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Humacyte, Inc.
$0.66
+0.03 (+3.99%)
B 61Pipeline Score Undervalued Biotech · Clinical
Market Cap
183.96 M
EPS
-0.35
P/E Ratio
-
Value Trade
2.07 M
13.84 %
Week
-1.77 %
1 Month
-40.34 %
3 Month
-40.88 %
6 Month
-89.39 %
5 Year
-89.18 %
All Time
Cash Data
Cash Position
-
Monthly Burn
-
Runway
-
Overview
Volume
3.76 M
52 Week Range
0.53 - 2.55
% held by Insiders
7.68 %
% held by Institutions
26.41 %
Enterprise Value
140.38 M
Total Shares
277.70 M
Short %
12.28 %
Float Shares
245.49 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Humacyte, Inc.
487Total events
7Upcoming
147Tier-1 (high impact)
2020 – 2027Coverage
Upcoming catalysts 2
TBD
T2Trial Initiation
Subscribe to view catalyst details
TBD
T1Topline Readout
Subscribe to view catalyst details
Event history 2
TBD
▲PublicationATEVApprovedPresentation
Subscribe to view catalyst details
TBD
▲Product LaunchSymvessApprovedPost-Market
Subscribe to view catalyst details
Past FDA Catalysts & PDUFA Decisions
| Date | Drug | Catalyst | Stage | Outcome | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|---|
2025-12-31 | Coronary Tissue Engineered Vessel (CTEV) | IND Filing | IND | — | – | – | – |
2025-12-31 | Coronary Tissue Engineered Vessel (CTEV) | IND Filing | IND | — | – | – | – |
2025-12-31 | Coronary Tissue Engineered Vessel (CTEV) | IND Filing | IND | — | – | – | – |
Drug Pipeline Intelligence
B61
Pipeline Score $1.0B
Pipeline ValueUndervalued
Valuation Signal5
Drugs Scored15.0x
rNPV / MCap Top 91%
Micro Cap (rank 85 of 933)
Percentile RankHumacyte, Inc. holds a solid B-grade pipeline (61/100), with $7.7B risk-adjusted pipeline value, led by Acellular Tissue Engineered Vessel in End Stage Renal Disease (ESRD) (Phase 3).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acellular Tissue Engineered Vessel Monoclonal antibody | End Stage Renal Disease (ESRD) | Phase 3 | NCT05908084 | 57% | $4.8B | ACTIVE NOT_RECRUITING | 121 | SLOW | B (63) | Jun 1, 2028 | LOW_RISK | MEDIUM Jun 26, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
ATEV PriorityFast TrackRMAT | women on dialysis | Phase 3 | 2026-06-15 | average 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 fistula Read More | 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 Read More | |
ATEV PriorityFast TrackRMAT | women on dialysis | Phase 3 | 2026-06-15 | average 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 fistula Read More | 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 Read More | |
ATEV PriorityFast TrackRMAT | women on dialysis | Phase 3 | 2026-06-15 | average 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 fistula Read More | 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 Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in HUMA
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
HUMA Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2026-10-16 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-10-16 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-10-16 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
HUMA▲ +4%today
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.
Read more →HUMA▲ +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.
Read more →HUMABoard-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.
Read more →HUMA▼ -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 →HUMAHumacyte 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.
Read more →HUMA▲ +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.
Read more →HUMAHumacyte 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.
Read more →HUMAHumacyte'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.
Read more →HUMA▼ -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.
Read more →HUMAHumacyte, 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.
Read more →HUMAHumacyte 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▲ +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.
Read more →HUMA▲ +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.
Read more →HUMA▲ +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%.
Read more →HUMA▼ -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.
Read more →HUMAHumacyte 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▲ +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.
Read more →HUMAHumacyte Expands Commercial and Business Development Opportunities Through Realignment of Ex-U.S. Rights to Symvess - Ex-U.S. rights realigned under amendment to distribution agreement with Fresenius Medical Care - - Pos
Humacyte, Inc. has announced the realignment of ex-U.S. rights to its product Symvess through a new amendment in its distribution agreement with Fresenius Medical Care. This adjustment is expected to bolster the company's international expansion efforts, particularly in Saudi Arabia and Israel. Additionally, Humacyte will now hold exclusive rights to distribute Symvess outside the U.S., while Fresenius Medical Care will receive royalties on sales. This move reflects the company's ongoing commitment to advancement in bioengineered human tissues.
Read more →HUMA▲ +7%on this news· ran to +22% by day 3shared move
Humacyte Appoints Jim Mercadante as Chief Commercial Officer
Humacyte has appointed Jim Mercadante as Chief Commercial Officer to lead its commercial strategy as it accelerates the launch of Symvess, a bioengineered tissue product. Mercadante, who has over 25 years of experience in healthcare and medical technology, will oversee sales, marketing, and market access for the company. His leadership is expected to enhance market adoption of Symvess and further develop Humacyte's pipeline. This strategic appointment comes as the company aims to expand its presence in the vascular sector and prepare for future product indications.
Read more →HUMAHumacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess for Vascular Trauma Repair
Humacyte, Inc. announced that the Israeli Ministry of Health has accepted its Marketing Authorization Application (MAA) for Symvess, an acellular tissue engineered vessel aimed at arterial trauma repair. The Ministry set a 180-working-day review period for the application, following the recent FDA approval for the same product in the U.S. This marks a step towards Humacyte's broader expansion strategy to deliver its regenerative medicine solutions globally and address unmet medical needs for patients with severe vascular injuries. Clinical trials have shown promising results for Symvess, supporting its effectiveness in treating vascular trauma.
Read more →HUMA▼ -13.2%on this news· ran to -26% by day 1
Humacyte Announces Fourth Quarter and Year End 2025 Financial Results and Provides Business Update
Humacyte, Inc. announced its financial results for Q4 and full year 2025, reporting total revenues of $2.0 million. The company received a $1.475 million purchase commitment for Symvess in Saudi Arabia and submitted a Marketing Authorization Application in Israel. The U.S. Department of Defense has authorized funding for bioengineered blood vessels, and Humacyte anticipates top-line interim results from the V012 Phase 3 study in hemodialysis access in Q2 2026.
Read more →HUMA▼ -5.4%on this news· ran to -26% by day 3shared move
Humacyte Appoints Rick McElheny as Senior Vice President of Business Development
Humacyte has appointed Rick McElheny as Senior Vice President of Business Development. With over 15 years of experience in corporate development, he will work to enhance corporate collaborations and expedite the commercialization of Humacyte's regenerative medicine pipeline. His expertise is expected to significantly contribute to the company's growth and innovation.
Read more →HUMA▲ +8.6%on this newsshared move
Humacyte To Announce 2025 Fourth Quarter and Year End Financial Results and Provide Business Update on March 27, 2026
Humacyte, Inc. will release its financial results for Q4 and the year ending December 31, 2025, on March 27, 2026. The company will also provide a corporate and financial update via a webcast and conference call. Humacyte is known for developing bioengineered human tissues and has received FDA approvals for its acellular tissue engineered vessel.
Read more →HUMA▼ -19.4%on this newsshared move
Humacyte, Inc. Announces Pricing of $20 Million Registered Direct Offering of Common Stock
Humacyte, Inc. has announced a $20 million registered direct offering of common stock to fund the commercialization of its product, Symvess, particularly in the vascular trauma indication. The offering will also support the upcoming Phase 3 results in hemodialysis. The deal is expected to close on March 20, 2026.
Read more →HUMA▼ -19.4%on this newsshared move
Universally Implantable Regenerative Human Tissue 2 Disclaimer These slides and the accompanying oral presentation contain forward-looking statements. All statements, other than statements of historical fact, included in
Humacyte's BioVascular Pancreas (BVP) has demonstrated promising results in non-human primates, showing excellent islet survival and insulin production for at least seven months. The technology aims to address significant unmet needs in the treatment of Type 1 Diabetes by providing a mechanism that supports islet engraftment and function. Humacyte is preparing for a first-in-human study expected in 2027, while also pursuing multiple preclinical developments and expansions into international markets. The promising results indicate a potential breakthrough in regenerative medicine, although long-term human efficacy is yet to be evaluated.
Read more →HUMA▼ -19.4%on this newsshared move
Humacyte Receives Symvess Purchase Commitment for Clinical Evaluation and Outreach Program in the Kingdom of Saudi Arabia
Humacyte, Inc. has secured a minimum purchase commitment of $1.475 million for its Symvess acellular tissue engineered vessel for a clinical evaluation program in Saudi Arabia. This initiative aims to train local medical professionals and increase familiarity with Symvess technology, seeking to pave the way for a potential commercial launch. The company is also engaged in discussions to establish a joint venture for commercialization in the region, although final agreements remain pending. Symvess has not yet received regulatory approval outside its existing indications, raising some uncertainty regarding its market introduction.
Read more →HUMAHumacyte Submits Marketing Authorization Application for Symvess® in Israel for Vascular Trauma Repair
Humacyte, Inc. has submitted a Marketing Authorization Application for its acellular tissue engineered vessel, Symvess, to the Israel Ministry of Health for arterial trauma repair. The company is also exploring options to make Symvess available on a hospital-by-hospital basis prior to approval. The product has demonstrated low infection rates and high limb salvage rates in clinical studies, including those conducted in Ukraine.
Read more →HUMAHumacyte To Participate in Upcoming Investor Conferences
Humacyte, Inc. has announced its participation in several investor conferences in March 2026, including the TD Cowen 46th Annual Healthcare Conference and the Barclays 28th Annual Global Healthcare Conference. The company is known for developing bioengineered human tissues and has received FDA approval for its acellular tissue engineered vessel, Symvess. Humacyte continues to progress in late-stage clinical trials for various vascular applications.
Read more →HUMA▼ -5.3%on this news
Humacyte Announces Presentation of Symvess® Long-Term Safety and Efficacy Results at VESS Meeting
Humacyte presented long-term data on its acellular tissue engineered vessel, Symvess, at the VESS meeting. The results from the V005 trial showed high limb salvage rates and low infection rates among extremity arterial trauma patients over 36 months. Symvess maintained structural integrity with no significant changes in diameter, indicating its potential as a reliable alternative to autologous vein grafts.
Read more →HUMA▲ +30%on this news
Humacyte Announces New U.S. Department of Defense Funding for Procurement of Bioengineered Blood Vessels
Humacyte, Inc. has announced new funding from the U.S. Department of Defense to support the procurement of its bioengineered blood vessels, Symvess. This funding aims to enhance care for military personnel suffering from traumatic vascular injuries. Symvess is the only FDA-approved human-derived vascular conduit and has demonstrated successful outcomes in battlefield applications.
Read more →HUMAHumacyte Announces Hospital Charge Data Showing High Expense of Preventable Extremity Arterial Injury Complications
Humacyte, Inc. has released findings from a five-year analysis showing the significant financial impact of preventable complications from extremity arterial injuries. Preventable complications such as amputation and conduit infection led to average hospital charges rising by nearly $493,000 and $590,000 per patient respectively. The company's Symvess product, an acellular tissue engineered vessel, demonstrated low infection rates and high limb salvage, potentially offering a cost-effective alternative in treating such injuries. The study underscores the economic burden of complications rather than initial injuries and highlights the potential savings and improved outcomes from using Symvess.
Read more →HUMA▲ +8.7%on this news· ran to +20% by day 3shared move
Humacyte Announces Planned Marketing Authorization Application for Symvess® in Israel
Humacyte, Inc. announced plans to submit a Marketing Authorization Application for its acellular tissue engineered vessel, Symvess, in Israel during Q1 2026. The application is supported by positive feedback from Israeli surgeons and hospitals, as well as favorable results from the V005 Phase 2/3 trial. The company aims to expand Symvess into other territories following its FDA approval.
Read more →HUMAHumacyte Announces Publication of Long-Term Safety and Efficacy Results of Symvess® in Extremity Trauma Repair
Humacyte has published long-term data on its Symvess biologic conduit for extremity trauma repair, showing high limb salvage rates and low infection rates over a follow-up period of up to 36 months. The study, published in the Journal of Vascular Surgery Cases, represents the first prospective long-term data for this type of treatment. Notably, no unprovoked structural failures were reported, highlighting the conduit’s durability in a high-risk patient population.
Read more →HUMA▼ -5.1%on this news
Humacyte Announces Credit Facility of Up to $77.5 Million with Avenue Capital
Humacyte, Inc. announced a credit facility with Avenue Capital Group, allowing for financing of up to $77.5 million. The initial $40 million tranche will be utilized to retire existing debt, while additional funds will be contingent upon meeting certain conditions. The company is optimistic about its growth trajectory in 2026, focusing on expanding its product Symvess and advancing clinical trials. Humacyte's CFO expressed satisfaction with the facility, which aims to provide non-dilutive financing for future projects.
