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\n
\n
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').concat(e.i18n.t("search.voice.permission_text"),"
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\n
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\n
\n
\n
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\n ').concat(e.i18n.t("search.voice.trending_title"),'\n \n
\n
\n
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Corporate Changes & Voting Matters
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GigaGen Receives FDA Clearance of IND Application for Phase 1 Trial of Recombinant Polyclonal for HBV Treatment, GIGA-2339 GIGA-2339 is the first recombinant polyclonal therapeutic in development to treat and functionally cure chronic hepatitis B virus (HBV) infection; trial initiation expected in Q4 2024 Containing more than 1,000 fully human recombinant anti-HBV antibodies, GIGA-2339 reproduces the human body’s natural immune response GigaGen’s recombinant polyclonals are part of Grifols’ robust innovation strategy and commitment to delivering the next generation of antibody drugs for patients and healthcare profe GlobeNewswire • 20 days ago
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Grifols receives expanded XEMBIFY® (immune globulin subcutaneous human-klhw) label in U.S., strengthening its Ig portfolio for patients XEMBIFY is the first and only 20% subcutaneous immunoglobulin (SCIg) with FDA-approved dosing for treatment-naïve patients, enabling them to go straight to SCIg without initial intravenous therapy Approval, which also includes biweekly dosing, follows phase 4 study data demonstrating comparable total Ig levels when administering XEMBIFY every two weeks versus weekly The expanded label for XEMBIFY provides added flexibility and convenience for patients with primary humoral immunodeficiencies Incr GlobeNewswire • 22 days ago
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Grifols’ Biotest to achieve USD 1 billion in US sales of Yimmugo® over next seven years Biotest, a Grifols Group company, is expected to launch its recently FDA-approved intravenous immunoglobulin in the U.S. in first quarter 2025 Yimmugo will be distributed by Kedrion in the U.S. as part of a broader Group channel strategy, with Grifols focusing on continued growth of its current portfolio for this market It adds to Grifols’ strong franchise of intravenous and subcutaneous immunoglobulins to meet growing patient demand for these therapeutics Yimmugo will be followed by other prote GlobeNewswire • last month
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Grifols completes sale of a 20% equity stake in SRAAS and forges strategic alliance with Haier Group With today’s announcement of the transaction completion, Grifols and Haier Group will work together through Shanghai RAAS (SRAAS) to drive synergies that enhance China’s healthcare systemThrough a share purchase agreement Grifols has sold a 20% equity stake in SRAAS to Haier Group for RMB 12.5 billion (approximately EUR 1.6 billion)Grifols and SRAAS extend their exclusive albumin distribution agreement over the next 10 years, and SRAAS has the option to prolong it through 2044Grifols will use al GlobeNewswire • 2 months ago
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Grifols’ Biotest receives FDA approval for innovative Yimmugo® immunoglobulin to treat primary immunodeficiencies With Biotest-developed Yimmugo, Grifols adds to its remarkable franchise of intravenous and subcutaneous immunoglobulins to meet strong demand Yimmugo, already approved for production and marketing in Europe, is the first U.S.-approved medicine in Biotest’s portfolio and is manufactured with an innovative process at Biotest’s new FDA-certified ‘Next Level’ facility U.S. approval of Yimmugo paves the way for other Biotest proteins in late-stage development, including fibrinogen and trimodulin Lau GlobeNewswire • 2 months ago
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Grifols 2023 Annual Report on Form 20-F filed with the SEC Grifols, S.A. ("Grifols") (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announces the filing of its Annual Report on Form 20-F for the fiscal year ended December 31, 2023, with the United States Securities and Exchange Commission ("SEC"). PR Newswire • 3 months ago
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Grifols Celebrates 50 Years of Manufacturing Life-Changing Plasma-Derived Medicines for Patients at Flagship Site in Clayton, N.C. The addition of the Clayton site in 2011 marked a new milestone for Grifols, turning the company into a top-three plasma industry leader and setting the stage for sustained business growth The flagship Grifols campus is a touchstone of Grifols’ leadership in plasma therapeutics, producing about 40% of the company’s total medicinal output globally and helping enhance the quality of life of patients all over the worldAn engineering masterwork, the Clayton site is a model for new Grifols plants whi GlobeNewswire • 4 months ago
