Humacyte(HUMA)
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Humacyte (HUMA) Faces Questions After FDA Inspection – Hagens Berman
GlobeNewswire News Room· 2024-10-24 18:55
SAN FRANCISCO, Oct. 24, 2024 (GLOBE NEWSWIRE) -- On October 17, 2024, the U.S. Federal Food & Drug Administration (“FDA”) published its April 5, 2024 report addressed to Humacyte’s Chief Operating Officer (Heather Prichard) detailing problems with Humacyte’s facilities. The FDA’s April 5, 2024 report submitted to Prichard appears to potentially contradict her assurances to investors at an earnings call on May 12, 2024 in response to analyst questions. Hagens Berman urges investors in Humacyte, Inc. (NASDAQ: ...
Humacyte, Inc. (HUMA) Advances While Market Declines: Some Information for Investors
ZACKS· 2024-10-15 23:21
In the latest market close, Humacyte, Inc. (HUMA) reached $5.70, with a +0.53% movement compared to the previous day. This change outpaced the S&P 500's 0.76% loss on the day. Meanwhile, the Dow lost 0.75%, and the Nasdaq, a tech-heavy index, lost 1.01%. Shares of the company have appreciated by 7.39% over the course of the past month, outperforming the Medical sector's loss of 3.35% and the S&P 500's gain of 4.31%. Market participants will be closely following the financial results of Humacyte, Inc. in its ...
Humacyte 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
GlobeNewswire News Room· 2024-10-08 12:00
DURHAM, N.C., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its late-breaking abstract on the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients with end-stage renal disease was accepted for an oral presentation at the American Society of Nephrology's (ASN) Kidney Week 2024. The la ...
Humacyte Announces Pricing of $30.0 Million Registered Direct Offering
GlobeNewswire News Room· 2024-10-04 12:00
DURHAM, N.C., Oct. 04, 2024 (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 entered into a securities purchase agreement with an institutional investor to purchase approximately $30.0 million worth of its common stock and warrants in a registered direct offering. Under the terms of the securities purchase agreement, the Company has agreed to sell 5,68 ...
Humacyte, Inc. (HUMA) Increases Yet Falls Behind Market: What Investors Need to Know
ZACKS· 2024-09-26 23:21
The most recent trading session ended with Humacyte, Inc. (HUMA) standing at $5.46, reflecting a +0.09% shift from the previouse trading day's closing. This move lagged the S&P 500's daily gain of 0.4%. At the same time, the Dow added 0.62%, and the tech-heavy Nasdaq gained 0.6%. Heading into today, shares of the company had lost 15.43% over the past month, lagging the Medical sector's loss of 2.27% and the S&P 500's gain of 1.71% in that time. The investment community will be paying close attention to the ...
Humacyte 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
GlobeNewswire News Room· 2024-09-26 21:26
DURHAM, N.C., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced it will host a virtual KOL event on Monday, September 30, 2024 at 8:00 AM ET. To register, click here. The event will feature Charles Fox, MD (University of Maryland School of Medicine), Rishi Kundi MD, RPVI, FACS, FSVS (University of Maryland School of Medicine), and YingWei Lum, MD ...
Humacyte: Navigating The FDA Uncertainty And ATEV's Potential
Seeking Alpha· 2024-09-24 12:00
Group 1 - The article discusses the author's extensive background in life sciences, specifically in the research and development of novel Cell & Gene Therapies (CGT) for various clinical needs, including orthopaedics and rare diseases [1] - The author emphasizes the importance of assessing the potential of novel treatments, particularly those utilizing CGT, in driving shareholder returns [1] - The focus of the analysis will be on biotechnology, pharmaceutical, Medtech, and healthcare stocks, providing insights into the companies within these sectors [1]
Humacyte, Inc. (HUMA) Is Considered a Good Investment by Brokers: Is That True?
ZACKS· 2024-09-18 14:31
Core Viewpoint - The article discusses the reliability of brokerage recommendations, particularly focusing on Humacyte, Inc. (HUMA), and emphasizes the importance of using these recommendations in conjunction with other research tools like the Zacks Rank. Group 1: Brokerage Recommendations for Humacyte, Inc. - Humacyte, Inc. has an average brokerage recommendation (ABR) of 1.29, indicating a consensus between Strong Buy and Buy, with 85.7% of the recommendations being Strong Buy from seven brokerage firms [2][3]. - Despite the positive ABR, the article cautions against making investment decisions solely based on this information, as studies show limited success of brokerage recommendations in predicting stock price increases [3][4]. Group 2: Limitations of Brokerage Recommendations - Brokerage analysts often exhibit a positive bias in their ratings due to vested interests, leading to a disproportionate number of Strong Buy recommendations compared to Strong Sell [4][8]. - The article suggests that the best use of brokerage recommendations is to validate independent research rather than rely on them as the sole indicator of stock performance [5]. Group 3: Zacks Rank as an Alternative Indicator - The Zacks Rank is presented as a more reliable indicator of near-term stock performance, based on earnings estimate revisions, and is distinct from the ABR [6][9]. - The Zacks Rank is timely and reflects changes in earnings estimates quickly, unlike the ABR, which may not be up-to-date [10]. Group 4: Current Earnings Estimates for Humacyte, Inc. - The Zacks Consensus Estimate for Humacyte, Inc. remains unchanged at -$1.09, indicating steady analyst views on the company's earnings prospects [11]. - Due to the unchanged consensus estimate and other factors, Humacyte, Inc. holds a Zacks Rank of 3 (Hold), suggesting caution despite the Buy-equivalent ABR [12].
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 ...
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 ...