Read more →HUMAHumacyte Announces Presentations at VEITHsymposium Highlighting Positive Acellular Tissue Engineered Vessel (ATEV™) Clinical Results
Humacyte presented positive clinical results for its acellular tissue engineered vessel (ATEV) at the VEITHsymposium. The ATEV demonstrated significant recellularization into living tissue and showed promising outcomes for dialysis patients suffering from Steal syndrome. Additional presentations highlighted durable outcomes for patients treated during the Ukraine conflict and for those with torso arterial trauma.
Read more →HUMAHumacyte Announces Six Presentations Scheduled for the Upcoming 52nd Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITHsymposium)
Humacyte, Inc. announced six presentations scheduled for the 52nd Annual VEITHsymposium, focusing on its acellular tissue engineered vessel (ATEV). The presentations will cover various clinical outcomes, including the use of ATEV in vascular trauma and dialysis access. The symposium will take place from November 18-22, 2025, in New York City.
Read more →HUMAHumacyte Announces Third Quarter 2025 Financial Results and Provides Business Update
Humacyte, Inc. reported total revenues of $753,000 for Q3 2025, driven by strong sales of its product Symvess. The company is progressing towards a Biologics License Application (BLA) filing for its acellular tissue engineered vessel (ATEV) in dialysis and has submitted an IND for coronary artery bypass grafting (CABG) studies. Positive results from preclinical studies support the advancement of its pipeline.
Read more →HUMAHumacyte Announces Presentation of Positive Two-Year Results from Phase 3 Dialysis Access Trial at the American Society of Nephrology’s Kidney Week 2025
Humacyte announced positive two-year results from its V007 Phase 3 trial of the acellular tissue engineered vessel (ATEV) for hemodialysis access. The ATEV demonstrated superior duration of use compared to the traditional AV fistula, especially in high-need subgroups such as female, obese, and diabetic patients. The findings suggest that ATEV could significantly improve dialysis access and reduce complications associated with catheter reliance.
Read more →HUMA▼ -9.7%on this newsshared move
Humacyte to Present Third Quarter Financial Results and Provide Business Update on November 12, 2025
Humacyte, Inc. will announce its financial results for Q3 2025 on November 12, 2025. The company is known for developing bioengineered human tissues and has received FDA approvals for its acellular tissue engineered vessel. A conference call will follow the results release, providing further insights into the company's operations and future plans.
Read more →HUMAHumacyte Announces Publication of New Data Comparing Symvess™ to Autologous Vein in Extremity Arterial Trauma
Humacyte has published a study in the AAST's journal comparing its Symvess product to autologous vein in treating extremity arterial trauma. The results indicate that Symvess achieved similar short-term outcomes in terms of patency and limb salvage, suggesting it could serve as a viable alternative when autologous vein is not available. The study utilized data from two clinical trials and matched it with the PROOVIT registry.
Read more →HUMA▼ -33.7%on this news
Humacyte Announces Pricing of $60.0 Million Oversubscribed Registered Direct Offering
Humacyte, Inc. announced a $60 million oversubscribed registered direct offering of common stock and warrants. The offering involves the sale of approximately 28.4 million shares at a price of $2.11 each. The proceeds will support the company's development of bioengineered human tissues. The offering is expected to close on October 8, 2025.
Read more →HUMA▼ -33.7%on this newsshared move
Humacyte Announces P ricing of $60.0 Million Oversubscribed Registered Direct Offering DURHAM, N.C.
Humacyte, Inc. announced a successful oversubscribed registered direct offering, raising approximately $60 million through the sale of shares and warrants. The company plans to sell 28,436,018 shares at a price of $2.11 each, with the transaction expected to close shortly. This funding will support Humacyte's innovative work in developing universally implantable bioengineered human tissues, following recent approvals from the FDA for its acellular tissue engineered vessel. The offering reflects strong investor confidence in the company's future prospects.
Read more →HUMA▲ +18.1%on this newsshared move
Humacyte Announces Publication of Long-Term Results for Ukrainian Patients Treated in Real-World Combat Setting with Symvess™
Humacyte, Inc. announced positive long-term results for its Symvess treatment used in wartime vascular trauma in Ukraine. A study published in Military Medicine Journal showed that patients experienced zero infections, amputations, or deaths, with a high patency rate of 87.1% after 18 months. The findings highlight the potential of Symvess to enhance vascular trauma care.
Read more →HUMAHumacyte Announces Expansion of Intellectual Property for Pipeline Products with Granting of New U.S. Patent for Bioengineered Esophagus
Humacyte, Inc. has announced the granting of a new U.S. patent for a bioengineered esophagus, which is part of their regenerative tissue platform. This patent, effective until 2041, covers key attributes necessary for esophageal replacement. The company aims to address significant patient needs with its advanced tissue constructs, which are currently in preclinical evaluation.
Read more →HUMA▲ +17%on this news
Humacyte Announces Publication of Preclinical Data on Use of the CTEV as a Coronary Artery Bypass Graft (CABG)
Humacyte has published promising preclinical data on its coronary tissue engineered vessel (CTEV) as a conduit for coronary artery bypass grafting (CABG). The study demonstrated that all implanted CTEVs remained patent for six months and successfully recellularized with host cells. The company plans to advance the CTEV into first-in-human studies, aiming to address significant clinical needs in CABG procedures.
Read more →HUMAHumacyte Announces Publication of Outcomes for Patients with Hospital-Acquired Vascular Complications Treated with Symvess™
Humacyte, Inc. announced the publication of positive outcomes for patients treated with Symvess for hospital-acquired vascular complications. The study, published in the Journal of Vascular Surgery, reported 100% limb salvage and zero conduit infections among 12 patients. Symvess, a bioengineered vascular conduit, is designed for urgent revascularization when autologous vein grafts are not feasible.
Read more →HUMA▼ -29.6%on this news
Humacyte Announces Second Quarter 2025 Financial Results and Provides Business Update - Total revenues of $301,000 for quarter, and $818,000 for first six months of 2025, from sales and collaborative research agreement -
Humacyte, Inc. reported financial results for the second quarter of 2025, with total revenues of $301,000 for the quarter and $818,000 for the first six months. The company announced a significant increase in VAC approvals for its product Symvess, now available in 82 civilian hospitals and 35 military facilities following ECAT approval. Despite some operational challenges, Humacyte achieved its first commercial sale to a military treatment facility and celebrated the strong results of its V007 clinical trial, which was presented at a major conference. Additionally, the company has initiated cost-saving measures expected to yield substantial savings in the coming years.
Read more →HUMA▲ +11.8%on this newsshared move
Humacyte to Present Second Quarter Financial Results and Provide Corporate Update on August 11, 2025
Humacyte, Inc. will announce its second-quarter financial results for 2025 on August 11, with a conference call and webcast scheduled for 8:00 a.m. Eastern Time. The company is known for developing bioengineered human tissues, and it has recently gained FDA approval for its acellular tissue engineered vessel. Humacyte is involved in multiple late-stage clinical trials aimed at treating vascular conditions, reflecting its commitment to addressing significant medical needs.
Read more →HUMA▲ +18.7%on this news
Humacyte Announces First Symvess™ Sale to Military Treatment Facility
Humacyte, Inc. has announced its first sale of Symvess to a U.S. Military Treatment Facility following an Electronic Catalog approval from the U.S. Defense Logistics Agency. This availability allows health care professionals at approximately 35 military treatment facilities and 160 U.S. Department of Veterans Affairs hospitals to access the acellular tissue engineered vessel. Humacyte aims to improve medical options for military personnel, with Symvess having received FDA approval for use in extremity vascular trauma. The company is also pursuing further discussions with additional Department of Defense hospitals.
Read more →HUMA▲ +19%on this news
Humacyte announces Symvess™ ECAT Approval from U.S. Defense Logistics Agency
Humacyte, Inc. has announced that its product Symvess has received Electronic Catalog (ECAT) listing approval from the U.S. Defense Logistics Agency, making it accessible to healthcare professionals catering to military service members and veterans. The product had previously received FDA approval for use in extremity vascular trauma. This approval is expected to improve patient care by making Symvess more readily available in Department of Defense and Veterans Affairs facilities. The company's CEO expressed optimism about the product's potential impact based on positive feedback from hospitals.
Read more →HUMAHumacyte Clinical Results in High-Risk Dialysis Patients from V007 Pivotal Phase 3
Humacyte, Inc. has announced that its abstract concerning the V007 Pivotal Phase 3 clinical trial of its acellular tissue engineered vessel (ATEV) has been accepted for oral presentation at the upcoming Society for Vascular Surgery Vascular Annual Meeting. The study claims that the ATEV outperforms traditional arteriovenous fistulas for high-risk patients undergoing hemodialysis. The presentation will take place on June 6, 2025, in New Orleans, led by Dr. Mohamad A. Hussain. Humacyte continues to develop its ATEV for various applications and has received FDA approvals and designations for its innovative biotechnological solutions.
Read more →HUMAHumacyte to Present at the H.C. Wainwright 3rd Annual BioConnect Investor Conference at Nasdaq
Humacyte, Inc. has announced that its CEO, Laura Niklason, will present at the H.C. Wainwright 3rd Annual BioConnect Investor Conference at Nasdaq on May 20, 2025. The company is known for developing bioengineered human tissues and has recently gained FDA approval for its acellular tissue engineered vessel intended for vascular trauma treatment. Additionally, Humacyte is engaged in late-stage clinical trials for various vascular conditions and has received significant designations from the FDA.
Read more →HUMA▲ +31.1%on this news· ran to +70% by day 3
Humacyte Announces First Quarter 2025 Financial Results and Provides Business Update - Commenced market launch and first commercial sales of Symvess (acellular tissue engineered vessel-tyod) for the treatment of extremit
Humacyte has announced its first quarter 2025 financial results, highlighting the market launch and initial sales of Symvess, an acellular tissue engineered vessel. The company reported total revenues of $517,000 during the quarter, supported by a recent public offering that raised $46.7 million. Humacyte is actively expanding its commercial launch, with strong interest from hospitals and plans to file an IND application with the FDA for further clinical testing. Additionally, the company has implemented cost reduction measures to optimize its cash runway amidst a volatile economic climate.
Read more →HUMAHumacyte to Present First Quarter Financial Results and Provide Corporate Update on May 13, 2025
Humacyte, Inc. will present its financial results for Q1 2025 on May 13, 2025, along with a corporate update. The company develops bioengineered human tissues and has received FDA approval for its acellular tissue engineered vessel for vascular trauma. Additionally, Humacyte’s product is in late-stage clinical trials for several vascular applications and continues to pursue preclinical development for various other indications. The webcast for this event will be accessible shortly before its start time.
Read more →HUMA▲ +8.4%on this news
Document Humacyte Statement on Recent Attacks DURHAM, N.C.
Dr. Laura Niklason, President and CEO of Humacyte, Inc., publicly addressed a citizen petition aimed at stopping the company's operations in a recent statement. She criticized the petition, highlighting that its signatories lack experience with Humacyte's products and have previous ties to competitors. Niklason urged media outlets to disclose conflicts of interest related to the petition's authors. She affirmed that Humacyte will respond to the petition's claims at the appropriate time, firmly defending the company's reputation and achievements.
Read more →HUMAHumacyte Announces Fourth Quarter and Year End 2024 Financial Results and Provides Business Update - Received U.S. Food and Drug Administration (FDA) approval of Symvess (acellular tissue engineered vessel-tyod) for the
Humacyte, Inc. announced the FDA approval of its product Symvess for extremity vascular trauma, marking a significant advancement in vascular surgery. Following the approval, the company commenced the commercial launch and made its first sales, with interest from hospitals already notable. A recently published Budget Impact Model suggests that using Symvess could lead to substantial cost savings in treating trauma patients by reducing amputations and infections. The company plans further developments, including a clinical study for coronary artery bypass grafting and additional regulatory filings in the coming years.
Read more →HUMAHumacyte Statement on New York Times Article DURHAM, N.C.
Dr. Laura Niklason, President and CEO of Humacyte, addressed concerns raised in a recent New York Times article regarding the FDA's approval of Symvess. She emphasized that the FDA's review was thorough and included extensive consultation with external experts. Despite criticism from Dr. Robert E. Lee, who questioned the product's safety, Niklason reaffirmed the effectiveness of Symvess based on previous trials and the agency's assessment. Additionally, she criticized the Times for relying on limited sources and misrepresenting certain clinical realities related to trauma surgeries.
Read more →HUMA▼ -30.4%on this news· ran to -41% by day 3shared move
Humacyte to Present Fourth Quarter and Full Year Financial Results and Provide Corporate Update on March 28, 2025
Humacyte, Inc. is set to present its fourth quarter and full year financial results for 2024 on March 28, 2025. The company recently received FDA approval for its acellular tissue engineered vessel (ATEV) for extremity vascular trauma, a significant advancement for their product line. In addition, Humacyte is progressing through late-stage clinical trials targeting various vascular applications. The upcoming conference call will provide investors with updates on the company’s ongoing projects and corporate strategies.
Read more →HUMA▼ -13.4%on this news· ran to -41% by day 3shared move
Humacyte, Inc. Announces Proposed Public Offering of Common Stock DURHAM, N.C.
