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Humacyte, Inc.

HUMA
UndervaluedBiotech · Commercial
FDA catalysts, PDUFA dates & pipeline intelligence
$0.45
▼ -0.02 · -4.95%

Financials

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52W LOW $0.4452W HIGH $1.90
Volume
5.49 M
Value Traded
2.07 M
Short % Float
12.38%
-14.27%Week
-22.78%1 Month
-35.55%3 Month
-30.73%6 Month
-89.39%5 Year
-89.18%All Time

Cash Data

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  • Burn Trend
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  • SEC Filing

Key Stats

Market Cap
124.20 M
EPS (TTM)
-0.35
P/E Ratio
-
Ent. Value
80.62 M
Total Shares
277.70 M
Float Shares
256.83 M
Insiders
7.55%
Institutions
26.67%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
sBLA Submission
Symvess (ATEV)
dialysis access
RMAT
sBLABiologicsRenal/Genitourinary System
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

HUMA Catalyst Timeline

Dated clinical, regulatory and corporate events for Humacyte, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Humacyte, Inc.

496Total events
12Upcoming
140Tier-1 (high impact)
2020 to 2027Coverage

Upcoming catalysts 2

T2sBLA Submission
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SymvessApproved
T2sBLA Submission
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SymvessApproved

Event history 50

●Management ChangeCorporate
Paul Kuznik appointed to Humacyte Board of Directors and Commercial Committee
▲Label ExpansionSymvessApprovedFDA Decision
FDA authorizes Symvess shelf life extension from 18 to 36 months
extremity arterial injurysource ↗
▲Manufacturing MilestoneSymvessApprovedCMC / Inspection
FDA authorizes extension of Symvess expiration dating from 18 months to 36 months
extremity arterial injurysource ↗
▲PublicationSymvessApprovedPresentation
Publication of V007 Phase 3 one-year results in The Lancet Digital Health
hemodialysis accesssource ↗
▲Product LaunchSymvessApprovedPost-Market
First commercial Symvess implantation performed
▲Topline ReadoutSymvessApprovedClinical Data
V012 dialysis access Phase 3 study topline results
dialysis accesssource ↗
▲IND ClearanceIND
FDA accepted IND
▲IND ClearanceCTEVIND
FDA accepted IND for CTEV in CABG
coronary artery bypass grafting (CABG)source ↗
◆Trial InitiationCTEVTrial
Phase 2a study of CTEV in CABG expected to start this quarter
coronary artery bypass grafting (CABG)source ↗
▲Oral PresentationSymvessApprovedPresentation
V012 Phase 3 results presented at SVS Vascular Annual Meeting
hemodialysis access in womensource ↗
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Past FDA Catalysts and PDUFA Decisions

How HUMA actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-06-30ATEV (acellular tissue engineered vessel, V012) Phase 3 topline data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

C53 / 100
Pipeline Score
$600M
Pipeline Value
$2M
Commercial Value
Undervalued
Valuation Signal
2
Drugs Scored
4.6x
rNPV / MCap
Top 13%
Micro Cap
(rank 86 of 658)
Percentile Rank
Humacyte, Inc. carries a moderate pipeline score (53/100), with $4.9B risk-adjusted pipeline value, led by Symvess in End-stage Renal Disease (Phase 3), across $147B in total addressable markets.
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026; product lines: last four quarters to Jun 2026 (10-K and 10-Q)) Revenue $2.1M x 1.0 = $2M
ProductRevenuePrior periodChange
Symvess$2M--
Showing 1 of 2 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Symvess Monoclonal antibodyNCT05908084End-stage Renal DiseasePhase 3 ACTIVE NOT_RECRUITING 141Jun 1, 2028
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Clinical Trial Results

