Tag: safety profile

Cross-study findings indicate significant clinical benefit of frontline fixed-duration ibrutinib plus venetoclax with improved likelihood of undetectable minimal residual disease and progression-free survival versus acalabrutinib plus venetoclax¹

BRUSSELS and CAMBRIDGE, Mass., June 12, 2025 (GLOBE NEWSWIRE) -- UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today presented additional detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate. In the study, DZP demonstrated significant clinical improvements in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE), as measured by the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) at Week 48, the primary endpoint. Improvements were also seen across additional clinical measures, including fatigue and disease activity/remission. These results were presented at EULAR 2025, the European Alliance of Associations for Rheumatology’s annual meeting, in Barcelona, Spain. The safety and efficacy of DZP in SLE have not been established, and it is not approved for use in SLE by any regulatory authority worldwide. A second Phase 3 trial of dapirolizumab pegol is ongoing with the goal of confirming the results from PHOENYCS GO.

PESG issues a new briefing following PolyPid’s clinical success; Revolutionary 58% Reduction in Surgical Site Infections Positions PolyPid’s D-PLEX100 as Potential New Standard of Care in the Future

US EPA projects taking a regulatory decision by end of September 2025; Dutch authorities finalise first phase of regulatory dossier for EVOCA in Europe 

June 11, 2025, 12:01 AM CET

Tuebingen, Germany, June 10, 2025 – HepaRegeniX GmbH (“HepaRegeniX”), a clinical-stage company advancing novel therapies to treat acute and chronic liver disease, today announced that the first patient has been dosed in their Phase Ib clinical trial of its lead candidate HRX-215. The trial is evaluating the safety and efficacy of HRX-215, an orally available small-molecule inhibitor of MKK4, in patients undergoing partial liver resection due to liver metastases deriving from colorectal cancer. HXR-215 is designed to treat advanced-stage liver disease by increasing the regenerative capacity of hepatocytes. An initial data readout is planned for the second half of 2025.