Humacyte, Inc. has announced a public offering of its common stock to raise funds for commercialization and development initiatives. The offering is underwritten and includes an option for underwriters to purchase more shares. While the proceeds aim to enhance their portfolio and working capital, market conditions could affect the offering’s success. Humacyte is known for its acellular tissue engineered products, which have gained FDA approvals for certain applications.
Read more →HUMA▼ -6.1%on this news
Humacyte Announces Publication of the Budget Impact Model (BIM) for Symvess™ (acellular tissue engineered vessel-tyod) in the Journal of Medical Economics
Humacyte, Inc. announced the publication of the Budget Impact Model for Symvess in the Journal of Medical Economics, indicating that it offers significant cost savings for trauma centers and third-party payers. This bioengineered tissue is designed for use in arterial replacement and has been shown to reduce costs associated with amputations and vascular infections. FDA approved Symvess for urgent revascularization needs in December 2024, demonstrating its clinical efficacy and safety. The publication highlights the economic implications of using Symvess, reinforcing its value in healthcare decision-making.
Read more →HUMA▼ -10.1%on this news
Humacyte to Host In-Person and Virtual Investor Event in New York to Discuss Commercial Launch of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma on March 6, 2025
Humacyte, Inc. announced that it will conduct an in-person and virtual investor event on March 6, 2025, to discuss the commercial launch of its product, Symvess. This acellular tissue engineered vessel has achieved full FDA approval for use in extremity vascular trauma. The event will feature key opinion leaders in vascular surgery, highlighting the product's early market success and the company's strategic plans. The information will also cover potential benefits and regulatory challenges associated with Symvess’s commercialization.
Read more →HUMAHumacyte Announces Issuance of U.S. Patent Covering Manufacturing of Symvess™ and Other Bioengineered Tissues
Humacyte, Inc. announced the issuance of a U.S. Patent covering key aspects of their bioreactor manufacturing system for Symvess, a bioengineered tissue product. This patent is effective until 2040 and enhances the protection of Humacyte's manufacturing technologies. Symvess has received FDA approval for use in extreme cases of vascular trauma. The company continues to evaluate its products for additional applications, aiming to revolutionize patient care with universally implantable tissues.
Read more →HUMAHumacyte to Present at the TD Cowen 45th Annual Health Care Conference
Humacyte, Inc. announced that its CEO, Laura Niklason, will present at the TD Cowen 45th Annual Health Care Conference on March 4, 2025, in Boston, MA. The company, known for developing universally implantable bioengineered human tissues, is making progress with its acellular tissue engineered vessels (ATEVs) that are currently in late-stage clinical trials. Humacyte's ATEVs focus on applications including vascular trauma repair and hemodialysis access, with several already receiving FDA designations. This presentation comes as Humacyte continues to develop its innovative solutions within the biotechnology space.
Read more →HUMA▲ +12.8%on this newsshared move
Humacyte Announces Commercial Launch of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma
Humacyte, Inc. has announced the commercial launch of Symvess, an acellular tissue engineered vessel authorized by the FDA for urgent vascular repair in cases where autologous vein grafts are not feasible. The launch follows positive initial responses from surgeons and trauma centers, with 21 hospitals starting the approval process for the product. Symvess aims to improve patient outcomes in extremity arterial injuries, and early sales indicate strong interest from medical institutions. Humacyte’s CEO emphasizes the significance of this development for both their growth and patient care.
Read more →HUMAHumacyte and Pluristyx Announce Gene Editing Partnership to Support BioVascular Pancreas (BVP™) Development Using iPSCs
Humacyte, Inc. has announced an expanded partnership with Pluristyx to develop BioVascular Pancreas (BVP™) using gene editing techniques on iPSCs. The BVP™ aims to treat insulin-dependent diabetes by delivering insulin-producing islets within a carrier system. Pluristyx will leverage its licensed Mad7 gene editing technology to assist in this development. This collaboration builds on an existing partnership and follows Humacyte's recent FDA approval for a related vascular product.
Read more →HUMAHUMACYTE ALERT: Bragar Eagel & Squire, P.C. is Investigating Humacyte, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
Bragar Eagel & Squire, P.C. is investigating Humacyte, Inc. on behalf of long-term stockholders following a class action complaint filed in November 2024. The complaint alleges breaches of fiduciary duties by the board of directors and claims that the company made materially false or misleading statements during the Class Period. Key issues include non-compliance of the Durham facility with manufacturing practices and delays in FDA review for the ATEV product due to identified deficiencies, posing significant risks to Humacyte's operations and investor confidence.
Read more →HUMAHumacyte Announces Planned IND Filing in 2025 to Support First-In-Human Clinical Study of Small-Diameter ATEV™ for Coronary Artery Bypass Grafting
Humacyte plans to submit an Investigational New Drug application in 2025 for its small-diameter acellular tissue engineered vessel (sdATEV) aimed at enhancing coronary artery bypass grafting (CABG) procedures. Following a meeting with the FDA, the company is geared towards initiating human clinical trials based on favorable preclinical outcomes. The sdATEV demonstrated promising results by maintaining blood flow and integrating with host cells in preclinical models, indicating potential as a viable alternative to traditional grafts. The technology, if successful in clinical trials, may revolutionize CABG surgeries.
Read more →HUMAHumacyte Provides Update on Commercial Launch and Pricing of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma
Humacyte Inc. announced the commercial launch and pricing details for Symvess, a bioengineered human tissue approved by the FDA for extremity arterial injury. The product is designed to provide an off-the-shelf solution for urgent revascularization cases where traditional vein grafts are not feasible. A trained sales team has been assembled to support the introduction of this novel treatment to hospitals. Symvess is priced at $29,500 per unit, with expectations that its use will reduce clinical complications and associated costs compared to current standards of care.
Read more →HUMAHumacyte, Inc. Sued for Securities Law Violations – Investors Should Contact Levi & Korsinsky Before January 17, 2025 to Discuss Your Rights – HUMA
Humacyte, Inc. is facing a class action lawsuit for alleged securities fraud involving misleading statements regarding manufacturing practices and FDA approvals. The complaint claims that the company's Durham facility did not comply with required quality standards, which could delay the FDA's review of its biologics application. Investors who suffered losses between May and October 2024 are invited to participate in the lawsuit, which offers no upfront costs. The lawsuit raises significant concerns about the company's operations and potential risks to product approval.
Read more →HUMAHUMACYTE, INC. (NASDAQ: HUMA) DEADLINE ALERT: Bernstein Liebhard LLP Reminds Humacyte, Inc. Investors of Upcoming Deadline
Humacyte, Inc. is under investigation due to a securities fraud class action lawsuit filed on behalf of investors who purchased shares between May and October 2024. The lawsuit alleges misrepresentations regarding potential FDA approval for one of its products at the company's Durham, North Carolina facility. Investors are reminded of an upcoming deadline to file as lead plaintiffs by January 17, 2025, and have the opportunity to discuss their rights and options with Bernstein Liebhard LLP.
Read more →HUMAHumacyte, Inc. Investors: Please contact the Portnoy Law Firm to recover your losses. January 17, 2025 Deadline to file Lead Plaintiff Motion
Humacyte, Inc. is facing a class action lawsuit for allegedly making misleading statements regarding their manufacturing practices and FDA submissions. Investors who bought Humacyte stock between May 10, 2024, and October 17, 2024, have until January 17, 2025, to file a lead plaintiff motion. The lawsuit claims that the company's Durham facility did not comply with good manufacturing practices, which could delay FDA approval for their Acellular Tissue Engineered Vessel. Following recent announcements about the FDA's concerns, Humacyte's stock price experienced substantial declines.
Read more →HUMAHUMACYTE ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against Humacyte, Inc. and Encourages Investors to Contact the Firm
A class action lawsuit has been filed against Humacyte, Inc. in the U.S. District Court for the Middle District of North Carolina. The lawsuit alleges that the company made materially false statements and failed to disclose significant operational deficiencies related to its Durham facility. These deficiencies include non-compliance with good manufacturing practices, which may affect the FDA's review of its application for ATEV for vascular trauma. Investors are encouraged to contact the law firm Bragar Eagel & Squire for more details, as the complaint outlines risks to the company's prospects and investor interests.
Read more →HUMAHumacyte’s (HUMA) Insiders Sell Millions in Stock Amidst Lawsuit and Regulatory Troubles – Hagens Berman
Humacyte, Inc. (HUMA) insiders recently sold a large portion of their stock for approximately $6.6 million, coinciding with a class-action lawsuit alleging that the company misled investors regarding its product status and regulatory compliance. The company reported no revenue and considerable losses in its latest quarter, raising concerns about its financial health. Additionally, an FDA inspection of its Durham facility revealed significant violations, leading to a delay in the review of its key product's Biologic License Application. Investors have been encouraged to report their losses as legal investigations continue.
Read more →HUMAHumacyte, Inc. Class Action Lawsuit Alert: Johnson Fistel Announces Shareholders with Losses Should Contact the Law Firm for More Information
A class action lawsuit has been initiated against Humacyte, Inc. on behalf of investors who purchased shares between May 10, 2024, and October 17, 2024. Johnson Fistel, LLP is leading the action, which alleges that Humacyte misled investors regarding its manufacturing practices and the FDA approval process for its Acellular Tissue Engineered Vessel. Affected investors are encouraged to apply by January 17, 2025, to be appointed as lead plaintiff in the case. The lawsuit cites significant compliance issues at Humacyte's Durham, North Carolina facility that could impact the company's future success.
Read more →HUMAHumacyte Announces FDA Approval of SYMVESS (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma - SYMVESS is a first-in-class bioengineered human tissue designed to be a universally im
Humacyte announced FDA approval of SYMVESS, a bioengineered vascular conduit for treating extremity arterial injuries. This first-in-class product is designed for urgent revascularization when autologous vein grafts are not feasible. In clinical trials, SYMVESS showed high rates of patency and low infection rates, promising significant advancements in trauma care. The company has prepared a trained sales team for its upcoming launch.
Read more →HUMA▲ +5.9%on this newsshared move
Humacyte’s (HUMA) Statements to Investors Called Into Question in Light of FDA Violations – Hagens Berman
Humacyte is facing a class action lawsuit from investors who claim the company misled them about the regulatory status of its key product, the Biologic License Application (BLA) for an acellular tissue engineered vessel. Allegations include significant manufacturing compliance problems at their Durham, North Carolina facility, particularly in quality assurance. The lawsuit follows an FDA inspection which revealed various violations and led to a delay in the BLA review. As a result of these events, Humacyte's stock price has significantly dropped.
Read more →HUMAHumacyte to Present at the Piper Sandler 36th Annual Healthcare Conference
Humacyte, Inc. will participate in the Piper Sandler 36th Annual Healthcare Conference on December 5, 2024, where CEO Laura Niklason will present. The company is advancing its bioengineered human tissue platform, with products in late-stage clinical trials for various vascular applications. A Biologics License Application for one of its candidates is currently under FDA review. The firm has received multiple FDA designations for its innovative products.
Read more →HUMAHumacyte (HUMA) Faces Class Action Lawsuit After FDA Inspection Reveals Manufacturing Issues – Hagens Berman
Humacyte, Inc. is facing a class action lawsuit following an FDA inspection that revealed manufacturing compliance issues at its Durham, North Carolina facility. The lawsuit alleges that the company and its executives misled investors regarding the status of its Biologic License Application and failed to disclose important adverse facts. After the FDA's inspection and subsequent requirement for additional review time, Humacyte's stock price experienced a notable decline. The legal action reflects serious concerns about the company's transparency with investors.
Read more →HUMAHumacyte, Inc. Shareholder Alert: Robbins LLP Reminds Investors of the HUMA Securities Class Action
Robbins LLP has launched a class action lawsuit against Humacyte, Inc. on behalf of investors who purchased the company's securities from May 10, 2024, to October 17, 2024. The lawsuit arises from allegations that Humacyte misled investors about its manufacturing practices for the Acellular Tissue Engineered Vessel (ATEV) amid FDA reviews. The FDA has raised concerns about the compliance of Humacyte's Durham, North Carolina facility with manufacturing regulations, leading to notable declines in the company's stock price. Investors have until January 17, 2025, to submit their application to serve as lead plaintiffs in the case.
Read more →HUMAHumacyte to Present Efficacy and Safety Results from V007 Phase 3 AV Access Clinical Trial at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH)
Humacyte, Inc. is set to present Phase 3 results from its clinical study on the efficacy and safety of its acellular tissue engineered vessel (ATEV) in comparison to traditional AV fistulas for patients suffering from end stage renal disease. The presentation will take place on November 23, 2024, at the 51st Annual Symposium on Vascular and Endovascular Issues in New York. The ATEV, which is still under investigation and has not received FDA approval, aims to improve treatment options for vascular access in hemodialysis patients.
