Company: AZN
Filing Date: 2025-04-29
Form Type: 6-K
Source: 0001654954-25-004737
Chunk: 10

Company: ASTRAZENECA PLC
Filing Date: 2025-04-29
Form: 6-K
Chunk 10
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 ALXN1210-TMA-314 
 April 2025       
 New disclosure   | ∗High-level results from the ALXN1210-TM-314                        
 Phase III, single-arm, open label trial                             
 evaluatingUltomirisin paediatric patients with severe HSCT-TMA      
 demonstrated clinically meaningful improvements in the individual   
 components of TMA response (platelets, LDH and urinary              
 protein/creatinine ratio) at 26 weeks. Additionally, results showed 
 a clinically meaningful improvement in the secondary endpoint of    
 overall survival at six months. Further analyses anticipated in H2  
 2025 to assess the statistical significance of the single-arm       
 trial, and separately, the high-level results from the randomised,  
 double-blind, placebo-controlled, Phase III trial in adults and     
 adolescents. Safety profile was consistent with that observed in    
 other approved indications.                                         |
| Approval          
 CN                | CHAMPION-MG      
 April 2025       
 New disclosure   | ∗For adult patients with anti-acetylcholine                         
 receptor antibody-positive gMG                                      |

Koselugo

| Priority Review 
 US              | SPRINKLE       
 February 2025  
 New disclosure | ∗For paediatric patients aged between one and         
 seven years with NF1 who have symptomatic, inoperable 
 PN.                                                   |

Soliris

| Approval 
 US       | NCT03759366    
 March 2025     
 New disclosure | ∗For paediatric patients six years of age and            
 older with anti-acetylcholine receptor antibody-positive 
 gMG.                                                     |

Beyonttra (acoramidis)

| Approval 
 JP       | NCT04622046    
 March 2025     
 New disclosure | ∗For adults with ATTR-CM. |

eneboparatide

| Phase III readout | CALYPSO    
 March 2025 | ∗eneboparatide (AZP-3601), an investigational                     
 parathyroid hormone receptor 1 agonist, met its primary composite 
 endpoint in adults with chronic hypoparathyroidism at 24 weeks.   
 eneboparatide demonstrated a statistically significant benefit by 
 normalising albumin-adjuskted serum calcium levels and achieving  
 independence from active vitamin D and oral calcium therapy       
 compared to placebo. The trial will continue to 52 weeks to fully 
 characterise the risk-benefit profile.                            |

Sustainability

In preparation for new new reporting regulations, AstraZen