Asset profile

ATEV · Humacyte (HUMA)

Indication: dialysis access in female patients with end-stage kidney disease at increased risk of AV fistula maturation failure
Also known as: acellular tissue engineered vessel, Symvess

Company

Humacyte Inc is developing a commercial-stage biotechnology platform to deliver universally implantable bioengineered human tissues and organs designed to improve the lives of patients and transform the practice of medicine. It develops and manufactures acellu…

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On the calendar

Jun 2027

~ Jun 2027

HUMAHumacyte

ATEV: Phase 3 trial NCT05908084 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Dec 2028

~ Dec 2028

HUMAHumacyte

ATEV: Phase 3 trial NCT07762313 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Aug 2030

Aug 31, 2030

in 1445 days

HUMAHumacyte

ATEV: Phase 1/Phase 2 trial NCT07785661 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Timeline

Newest first.

Decision-grade

Aug 12, 2026

11:03 AM

HUMAHumacyte

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

Topline resultsSEC 8-K Open record3 updates

Minor

Apr 24, 2026

12:09 PM

HUMAHumacyte

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

OtherSEC 8-K

Decision-grade

Mar 19, 2026

12:25 PM

HUMAHumacyte

Humacyte Symvess BLA approved by FDA for extremity vascular trauma

FDA approvalSEC 8-K Open record

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Sep 15, 2026

Primary endpoint metFavourable

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

Overall survival significant or trendingUnknown

US / Western patient shareFavourable

60 of 62 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedUnknown

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentUnknown

Related companies

Each relationship is backed by the filing that stated it.

FME Not US-listedPartner

FMSFresenius Medical CarePartner

SEC 8-K Apr 24, 2026

HUMAHumacyteOwner

SEC 8-K Jun 10, 2026
SEC 8-K Mar 19, 2026
Company press release Jun 10, 2026

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT03005418	Phase 2/3	Completed	Sep 19, 2023	72	27 of 29 sites in the United States
NCT07785661	Phase 1/2	Not yet recruiting	Aug 31, 2030	6	1 of 1 sites in the United States
NCT05908084	Phase 3	Active, not recruiting	Jun 1, 2027	121	32 of 32 sites in the United States
NCT07762313	Phase 3	Not yet recruiting	Dec 1, 2028	10

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