Read more →HUMAHUMACYTE, INC. (NASDAQ: HUMA) INVESTOR ALERT: Investors With Large Losses in Humacyte, Inc. Should Contact Bernstein Liebhard LLP To Discuss Their Rights
Bernstein Liebhard LLP has announced a class action lawsuit on behalf of Humacyte, Inc. investors who purchased securities between May 10, 2024, and October 17, 2024. The lawsuit alleges that the company made misleading statements about the FDA approval of its Acellular Tissue Engineered Vessel and operational conditions at its Durham facility. Investors have until January 17, 2025, to file papers if they wish to serve as lead plaintiff. The legal representation is on a contingency fee basis, with no upfront costs for shareholders.
Read more →HUMAHumacyte Clinical Results Highlighting Benefit of the ATEV™ in the Repair of Civilian and Military Arterial Injuries Published in JAMA Surgery
Humacyte, Inc. announced the publication of clinical results in JAMA Surgery demonstrating the efficacy of its acellular tissue engineered vessel (ATEV) in treating extremity vascular injuries. The ATEV showed superior outcomes in patency, limb salvage, and infection resistance compared to traditional synthetic grafts. The studies highlighted its potential benefits for both civilian trauma cases and military injuries, indicating a significant advancement in vascular trauma care. A Biologics License Application for the ATEV is currently under FDA review.
Read more →HUMAHumacyte (HUMA) Faces Class Action Lawsuit After FDA Inspection Reveals Manufacturing Issues– Hagens Berman
Humacyte, Inc. is facing a class action lawsuit following an FDA inspection revealing manufacturing compliance issues at its Durham facility. The lawsuit claims that Humacyte misled investors about the status of its Biologic License Application and failed to disclose crucial operational difficulties. This lack of transparency allegedly led to a significant decline in the company's stock price when the FDA's findings were released. Investors who incurred losses during the specified period are urged to participate in the lawsuit.
Read more →HUMA▼ -8.1%on this newsshared move
Humacyte Presents Preclinical Results of Small-Diameter ATEV™ for Coronary Artery Bypass Grafting at American Heart Association’s Scientific Sessions 2024
Humacyte, Inc. has announced favorable preclinical results for its small-diameter acellular tissue engineered vessel (sdATEV) used in coronary artery bypass grafting (CABG). Within a six-month study on baboons, the sdATEV demonstrated sustained patency, recellularization by host cells, and effective remodeling that minimizes size mismatches with native arteries. The findings were presented at the American Heart Association's Scientific Sessions 2024, indicating that the sdATEV could potentially address unmet clinical needs in CABG procedures.
Read more →HUMA▼ -9.4%on this newsshared move
Humacyte Announces Pricing of $15.0 Million Registered Direct Offering DURHAM, N.C.
Humacyte, Inc. announced a registered direct offering to institutional investors, pricing the sale of approximately $15.0 million worth of its common stock and warrants. The offering involves the sale of 2,808,988 common shares at an exercise price of $5.34 per share, with expected proceeds funding further development of its bioengineered human tissues. The offering is anticipated to close on or about November 15, 2024, subject to customary conditions.
Read more →HUMAHUMACYTE ALERT: Bragar Eagel & Squire, P.C. is Investigating Humacyte, Inc. on Behalf of Humacyte Stockholders and Encourages Investors to Contact the Firm
Bragar Eagel & Squire, P.C. is investigating Humacyte, Inc. over potential violations of federal securities laws and unlawful business practices. This follows recent FDA inspections that revealed serious manufacturing violations at Humacyte's North Carolina facility. Following these developments, Humacyte's stock price has dropped significantly, leading to concerns among investors.
Read more →HUMAHumacyte (HUMA) Faces Questions After FDA Inspection – Hagens Berman
Humacyte, Inc. (HUMA) is under scrutiny following an FDA report that highlighted serious issues with its manufacturing facilities. The report, dated April 5, 2024, was only made public on October 17, 2024, and it contradicts the positive statements made by the company's COO during an earnings call. Following the disclosure of these concerns, Humacyte's shares declined sharply, losing 16% of their value. An investigation is being led by Hagens Berman focusing on these discrepancies and the potential implications for investors.
Read more →HUMA▲ +9.9%on this newsshared move
Humacyte Third Quarter 2024 Financial Results and Business Update - FDA review of acellular tissue engineered vessel (ATEV ) BLA for the Treatment of Vascular Trauma is ongoing - - Results from the V007 Phase 3 clinical
Humacyte, Inc. announced its third quarter 2024 results and provided an update on the ongoing FDA review of its biologics license application (BLA) for the acellular tissue engineered vessel (ATEV) aimed at treating vascular trauma. Positive results from the Phase 3 V007 clinical trial were shared at the American Society of Nephrology's Kidney Week, highlighting the ATEV's superiority in function for hemodialysis access. Additionally, long-term outcomes from the use of ATEV in treating injuries from the Ukraine conflict were presented, further establishing its therapeutic potential. Despite these developments, the FDA has not given a timeline for the BLA review, and the company has reported no revenue for the quarter.
Read more →HUMAHumacyte to Present Third Quarter Financial Results and Provide Corporate Update on November 8, 2024
Humacyte, Inc. will announce its third quarter financial results for 2024 on November 8, 2024. A webcast and conference call is scheduled for 8:30 AM ET to discuss the company's recent corporate updates, particularly regarding its acellular tissue engineered vessel (ATEV) programs. Humacyte is developing advanced bioengineered human tissues and is currently in late-stage trials for various vascular applications. The company’s portfolio includes products that have received significant FDA designations, emphasizing its role in transforming medical practices.
Read more →HUMAHumacyte Announces Presentation of Positive Results from V007 Phase 3 AV Access Clinical Trial at the American Society of Nephrology's Kidney Week 2024 - ATEV demonstrated superiority at six and 12 months (co-primary end
Humacyte, Inc. announced positive results from its V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV) for arteriovenous access in patients with end-stage renal disease. The trial demonstrated superior function and patency of the ATEV compared to autogenous fistula, particularly in female, obese, and diabetic patients. The presentation occurred at the American Society of Nephrology's Kidney Week 2024, highlighting the potential of ATEV to improve access for hemodialysis patients. However, the ATEV remains an investigational product pending FDA approval.
Read more →HUMAHumacyte to Host Virtual KOL Event on the Use of Acellular Tissue Engineered Vessel (ATEV™) for AV Access in Hemodialysis on October 31, 2024
Humacyte, Inc. will host a virtual Key Opinion Leader (KOL) event on October 31, 2024, focusing on its acellular tissue engineered vessel (ATEV) for arteriovenous access in hemodialysis patients. Leading vascular surgeons will present recent Phase 3 clinical trial results and discuss the unmet needs in hemodialysis access. Although the ATEV shows promise, it remains investigational and lacks regulatory approval for consumer sale. The event aims to engage the medical community in advancing vascular treatment options.
Read more →HUMAHumacyte Late-Breaking Abstract Accepted for Oral Presentation on V007 Phase 3 AV Access Clinical Trial at the American Society of Nephrology’s Kidney Week 2024
Humacyte, Inc. announced that its late-breaking abstract regarding the V007 Phase 3 clinical trial of its acellular tissue engineered vessel has been accepted for oral presentation at the American Society of Nephrology's Kidney Week 2024. The presentation will take place on October 26, 2024, and will feature Dr. Mohamad A. Hussain from Brigham and Women's Hospital. This trial focuses on AV access for patients with end-stage renal disease, highlighting Humacyte's innovative approach in biotechnology.
Read more →HUMAHumacyte Announces Pricing of $30.0 Million Registered Direct Offering DURHAM, N.C.
Humacyte, Inc. has announced a registered direct offering, raising approximately $30.0 million through the sale of common stock and warrants. The agreement allows the company to sell over five million shares at an exercise price of $5.28. This capital will support the company's ongoing development of universally implantable human tissues, with various applications currently in clinical trials, including treatments for vascular diseases. The offering is expected to close on or around October 7, 2024, subject to customary conditions.
Read more →HUMAHumacyte to Host Virtual KOL Event to Discuss Case Studies on the Use of Acellular Tissue Engineered Vessel (ATEV™) in Vascular Trauma Treatment on September 30, 2024
Humacyte, Inc. will host a virtual KOL event on September 30, 2024, focused on case studies related to its acellular tissue engineered vessel (ATEV) for vascular trauma. Notable speakers from the University of Maryland and Johns Hopkins are set to discuss the current treatment landscape and unmet medical needs in urgent arterial repair. The event aims to showcase findings from Phase 3 trials in the U.S., Israel, and humanitarian efforts in Ukraine. The ATEV represents a first-in-class bioengineered solution and is currently under FDA review for its application in vascular trauma.
Read more →HUMAHumacyte Announces Allowance of U.S. Patent Covering BioVascular Pancreas (BVP™)
Humacyte, Inc. has announced the allowance of a U.S. patent for its BioVascular Pancreas (BVP), a potential treatment for type 1 diabetes. The BVP aims to deliver insulin-producing islets successfully within the body, utilizing an investigational acellular tissue engineered vessel. Preclinical studies have shown promising results, including restored normal blood sugar levels in diabetic mice and successful islet implantation in non-human primates. This patent milestone, achieved in collaboration with Yale University, marks an important advancement for Humacyte in the field of diabetes treatment.
Read more →HUMA▼ -8.5%on this news
Humacyte to Participate at Upcoming Investor Conferences in September
Humacyte, Inc. is set to participate in two investor conferences in September 2024, where its CEO and CFO will represent the company. The firm is recognized for its bioengineered human tissues, currently under FDA review for various applications, including vascular trauma and hemodialysis access. Its innovative ATEV products have also received important regulatory designations, highlighting their potential in addressing critical medical conditions. This upcoming participation could enhance investor interest and support for the company's ongoing developments.
Read more →HUMA▼ -5.5%on this news
Humacyte Presents Positive Long-Term Results of ATEV™ in Treatment of Vascular Trauma in Military Setting from Ukraine Humanitarian Program
Humacyte Inc. presented long-term results at the Military Health System Research Symposium, showing positive outcomes for its investigational acellular tissue engineered vessel (ATEV) used to treat vascular trauma in Ukraine. In a study involving 16 patients, the ATEV achieved a 12-month patency rate of 87.1% with no infections or amputations reported. The results highlight the potential of ATEV as an off-the-shelf solution for severe wartime injuries. Despite one thrombosis event noted, the overall findings support the product's durability and effectiveness in critical care settings.
Read more →HUMAHumacyte Second Quarter 2024 Financial Results and Business Update
Humacyte, Inc. reported its financial results for Q2 2024 and provided updates on its ATEV (acellular tissue engineered vessel) product. Despite receiving a Priority Review status from the FDA, the company has been informed that the review will take additional time, causing uncertainty about the timeline for potential approval for treating vascular trauma. However, positive topline results were announced from a Phase 3 trial on the ATEV's use in hemodialysis access, and it received a third Regenerative Medicine Advanced Therapy designation. The company remains optimistic about its future prospects.
Read more →HUMA▼ -16.4%on this newsshared move
Humacyte to Present Second Quarter Financial Results and Provide Corporate Update on August 13, 2024
Humacyte, Inc. is set to announce its second quarter financial results on August 13, 2024, with a conference call and webcast scheduled for 8:30 a.m. ET. The company is involved in developing bioengineered human tissues and has several products in late-stage clinical trials, including their acellular tissue engineered vessel (ATEV) portfolio targeting various vascular conditions. The FDA is currently reviewing a Biologics License Application for the ATEV related to vascular trauma, which has been granted Priority Review status. Investors can expect updates on these developments during the upcoming call.
Read more →HUMAHumacyte Announces FDA Communication of Additional Time Required to Complete Review of acellular tissue engineered vessel (ATEV TM ) BLA for the Treatment of Vascular Trauma - 2nd quarter conference call to be held Tuesd
Humacyte, Inc. has announced that the FDA will require additional time to finish its Biologic License Application review for its ATEV product aimed at treating vascular trauma. This news comes ahead of the previously scheduled PDUFA date of August 10, 2024. Although the FDA has granted Priority Review for the ATEV and indicated its first-in-class status, delays in the review process have raised concerns. The CEO of Humacyte remains optimistic about the product's prospects, based on positive data from clinical interactions with the FDA.
Read more →HUMA▲ +15.4%on this news
Humacyte Acellular Tissue Engineered Vessel (ATEV ) Meets Primary Endpoints in V007 Phase 3 Clinical Trial in Arteriovenous Access for Hemodialysis - ATEV demonstrated superiority at six and 12 months (co-primary endpoin
Humacyte announced positive results from its V007 Phase 3 Clinical Trial showing that its Acellular Tissue Engineered Vessel (ATEV) met co-primary endpoints in arteriovenous access for hemodialysis. Over six and twelve months, ATEV demonstrated a significantly higher functional patency compared to the current standard of care, autogenous fistula. However, some adverse events were reported in patients receiving the ATEV. Humacyte plans to discuss potential market authorization with the FDA soon.
