HUMA Humacyte

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, Inc. Announces Pricing of Public Offering of Common Stock

Humacyte announced the pricing of its underwritten public offering of common stock, with aggregate gross proceeds expected to be $50 million. The company intends to use these proceeds to fund the commercialization of Symvess, planned BLA supplement filing for hemodialysis, pipeline development, and general corporate purposes.

Humacyte ATEV Meets Primary Endpoint in V012 Phase 3 Study

Humacyte announced positive top-line interim results for the V012 Phase 3 study of its acellular tissue engineered vessel (ATEV) in female dialysis access patients. The ATEV met the study's primary endpoint, demonstrating superior catheter-free days compared to autologous AV fistula. The company plans to file a supplemental BLA with the FDA in the second half of 2026.

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.

Humacyte submits IND for CTEV in CABG indication

Humacyte submitted an IND to the FDA for its coronary tissue engineered vessel (CTEV) to support a planned first-in-human study in coronary artery bypass grafting (CABG) in 2026. This filing advances the CTEV program from preclinical to clinical development, following positive non-human primate data published in JACC: Basic to Translational Science.