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Humacyte to Present at the H.C. Wainwright 28th Annual Global Investment Conference

Thu, 10 Sep 2026 08:00:00 -0400

DURHAM, N.C., Sept. 10, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 28th Annual Global Investment Conference in New York, NY on September 16, 2026, at 11:00am Eastern Time. Management will also be available for one-on-one meetings.

Event: H.C. Wainwright 28th Annual Global Investment Conference
Location: Lotte New York Palace Hotel, New York, NY
Presentation: Wednesday, September 16, 2026 at 11:00am ET
Webcast: click here

Humacyte to Present at the H.C. Wainwright 28th Annual Global Investment Conference

Thu, 10 Sep 2026 08:00:00 -0400

FDA extends Symvess shelf life from 18 to 36 months

Wed, 09 Sep 2026 08:07:46 -0400

Humacyte, Inc. (NASDAQ: HUMA) announced that the U.S. Food and Drug Administration has authorized an extension of the expiration dating period for its Symvess vascular graft product from 18 months to 36 months when stored refrigerated at 2°C to 8°C.

The extension is supported by stability data showing Symvess continues to meet product quality specifications throughout the extended period under approved storage conditions. No changes to storage requirements are involved.

"Extending the shelf life to 36 months provides greater inventory flexibility while maintaining the same storage requirements and approved clinical use," said Laura Niklason, MD, PhD, Founder, President and Chief Executive Officer

FDA extends Symvess shelf life from 18 to 36 months

Wed, 09 Sep 2026 08:07:46 -0400

Form 25-NSE Humacyte, Inc. Filed by: Nasdaq Stock Market LLC

Tue, 25 Aug 2026 16:18:00 -0400

si-local-file:///var/storage/secattach/20260825/26974990.html

Form 25-NSE Humacyte, Inc. Filed by: Nasdaq Stock Market LLC

Tue, 25 Aug 2026 16:18:00 -0400

si-local-file:///var/storage/secattach/20260825/26974990.html

Humacyte plans supplemental BLA filing for dialysis use in Nov. 2026

Mon, 24 Aug 2026 08:03:29 -0400

Humacyte, Inc. (Nasdaq: HUMA) announced that discussions with the Food and Drug Administration confirm the company's plan to file a supplemental Biologics License Application for its acellular tissue engineered vessel (ATEV) in dialysis access in November 2026.

The filing would seek to add dialysis access as a second approved indication for the ATEV, following its December 2024 FDA approval for vascular trauma. The supplemental BLA will be supported by results from three Phase 3 studies, including the V012 trial, the V007 study, and the V006 study.

The V012 trial, conducted in female dialysis access patients, found that women who received the ATEV

Humacyte plans supplemental BLA filing for dialysis use in Nov. 2026

Mon, 24 Aug 2026 08:03:29 -0400

The V012 trial, conducted in female dialysis access patients, found that women who received the ATEV

Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions

Mon, 24 Aug 2026 08:00:00 -0400

– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 –

– Supplemental BLA will be supported by results from three Phase 3 studies of ATEV, including results from V012 dialysis access study in women –

– The V012 dialysis access study found that women who received Humacyte's ATEV experienced an average of three more months without a dialysis catheter than women who received AV fistula, the current standard of care –

DURHAM, N.C., Aug. 24, 2026

Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions

Mon, 24 Aug 2026 08:00:00 -0400

– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 –

– Supplemental BLA will be supported by results from three Phase 3 studies of ATEV, including results from V012 dialysis access study in women –

DURHAM, N.C., Aug. 24, 2026

Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions

Mon, 24 Aug 2026 08:00:00 -0400

– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 –

– Supplemental BLA will be supported by results from three Phase 3 studies of ATEV, including results from V012 dialysis access study in women –

DURHAM, N.C., Aug. 24, 2026

Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions

Mon, 24 Aug 2026 08:00:00 -0400

– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 –

– Supplemental BLA will be supported by results from three Phase 3 studies of ATEV, including results from V012 dialysis access study in women –

DURHAM, N.C., Aug. 24, 2026

Form 4 Humacyte, Inc. For: Aug 20 Filed by: Jones Keith Anthony

Fri, 21 Aug 2026 16:05:00 -0400

si-local-file:///var/storage/secattach/20260821/26961354.html

Form 4 Humacyte, Inc. For: Aug 20 Filed by: Jones Keith Anthony

Fri, 21 Aug 2026 16:05:00 -0400

si-local-file:///var/storage/secattach/20260821/26961354.html

Form 4 Humacyte, Inc. For: Aug 17 Filed by: Jones Keith Anthony

Wed, 19 Aug 2026 16:00:00 -0400

si-local-file:///var/storage/secattach/20260819/26949912.html

Form 4 Humacyte, Inc. For: Aug 17 Filed by: Jones Keith Anthony

Wed, 19 Aug 2026 16:00:00 -0400

si-local-file:///var/storage/secattach/20260819/26949912.html

Humacyte publishes Phase 3 hemodialysis trial data in Lancet