Read more →HUMAHumacyte Board of Directors Strengthened with Addition of John P. Bamforth and Keith Anthony Jones
Humacyte, Inc. has expanded its Board of Directors with the appointments of Dr. John P. Bamforth and Dr. Keith Anthony Jones. These leaders bring extensive experience in commercialization and healthcare systems to support the company's upcoming commercial launch of the Acellular Tissue Engineered Vessel (ATEV) for vascular trauma. Dr. Bamforth's background at Eli Lilly and Dr. Jones' roles at the University of Alabama at Birmingham position the company well for its anticipated market entry. Additionally, the ATEV is currently undergoing regulatory review with a PDUFA date set for August 10, 2024.
Read more →HUMA▲ +11.9%on this news
Humacyte Acellular Tissue Engineered Vessel (ATEV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Patients with Advanced Peripheral Artery Disease (PAD)
Humacyte, Inc. has been awarded the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its Acellular Tissue Engineered Vessel (ATEV), targeting advanced peripheral artery disease (PAD). This marks the third RMAT designation for the ATEV, which is also undergoing evaluation for vascular trauma repair and hemodialysis access. The designation is intended to facilitate expedited development and closer collaboration with the FDA for Humacyte's therapy. The ATEV is designed as a universally implantable vascular conduit, potentially addressing the needs of patients lacking suitable autologous vein for revascularization.
Read more →HUMAHumacyte Presents Positive Preclinical Data For Its BioVascular Pancreas (BVP™) Program
Humacyte, Inc. presented promising preclinical data on its BioVascular Pancreas (BVP) program as a potential treatment for type 1 diabetes. The data, shared at two scientific meetings, demonstrated that stem cell-derived islets restored normal blood glucose levels in diabetic mice and survived in primate models, maintaining insulin production over a three-month period. No adverse safety events were reported. The BVP aims to enhance pancreatic islet transplantation outcomes, addressing current deficiencies in islet administration methods.
Read more →HUMA▲ +18%on this news
Humacyte to Present at the Jefferies Global Healthcare Conference
Humacyte, Inc. (Nasdaq: HUMA) has announced that CEO Laura Niklason will present at the Jefferies Global Healthcare Conference in New York on June 6, 2024. The company is engaged in developing universally implantable, bioengineered human tissues and is in late-stage clinical trials for its Human Acellular Vessel (HAV) targeting vascular trauma and other applications. The FDA has accepted a Biologics License Application for HAV and granted it Priority Review status. Humacyte has received multiple designations from the FDA, further emphasizing its innovative approach in the biotech field.
Read more →HUMA▲ +16.6%on this news· ran to +37% by day 1
Humacyte to Participate at Upcoming Investor Conferences in May
Humacyte, Inc. announced its participation in two investor conferences in May 2024. The company will be represented by CEO Laura Niklason and other executives at the H.C. Wainwright BioConnect Investor Conference and Benchmark’s 4th Annual Healthcare House Call Investor Conference. Humacyte focuses on developing bioengineered human tissues for various medical applications and is advancing several projects in clinical trials and preclinical development, attracting attention within the investment community.
Read more →HUMAHumacyte First Quarter 2024 Financial Results and Business Update - Biologics License Application (BLA) for HAV Accepted by FDA - - BLA Granted Priority Review for Vascular Trauma Indication PDUFA date set for
Humacyte, Inc. recently announced the acceptance of its Biologics License Application (BLA) for the Human Acellular Vessel (HAV) by the FDA, which has been granted Priority Review with a PDUFA date set for August 10, 2024. The company also reported raising approximately $43 million through a public offering and highlighted the successful outcomes from clinical trials that support their application for vascular trauma treatment. Furthermore, Humacyte is actively preparing for the U.S. market launch of the HAV, emphasizing its economic value compared to current standard of care.
Read more →HUMAHumacyte to Present First Quarter Financial Results and Provide Corporate Update on May 10, 2024
Humacyte, Inc. (Nasdaq: HUMA) will announce its first quarter financial results for 2024 on May 10, 2024, along with a corporate update during a scheduled webcast. The company is focused on creating universally implantable bioengineered human tissues and is making strides in clinical trials, particularly with their HAVs for vascular applications. They have achieved significant regulatory designations for their products, underscoring their innovative approach in the biopharma space.
Read more →HUMAHumacyte to Host Virtual KOL Event “Hemodialysis Access: A Crossroads of Care,” on March 28, 2024
Humacyte, Inc. has announced a virtual KOL event on March 28, 2024, focusing on hemodialysis access complications and treatment costs. The event will feature insights from notable medical professionals and will include a question-and-answer session. Additionally, the FDA has accepted Humacyte's Biologics License Application for the Human Acellular Vessel, highlighting the company's advances in clinical trials. The HAV is intended for urgent vascular trauma cases where other treatments are not viable.
Read more →HUMA▼ -8.1%on this newsshared move
Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update -Biologics License Application (BLA) for HAV Accepted by FDA on
Humacyte announced its fourth quarter and year-end 2023 financial results, highlighting the FDA's acceptance of its Biologics License Application (BLA) for the Human Acellular Vessel (HAV), now under Priority Review for vascular trauma. The company raised approximately $43.1 million from a public stock offering to support ongoing initiatives. However, despite these advancements, Humacyte reported no revenue for 2023 and increased operating expenses. The Prescription Drug User Fee Act (PDUFA) date is set for August 10, 2024, when the FDA will announce its decision on the HAV.
Read more →HUMA▲ +8.3%on this news
Humacyte to Present 2023 Fourth Quarter and Year-End Financial Results and Provide Corporate Update on March 22, 2024
Humacyte, Inc. will announce its fourth quarter and year-end financial results for 2023 on March 22, 2024. As a clinical-stage biotechnology platform, Humacyte aims to revolutionize medical treatment with bioengineered human tissues. The management team will also provide a corporate update during a scheduled conference call. Their leading product candidate has gained notable FDA designations, which reflects their progress in clinical trials.
Read more →HUMA▼ -25.5%on this news
Humacyte, Inc. Announces Pricing of $40.2 Million Public Offering of Common Stock
Humacyte, Inc. has announced the pricing of a public offering of 13.4 million shares of common stock at $3.00 per share, expected to raise a total of $40.2 million before expenses. The funds will be utilized to advance its regenerative medicine pipeline and support its FDA review for approval of bioengineered human acellular vessels (HAVs). The closing of the offering is anticipated around March 5, 2024, subject to customary conditions. Additionally, the underwriters have a 30-day option to purchase up to 2.01 million additional shares.
Read more →HUMA▼ -25.5%on this news
Humacyte, Inc. to Present at the TD Cowen 44th Annual Health Care Conference
Humacyte, Inc. announced that its executives will present at the TD Cowen 44th Annual Health Care Conference in Boston on March 4, 2024. The company's focus is on developing bioengineered human tissues and advanced tissue constructs, with its HAV product candidates in late-stage clinical trials for various vascular applications. Notably, Humacyte's 6mm HAV has received FDA designations that underline its potential in the medical field. The event will also provide opportunities for one-on-one meetings with management.
Read more →HUMADisclaimer These slides and the accompanying oral presentation contain forward-looking statements. All statements, other than statements of historical fact, included in these slides and the accompanying oral presentation
Humacyte is advancing its bioengineered human acellular vessels (HAVs) with the FDA granting Priority Review for a Biologics License Application aimed at vascular trauma, expecting a PDUFA date by August 10, 2024. The company emphasizes its proprietary technology which permits universally implantable regenerative tissues and its commercial-scale manufacturing capacity. Having conducted trials on over 500 patients, HAVs have demonstrated promising attributes like self-healing and low infection rates, positioning Humacyte favorably in the regenerative medicine field.
Read more →HUMA▲ +15.8%on this news· ran to +34% by day 3
Human Acellular Vessel (HAV ) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma - BLA submission supported by results from Phase 2 3 clinical trial and outcomes of rea
Humacyte, Inc. has announced that the U.S. FDA has accepted and granted Priority Review for its Biologics License Application (BLA) for the Human Acellular Vessel (HAV), aimed at treating vascular trauma. This BLA is backed by positive results from the Phase 2/3 clinical trial and experiences from its use in wartime humanitarian efforts in Ukraine. The HAV has demonstrated superior performance in terms of blood flow maintenance and reduced complications when compared to synthetic grafts. The FDA has set a PDUFA date for August 10, 2024, signaling a potential significant advancement in regenerative medicine for patients suffering from traumatic vascular injuries.
Read more →HUMAHumacyte Submits Biologics License Application (BLA) to U.S. FDA Seeking Approval of Human Acellular Vessel (HAV ) for the Treatment of Vascular Trauma - BLA supported by results from Phase 2 3 clinical trial and outcome
Humacyte, Inc. has filed a Biologics License Application (BLA) with the FDA for its Human Acellular Vessel (HAV), aimed at treating vascular trauma. The application is supported by positive data from the V005 Phase 2/3 trial and results from a humanitarian program in Ukraine. Notably, the HAV demonstrated higher patency rates and lower rates of infection and amputation when compared to traditional synthetic grafts. The FDA has granted RMAT designation for the HAV, expediting its review process significantly.
Read more →HUMAHumacyte to Present at the Piper Sandler 35th Annual Healthcare Conference
Humacyte, Inc. (Nasdaq: HUMA) announced that its leadership will present at the Piper Sandler 35th Annual Healthcare Conference in New York on November 30, 2023. CEO Laura Niklason and CFO Dale Sander will participate in a fireside chat and are available for one-on-one meetings. The company specializes in developing universally implantable bioengineered human tissues, with its initial portfolio targeting several vascular applications currently in late-stage clinical trials.
Read more →HUMAHumacyte Announces Two Presentations at the VEITHsymposium of Positive Clinical Results of the Human Acellular Vessel™ (HAV™) in the Treatment of Vascular Trauma
Humacyte Inc. announced positive results from its Phase 2/3 clinical trial of the Human Acellular Vessel (HAV) at the VEITHsymposium. The HAV showed significantly higher rates of patency and lower amputation and infection rates when compared to synthetic graft benchmarks. The data included outcomes from a humanitarian program treating wartime injuries in Ukraine and supports Humacyte's upcoming Biologics License Application to the FDA for use in vascular trauma. The results were well-received among clinical investigators, indicating promising potential for future use in vascular regenerative medicine.
Read more →HUMAHumacyte Third Quarter 2023 Financial Results and Business Update - Positive top line results from the V005 Phase 2 3 trial of the Human Acellular Vessel (HAV ) in vascular trauma repair - - BLA for an indication in vasc
Humacyte is reporting strong results for the third quarter of 2023, highlighting positive outcomes from the V005 Phase 2 3 trial of its Human Acellular Vessel (HAV) for vascular trauma repair. The company is planning to file a Biologics License Application (BLA) with the FDA this quarter, aiming to introduce the HAV to the market. Additionally, the HAV has shown effectiveness in treating war-related injuries in Ukraine, with impressive outcomes reported. Financially, Humacyte holds $100 million in cash, indicating a solid footing for ongoing operations.
Read more →HUMA▲ +6%on this news· ran to +21% by day 3
Humacyte to Present Third Quarter Financial Results and Provide Corporate Update on November 9, 2023
Humacyte, Inc. is set to announce its third quarter financial results for 2023 on November 9, 2023. This announcement will be followed by a conference call where management will provide insights into the company's corporate and financial status. Humacyte is developing bioengineered human tissues and has several ongoing clinical trials for its vascular products, showcasing its position in the biotechnology sector. The company has received several designations from the FDA, indicating regulatory recognition of its innovative therapeutic approaches.
Read more →HUMAHumacyte Publishes Preclinical Results Showing Human Acellular Vessel™ (HAV™) Patency as Modified Blalock–Taussig–Thomas Shunt in Juvenile Primate Model
Humacyte, Inc. announced positive preclinical results for its Human Acellular Vessel (HAV) in treating Tetralogy of Fallot in a juvenile primate model. The study, published in the Journal of Thoracic and Cardiovascular Surgery, showed that HAVs remained patent for up to six months and indicated successful host cell repopulation. This research marks an extension of Humacyte's capacity to create smaller diameter vessels, which could potentially benefit pediatric heart patients and transform their treatment options.
Read more →HUMAHumacyte to Present at the Cantor Global Healthcare Conference
Humacyte, Inc. will present at the Cantor Global Healthcare Conference on September 28, 2023, in New York City. The presentation will be led by CEO Laura Niklason and CFO Dale Sander, who will also be available for one-on-one meetings. Humacyte focuses on developing universally implantable, bioengineered human tissues and has notable advancements in clinical trials targeting vascular applications. Their 6mm HAV has received both RMAT and Fast Track designations from the FDA.
Read more →HUMA▼ -5.7%on this newsshared move
Humacyte to Host In-Person KOL Event at the New York EDITION on September 20, 2023
Humacyte, Inc. is set to host an in-person key opinion leader (KOL) event on September 20, 2023, at The New York EDITION Hotel. The event will feature a discussion led by Dr. Michael Curi and a patient focusing on the recent Phase 2/3 V005 trial results related to Humacyte's Human Acellular Vessel (HAV). The HAV is recognized for its potential in treating traumatic vascular injuries, having received priority and RMAT designations from U.S. health authorities. This event is aimed at addressing the significant unmet clinical need in vascular trauma treatment.