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Grifols Procleix ArboPlex Assay® Receives CE Mark, the First and Only 4-in-1 NAT for Arbovirus Screening Grifols’ in vitro nucleic acid test detects four types of arboviruses, helping mitigate the risk of transfusion-transmitted infections Arboviruses are a growing emerging threat, with changes in climate and increasing global connectivity making the geographic spread more prevalent CE mark for Grifols’ Procleix ArboPlex Assay reinforces the company’s leadership in transfusion medicine and commitment to ensuring the safety of the world’s blood supply BARCELONA, Spain, April 04, 2024 (GLOBE NEWSWIRE GlobeNewswire • 4 months ago
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Grifols announces positive topline phase 3 fibrinogen clinical trial results In the AdFIrst study, Biotest's fibrinogen concentrate (FC), BT524, met the primary endpoint, demonstrating its effectiveness in treating acquired fibrinogen deficiency (AFD) as equivalent to standard of care, while maintaining an excellent safety profileRegulatory approval process in Europe and United States set to begin in Q4 2024. It would be the first FC approved for an AFD indication in the U.S. in a global market for AFD with an estimated potential of USD 800 millionThis milestone is part GlobeNewswire • 6 months ago
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Grifols launches new solution to facilitate pre-transfusion compatibility testing in multiple myeloma patients Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world's leading producers of plasma-derived medicines and innovative diagnostic solutions, today announced the launch of its new Grifols sCD38 solution, the industry's first-ever soluble recombinant protein designed to block anti-CD38 antibodies in multiple myeloma patients receiving daratumumab therapy, ensuring quick and accurate blood transfusion tests that are critical for proper treatment. PR Newswire • 8 months ago
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Grifols Completes Cohort 1 in Clinical Study of Alpha-1 15%, Evaluating First-in-Human Subcutaneous Dosing Option for Patients with Alpha1-Antitrypsin Deficiency Study designed to demonstrate impact of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% (Alpha-1 15%), an alpha1 antitrypsin treatment, compared with Liquid Alpha1-Proteinase Inhibitor (Human) intravenousThis first in-human subcutaneous approach to treating alpha1-antitrypsin deficiency, if proven successful in clinical trials, could give patients the convenience and flexibility to administer their medication from home BARCELONA, Spain, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Grifols (MCE: GRF, M GlobeNewswire • 9 months ago
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GigaGen Presents IND-Enabling Data and Phase 1 Trial Strategy for its Novel Anti-CTLA-4 Oncology Drug Candidate, GIGA-564, at SITC 2023 Researchers from the National Cancer Institute will conduct the Phase 1 trial, as established in a recently signed Cooperative Research and Development Agreement (CRADA) GigaGen anticipates trial initiation in 2024 GIGA-564 is a differentiated anti-CTLA-4 antibody with potential to enhance anti-tumor activity and mitigate immune-related toxicities associated with traditional CTLA-4 blockade SAN CARLOS, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing tran GlobeNewswire • 9 months ago
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Araclon Biotech Presents Positive Final Results from Phase 2 Clinical Study of ABvac40 Alzheimer’s Vaccine at CTAD Trial met primary endpoints, confirming vaccine’s safety, tolerability and robust immune response against the Aβ40 peptide in early-stage Alzheimer's patientsABvac40 treatment slowed disease progression up to 38% compared with placebo as measured by the Mini-Mental State Examination scoreVaccine’s unique design offers a new approach to address growing need for effective Alzheimer’s treatments as the prevalence of Alzheimer’s disease is expected to double by the year 2050 in the U.S. alone1 ZARAG GlobeNewswire • 9 months ago
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GigaGen Granted Expansion of Contract with US Department of Defense to Develop Synthetic Human Antibody Treatments for Botulinum Neurotoxins Modified agreement expands total grant value to $11.8M to advance development activities including manufacturing and investigational new drug (IND)-enabling studiesSOUTH SAN FRANCISCO, Calif., Oct. 19, 2023 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today the company has been granted an expansion of its contract with the U.S. GlobeNewswire • 9 months ago
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GigaGen Partners with the National Cancer Institute to Advance Oncology Drug Candidate GIGA-564 Collaboration sets stage for GigaGen’s first oncology asset to enter clinical development GIGA-564 is a differentiated anti-CTLA4 antibody with potential to enhance anti-tumor activity and mitigate immune-related toxicities associated with traditional CTLA-4 blockade GigaGen and NCI will present investigational new drug (IND)-enabling data and clinical trial strategy for GIGA-564 at the 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting SAN CARLOS, Calif., Sept. 28, 2023 (GLOBE NEWSW GlobeNewswire • 10 months ago
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Return | GRFS | IBEX 35... | YTD | -38.11% | +9.60% |
1-Year | -28.59% | +19.47% |
3-Year | -51.26% | +24.38% |