Investigation into Humacyte continues after FDA cites manufacturing violations and lawsuit proceeds.
Kahn Swick & Foti, LLC is investigating Humacyte, Inc. following an FDA inspection that found significant manufacturing violations, including issues with microbial quality assurance and testing. This led to a delay in the FDA's approval of Humacyte's Biologic License Application. Additionally, a securities class action lawsuit against the company is moving forward, alleging that Humacyte and its executives failed to disclose material information to investors.
Humacyte Investigation Continued: Kahn Swick & Foti, LLC Continues to Investigate the Officers and Directors of Humacyte, Inc. - HUMA
Kahn Swick & Foti, LLC (KSF) is continuing its investigation into Humacyte, Inc. (HUMA) and its officers and directors following a securities class action lawsuit. The lawsuit stems from Humacyte's announcement in August 2024 that the FDA required more time to review its Biologic License Application and a subsequent FDA Form 483 in October 2024 detailing manufacturing violations. KSF's investigation focuses on potential breaches of fiduciary duties or violations of state or federal laws by Humacyte's leadership.
Humacyte Stock (HUMA) Opinions on Phase 3 Trial Results
This article discusses investor opinions on the Phase 3 trial results for Humacyte (HUMA). The company announced positive results for its Human Acellular Vessel (HAV) in arteriovenous fistula (AVF) for hemodialysis, achieving superiority in primary endpoints compared to autogenous fistula. Investors are assessing the implications of these results for the company's future and stock performance.
Humacyte Stock (HUMA) Opinions on Phase 3 Trial Results
Discussions on Humacyte's Phase 3 trial outcomes for its vascular technology are driving notable stock gains, with observers pointing to accelerated buying. Insider activity shows both acquisitions and sales, contributing to varied commentary on the company's trajectory. Despite some mixed signals, the stock shows resilient performance amid broader biotech interest, leading to cautious optimism.
Humacyte publishes Phase 3 trial results in Lancet journal By Investing.com
Humacyte Inc. (NASDAQ: HUMA) announced the publication of one-year results from its V007 Phase 3 clinical trial in The Lancet Digital Health. The study demonstrated the superiority of Humacyte's acellular tissue engineered vessel (ATEV) over traditional arteriovenous fistula for hemodialysis access, especially for female patients and obese/diabetic male patients. The company previously reported positive two-year results from V007 and interim results from V012, and plans to submit a supplemental Biologics License Application for ATEV based on these findings.
A bioengineered vessel beat fistulas for women and men with obesity and diabetes on dialysis
Humacyte announced the publication of one-year results from its V007 Phase 3 trial in The Lancet Digital Health, showing superiority of its acellular tissue engineered vessel (ATEV) for hemodialysis access, especially in women and men with obesity and diabetes. This validation, along with positive V012 Phase 3 results, supports Humacyte's plan to submit a supplemental Biologics License Application (sBLA) in the second half of 2026 to expand the Symvess® label for a second AV access indication. The ATEV is currently FDA-approved only for extremity vascular trauma.
Humacyte Symvess: First Arizona Implant, 4 Cases | HUMA Stock News
Humacyte (Nasdaq: HUMA) announced that board-certified vascular surgeon Jeromy Brink, MD, performed the first four post-BLA-approval Symvess implants in Arizona within two weeks. Symvess is an FDA-approved off-the-shelf bioengineered blood vessel for urgent revascularization in extremity arterial injury when autologous vein grafts are not feasible. This development led to a moderate positive market reaction, with HUMA stock gaining 3.89%.
HC Wainwright Predicts Humacyte's Q3 Earnings (NASDAQ:HUMA)
HC Wainwright has revised its Q3 2026 EPS forecast for Humacyte (NASDAQ:HUMA) to a loss of $0.10 per share, down from $0.09, while maintaining a Buy rating and a $4.00 price target. The company recently reported a Q2 loss of $0.16 per share and revenue of $0.41 million, both missing consensus estimates. Despite a "Moderate Buy" consensus from analysts, shares are trading near their 52-week low, and some firms have lowered price targets or downgraded the stock.