Read more →HUMAHumacyte Announces Positive Top Line Results from Phase 2 3 Trial of Human Acellular Vessel (HAV ) in Treatment of Patients with Vascular Trauma -- Single-arm clinical trial was a success and showed the HAV had higher ra
Humacyte, Inc. announced positive results from its Phase 2/3 trial of the Human Acellular Vessel (HAV) in patients with vascular trauma. The HAV showed higher rates of blood flow (patency) and lower rates of amputation and infection compared to historical synthetic graft benchmarks. Humacyte plans to submit a Biologics License Application (BLA) to the FDA in the fourth quarter of 2023. The trial results suggest that HAV could offer a significant improvement in the treatment of major traumatic injuries.
Read more →HUMAHumacyte to Announce Top Line Data from Phase 2/3 V005 Trial in Vascular Trauma Evaluating its Human Acellular Vessel™ (HAV™) Tuesday, September 12, 2023 at 8:00 AM ET
Humacyte, Inc. is set to announce top line data from its Phase 2/3 V005 trial that evaluates its Human Acellular Vessel (HAV) for vascular trauma repair. This virtual webinar will feature discussions by Dr. Michael Curi regarding the desperate need in the field of vascular trauma. The HAV has received important designations from the FDA and the Department of Defense, highlighting its potential as an innovative treatment option. The announcement is scheduled for September 12, 2023, at 8:00 AM ET.
Read more →HUMA▲ +10.9%on this news
Humacyte Presents Clinical Performance of Human Acellular Vessel™ (HAV™) From Ukrainian Humanitarian Program
Humacyte, Inc. presented positive clinical outcomes of its Human Acellular Vessel (HAV) during the Military Health System Research Symposium. The HAV has been used on the frontlines in Ukraine to treat traumatic vascular injuries, showing a 95% patency rate and a 100% limb salvage rate among patients treated. These results will be included in Humacyte's upcoming Biologics License Application to the FDA, planned for Q4 2023. The investigational HAV, designed to be universally implantable, demonstrates significant promise for improving patient outcomes in both military and civilian settings.
Read more →HUMA▲ +23.5%on this news· ran to +37% by day 1shared move
Humacyte Second Quarter 2023 Financial Results and Business Update - Completed Enrollment in Phase 2 3 V005 Trial of HAV in Vascular Trauma Repair Top-Line Results on Track for Q3 2023 - - Results from Vascular Trauma Hu
Humacyte, Inc. (Nasdaq HUMA) reported its Q2 2023 financial results, completing enrollment in the Phase 2 3 trial of its Human Acellular Vessel (HAV) for vascular trauma repair. The trial's top-line results are anticipated by Q3 2023, ahead of a planned Biologics License Application with the FDA in Q4 2023. The company reported a significant success rate in treating wartime vascular trauma injuries in Ukraine, with a 100% limb salvage and survival rate. However, Humacyte did not generate any revenue for the quarter, raising concerns about its financial trajectory.
Read more →HUMAHumacyte to Present Second Quarter Financial Results and Provide Corporate Update on August 14, 2023
Humacyte, Inc. will announce its second-quarter financial results on August 14, 2023, during a scheduled webcast and conference call. The company is focused on developing bioengineered human tissues and has products in late-stage clinical trials for various vascular applications. They have garnered FDA designations for their innovative therapies, indicating their commitment to advancing medical treatments. The webcast will be accessible for investors and interested parties for follow-up viewing.
Read more →HUMAHumacyte Announces Publication of Biological Mechanism Explaining Low Rates of Infection Observed in Clinical Study of Human Acellular Vessel™ (HAV™)
Humacyte has published a study in the Journal of Vascular Surgery that describes the biological mechanisms behind the low infection rates observed with its investigational human acellular vessel (HAV) compared to synthetic grafts. The results illustrate that the HAV promotes host cell infiltration and supports neutrophil vitality, which contributes to its enhanced resistance to bacterial infections. This data indicates the HAV's potential to revolutionize treatment for patients facing vascular challenges, given its promising safety profile and clinical experiences. Currently, the HAV is undergoing late-stage clinical trials for various vascular applications.
Read more →HUMAHumacyte Completes Enrollment in Phase 2 3 Trial of Human Acellular Vessel (HAV ) for Vascular Trauma Repair -Top-line results planned to be released in third quarter 2023 -Trial results are intended to support Biologics
Humacyte, Inc. has completed enrollment in its Phase 2/3 vascular trauma trial (V005) for its Human Acellular Vessel (HAV), targeting a Biologics License Application (BLA) filing planned for Q4 2023. The HAV is a bioengineered artery aimed at providing a durable replacement for damaged vessels and is supported by promising preliminary results indicating a high potential for infection resistance. The trial, conducted at U.S. and Israeli trauma centers, focuses on patients with extremity vascular trauma and aims to demonstrate efficacy through 30-day vessel patency. Additionally, data from a humanitarian program in Ukraine will also contribute to the upcoming BLA filing.
Read more →HUMA▲ +5.1%on this news· ran to +20% by day 3
Humacyte to Present at the Jefferies Healthcare Conference
Humacyte, Inc. will present at the Jefferies Healthcare Conference on June 9, 2023, in New York City. The presentation will be led by CEO Laura Niklason and CFO Dale Sander, who will also hold one-on-one meetings with attendees. The company is known for developing universally implantable bioengineered human tissues and advanced tissue constructs aimed at treating various diseases and injuries. Humacyte's products are currently in late-stage clinical trials, including treatments for vascular trauma and dialysis access.
Read more →HUMA▼ -6.5%on this news
Humacyte and Oberland Capital Announce Funding Arrangement Totaling Up to $160 Million
Humacyte, Inc. has entered into a funding arrangement with Oberland Capital Management totaling up to $160 million. The agreement includes an upfront fee along with additional funds contingent upon FDA acceptance and approval of its Human Acellular Vessel (HAV) for vascular trauma. This funding aims to extend Humacyte's financial runway and support the development of both the HAV and other early-stage product candidates. The company's innovative approach in bioengineered human tissues is in late-stage clinical trials targeting multiple vascular applications.
Read more →HUMA▼ -6.5%on this news
Humacyte First Quarter 2023 Financial Results and Business Update - Human Acellular Vessel (HAV ) granted second RMAT designation by the FDA, for Vascular Trauma - - Completion of enrollment in Phase 3 trial of HAV in He
Humacyte, Inc. reported its first quarter 2023 financial results, highlighting significant milestones such as receiving a second RMAT designation from the FDA for its Human Acellular Vessel (HAV) aimed at treating vascular trauma. Additionally, the company completed enrollment in a Phase 3 trial that evaluates HAV for hemodialysis access. Despite these advancements, financial results revealed no revenue for Q1 2023 and an increased net loss of $37 million, largely attributed to a rise in R&D expenses and contingent liabilities.
Read more →HUMA▼ -10.7%on this newsshared move
Humacyte Announces Publication in Lancet Regional Health - Europe Presenting Use of Human Acellular Vessel™ (HAV™) to Treat Vascular Injuries in Ukraine
Humacyte, Inc. announced the publication of a study in The Lancet Regional Health - Europe, detailing the use of its Human Acellular Vessel (HAV) in treating vascular trauma in the Ukraine-Russia conflict. The study demonstrates the positive clinical outcomes for patients treated with HAVs, which have shown success in preventing amputations and infections. Ukrainian surgeons conducted procedures using video conferencing training, and the HAV has been implemented in several hospitals across Ukraine. As Humacyte nears completion of a Phase 2/3 trial for civilian vascular trauma, the HAV continues to demonstrate promise in regenerative medicine applications.
Read more →HUMAHumacyte to Present First Quarter Financial Results and Provide Corporate Update on May 12, 2023
Humacyte, Inc. (Nasdaq: HUMA) plans to release its financial results for Q1 2023 on May 12, 2023, and will hold a conference call at 8:00 a.m. ET to discuss these results along with a corporate update. The company is advancing its innovative biotechnology platform aimed at developing universally implantable bioengineered human tissues. Notably, Humacyte's HAVs are in late-stage clinical trials, targeting several vascular applications and have received significant FDA designations, highlighting the potential impact of its products on medical practice.
Read more →HUMA▲ +7.1%on this newsshared move
Humacyte’s Human Acellular Vessel™ (HAV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Urgent Arterial Repair Following Vascular Trauma
Humacyte, Inc. has received the FDA's Regenerative Medicine Advanced Therapy designation for its Human Acellular Vessel (HAV) for urgent arterial repair due to vascular trauma. This marks the second RMAT designation for the HAV, which is designed to be a universally implantable vascular conduit with a low infection rate. The designation allows for more interaction with the FDA and a potential expedited review for the upcoming Biologics License Application (BLA). Humacyte is currently conducting its Phase 2/3 clinical trial and plans to file for BLA later in 2023.
Read more →HUMAHumacyte to Present at the H.C. Wainwright BioConnect Investor Conference at NASDAQ
Humacyte, Inc. is set to present at the H.C. Wainwright BioConnect Investor Conference on May 2, 2023, where CEO Laura Niklason and CFO Dale Sander will speak. The company focuses on developing bioengineered human tissues with applications in treating various diseases and conditions. Their human acellular vessels have already received significant FDA designations, including RMAT and Fast Track. The event could enhance Humacyte's visibility among investors and stakeholders in the biotechnology industry.
Read more →HUMAHumacyte, JDRF Collaborating to Develop Insulin-Producing Biovascular Pancreas to Treat Type 1 Diabetes
Humacyte, Inc. has announced a collaboration with JDRF International to advance the development of its Biovascular Pancreas (BVP) for treating Type 1 Diabetes (T1D). The BVP aims to deliver insulin-producing islets using Humacyte's Human Acellular Vessel as a carrier. JDRF will fund the development and testing of this innovative therapy, which could potentially overcome existing challenges in insulin cell delivery, improving outcomes for T1D patients. Both organizations emphasize the potential impact of this therapy on the lives of those affected by the disease.
Read more →HUMAHumacyte Announces Publication of Preclinical Study Comparing Human Acellular Vessel™ (HAV™) to Expanded Polytetrafluoroethylene (ePTFE) Graft in Vascular Trauma
Humacyte, Inc. has announced the publication of a preclinical study in the Journal of Trauma and Acute Care Surgery, showcasing the performance of its Human Acellular Vessel (HAV) compared to ePTFE grafts in vascular trauma repair. The study revealed that the HAV outperformed ePTFE in several critical metrics including limb function recovery and graft patency, while also eliminating risks of infection and mechanical failure. Additionally, the company is nearing completion of enrollment for its Phase 2/3 trial for the HAV as part of its efforts to support a Biologics License Application (BLA) filing with the FDA.
Read more →HUMA▲ +12.6%on this news
Humacyte Completes Enrollment in Phase 3 Trial of Human Acellular Vessel™ (HAV™) for Hemodialysis Access in End-Stage Renal Disease Patients
Humacyte, Inc. announced the completion of enrollment in its Phase 3 trial, V007, which tests the efficacy of the Human Acellular Vessel (HAV) for vascular access in hemodialysis patients with end-stage renal disease. The study aims to compare the HAV's performance to traditional autogenous arteriovenous fistulas in terms of usability and infection rates. The HAV is designed to offer a safer and quicker option for hemodialysis access, potentially transforming patient outcomes. As of now, the HAV has not received FDA approval for market sale.
Read more →HUMA▼ -5.8%on this news
Humacyte Announces Fourth Quarter and Year End 2022 Financial Results and Business Update -- Enrollment Nearing Completion in Human Acellular Vessel (HAV ) Phase 2 3 Trial in Vascular Trauma and Phase 3 Trial in Arteriov
Humacyte, Inc. announced its fourth quarter and full-year financial results for 2022, highlighting significant progress in its clinical developments, particularly with the Human Acellular Vessel (HAV). Enrollment is approaching completion in both the Phase 2/3 trial for vascular trauma and the Phase 3 trial for arteriovenous access in hemodialysis patients. Encouraging data from Ukrainian medical professionals using HAV in wartime trauma cases was also presented. However, the company reported no revenue in Q4 2022 and continues to face high operating expenses.
Read more →HUMA▲ +8.2%on this newsshared move
Humacyte to Present Fourth Quarter and Full Year Financial Results and Provide Corporate Update on March 24, 2023
Humacyte, Inc. is set to announce its financial results for the fourth quarter and the year ending December 31, 2022, on March 24, 2023. The company, known for developing universally implantable bioengineered human tissues, will provide both financial and corporate updates during a webcast at 8:00 a.m. ET. They are currently advancing several innovative treatments through late-stage clinical trials, reflecting their commitment to improving medical practices and patient outcomes.
