FMS Fresenius Medical Care

Fresenius completes acquisition of remaining 45% of mAbxience

Fresenius has acquired the remaining 45% stake in mAbxience from Insud Pharma, achieving full ownership of the biosimilars platform within Fresenius Kabi's Biopharma business. This builds on the 2022 majority-stake partnership and strengthens control over development, manufacturing, supply resilience, and future biosimilar launches as multiple biologics lose exclusivity.

Humacyte reports V012 Phase 3 topline; ATEV beats AV fistula in women

V012 Phase 3 interim results in 80 female dialysis patients showed ATEV significantly outperforming AV fistula on the primary endpoint of catheter-free days and on infection rates. The company plans to file an sBLA for the dialysis-access indication in the second half of 2026 based on these data plus prior V007 results.

Humacyte realigns ex-U.S. rights to Symvess with Fresenius

Humacyte amended its distribution agreement with Fresenius Medical Care to regain exclusive ex-U.S. commercial rights to Symvess. Fresenius will now receive low-single-digit royalties on net sales outside the U.S. Existing U.S. distribution terms remain unchanged.

Humacyte Symvess BLA approved by FDA for extremity vascular trauma

The document states that the FDA approved the Symvess BLA in December 2024 for extremity vascular trauma, and U.S. market launch commenced in 2025. This converts the asset from an investigational product to an approved biologic with immediate commercial availability in the United States.