Readouts, endpoints and source filings for every HUMA program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
ATEV
PriorityFast TrackRMAT
women on dialysisPhase 32026-06-15average days free of catheter: 220 days for ATEV, 129 days for AV fistula; infections per 100 patient years: 6 for ATEV, 23 for AV fistula; six month catheter free days: 88 days for ATEV, 32 days for AV fistula; functional patency: 250 days for ATEV, 152 days for AV fistulaRead MoreHumacyte's Bioengineered Blood Vessel Outperforms the Standard of Care for Women on Dialysis in Phase 3 Results Presented at the Society for Vascular Surgery Vascular Annual MeetingRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Jones Keith AnthonyDirectorBuy 10,000 50,000 held$0.56 09/14/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
GREAT POINT PARTNERS LLC 0.6 % (20 %) 2.93 M 3.75 M
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

HUMA Institutional Ownership Trends

Options Data

Option Volume

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Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-12-18
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

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Competitive positioning

How HUMA ranks across every disease it competes in

Competitive Position is a premium feature
See how HUMA ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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HUMA News

HUMA
Sep 28, 2026
HUMAGeneral

Humacyte Expands Board Expertise with Appointment of Scott Coward and Paul Kuznik

Humacyte, Inc. has appointed Scott Coward and Paul Kuznik to its Board of Directors, enhancing its leadership team as it prepares for the commercial launch of its ATEV in dialysis access. Coward and Kuznik bring extensive experience in commercialization and life sciences, which is expected to support Humacyte's growth and product expansion. The company is focused on its innovative regenerative medicine technologies.

Read more →
HUMA
Sep 10, 2026
HUMAConferences/Events

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

Humacyte, Inc. will present at the H.C. Wainwright 28th Annual Global Investment Conference on September 16, 2026. CEO Laura Niklason will participate in a fireside chat, and management will be available for one-on-one meetings. The company focuses on developing universally implantable human tissues and has received FDA approvals for its acellular tissue engineered vessel.

Read more →
HUMA
Sep 9, 2026
HUMAFDA Updates

Humacyte Announces FDA Authorization Extending Symvess Shelf Life to 36 Months

Humacyte, Inc. announced that the FDA has authorized an extension of the expiration dating for its product, Symvess, from 18 months to 36 months. This decision is backed by additional stability data confirming that Symvess meets quality specifications throughout the extended period. The longer shelf life is expected to improve inventory management in hospitals and facilitate access to this critical product for urgent vascular repairs.

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HUMA
Aug 24, 2026
HUMAFDA Updates

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

Humacyte, Inc. has confirmed its plans to file a supplemental Biologics License Application (BLA) for its acellular tissue engineered vessel (ATEV) aimed at dialysis access by November 2026. This filing will be supported by positive results from three Phase 3 studies, particularly highlighting the benefits seen in female patients. The ATEV is expected to provide a reliable option for patients who struggle with traditional dialysis access methods.

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HUMA
Aug 19, 2026
HUMAPhases
▲ +26.3%on this newsshared move

Humacyte Announces Lancet Digital Health Publication of V007 Phase 3 Hemodialysis Access Trial Results

Humacyte has published one-year results from its V007 Phase 3 trial of the acellular tissue engineered vessel (ATEV) for hemodialysis access in The Lancet Digital Health. The study shows that ATEV outperforms traditional arteriovenous fistulas, especially benefiting women and men with obesity and diabetes. This publication adds validation to Humacyte's findings and supports plans for further regulatory submissions.

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HUMA
Aug 18, 2026
HUMAFDA Updates

Board-Certified Vascular and Endovascular Surgeon Performs First Commercial Symvess® Implantation; Cites Bioengineered Blood Vessel as “Revolutionary Advancement”

Dr. Jeromy Brink, a vascular surgeon trained at Mayo Clinic, has successfully performed the first commercial implantation of Symvess in Arizona. This bioengineered blood vessel is the first and only FDA-approved option available off-the-shelf, which significantly reduces the time surgeons spend on harvesting vessels. The innovation is seen as a major advancement in the field of vascular surgery.