Humacyte (NASDAQ:HUMA) Rating Lowered to Strong Sell at Wall Street Zen
Wall Street Zen downgraded Humacyte (NASDAQ:HUMA) to a "strong sell" rating, though the broader analyst consensus remains a "Moderate Buy" with a $6.11 price target. The company reported a quarterly loss of $0.16 per share, missing estimates by $0.05, and revenue of $0.41 million, falling short of the $1.04 million forecast. Despite a 10% rise, HUMA shares are trading near their 52-week low of $0.53, with institutional investors holding 44.71% and insiders 3.10% of the company.
Humacyte (HUMA) Stock Looks Stretched On Book Value Yet Reasonable After A 93% Fall
Humacyte stock has fallen 93.3% over the last five years, yet current valuations suggest it is still expensive, particularly based on its P/B ratio of 15.4x compared to the biotech industry average of 2.5x. This high valuation indicates that investors are placing a significant premium on its tissue engineered vessel platform and recent regulatory progress. The article concludes that the current stock price relies heavily on the success of its programs converting into commercial products on reasonable timelines, questioning whether this premium is justified by future outcomes.
Price to book forward of Humacyte, Inc. – NASDAQ:HUMAW
This article focuses on the "Price to book forward" financial metric for Humacyte, Inc., traded on NASDAQ under the symbol HUMAW. It provides a snapshot of this financial data point within the context of the company's financial overview on a trading platform. The content is primarily a data presentation with surrounding navigation and copyright information.
H.C. Wainwright Maintains Humacyte(HUMA.US) With Buy Rating, Maintains Target Price $4
H.C. Wainwright has reiterated its Buy rating for Humacyte (HUMA.US), maintaining a price target of $4. This continued positive outlook from the analyst firm suggests confidence in the company's future performance.
Benchmark Lowers Humacyte (NASDAQ:HUMA) Price Target to $1.00
Benchmark has lowered its price target for Humacyte (NASDAQ:HUMA) to $1.00 from $2.00, while maintaining a "speculative buy" rating, implying a potential 51% upside. This adjustment comes after Humacyte missed Q2 earnings expectations, reporting a loss of $0.16 per share against an estimated $0.11 loss and revenue of $0.41 million below the $1.12 million estimate. Despite mixed analyst views, the consensus remains a "Moderate Buy" with an average target of $6.11, with potential catalysts including positive Phase 3 dialysis results and improved Symvess sales, though shareholder dilution and cash runway remain concerns.
Humacyte, Inc. Q2 2026: Revenue $406K, EPS $(0.16) — 10-Q Summary
Humacyte, Inc. reported its Q2 2026 financial results, showing $406K in revenue and a diluted EPS of $(0.16). The company achieved significant year-over-year revenue growth due to the commercial launch of Symvess and reduced its net loss. Humacyte is also progressing with clinical programs, planning an sBLA submission, and has reacquired worldwide commercialization control for its products.
Humacyte (HUMA) Reports Stronger Phase 3 Dialysis Results In Women
Humacyte (HUMA) announced stronger Phase 3 dialysis access data for its acellular tissue engineered vessel in female patients, outperforming the standard of care. The company plans to submit a supplemental Biologics License Application based on these results and has also received FDA acceptance for an Investigational New Drug application for a new coronary vessel candidate. This advancement highlights Humacyte's strategy to expand its bioengineered tissue platform beyond niche trauma uses into larger chronic indications like dialysis and coronary artery bypass graft.
Is Humacyte (HUMA) Undervalued Following Q2 2026 Earnings And Dialysis Trial Data?
Humacyte (HUMA) is in focus after its Q2 2026 earnings report, which showed modest revenue and a significant quarterly loss, compounded by a Nasdaq minimum bid price notice and interim Phase III dialysis trial data. Despite a fair value estimate of $4.00, suggesting it's 83.4% undervalued, the stock faces substantial execution risks, including high cash burn relative to revenue and an elevated P/B ratio compared to peers. The company's future hinges on the successful uptake of its dialysis and trauma treatments, aligning with optimistic analyst forecasts.
