Welcome to our dedicated page for Humanigen news (Ticker: HGEN), a resource for investors and traders seeking the latest updates and insights on Humanigen stock.
Humanigen, Inc. (OTC Pink: HGEN) is a clinical-stage biopharmaceutical company with a focus on developing innovative therapies to enhance patient outcomes. At the core of the company's mission is the development of lenzilumab, a first-in-class monoclonal antibody designed to neutralize granulocyte-macrophage colony-stimulating factor (GM-CSF), a key cytokine involved in inflammatory responses.
The company's leading product, lenzilumab, is currently being investigated in multiple clinical trials. One of the major studies is the RATinG (Risk Adapted Therapy in Acute GvHD) trial, which aims to explore lenzilumab's efficacy in treating acute Graft versus Host Disease (aGvHD). This condition affects a significant proportion of patients who undergo allogeneic stem cell transplants, with high rates of morbidity and mortality. The Phase 2/3 study is conducted in collaboration with the UK-based IMPACT partnership and is poised to enroll patients across 18 treatment centers.
In addition to aGvHD, lenzilumab is also being tested as a treatment for chronic myelomonocytic leukemia and to mitigate toxicities associated with CAR-T therapy through investigator-initiated trials. The company's expertise in antibody development extends beyond lenzilumab, as demonstrated by the development of an antibody drug conjugate (ADC) utilizing its EphA-3 targeted monoclonal antibody ifabotuzumab for the treatment of solid tumors.
Humanigen’s pipeline is fortified by state-of-the-art antibody customization technologies designed to optimize therapeutic effects while minimizing undesired side effects. The company’s research and development efforts are supported by extensive partnerships with leading institutions such as the University of Birmingham's Cancer Research UK Clinical Trials Unit and the British Society of Blood and Marrow Transplantation.
Despite being at a pre-commercial stage, Humanigen demonstrates resilience and strategic focus, advancing its therapeutic candidates through critical clinical milestones. Financial and market challenges remain, but the company is actively exploring strategic options, including potential restructuring to maintain its innovative edge and ongoing operations.
For more detailed information, including the latest updates and news, visit www.humanigen.com and follow Humanigen on Twitter.
Humanigen, Inc. (Nasdaq:HGEN) announced positive Phase 1 trial results for ifabotuzumab in glioblastoma multiforme (GBM) patients, demonstrating effective tumor targeting without dose-limiting toxicities. The study, aimed at ensuring safety and determining a recommended Phase 2 dose, showed that ifabotuzumab effectively targeted the EphA3 receptor in all patients. Results will be presented at the AACR Annual Meeting 2021.
With an estimated 18,000 annual U.S. deaths from brain cancer, these findings suggest potential for further investigation into ifabotuzumab in solid tumors.
Humanigen, Inc. (Nasdaq: HGEN) announced its successful underwritten public offering of common stock, generating approximately $92.5 million in gross proceeds on April 5, 2021. These funds will support manufacturing and commercial preparation for its lead drug candidate, lenzilumab™, as it seeks Emergency Use Authorization from the FDA for treating hospitalized COVID-19 patients. The offering's registration has been declared effective by the SEC, and the company plans to use the net proceeds for working capital and other general corporate purposes.
Humanigen, Inc. (Nasdaq:HGEN) has priced its public offering of 5,000,000 shares of common stock at $18.50 each, raising approximately $92.5 million before deductions. The offering is expected to close around April 5, 2021, with an option for underwriters to purchase an additional 750,000 shares. Proceeds will be used for manufacturing and commercial preparation for the COVID-19 treatment lenzilumab™, pending FDA Emergency Use Authorization, along with general corporate purposes.
Humanigen (Nasdaq: HGEN) has initiated an underwritten public offering of 5,000,000 shares of its common stock, with a potential 30-day option for underwriters to purchase an additional 750,000 shares. The offering's completion is uncertain and depends on market conditions. The net proceeds will be utilized for manufacturing and commercial preparation related to its lead drug lenzilumab in COVID-19 patients, along with working capital. Jefferies, Credit Suisse, and Cantor are managing the offering.
Humanigen, Inc. (Nasdaq: HGEN) reported positive topline results from its Phase 3 clinical trial of lenzilumab for COVID-19 patients. The trial indicated a 54% higher relative likelihood of survival without needing invasive mechanical ventilation (IMV) for those treated with lenzilumab compared to placebo. The study achieved its primary endpoint of ventilator-free survival through day 28, showing statistically significant results. The company plans to seek Emergency Use Authorization (EUA) from the FDA promptly.
Humanigen, Inc. (Nasdaq: HGEN) announced a conference call today to discuss topline results from the Phase 3 trial of its leading drug, lenzilumab, for treating hospitalized COVID-19 patients. The randomized, double-blind study aimed to evaluate lenzilumab's effectiveness in enhancing ventilator-free survival alongside standard treatments like dexamethasone. Enrolled were 520 patients across 29 sites in the US and Brazil. Results will be submitted for potential publication in a peer-reviewed journal. For further details, visit www.humanigen.com.
Humanigen, Inc. (Nasdaq: HGEN) has scheduled its 2021 Annual Meeting of Shareholders for June 17, 2021, to be held virtually. The record date for shareholder voting is April 21, 2021. Shareholders are encouraged to vote in advance, with further details to be provided in a proxy statement. Humanigen is focused on developing therapies for immune hyper-responses like cytokine storms and is actively working on advanced treatments for cancers and infectious diseases, including its lead candidate, lenzilumab™.
Humanigen, a clinical-stage biopharmaceutical company, has secured a term loan facility of up to $80 million from Hercules Capital to support the production of its lead drug candidate, lenzilumab. The facility includes a $25 million initial term loan and an additional $55 million contingent on achieving milestones. This financing aims to bolster Humanigen's balance sheet and prepare for the potential Emergency Use Authorization of lenzilumab in 2021, enhancing financial flexibility amidst ongoing COVID-19 treatment development.
Humanigen, Inc. (HGEN) reported significant advancements and financial results for 2020, including a net loss of $89.5 million, largely attributed to increased R&D expenses of $72.7 million driven by its COVID-19 treatment, lenzilumab. The company completed a Phase 3 study enrolling 520 patients, with results expected by March 2021. 2021 goals include submitting an Emergency Use Authorization and a Marketing Authorization Application for lenzilumab. Humanigen raised $140 million through equity financing and expanded its leadership team during the year.
Humanigen (Nasdaq: HGEN) has announced its participation in the Roth Conference from March 15-17, 2021. Management will focus on the Phase 3 clinical trial of lenzilumab for COVID-19 patients and discuss the upcoming timeline for topline data and Emergency Use Authorization (EUA) submission to the FDA. An Advance Video Webinar will be accessible starting March 8, 2021. The Company will also update on commercial preparations for lenzilumab and provide insights into other development programs. For details on the fireside chat and webcasts, visit the Humanigen website.
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