Read more →HUMAHumacyte to Present at Upcoming Investor Conferences in March
Humacyte, Inc. will be represented by CEO Laura Niklason and CFO Dale Sander at two upcoming investor conferences in March 2023: Cowen’s 43rd Annual Health Care Conference and Oppenheimer’s 33rd Annual Healthcare Conference. The presentations will highlight Humacyte's development of universally implantable bioengineered human tissues and organ systems. The company's Human Acellular Vessels (HAVs) are in late-stage trials for various vascular applications and have garnered FDA designations, underlining their potential impact in regenerative medicine.
Read more →HUMAHumacyte Publication in the Journal of Vascular Surgery – Vascular Science Reports the Human Acellular Vessel™ (HAV™) Remains Durable at Six Years in Patients with Peripheral Artery Disease
Humacyte announced a publication detailing a Phase 2 study of its Human Acellular Vessel (HAV), which has shown durability in patients with peripheral artery disease (PAD) over six years. The vessel maintained a 60% patency rate according to Kaplan Meier analysis, with no reports of infection or graft rejection among participants. Researchers indicate that the HAV can offer a promising alternative for restoring blood supply to the lower extremities in complex cases of PAD. Humacyte continues to evaluate the HAV in multiple ongoing clinical trials seeking regulatory approval.
Read more →HUMA▼ -8.7%on this news· ran to -19% by day 3
Humacyte Hosting Key Opinion Leader Webinar on Vascular Trauma: Ukrainian Surgeons Discuss Use of Human Acellular Vessels™ (HAV™) in Wartime
DURHAM, N.C., Dec. 13, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that it will host a key opinion leader (KOL) webinar o
Read more →HUMAHumacyte Human Acellular Vessel™ (HAV™) Ukraine Humanitarian Results to be Presented at Multiple Vascular Conferences in December 2022
DURHAM, N.C., Dec. 01, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced pres
Read more →HUMAHumacyte to Present at the 34th Annual Piper Sandler Healthcare Conference
DURHAM, N.C., Nov. 23, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President,
Read more →HUMAHumacyte Third Quarter 2022 Financial Results and Business Update -- Progress Continues in Clinical Development of Human Acellular Vessel (HAV ) for Vascular Trauma BLA Filing Anticipated mid 2023 - -- Experience with HA
Humacyte Third Quarter 2022 Financial Results and Business Update -- Progress Continues in Clinical Development of Human Acellular Vessel (HAV ) for Vascular Trauma BLA Filing Anticipated mid 2023 - -- Experience with HAV in Ukrainian War Vascular Trauma Mirrors Clinical Experi
Read more →HUMAHumacyte Presents Six-Month Human Acellular Vessel™ (HAV™) Coronary Artery Bypass Graft (CABG) Data at the American Heart Association Scientific Sessions 2022 Meeting
Six-month primate HAV CABG model demonstrates patency, recellularization and remodeling resembling native blood vessels HAV may address many limitations of current standard of care grafts used in CABG procedure DURHAM, N.C., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nas
Read more →HUMAHumacyte to Present Third Quarter Financial Results and Provide Corporate Update on November 10, 2022
DURHAM, N.C., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue, complex tissue systems, and organs at commercial scale, will release its financial results
Read more →HUMAHumacyte Announces Presentations by Ukrainian Surgeons on Use of the Human Acellular Vessel™ to Treat Wartime Vascular Trauma at the European Society for Vascular Surgery Annual Meeting
DURHAM, N.C., Sept. 23, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, complex tissue systems, and organs at commercial scale, today announced the presentation
Read more →HUMAHumacyte Expands Board of Directors and Leadership Team with New Appointments Lt. General Bruce Green, M.D., USAF-ret. Joins Board of Directors Cindy Cao, Ph.D. Appointed as Chief Regulatory Officer DURHAM, N.C.
Humacyte Expands Board of Directors and Leadership Team with New Appointments Lt. General Bruce Green, M.D., USAF-ret. Joins Board of Directors Cindy Cao, Ph.D. Appointed as Chief Regulatory Officer DURHAM, N.C., -- Sept. 20, 2022 -- Humacyte, Inc. (Nasdaq HUMA), a clinical-st
Read more →HUMAHumacyte Announces Presentation on Investigational Human Acellular VesselTM for Treatment of Vascular Trauma at the International Committee of Military Medicine World Congress
DURHAM, N.C., Sept. 09, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, complex tissue systems, and organs at commercial scale, today announced the presentation
Read more →HUMA▲ +8.4%on this newsshared move
Humacyte Presents at Multiple Conferences in September 2022
DURHAM, N.C., Sept. 08, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and complex tissue and organ systems at commercial scale, today announced an oral present
Read more →HUMA▲ +5%on this news
Humacyte Second Quarter 2022 Financial Results and Business Update -- Human Acellular Vessels (HAVs ) successfully implanted in wounded Ukrainian citizens and reported to be functioning, saving limbs - -- Hosted key opin
Humacyte Second Quarter 2022 Financial Results and Business Update -- Human Acellular Vessels (HAVs ) successfully implanted in wounded Ukrainian citizens and reported to be functioning, saving limbs - -- Hosted key opinion leader (KOL) webinar on HAV in the treatment of vascul
Read more →HUMAHumacyte to Present Second Quarter 2022 Financial Results and Provide Recent Corporate Update on August 12, 2022
DURHAM, N.C., Aug. 05, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will release its financial results for the second quarter ended June 3
Read more →HUMAHumacyte Preclinical Data on Small-Diameter Human Acellular Vessel™ (HAV™) in Coronary Artery Bypass Grafting (CABG) Presented at American Heart Association Meeting
-- Preclinical model data expected to support development of small diameter HAV to treat patients with coronary artery disease-- -- Small-diameter HAV observed to maintain patency and exhibit host-cell remodeling at six months post-implantation in a non-human primate model– --R
Read more →HUMAHumacyte Announces Presentation of Preclinical Data on the HAV™ in Coronary Artery Bypass Grafting at the Basic Cardiovascular Sciences Scientific Sessions
DURHAM, N.C., July 19, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, today announced that six-month outcomes from a preclinical study of a small diameter Huma
Read more →HUMA▲ +6.3%on this news
Humacyte Hosting Key Opinion Leader Webinar on Human Acellular Vessels™ in the Treatment of Vascular Trauma
DURHAM, N.C., July 07, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that it will host a key opinion leader (KOL) webinar o
Read more →HUMAHumacyte Announces JAMA Surgery Publication Highlighting Potential of Human Acellular Vessel™ (HAV™) to Expand Vascular Trauma Reconstruction and Bypass Treatment Options
-- HAV implanted in nearly 500 patients with more than 1,000 patient-years of follow up to date, for treatment of peripheral arterial disease, arteriovenous access for hemodialysis, and trauma – -- Immediately-available HAV, if approved, would represent significant and innovativ
Read more →HUMAHumacyte Expands Board of Directors with Appointment of Diane Seimetz, Ph.D.
DURHAM, N.C., June 27, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the appointment of Diane Seimetz, Ph.D., to its board
Read more →HUMAHumacyte Provides Update on Patients Treated at Front-Line Hospitals in Ukraine with the Human Acellular Vessel™ (HAV™) for Repair of Vascular Trauma Injuries
-- Successful first two HAV implantations in wounded Ukrainian citizens -- HAVs were provided under Humacyte’s initiative to assist Ukraine humanitarian medical effort -- Provides further real-world evidence of the potential of HAV treatment for trauma DURHAM, N.C., June 21, 2
Read more →HUMAHumacyte Presents New Immunogenicity Data on Human Acellular Vessels™ (HAVs™)
-- Data indicate HAV does not stimulate increase in panel reactive antibodies, an adaptive immune response correlated with increased risk of implant failure -- -- Data presented today in IMPACT session at American Transplant Congress (ATC) 2022 -- DURHAM, N.C., June 08, 2022 (G
Read more →HUMA▼ -15.1%on this news
Humacyte to Present at the H.C. Wainwright Global Investment Conference
DURHAM, N.C., May 16, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Dale Sander, Chief Financial Officer, and Heather
Read more →HUMA▲ +6.5%on this newsshared move
Humacyte First Quarter 2022 Financial Results and Business Update -- Human Acellular Vessels (HAVs ) shipped to six hospitals in Ukraine for treatment of civilian and military vascular trauma injuries - -- Strengthened l
Humacyte First Quarter 2022 Financial Results and Business Update -- Human Acellular Vessels (HAVs ) shipped to six hospitals in Ukraine for treatment of civilian and military vascular trauma injuries - -- Strengthened leadership team with appointment of Shamik Parikh M.D., as
Read more →HUMA▼ -9.2%on this news· ran to -20% by day 3
Humacyte to Provide Human Acellular Vessels™ (HAVs™) to Front-line Hospitals in Ukraine for Treatment of Vascular Trauma Injuries
-- First shipment of HAVs to six Ukrainian hospitals made today -- -- Product candidate to be used for civilian and military vascular trauma repair, the HAV’s lead investigational indication -- DURHAM, N.C., May 09, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clin
Read more →HUMA▼ -11.9%on this news· ran to -29% by day 3shared move
Humacyte to Present First Quarter 2022 Financial Results and Provide Recent Corporate Update on May 13, 2022
DURHAM, N.C., May 06, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will release its financial results for the first quarter ended March 31
Read more →HUMAHumacyte Expands Leadership Team with Appointment of Shamik Parikh, M.D., as Chief Medical Officer
--Seasoned physician, scientist and life science executive brings expertise in clinical research and development across product life cycle-- --Key appointment as Humacyte advances HAV through multiple late-stage clinical trials in initial vascular applications-- DURHAM, N.C., A
Read more →HUMAHumacyte Announces Date of Annual Shareholder Meeting
DURHAM, N.C., April 04, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that its 2022 annual meeting of shareholders will be
Read more →HUMA▲ +5.7%on this news
Humacyte Reports Fourth Quarter and Year End 2021 Financial Results and Provides Business Update -- Advancing late-stage clinical and preclinical programs of the Human Acellular Vessel (HAV ) and other engineered tissues
Humacyte Reports Fourth Quarter and Year End 2021 Financial Results and Provides Business Update --Advancing late-stage clinical and preclinical programs of the Human Acellular Vessel (HAV ) and other engineered tissues across several indications-- --Multiple publications and s
Read more →HUMAHumacyte to Present Fourth Quarter and Full Year 2021 Financial Results and Provide Corporate Update on March 29, 2022
DURHAM, N.C., March 21, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will release its financial results for the fourth quarter and full ye
Read more →HUMA▲ +5.1%on this newsshared move
Humacyte Announces Publication of Positive Long-Term Follow-Up Data from Phase 2 Trial of HAV™ for Hemodialysis
-- Five-year data demonstrate the potential of the Human Acellular VesselTM (HAV) to be a durable and safe option for vascular access for routine, long-term hemodialysis -- -- Results published in EJVES Vascular Forum -- DURHAM, N.C., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Humacyte,
Read more →HUMA▲ +7.5%on this news
Humacyte to Participate in Fireside Chat at BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference
DURHAM, N.C., Feb. 09, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Chief Executive Offi
Read more →HUMA▲ +15.7%on this news
Humacyte Announces Clinical Case Series Demonstrating Potential of Human Acellular Vessel™ (HAV™) to Expand Opportunities for Limb Salvage in Multiple Complex Vascular Reconstruction Scenarios
– Outcomes of first eight compassionate use cases presented at 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society – – HAV observed to maintain patency and resist infection in the treatment of critical limb ischemia, infection and vascular trauma – – All
Read more →HUMA▼ -7.6%on this newsshared move
Humacyte Announces Preclinical Results of Small-Diameter Human Acellular Vessel™ (HAV™) in Coronary Artery Bypass Grafting
-- HAV remained patent and host-cell remodeling was observed in non-human primate model -- -- Preclinical study represents milestone in the development of small-diameter HAVs for use in cardiac bypass surgery -- -- Results presented at Advanced Therapies Week 2022 -- DURHAM, N
Read more →HUMAHumacyte, Inc. Universally Implantable Regenerative Human Tissue 2 DISCLAIMER These slides and the accompanying oral presentation contain forward-looking statements. All statements, other than statements of historical fa
Universally Implantable Regenerative Human Tissue 35 APPENDIX 36 HUMAN ACELLULAR VESSELS (HAVs) Human donor aorta Working cell stock Flexible, single-use bioreactor bag Polymer mesh Seeded polymer mesh in bioreactor bag Vascular cells isolated from human aorta & cryopreserved Cel
Read more →HUMA▼ -8.6%on this newsshared move
Humacyte Announces Presentation of First Eight Expanded Access Cases Using Human Acellular Vessel™ (HAV) for Treatment of Critical Limb Ischemia at 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society
DURHAM, N.C., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that results from the first series of compassionate us
Read more →HUMAHumacyte Announces Presentation of First Preclinical Results of the HAV™ in Coronary Artery Bypass Grafting at Advanced Therapies Week Conference
DURHAM, N.C., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the first preclinical results of the use of Humacyte’s
Read more →HUMAHumacyte Announces the Appointments of Three Surgical and Cardiovascular Opinion Leaders to Advisory Roles
DURHAM, N.C., Dec. 31, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the appointment of Surgical Key Opinion Leaders (KOLs)
Read more →HUMAHumacyte Announces Publication Highlighting the First Use of the Human Acellular Vessel (HAV™) as Arterial Bypass Conduit for Replacement of Infected Prosthetic Graft
-- Vanderbilt University Medical Center patient received the HAV under the U.S. Food and Drug Administration’s (FDA) Expanded Access Program (EAP) in April 2019 -- -- After replacement, the patient resumed regular physical activity with no signs of infection of the HAV implant o
Read more →HUMA▲ +7.6%on this news
Humacyte Presents Preclinical Results of Small-Diameter HAV™ for Use as a BTT Shunt in Pediatric Heart Disease at American Heart Association’s Scientific Sessions 2021
-- Patency and host cell remodeling of the HAV were observed in all study implants – -- Preclinical study is one component of Humacyte’s expansion of the testing of the HAV in a broader cardiac bypass surgery application – DURHAM, N.C., Nov. 16, 2021 (GLOBE NEWSWIRE) -- Humacyt
Read more →HUMAHumacyte Presents New 12-Month Data from HAVs Produced Using Commercial-Scale Manufacturing System -- Performance of HAVs produced in the LUNA200 TM commercial-scale system demonstrated efficacy that is similar to prior
Presents New 12-Month Data from HAVs Produced Using Commercial-Scale Manufacturing System Performance of HAVs produced in the LUNA200TM commercial-scale system demonstrated efficacy that is similar to prior HAV performance in dialysis access trials - 83% secondary patency obse
Read more →HUMA▲ +5.7%on this news· ran to +18% by day 3shared move
Humacyte Reports Third Quarter 2021 Financial Results and Provides Business Highlights -- Completed business combination with Alpha Healthcare Acquisition Corp. and raised $242M in proceeds -- -- Progressed advanced-stag
Reports Third Quarter 2021 Financial Results and Provides Business Highlights -- Completed business combination with Alpha Healthcare Acquisition Corp. and raised $242M in proceeds -- -- Progressed advanced-stage clinical- and early-stage programs of the human acellular vesse
Read more →HUMAHumacyte Leadership to Present at Credit Suisse 30th Annual Healthcare Conference
DURHAM, N.C., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Chief Executive Offi
Read more →HUMAHumacyte Leadership to Present at Multiple Scientific Events in November
DURHAM, N.C., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that leadership will present new data and additional i
Read more →HUMAHumacyte Leadership to Present at Seven Scientific and Industry Events in October
DURHAM, N.C., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that senior leadership will present at seven scientifi
Read more →HUMAHumacyte Announces Issuance of Three Additional U.S. Patents Covering its Proprietary Universally Implantable Bioengineered Human Tissue Platform
Patent estate also expanded by the issuance of 23 additional patents in international markets Humacyte now owns or licenses 119 patents covering its proprietary platform DURHAM, N.C., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnolo
Read more →HUMAHumacyte Leadership to Present at Five Scientific Events in September
DURHAM, N.C., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that senior leadership will present at five scientifi
Read more →HUMA▲ +9%on this news· ran to +30% by day 3
Report of Independent Registered Public Accounting Firm To the Board of Directors and Stockholders of Humacyte, Inc. Opinion on the Financial Statements We have audited the accompanying balance sheets of Humacyte, Inc. (
Report of Independent Registered Public Accounting To the Board of Directors and Stockholders of Humacyte, Inc. Opinion on the Financial Statements We have audited the accompanying balance sheets of Humacyte, Inc. (the "Company") as of December 31, 2020 and 2019, and the rela
Read more →HUMAHumacyte Announces Successful Closing of Business Combination with Alpha Healthcare Acquisition Corp.