Humacyte, Inc. (HUMA) Reports Q2 Loss, Misses Revenue Estimates
Humacyte, Inc. (HUMA) reported a Q2 loss of $0.16 per share, missing the Zacks Consensus Estimate of a $0.1 loss, and revenues of $0.41 million, falling short of estimates by 70.79%. The company's shares have dropped 26.1% year-to-date, and it currently holds a Zacks Rank #3 (Hold) with a mixed outlook from estimate revisions.
Humacyte Inc (HUMA) (Q2 2026) Earnings Call Highlights: Strong Trial Results and Strategic ...
Humacyte Inc. (HUMA) reported strong interim Phase III trial results for its ATEV in female dialysis patients, showing significant improvements over standard care. Despite low commercial sales in Q2 2026, the company is rebuilding its commercial team and preparing for a supplemental BLA submission for dialysis access. Humacyte is also advancing its coronary tissue-engineered vessel program and has secured DoD funding for vascular repair technology, indicating strategic progress despite ongoing net losses.
Humacyte Q2 Earnings Call Highlights
Humacyte reported Q2 commercial sales growth and outlined plans to expand adoption of its SYMVESS vascular repair product. The company also announced its intention to submit a supplemental biologics license application for dialysis access in the second half of 2026 and initiate a first-in-human coronary bypass study. Financial results showed a net loss of $36.8 million, an improvement from the prior year, with cash equivalents totaling $80.3 million.
Humacyte Q2 Earnings Call Highlights
Humacyte reported its Q2 earnings, highlighting commercial sales growth for its SYMVESS product and plans for a supplemental BLA submission for dialysis access. The company also detailed positive interim data from its V012 Phase III trial for dialysis patients and announced the initiation of a first-in-human coronary bypass study. Efforts are underway to expand SYMVESS adoption, rebuild its commercial team, and prepare for a potential dialysis access launch by Q2 2027.
Earnings call transcript: Humacyte misses Q2 2026 estimates as shares fall premarket
Humacyte missed analyst expectations for Q2 2026 revenue and EPS, causing its shares to fall over 10% in premarket trading. Despite the financial miss, the company highlighted progress in its commercial rebuild for SYMVESS, significant clinical trial results for its ATEV in dialysis access, and advancements in its CTEV coronary artery bypass grafting program. Management anticipates stronger adoption in the second half of 2026 and plans to file a supplemental Biologics License Application for dialysis access in November 2026.
Form 8K Humacyte Inc For: 12 August By Investing.com
This article from Investing.com announces that Humacyte Inc. has filed a Form 8K on August 12. The brief news item includes the company's stock symbol HUMA and notes its current price performance. No further details about the content of the Form 8K are provided.
Humacyte reports Q2 2026: Product revenue $0.4M, net loss $36.8M, cash $80.3M
Humacyte announced its second-quarter 2026 results, reporting product revenue of $0.4 million and a net loss of $36.8 million, with $80.3 million in cash. The company also shared positive interim Phase 3 results for its ATEV in female dialysis patients, planning a supplemental BLA submission in H2 2026, and received FDA acceptance for an IND for its CTEV, with a Phase 2a CABG study expected to start in Q3 2026.
Humacyte Inc (HUMA) Q2 2026 Earnings Report Preview: What To Expect
Humacyte Inc (HUMA) is scheduled to release its Q2 2026 earnings on August 12, 2026, with revenue expected at $1.12 million and an EPS of $-0.1. Analysts anticipate full-year 2026 revenue of $6.35 million and EPS of $-0.34. Despite previous revenue estimate declines, earnings estimates have shown an increase for both 2026 and 2027.
