ:GRFS).

What are the core areas of treatment Grifols focuses on?

Grifols focuses on treating conditions in immunology, hepatology, intensive care, pulmonology, hematology, neurology, and infectious diseases.

What is XEMBIFY®?

XEMBIFY® is a 20% solution of purified human immunoglobulin used for treating primary immunodeficiency diseases.

What is the significance of the ABvac40 trial?

The ABvac40 trial showed a robust immune response and some cognitive benefits in early-stage Alzheimer’s disease, indicating its potential as a therapeutic candidate.

Grifols, S.A.

Nasdaq:GRFS

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5.26B
261.43M
54.67%
1.21%
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