Humacyte raises $245M gross proceeds Combined company is expected to begin trading on the Nasdaq Global Select Market® under “HUMA” and “HUMAW” on August 27, 2021 Company well-positioned to deliver on promise of regenerative tissue HAV technology for initial indications in vasc
Read more →HUMAAlpha Healthcare Acquisition Corp. Announces Shareholder Approval of Business Combination with Humacyte NEW YORK and Durham, N.C.
Acquisition Corp. Announces Shareholder Approval Business Combination with Humacyte NEW YORK and Durham, N.C. - August 24, 2021 - Alpha Healthcare Acquisition Corp. (Nasdaq: AHAC) ("AHAC"), a special purpose acquisition company, today announced that its stockholders voted to
Read more →HUMAHumacyte Highlights Robust Expanded Access Program and Patient Testimonial for Human Acellular Vessels
In addition to the Company’s eight ongoing clinical trials, HAVs have been used in 13 expanded access cases for emergent life- and limb-saving vascular surgeries at seven hospitals across the U.S. Video testimonial features patient who experienced a traumatic leg injury and rece
Read more →HUMAHumacyte Announces Addition of Chief Commercial Officer and Integration of Commercial-Scale Manufacturing into Clinical Trial Programs Appoints proven commercial leader B.J. Scheessele as Chief Commercial Officer In-hous
Addition of Chief Commercial Officer and Integration of Commercial-Scale Manufacturing into Clinical Trial Programs Durham, N.C. - Aug. 17, 2021 - Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at co
Read more →HUMAHumacyte Announces Publication of In Vivo Data on Biovascular Pancreas Transplantation for the Treatment of Type 1 Diabetes
Data demonstrate biovascular pancreas may have the potential to provide an effective and safe method for pancreatic islet cell transplantation for the treatment of type 1 diabetes Data published in the Journal of Tissue Engineering DURHAM, N.C., Aug. 11, 2021 (GLOBE NEWSWIRE) -
Read more →HUMAAlpha Healthcare Acquisition Corp. Sets
Acquisition Corp. Sets August 24, 2021 for Special Shareholder Meeting to Vote on Humacyte Business Combination New York and Durham, N.C. - August 4, 2021 - Alpha Healthcare Acquisition Corp. (Nasdaq: AHAC) ("AHAC"), a special purpose acquisition company, today announced that i
Read more →HUMAHumacyte Presents Potential of Functional Lung Engineering at Janelia R3 – Replace, Repair, Regenerate Planning Workshop
DURHAM, N.C., July 22, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announces that Laura Niklason, M.D., Ph.D., Chief Executive Officer, delivered
Read more →HUMAHumacyte to Participate in Fireside Chat at Cowen 6th Annual FutureHealth Conference
DURHAM, N.C., June 10, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Chief Executive Officer, and Dale S
Read more →HUMAHumacyte Presents In Vivo Data on Biovascular Pancreas Transplantation for Type 1 Diabetes Treatment
Laboratory and preclinical models demonstrate biovascular pancreas platform technology may provide method to transplant islet cells that produce insulin in Type 1 diabetes patients Data presented at American Transplant Congress 2021 Virtual Connect DURHAM, N.C., June 08, 2021 (
Read more →HUMAHumacyte to Provide Investor Update on June 7 Durham, N.C.
Provide Investor Update on June 7 Durham, N.C. - June 4, 2021 - Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced an investor update presentation will be available
Read more →HUMAHumacyte to Provide Investor Update on June 7
DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced an investor update presentation will be available at 9:00 a.m. ET on
Read more →HUMAHumacyte Receives 2021 Life Sciences Award from Triangle Business Journal
DURHAM, N.C., May 26, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that the company has received a 2021 Life Sciences Award from the Tria
Read more →HUMAHumacyte Announces Presentation by Principal Investigator Highlighting Clinical Experience with HAVs at Vascular Access Society of the Americas 2021 Spring Conference -- HAV performance in the clinical setting as an arte
Announces Presentation by Principal Investigator Highlighting Clinical Experience with HAVs at Vascular Access Society of the Americas 2021 Spring Conference HAV performance in the clinical setting as an arteriovenous reconstruction underscores the potential for use as vascula
Read more →HUMAHumacyte CEO Dr. Laura Niklason Presents Advances in Whole-Lung Engineering Laboratory and pre-clinical models of whole-lung engineering further inform roadmap for building a functional lung alveolus Data presented for t
CEO Dr. Laura Niklason Presents Advances in Whole-Lung Engineering Durham, N.C. - May 21, 2021 - Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today shared new findings from cr
Read more →HUMAHumacyte Presents Advances in Whole-Lung Engineering
Laboratory and pre-clinical models of whole-lung engineering inform roadmap for building a functional lung alveolus, which is the key building block for making a functional lung Data presented at 38th Annual Meeting of the Japanese Association for Chest Surgery DURHAM, N.C., Ma
Read more →HUMAHumacyte Appoints Dale Sander as Chief Financial Officer -- Proven CFO with extensive financial leadership and commercialization experience, including multiple publicly listed life sciences companies -- Durham, N.C.
Appoints Dale Sander as Chief Financial Officer CFO with extensive financial leadership and commercialization experience, including multiple publicly listed life sciences companies -- Durham, N.C. - May 19, 2021 - Humacyte, Inc., a clinical-stage biotechnology platform company
Read more →HUMAHumacyte Leadership and Investigators to Present at Five Scientific Events in May Durham, N.C.
Leadership and Investigators to Present at Five Scientific Events in May N.C. - May 6, 2021 - Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that clinical investi
Read more →HUMAHumacyte Announces Positive Long-Term Follow-Up Data from Phase 2 Vascular Access Trial Five-year outcomes demonstrate HAV retained durability and structural integrity, potentially offering a safe and viable option for l
Announces Positive Long-Term Follow-Up Data from Phase 2 Vascular Access Trial Durham, N.C. - April 20, 2021 - Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced tha
Read more →HUMAHumacyte Secures $50 Million Debt Facility with Silicon Valley Bank Durham, N.C.
Secures $50 Million Debt Facility with Silicon Valley Bank Durham, N.C.- April 14, 2021 - Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the closing of a secured
Read more →HUMAHumacyte CEO Dr. Laura Niklason and Alpha Healthcare CEO Rajiv Shukla to Present at CED Venture Connect 2021 Online Summit
DURHAM, N.C., March 23, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Chief Executive Officer, and Rajiv
Read more →HUMAHumacyte to Present at Oppenheimer 31st Annual Healthcare Conference
DURHAM, N.C., March 11, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Chief Executive Officer, will pres
Read more →HUMAHumacyte to Present Long-Term Follow-Up Data from Phase 2 Vascular Access Trial at Charing Cross (CX) International Symposium 2021 Durham, N.C.
to Present Long-Term Follow-Up Data from Phase 2 Vascular Access Trial at Charing Cross (CX) International Symposium 2021 Durham, N.C. - March 5, 2021 - Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue
Read more →HUMAAlpha Healthcare + Humacyte Merger Announcement Presentation Transcription
Presentation Transcription My own background in healthcare covers the last 20 years. I've had a lot of experience in healthcare M&A at Pfizer, where I led acquisitions for the R&D division globally, as well as a private equity and hedge fund PM at Morgan Stanley and Citibank.
Read more →HUMAHumacyte, a Transformative Biotechnology Platform Company Capable of Manufacturing Universally Implantable Bioengineered Human Tissue at Commercial Scale, Going Public via Merger with Alpha Healthcare Acquisition Corp. -
a Transformative Biotechnology Platform Company Capable of Universally Implantable Bioengineered Human Tissue at Commercial Scale, Public via Merger with Alpha Healthcare Acquisition Corp. York & Durham, N.C. - February 17, 2021: Alpha Healthcare Acquisition Corp. (Nasdaq: AHA
Read more →HUMAAlpha Healthcare Acquisition Corp. Announces the Separate Trading of its Class A Common Stock and Warrants, Commencing
Healthcare Acquisition Corp. Announces the Separate Trading of its Class A Common Stock and Warrants, Commencing November 9, 2020 NEW YORK, Nov. 06, 2020 (GLOBE NEWSWIRE)-Alpha Healthcare Acquisition Corp. (the "Company") announced today that holders of the units sold in the C
Read more →HUMAALPHA HEALTHCARE ACQUISITION CORP. INDEX TO FINANCIAL STATEMENT Page Report of Independent Registered Public Accounting Firm F-2 Balance Sheet as of
HEALTHCARE ACQUISITION CORP. TO FINANCIAL STATEMENT Page Report of Independent Registered Public Accounting Firm F-2 Balance Sheet as of September 22, 2020 F-3 Notes to Balance Sheet F-4 OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM the Stockholders and Board of Directors
Read more →HUMAAlpha Healthcare Acquisition Corp. Announces Pricing of $100,000,000 Initial Public Offering New York, NY
Alpha Healthcare Acquisition Corp. Announces Pricing of $100,000,000 Initial Public Offering New York, NY, Sept. 17, 2020 (GLOBE NEWSWIRE) - Alpha Healthcare Acquisition Corp. (the "Company") announced today that it priced its initial public offering of 10,000,000 units at $1
Read more →Competitive Position
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