Humacyte, Inc. (NASDAQ:HUMA) Given Consensus Recommendation of "Moderate Buy" by Brokerages
Eight brokerages have given Humacyte, Inc. (NASDAQ:HUMA) a consensus recommendation of "Moderate Buy," with one analyst issuing a sell rating and seven a buy rating. The average one-year price target is $6.25. Insider activity shows a sale by Shamik J. Parikh and a purchase by Director Kathleen Sebelius, while institutional investors like Geode Capital Management LLC and Marshall Wace LLP have significantly adjusted their holdings.
Humacyte Investigation Continued: Kahn Swick & Foti, LLC Continues to Investigate the Officers and Directors of Humacyte, Inc. - HUMA
Kahn Swick & Foti, LLC (KSF) is continuing its investigation into Humacyte, Inc. regarding potential breaches of fiduciary duties by its officers and directors and violations of state or federal laws. This follows an FDA Form 483 inspection revealing violations at Humacyte's Durham facility and a securities class action lawsuit against the company, which recently had its motion to dismiss partially denied. KSF encourages long-term Humacyte shareholders with relevant information to contact them.
Humacyte To Announce 2026 Second Quarter Financial Results and Provide Business Update on August 12, 2026
Humacyte, Inc. (Nasdaq: HUMA) announced it will release its financial results for the second quarter and first half of 2026 on Wednesday, August 12, 2026. The company will also host a webcast and conference call at 8:00 a.m. Eastern Time to provide a corporate and financial update. Humacyte is a commercial-stage biotechnology company focused on developing universally implantable, bioengineered human tissues.
Humacyte To Announce 2026 Second Quarter Financial Results and Provide Business Update on August 12, 2026
Humacyte, Inc. (Nasdaq: HUMA) announced it will release its financial results for the second quarter and six months ended June 30, 2026, on Wednesday, August 12, 2026. The company will host a webcast and conference call at 8:00 a.m. Eastern Time to provide a corporate and financial update. Humacyte is a commercial-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues.
Humacyte, Inc. Revenue Breakdown – NASDAQ:HUMA
Humacyte, Inc. (NASDAQ: HUMA) generated $2.04 million USD in revenue last year, primarily from its Acellular Human Tissues segment. This represents an increase from $1.56 million USD in the previous year, with the United States being the sole contributor to this revenue.
Humacyte, Inc. Revenue Breakdown – BOATS:HUMA
Humacyte, Inc. (HUMA) generated $2.04 million USD in revenue last year, primarily from its Acellular Human Tissues segment. This represents an increase from $1.56 million USD the previous year. The United States was the largest contributor to this revenue.
Humacyte Disclosed Failure to Satisfy a Continued Listing Rule or Standard
Humacyte (HUMA) has received a notice from Nasdaq stating that its common stock failed to meet the minimum $1.00 bid price requirement for 30 consecutive business days. The company has until January 27, 2027, to regain compliance by maintaining a closing bid price of at least $1.00 for a minimum of 10 consecutive business days. Trading of HUMA shares will continue on the Nasdaq Global Select Market without immediate impact.
Humacyte Inc (HUMA) Institutional Confidence
Humacyte Inc (HUMA) has an institutional shareholding score of 3.00, placing it 191st out of 384 in the Biotechnology & Medical Research industry. Institutional investors currently hold 32.47% of shares, a 29.83% increase quarter-over-quarter. While some institutions like Fresenius SE & Co KGaA hold significant shares, others like Bill Nygren | OAKMX have substantially decreased their holdings.
Humacyte, Inc. (HUMA) Stock Dips While Market Gains: Key Facts
Humacyte, Inc. (HUMA) stock recently closed down 6.44% at $0.63, underperforming the S&P 500. The company's stock has also fallen by 15.62% over the past month, trailing its sector. Investors are looking forward to its upcoming earnings report, with projections of a 58.33% increase in EPS and a 363.33% rise in revenue compared to the prior year.
Humacyte Inc Lobbyists, 2024
This OpenSecrets.org page details the lobbying activities of Humacyte Inc for 2024, identifying seven lobbyists, three of whom are "revolving door" lobbyists with previous federal government experience. The company spent $100,000 on lobbying in 2024, with G2G Consulting employing six lobbyists and DLA Piper employing one. The article lists the specific lobbyists and the number of filings associated with each.