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HUMA
Aug 12, 2026
HUMAFDA Updates
▼ -6.3%on this news· ran to -23% by day 1

Humacyte Announces Second Quarter 2026 Financial Results and Provides Business Update

Humacyte reported positive financial results for Q2 2026, highlighting breakthrough outcomes from its Phase 3 study of V012 for dialysis access. The study demonstrated that ATEV significantly outperformed the traditional AV fistula. The company plans to submit a supplemental Biologic License Application to the FDA in the latter half of 2026.

Read more →
HUMA
Aug 7, 2026
HUMAGeneral

Humacyte To Announce 2026 Second Quarter Financial Results and Provide Business Update on August 12, 2026

Humacyte, Inc. will release its financial results for Q2 2026 on August 12, 2026. The company is known for developing bioengineered human tissues and has received FDA approval for its acellular tissue engineered vessel (ATEV) for vascular trauma. Management will provide a corporate update during a webcast following the results announcement.

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HUMA
Jul 27, 2026
HUMAPhases
▲ +7.9%on this news

Humacyte Announces FDA Acceptance of IND for First-In-Human Clinical Study of CTEV for Coronary Artery Bypass Grafting

Humacyte has announced the FDA's acceptance of its IND application for a first-in-human clinical study of the coronary tissue engineered vessel (CTEV) in coronary artery bypass grafting (CABG). The Phase 2a study is set to begin this quarter, aiming to evaluate the safety and efficacy of CTEV as a vascular conduit. This development is significant as it may offer a new off-the-shelf option for patients undergoing CABG.

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HUMA
Jul 14, 2026
HUMAGeneral

Humacyte Appoints Key Nephrologists as Advisors to Prepare for Planned Commercialization of the ATEV in Dialysis Access

Humacyte has appointed Dr. Robert J. Kossmann and Dr. Prabir Roy-Chaudhury as advisors to aid in the commercialization of the acellular tissue engineered vessel (ATEV) for hemodialysis access. Their extensive experience in nephrology will support health economic strategies and medical education. This follows promising results from a Phase 3 study, with plans for a supplemental Biologics License Application to the FDA.

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HUMA
Jun 15, 2026
HUMAPhases

Humacyte's Bioengineered Blood Vessel Outperforms the Standard of Care for Women on Dialysis in Phase 3 Results Presented at the Society for Vascular Surgery Vascular Annual Meeting

Humacyte's Phase 3 V012 study results show that its bioengineered blood vessel, ATEV, offers significant advantages over the standard AV fistula for women on dialysis. Patients with ATEV experienced an average of three additional months without a dialysis catheter and had fewer infections. The company plans to file a supplemental BLA with the FDA later this year.

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HUMA
Jun 11, 2026
HUMAGeneral
▼ -19.4%on this newsshared move

Humacyte, Inc. Announces Pricing of Public Offering of Common Stock

Humacyte, Inc. has announced the pricing of a public offering of 47,619,048 shares at $1.05 each, aiming to raise $50 million. The proceeds will be used for the commercialization of its product Symvess, among other corporate purposes. The offering is expected to close around June 12, 2026, pending customary conditions.

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HUMA
Jun 10, 2026
HUMAPhases

Humacyte ATEV Met Superiority Primary Endpoint Compared to Standard of Care AV Fistula in Interim Analysis of V012 Phase 3 Study in Female Dialysis Access Patients

Humacyte announced positive interim results from the V012 Phase 3 study of its acellular tissue engineered vessel (ATEV) for dialysis access in female patients. The ATEV met its primary endpoint, showing significantly more catheter-free days than the standard AV fistula. The company plans to file a supplemental Biologic License Application with the FDA in late 2026, targeting patients with end-stage kidney disease.

Read more →
HUMA
Jun 10, 2026
HUMAGeneral

Humacyte, Inc. Announces Proposed Public Offering of Common Stock

Humacyte, Inc. has announced a proposed public offering of its common stock to raise capital. The company plans to use the proceeds to fund the commercialization of its FDA-approved product, Symvess, and to support the development of its product pipeline. The offering is subject to market conditions and includes an option for underwriters to purchase additional shares.

