隶属于 基立福
Global healthcare company and leading producer of plasma-derived medicines, founded in Barcelona, Catalonia, Spain in 1909; serves over 110 countries with products spanning immunology, infectious diseases, pulmonology, and critical care.
相关临床试验
60
12 进行中
药物批准
52
批准总数
监管机构
5
监管机构数
成立时间
1940
进行中（未招募）
11
18.3%
已完成
34
56.7%
Enrolling By Invitation
1
1.7%
招募中
7
11.7%
终止
5
8.3%
撤回
2
3.3%
- QuidelOrtho reported second-quarter 2026 total revenue of $631 million, up 3% as reported and 2% in constant currency, with ex-China revenue growing 6%. - China revenue declined 23% year over year as customers reduced inventories ahead of proposed In Vitro Diagnostics (IVD) pricing guidelines, prompting a downward revision of full-year guidance. - The company lowered full-year 2026 revenue guidance to $2.52–$2.60 billion and adjusted EPS to $0.65–$0.90, while withdrawing free-cash-flow guidance amid uncertainty. - Adjusted EBITDA rose 21% to $129 million with margin expansion of 310 basis points, and the company highlighted the commercialization of its Neulixa point-of-care molecular platform.
- Grifols has dosed the first patients in two separate Phase 3 trials, SIGMA and XPERT, aiming to expand U.S. indications for its immunoglobulin products Gamunex-C and Xembify. - The SIGMA trial will evaluate Gamunex-C for preventing infections in patients with secondary immunodeficiency due to blood cancers including CLL, multiple myeloma, and non-Hodgkin lymphoma. - The XPERT trial will assess whether Xembify is non-inferior to Gamunex-C as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). - These trials build on Grifols' existing immunoglobulin portfolio, with Xembify already having received an FDA expanded label in July 2024 for treatment-naïve primary immunodeficiency patients.
- Grifols announced the U.S. launch of FESILTY, a new human fibrinogen concentrate approved by the FDA for acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency. - FESILTY offers rapid reconstitution in approximately three minutes, room-temperature storage, and predictable dosing without the need for crossmatching, unlike cryoprecipitate or fresh frozen plasma. - FDA approval was supported by a Phase I/III study (NCT02065882) with results published in Thrombosis and Haemostasis (2025) and Thrombosis Research (2026) confirming pharmacokinetics, hemostatic efficacy, and safety. - The launch expands Grifols' bleeding management portfolio and plasma-derived medicines offering for patients with this rare inherited coagulation disorder.
- Grifols' Chronos-PD platform identified biological changes associated with Parkinson's disease occurring up to 12 years before clinical diagnosis using advanced proteomics and AI analysis. - The proof-of-concept study analyzed over 2,600 longitudinal plasma samples and measured over 25,000 protein types, making it the most deeply profiled longitudinal proteomic study in Parkinson's disease to date. - Researchers discovered novel early biomarkers including modulation of the CXCL12-cell adhesion molecules-integrin axis, which governs blood-brain barrier integrity and neuroinflammation in Parkinson's disease. - The platform leverages Grifols' repository of more than 100 million plasma samples collected over 15 years, representing one of the world's largest biospecimen collections for disease research.
- The FDA has approved Grifols' fibrinogen, human-chmt (Fesilty) for treating acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency. - The therapy is manufactured by Biotest AG at their advanced facility in Germany and represents the second global approval following Germany's approval in November. - Fesilty is expected to be available in the US market during the first half of 2026, offering a more targeted treatment option compared to existing therapies. - Clinical studies showed the most common adverse reactions included pain in extremity, back pain, hypersensitivity reactions, and pyrexia in more than 2% of patients.
- The FDA has approved an expanded indication for Grifols' antithrombin III (THROMBATE III) to include pediatric patients with hereditary antithrombin deficiency, making it the first and only antithrombin concentrate approved for both adults and children with this rare blood clotting disorder. - The approval was based on extrapolated adult clinical data demonstrating that antithrombin concentrate can be safely and effectively used in pediatric patients with hereditary antithrombin deficiency. - This expansion addresses a significant unmet medical need, as hereditary antithrombin deficiency has one of the highest thrombotic risks among inherited thrombophilias, with 85% of patients experiencing at least one thrombotic episode by age 50. - The approval provides clinicians with added confidence to appropriately use antithrombin concentrate in children, helping to close a long-standing treatment gap for pediatric patients with this rare disorder.
- ABvac40, an investigational amyloid-β vaccine from Grifols, showed a 53% reduction in risk of meaningful cognitive decline compared to placebo in a 24-month phase 2 study of 97 patients with mild cognitive impairment or very mild Alzheimer's disease. - The strongest treatment effects were observed in amyloid-PET positive patients, with those having higher antibody levels showing an 81% reduction in cognitive decline risk. - The vaccine demonstrated a favorable safety profile with no reports of amyloid-related imaging abnormalities-edema or aseptic meningo-encephalo-myelitis, distinguishing it from traditional anti-amyloid therapies. - Results support ABvac40's potential to influence disease progression and warrant further investigation into its impact on brain vessels as a potential mechanism for cognitive benefits.
- BioCryst Pharmaceuticals announced that CEO Jon Stonehouse will retire on December 31, 2025, with current Chief Commercial Officer Charlie Gayer set to succeed him as president in August and CEO in January 2026. - Gayer led the successful commercial launch of ORLADEYO (berotralstat), the first oral prophylactic therapy for hereditary angioedema, driving exceptional revenue growth with expected peak sales of $1 billion. - The leadership transition comes as BioCryst has matured into a profitable company generating increasing cash resources through ORLADEYO revenue while advancing a promising pipeline of rare disease therapies. - Gayer brings over 10 years of experience at BioCryst and extensive rare disease commercial expertise from previous roles at Talecris Biotherapeutics, Grifols, and GlaxoSmithKline.
- Cingulate Inc. has appointed Nilay Patel as Chief Legal Officer ahead of submitting a new drug application to the FDA for CTx-1301, an innovative ADHD treatment. - The company's lead candidate CTx-1301 utilizes proprietary Precision Timed Release technology to deliver three precisely timed medication releases in a single tablet. - ADHD affects over 20 million diagnosed patients in the U.S., with current treatments failing to provide full active-day duration of action. - CTx-1301 is designed to address the long-standing challenge of providing entire active-day efficacy with rapid onset and extended duration coverage.
- Grifols' fibrinogen concentrate BT524 met its primary endpoint in the Phase III AdFIrst trial, demonstrating non-inferiority to standard of care for treating bleeding in acquired fibrinogen deficiency during major surgery. - The study showed BT524 reduced intraoperative blood loss by 279 mL compared to fresh frozen plasma/cryoprecipitate, with significantly lower thromboembolic events. - BT524 is on track for European launch later this year and U.S. approval in early 2026, potentially transforming hemorrhage management in surgical settings. - The positive results were published in The Lancet's eClinicalMedicine and presented at the International Society on Thrombosis and Haemostasis Congress.
