Core Viewpoint - Humacyte, Inc. announced that the FDA requires additional time to review its Biologic License Application for the acellular tissue engineered vessel (ATEV) intended for vascular trauma, which was initially set for a PDUFA date of August 10, 2024 [1][2] Company Overview - Humacyte is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][4] - The company is working on a portfolio of ATEVs targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease [4][5] - The ATEV is designed to be a first-in-class bioengineered human tissue that serves as a universally implantable vascular conduit for arterial replacement and repair [2][4] FDA Review Process - The FDA granted a Priority Review for the ATEV, which typically allows for a six-month review cycle compared to the standard ten-month cycle for most products [2] - The BLA for ATEV was submitted in December 2023, and the FDA has conducted inspections and engaged in discussions regarding the application [2][4] - The company remains confident in the approvability of the ATEV based on positive results from clinical studies and real-world evidence [2][4] Clinical Evidence - The BLA included results from the V005 pivotal Phase 2/3 clinical study and evidence from treating wartime injuries in Ukraine [2] - ATEV has been used in various traumatic injury cases, demonstrating high rates of patency and low rates of amputation and infection [2][4]

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 ...

– 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 ...

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 Investigational New Drug (IND) application for ...

– BioVascular Pancreas (BVP) product candidate is under development as a potential treatment for type 1 diabetes – – Humacyte's stem cell-derived islets observed to restore normal blood glucose in diabetic mice – – Non-human primate models of BVP implantation showed islet survival and continued insulin production – DURHAM, N.C., June 25, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinicalstage biotechnology platform company developing universally implantable, bioengineered human tissues at com ...

Additionally, investors should keep an eye on any recent revisions to analyst forecasts for Humacyte, Inc. Recent revisions tend to reflect the latest near-term business trends. As such, positive estimate revisions reflect analyst optimism about the company's business and profitability. Heading into today, shares of the company had lost 27.32% over the past month, lagging the Medical sector's gain of 0.44% and the S&P 500's gain of 3.15% in that time. Our research reveals that these estimate alterations are ...

– Four unique ICD-10-PCS codes, effective October 1, 2024, for replacement of arteries in the upper and lower extremities using Humacyte's HAV – – BLA submission under Priority Review by FDA for the treatment of vascular trauma, supported by Phase 2/3 clinical trial results and real-world use treating wartime trauma injuries in Ukraine – DURHAM, N.C., June 17, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinicalstage biotechnology platform company developing universally implantable, Human Acell ...

Core Insights - Humacyte Inc (NYSE:HUMA) and American Semiconductor Corp (NASDAQ:AMSC) are experiencing significant stock price increases, with HUMA up 20.5% to $9.29 and AMSC up 14.6% to $18.10 [1][2] Humacyte Inc (HUMA) - HUMA is participating in the Jefferies Global Healthcare Conference, contributing to its stock price surge [1] - The stock has increased approximately 230% since the beginning of the year, marking its best performance since August 2023 and trading at its highest levels since December 2021 [1] American Semiconductor Corp (AMSC) - AMSC reported strong first-quarter results, leading to a stock price increase of 14.6%, with a peak of $20.68 [2] - The stock has risen 61.7% since the start of 2024, reaching its highest levels in three years [2] Options Trading Activity - HUMA has seen four times its average daily options volume, with new positions opening at the most active June 10 call [3] - AMSC has experienced 14 times its average daily options volume, with new positions opening at the popular June 20 call [3] Short Interest - HUMA has a short interest representing 5.2% of its available float, while AMSC has a short interest of 5.4% [3]

Core Insights - The focus of insider trading discussions has shifted from Nancy Pelosi to Republican Senator Tommy Tuberville, particularly regarding his trades in Humacyte (NASDAQ: HUMA) stock [1] - Tuberville's acquisition of HUMA stock involved three separate purchases totaling approximately $80,000 on March 21, 2024 [1] - HUMA shares have experienced a significant surge, increasing by 96% in two months and 144.29% year-to-date, rising from $2.89 to $7.06 [2][3] Trading Performance - Despite the strong performance of HUMA stock, Tuberville sold $50,000 worth of shares on April 30, missing out on additional gains as HUMA shares increased by 80.10% in value thereafter [4] - Had Tuberville waited until May 20, his profit could have reached $75,000, effectively doubling his initial investment [5] Company Context - Humacyte is involved in biomedical projects and innovative treatments for trauma injuries, recently announcing testing of new technology in Ukraine for combat injuries [6] - Tuberville's position on the Armed Services Committee, which oversees grants and projects related to companies like Humacyte, raises suspicions about the nature of his trades [6][7]

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 March 31, 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 ______ ...