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HUMA
May 26, 2026
HUMAConferences/Events
▲ +5.7%on this news· ran to +24% by day 3

Humacyte Announces Presentation at VASA Meeting of Research Highlighting Self-Repair of ATEV After Cannulation for Dialysis Access

Humacyte, Inc. announced the successful presentation of research at the VASA 2026 meeting, highlighting the self-repairing properties of its acellular tissue engineered vessel (ATEV) used in dialysis access. Findings suggest that despite frequent cannulation, ATEVs maintain structural integrity and promote smooth muscle cell repopulation over an extended period. Humacyte is expecting to release top-line interim results from its Phase 3 V012 study later in June, which may support further applications for the ATEV in hemodialysis.

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HUMA
May 20, 2026
HUMAGeneral
▲ +11.1%on this news· ran to +34% by day 3shared move

Humacyte Announces Symvess is Now Under Contract with the Strategic Acquisition Center (SAC) of the U.S. Department of Veterans Affairs

Humacyte, Inc. has announced that its product Symvess is now under contract with the Strategic Acquisition Center (SAC) of the U.S. Department of Veterans Affairs. This contract will make Symvess more accessible across 170 VA hospitals by streamlining the approval process for healthcare professionals. Symvess is a first-in-class bioengineered tissue product that has received FDA approval for extremity vascular trauma indications. The company anticipates that this contract will enhance the visibility and availability of Symvess within the VA system.

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HUMA
May 13, 2026
HUMAGeneral
▲ +24.2%on this news

Humacyte Announces First Quarter 2026 Financial Results and Provides Business Update

Humacyte, Inc. reported a strong financial performance for Q1 2026, with sales of Symvess reaching $0.5 million, a notable increase from $0.1 million in Q1 2025. The company has secured a significant purchase commitment for a clinical program in Saudi Arabia and is preparing for the presentation of interim results from its Phase 3 trial in hemodialysis access. Despite the positive developments, Humacyte faced a net loss and has reduced its workforce by 25%.

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HUMA
May 12, 2026
HUMAGeneral
▼ -9%on this newsshared move

Humacyte Appoints Dr. Todd E. Rasmussen as Chief Surgical Officer

Humacyte, Inc. has appointed Dr. Todd E. Rasmussen as Chief Surgical Officer, leveraging his extensive experience in vascular surgery to enhance its leadership team. His role will focus on providing scientific support and medical education to healthcare professionals as the company prepares for increased clinical adoption of its Symvess® product. Rasmussen joins from the Mayo Clinic, where he will continue his clinical duties while contributing to Humacyte's development of bioengineered human tissues. His appointment comes as Humacyte's innovative products advance toward regulatory approval and market entry.

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HUMA
May 8, 2026
HUMAGeneral

Humacyte To Announce 2026 First Quarter Financial Results and Provide Business Update on May 13, 2026

Humacyte, Inc. will announce its financial results for Q1 2026 on May 13, 2026. The company is known for developing bioengineered human tissues and has received FDA approval for its acellular tissue engineered vessel, Symvess. A conference call will follow the announcement to provide further updates on corporate and financial matters.

Read more →
HUMA
Apr 27, 2026
HUMAConferences/Events
▲ +15.1%on this news

Humacyte to Host Virtual KOL Event to Discuss ATEV for Arteriovenous (AV) Access for Hemodialysis Patients on April 28, 2026

Humacyte, Inc. will host a virtual KOL event on April 28, 2026, to discuss its Acellular Tissue Engineered Vessel (ATEV) for hemodialysis patients. The event will feature experts who will address the current treatment landscape for patients with End-Stage Renal Disease (ESRD). The ATEV aims to provide a viable alternative to traditional AV fistulas, with ongoing trials showing promising results.

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About Humacyte, Inc.

Durham, NC 184 employees humacyte.com
Headquarters2525 EAST NORTH CAROLINA HIGHWAY 54, DURHAM, NC, 27713
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