FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer

The U.S. FDA granted an expanded indication to darolutamide, allowing its use with androgen deprivation therapy with or without docetaxel for men with metastatic castration-sensitive prostate cancer. Approval was based on results from the Phase III ARASENS trial, which showed darolutamide significantly reduced risk of death and prolonged time to progression when added to standard therapy. This marks an important milestone, providing a new standard of care for men with advanced disease and reinforcing the trend toward multi-modal early interventions in oncology.

TRexBio Begins Clinical Testing of Novel TNFR2 Agonist for Inflammatory Diseases

TRexBio announced the dosing of the first healthy volunteers in its Phase 1 trial with TRB-061, a new TNFR2 agonist designed to selectively boost regulatory T cells and control inflammation. The initial study will examine safety, pharmacology, and mechanistic effects in humans, paving the way for proof-of-concept trials in moderate-to-severe atopic dermatitis and other inflammatory disorders. This approach enables immune tolerance without broad immunosuppression, offering potential advantages for autoimmune disease management.

Spinogenix’s Regenerative Candidate Earns EMA Orphan Drug Status in ALS

Spinogenix’s SPG302, a first-in-class synaptic regenerative therapy, has been granted orphan drug designation by the European Medicines Agency for amyotrophic lateral sclerosis (ALS). SPG302 is designed to restore function through neuroregeneration and synapse repair, addressing critical gaps in ALS treatment. A Phase 1/2 trial completed in Australia demonstrated favorable tolerability, supporting plans for further international development in other neurodegenerative conditions.

Funding, Partnerships, and Industry Events

June opened with continued sector momentum: Immunic’s late-stage MS trials progress; biotech companies prepare to showcase pipeline advances at the Jefferies Global Healthcare Conference; and deal volume remains strong, with partnerships in protein therapeutics, small molecules, and cell therapies hitting milestones and attracting new investment.