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Humacyte, Inc. (HUMA) Is Considered a Good Investment by Brokers: Is That True?
ZACKS· 2024-09-18 14:31
When deciding whether to buy, sell, or hold a stock, investors often rely on analyst recommendations. Media reports about rating changes by these brokerage-firm-employed (or sell-side) analysts often influence a stock's price, but are they really important? Let's take a look at what these Wall Street heavyweights have to say about Humacyte, Inc. (HUMA) before we discuss the reliability of brokerage recommendations and how to use them to your advantage. Humacyte, Inc. currently has an average brokerage recom ...
Humacyte's (HUMA) ATEV BLA Review Period Extended by FDA
ZACKS· 2024-08-16 15:45
Humacyte, Inc. (HUMA) announced a delay in the FDA's review of its Biologic License Application (BLA) for its Acellular Tissue Engineered Vessel (ATEV). The FDA, which had granted a Priority Review to this pioneering vascular trauma treatment, now requires additional time beyond the original Prescription Drug User Fee Act (PDUFA) date of Aug 10, 2024, to complete its evaluation. Despite the delay, Humacyte remains confident about ATEV's potential approval and its transformative role in trauma care. Humacyte ...
Humacyte(HUMA) - 2024 Q2 - Quarterly Report
2024-08-13 20:47
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________________________________________________________________________ FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______. ...
Humacyte(HUMA) - 2024 Q2 - Earnings Call Transcript
2024-08-13 18:46
Humacyte, Inc. (NASDAQ:HUMA) Q2 2024 Earnings Conference Call August 13, 2024 8:30 AM ET Company Participants Lauren Marek - LifeSci Advisors Laura Niklason - President and CEO Dale Sander - CFO and Chief Corporate Development Officer Conference Call Participants Ryan Zimmerman - BTIG Josh Jennings - TD Cowen & Company Allison Bratzel - Piper Sandler Kristen Kluska - Cantor Fitzgerald Bruce Jackson - The Benchmark Company Operator Good afternoon, ladies and gentlemen, and welcome to the Humacyte's Second Q ...
Humacyte(HUMA) - 2024 Q2 - Quarterly Results
2024-08-13 11:04
Exhibit 99.2 Humacyte Second Quarter 2024 Financial Results and Business Update -FDA requires additional time to complete its review of ATEV™ (acellular tissue engineered vessel) BLA for the Treatment of Vascular Trauma- -Reported Positive Topline Results from Phase 3 Trial of ATEV in Hemodialysis Access- -ATEV Received Third Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA in Advanced Peripheral Artery Disease- -Conference call and live webcast at 8:30 a.m. ET today- DURHAM, N.C., August ...
Delay Hits Humacyte's Bioengineered Human Tissue Implant For Vascular Trauma Injuries, FDA Extends Time To Review
Benzinga· 2024-08-12 13:21
Friday, the FDA announced it would require additional time to complete its review of Humacyte Inc.'s HUMA Biologic License Application (BLA) for the acellular tissue-engineered vessel (ATEV) in the vascular trauma indication. The ATEV trauma program BLA was submitted to the FDA in December 2023, and the FDA granted a Priority Review in February 2024 and assigned a PDUFA date of August 10, 2024. In a phone call from FDA CBER leadership today, the Company was informed that the FDA required additional time to ...
Humacyte Announces FDA Communication of Additional Time Required to Complete Review of acellular tissue engineered vessel (ATEV™) BLA for the Treatment of Vascular Trauma
GlobeNewswire News Room· 2024-08-09 20:05
– 2nd quarter conference call to be held Tuesday, August 13th, at 8:30 a.m. ET – DURHAM, N.C., Aug. 09, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vas ...
Humacyte Acellular Tissue Engineered Vessel (ATEV™) Meets Primary Endpoints in V007 Phase 3 Clinical Trial in Arteriovenous Access for Hemodialysis
Newsfilter· 2024-07-31 11:00
"We are thrilled to announce positive results for the Phase 3 V007 trial, which we believe highlight the potential of the ATEV to improve AV access in hemodialysis patients who are underserved by the current standard of care," said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. "Achievement of this major milestone has taken a tremendous amount of effort and commitment from our patients, clinical investigators, employees, and other collaborators, and I thank them for their great support an ...
Humacyte, Inc. (HUMA) Sees a More Significant Dip Than Broader Market: Some Facts to Know
ZACKS· 2024-07-23 23:20
Additionally, investors should keep an eye on any recent revisions to analyst forecasts for Humacyte, Inc. Such recent modifications usually signify the changing landscape of near-term business trends. With this in mind, we can consider positive estimate revisions a sign of optimism about the company's business outlook. Heading into today, shares of the company had gained 63.73% over the past month, outpacing the Medical sector's gain of 0.37% and the S&P 500's gain of 1.96% in that time. Research indicates ...
Humacyte Acellular Tissue Engineered Vessel (ATEV™) Receives FDA's Regenerative Medicine Advanced Therapy (RMAT) Designation for Patients with Advanced Peripheral Artery Disease (PAD)
Newsfilter· 2024-07-01 12:00
– Third RMAT designation by FDA for ATEV – DURHAM, N.C., July 01, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, has been granted the U.S. Food and Drug Administration's (FDA's) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD). This RMAT designation is granted at the same time as FDA cleared a new Inve ...