Humacyte, Inc. Revenue Breakdown – NASDAQ:HUMAW
Humacyte, Inc. (NASDAQ:HUMAW) generated $2.04 million in revenue last year, primarily from its Acellular Human Tissues segment. This represents an increase from $1.56 million in the previous year. The United States was the primary source of this revenue, accounting for the entire $2.04 million.
Humacyte, Inc. (HUMA) Stock Dips While Market Gains: Key Facts
Humacyte, Inc. (HUMA) stock experienced a 6.44% decline to $0.63 in its latest trading session, underperforming the broader market which saw gains in the S&P 500 and Dow. The company's stock has also fallen 15.62% over the past month, lagging behind its sector. Investors are anticipating Humacyte's upcoming earnings report, with projections for significant year-over-year increases in both EPS and revenue.
Humacyte Inc (HUMA) Shareholder Structure: Major Shareholders & Institutional Holdings
The article details the shareholder structure of Humacyte Inc (HUMA), listing major institutional shareholders and their proportional holdings. It also provides a breakdown of shareholder types and historical institutional shareholding data from Q1 2023 to Q1 2026, alongside information on related ETFs.
Humacyte Plans First Human Study of Bioengineered Vessel in Heart Bypass
Humacyte (Nasdaq: HUMA) has received FDA acceptance for its Investigational New Drug (IND) application, paving the way for a first-in-human Phase 2a clinical study of its coronary tissue engineered vessel (CTEV) for coronary artery bypass grafting (CABG). The study, expected to enroll ten adult patients this quarter, will evaluate the safety and efficacy of the CTEV, which is designed as a universally implantable bioengineered human blood vessel. This development is significant as no new off-the-shelf conduits have been introduced for CABG in 40 years, offering a potential alternative to saphenous vein grafts that often have limitations.
Humacyte Announces FDA Acceptance of IND for First-In-Human Clinical Study of CTEV for Coronary Artery Bypass Grafting
Humacyte has announced that the FDA has accepted its Investigational New Drug (IND) application for a first-in-human clinical study of its coronary tissue engineered vessel (CTEV) for coronary artery bypass grafting (CABG). The company plans to initiate a Phase 2a study in ten adult patients this quarter to evaluate the safety and efficacy of CTEV as a potential off-the-shelf alternative to saphenous vein grafts. This marks a significant milestone, as current CABG procedures often rely on autologous vessels, which can have limitations in patency and lead to complications.
Humacyte Says US FDA Accepted IND for Human Trial of Coronary Tissue Engineered Vessel in Surgery
Humacyte, Inc. announced that the US FDA has accepted its Investigational New Drug (IND) application for a first-in-human clinical study of its Coronary Tissue Engineered Vessel (CTEV). This study will evaluate the CTEV for use in Coronary Artery Bypass Grafting (CABG) surgery. The company aims to develop universally implantable bioengineered human tissues to improve patient lives.
HUMA|Humacyte Inc|Price:0.625|Chg%:-0.014
Humacyte Inc. (HUMA) is a biotechnology company developing universally implantable bioengineered human tissues. The company is in late-stage clinical trials for vascular applications like hemodialysis and peripheral artery disease, and also has preclinical development in other areas. Trading at $0.625, the article provides an overview of the company, its executives, and institutional shareholdings.
Price to sales forward of Humacyte, Inc. – NASDAQ:HUMAW
This article from TradingView provides financial information for Humacyte, Inc. (NASDAQ: HUMAW), specifically focusing on its price-to-sales forward metric. The content highlights a specific period, value, and change percentage for this financial indicator, framed within a market data and analysis platform context.
Humacyte, Inc. (HUMA) Beats Stock Market Upswing: What Investors Need to Know
Humacyte, Inc. (HUMA) saw its stock close at $0.67, a 2.22% increase, outperforming the S&P 500's daily gain, despite a 21.82% drop over the past month. Analysts project a significant increase in EPS and revenue for the upcoming release and the full year, with the company currently holding a Zacks Rank of #3 (Hold) within the Medical sector. Investors are encouraged to monitor analyst estimate revisions, as these often predict future stock price performance.
