Company: GIFLF
Filing Date: 2025-02-26
Form Type: 6-K
Source: 0001104659-25-017501
Chunk: 47

Company: Grifols SA
Filing Date: 2025-02-26
Form: 6-K
Chunk 47
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 immunoglobulin (Ig)           
 Yimmugo®, following recent Food and Drug Administration (FDA) approval to treat primary immunodeficiencies              
 (PID). Yimmugo is the first Biotest medicine to be commercialized in the U.S. from its new FDA-certified “Next          
 Level” production facility in Dreieich, Germany. This Ig is already approved for production and marketing in            
 Europe, where Yimmugo has been commercialized since late 2022.                                                          
 INNOVATION                                                                                                              
 Grifols makes further strides in innovation                                                                             
 Grifols’ innovation pipeline continues to make solid progress focusing on product lifecycle management and new          
 proteins and indications. Fueled by internal research and external innovation, the company achieved its milestones      
 set for 2024, including the Yimmugo FDA approval, Xembify bi-weekly dosing approval, and Fibrinogen regulatory          
 submission, among others.                                                                                               
 Fibrinogen regulatory submissions                                                                                       
 Biotest trials also continue gaining ground. In February 2024, Grifols announced positive results from Biotest’s        
 ADFIRST Phase 3 clinical trial for fibrinogen concentrate, marking significant headway in treating acquired             
 fibrinogen deficiency. The trial achieved its primary goal, demonstrating efficacy equivalent to standard care and an   
 excellent safety profile. It is as effective as standard of care in reducing intraoperative blood loss in patients with 
 AFD. Regulatory submission documents completed in both the EU and US. The expected market launches are in the           
 second half of 2025 in EU and beggining of 2026 in the US. This positions the fibrinogen concentrate to becoming        
 the first fibrinogen concentrate approved for Acquired Fibrinogen Deficiency in the U.S., accessing a global market     
 with significant potential.                                                                                             
 PRECIOSA topline data from its Phase 3 clinical trial                                                                   
 Topline results were released. Although the trial did not meet its primary endpoint of one-year transplant-free         
 survival, an improvement in transplant-free survival, mortality and disease-related complications was observed for      
 patients treated with Albutein 20% plus standard medical treatment (SMT) compared with patients receiving only          
 SMT. Further, a notable improvement in time-to-liver transplant or death at three months was observed for the study     
 treatment plus SMT group of patients, when compared with the patients treated only with SMT. The safety and             
 tolerability profile was favorable, and there