Humacyte, Inc. (HUMA) Suffers a Larger Drop Than the General Market: Key Insights
Humacyte, Inc. (HUMA) experienced a larger drop than the general market, closing down 1.28% against a backdrop of slight S&P 500 and Nasdaq depreciation, and a 0.59% Dow downswing. The company's stock has fallen 28.09% in the past month, underperforming the Medical sector and S&P 500. Analysts expect a significant year-over-year revenue growth of 363.33% and improved earnings per share for its upcoming report, despite recent downward revisions in estimates.
Humacyte, Inc. (HUMA) Beats Stock Market Upswing: What Investors Need to Know
Humacyte, Inc. (HUMA) saw its stock price increase by 2.31% in a recent trading session, outperforming the S&P 500, Dow, and Nasdaq. The company is projected to report a significant increase in EPS and revenue in its upcoming financial release. Despite a recent downward shift in analyst EPS estimates, Humacyte currently holds a Zacks Rank of #3 (Hold).
Humacyte, Inc. (HUMA) Beats Stock Market Upswing: What Investors Need to Know
Humacyte, Inc. (HUMA) shares increased by 2.31%, outperforming the S&P 500. Despite a recent decline over the past month, the company is projected to see significant EPS and revenue growth in its upcoming financial release. Analysts are closely watching estimate revisions, and Humacyte currently holds a Zacks Rank of #3 (Hold).
Humacyte Appoints Key Nephrologists as Advisors to Prepare for Planned Commercialization of the ATEV in Dialysis Access
Humacyte, Inc. has appointed Dr. Robert J. Kossmann and Dr. Prabir Roy-Chaudhury as advisors to support the planned commercialization of their acellular tissue engineered vessel (ATEV) for hemodialysis access. These two leading nephrologists will help develop health economic, reimbursement, and market access strategies, and provide scientific and medical education. This strategic move follows positive results from their V012 Phase 3 dialysis access study and plans to file a supplemental Biologic License Application with the FDA.
Humacyte appoints two nephrologists as commercial advisors
Humacyte, Inc. (NASDAQ:HUMA) has appointed Dr. Robert J. Kossmann and Dr. Prabir Roy-Chaudhury as commercial advisors to assist with the planned commercialization of its acellular tissue engineered vessel (ATEV) for hemodialysis access. This move follows positive results from its V012 Phase 3 dialysis access study in women and plans to file a supplemental Biologic License Application with the FDA. Despite recent regulatory progress, the company's shares are trading significantly lower, though an InvestingPro analysis suggests the stock is undervalued, eyeing anticipated sales growth despite quick cash burn typical for late-stage biotechs.
Humacyte Appoints Key Nephrologists as Advisors to Prepare for Planned Commercialization of the ATEV in Dialysis Access
Humacyte has announced the appointment of Dr. Robert J. Kossmann and Dr. Prabir Roy-Chaudhury as advisors to assist with the planned commercialization of their acellular tissue engineered vessel (ATEV) for hemodialysis access. These leading nephrologists will contribute to health economic, reimbursement, and market access strategies, as well as provide scientific support and medical education. The appointments follow positive results from the V012 Phase 3 dialysis access study in women and Humacyte's plans to file a supplemental Biologic License Application with the FDA.
Two Kidney Specialists Join Humacyte Ahead of Planned Dialysis Access
Humacyte (Nasdaq: HUMA) has appointed leading nephrologists Dr. Robert J. Kossmann and Dr. Prabir Roy-Chaudhury as advisors to support the commercialization of its acellular tissue engineered vessel (ATEV) for hemodialysis access. These appointments follow positive Phase 3 study results for the ATEV in women and Humacyte's plan to file a supplemental Biologic License Application with the FDA. The advisors will contribute expertise in health economics, reimbursement, market access strategies, and medical education to prepare for the ATEV's potential launch in this indication.
