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 the award of two patents by the USPTO, strengthening its intellectual property portfolio related to its lead drug candidate, lenzilumab™. These patents highlight the efficacy of lenzilumab in mitigating cytokine storm, which impacts patients undergoing immunotherapy. The first patent focuses on reducing tumor relapse rates during immunotherapy, while the second addresses reducing immunotherapy-related toxicity. With over 100 issued patents, Humanigen's advancements in GM-CSF neutralization aim to improve immunotherapy outcomes and address critical conditions like COVID-19 and acute graft-versus-host disease.
Humanigen, Inc. (Nasdaq: HGEN) announced its management team will present at several upcoming conferences: H.C. Wainwright Global Life Sciences Conference (March 9-10, 2021), Roth Conference (March 15-17, 2021), and Oppenheimer Annual Healthcare Conference (March 16-17, 2021). They will discuss the Phase 3 trial of lenzilumab for COVID-19 patients, including timelines for topline data and Emergency Use Authorization. Details on commercial preparations and other development programs will also be presented.
Humanigen (Nasdaq: HGEN), a clinical stage biopharmaceutical company, announced CEO Cameron Durrant will participate in several key events, including the BIO CEO & Investor Virtual Conference on February 16, 2021, and a Fireside Chat with Cantor Fitzgerald Analyst Louise Chen on February 26, 2021. The company focuses on its lead drug candidate, lenzilumab™, aimed at preventing immune hyper-responses like cytokine storms. Additional participation includes the Endpoints Webinars on drug repurposing and the Vanguard Network Life Sciences Quarterly Forum.
Humanigen, Inc. (NASDAQ:HGEN) appointed Dr. Dale Chappell as a director of the Company effective February 5, 2021. He retains his role as chief scientific officer, enhancing the board with his expertise. Dr. Chappell brings significant experience in tumor immunology and cytokine storm research, particularly relevant for the ongoing development of lenzilumab for COVID-19 treatment. CEO Cameron Durrant praised Dr. Chappell's contributions to the company’s success. Humanigen focuses on therapies targeting cancers and infectious diseases, including COVID-19.
Avid Bioservices (NASDAQ:CDMO, CDMOP) and Humanigen (NASDAQ:HGEN) have entered a manufacturing services agreement to boost production for lenzilumab, aimed at treating COVID-19. This collaboration will involve cGMP drug substance batches essential for Humanigen’s upcoming regulatory filings, including emergency use authorization (EUA) and a Biologics License Application (BLA). Humanigen has successfully completed enrollment in a 520-patient Phase 3 clinical trial. Both companies emphasize their commitment to enhancing therapeutic access amid the ongoing pandemic.
Humanigen (NASDAQ:HGEN) has completed enrollment for its pivotal Phase 3 trial of lenzilumab for COVID-19, enrolling 520 patients. The study aims to determine if lenzilumab, alongside standard care, can alleviate cytokine release syndrome (CRS) and enhance ventilator-free survival in hypoxic COVID-19 patients. The company anticipates announcing top-line results in March 2021. Lenzilumab is designed to combat cytokine storms, a major complication in severe COVID-19 cases, with nearly 90% of hospitalized patients at risk.
Humanigen, Inc. (NASDAQ: HGEN) and Ajinomoto Bio-Pharma Services have expanded their manufacturing agreement for the investigational COVID-19 therapeutic lenzilumab. This expansion facilitates the aseptic fill-finish supply of lenzilumab, which is in Phase 3 trials for hospitalized COVID-19 patients. Humanigen is preparing for a potential Emergency Use Authorization (EUA) and is actively enrolling patients in the U.S. and Brazil. The partnership aims to streamline the supply chain for lenzilumab, enhancing its availability as the clinical phase concludes.
Emergent BioSolutions and Humanigen have entered into a contract development and manufacturing (CDMO) agreement to accelerate production of lenzilumab, an antibody aimed at treating COVID-19 related cytokine storms. The deal leverages manufacturing capacity reserved by the U.S. government through the Department of Defense and aims for an emergency use authorization (EUA) in Q1 2021. Emergent's advanced facilities in Baltimore will support increased production, forming a key part of Humanigen's growth strategy.
Humanigen (NASDAQ:HGEN) expands its Cooperative Research and Development Agreement with the Department of Defense's JPEO-CBRND, gaining access to BARDA's manufacturing capacity for its drug lenzilumab. This collaboration aims to expedite the development of lenzilumab for potential Emergency Use Authorization as a treatment for COVID-19. Lenzilumab, currently in Phase 3 trials, addresses cytokine storms, which can severely impact COVID-19 patients. CEO Cameron Durrant highlighted the vital role of BARDA in advancing this crucial project.
Humanigen (HGEN) announces a partnership with EVERSANA to expedite the availability of their drug lenzilumab for hospitalized COVID-19 patients, pending FDA Emergency Use Authorization (EUA). Lenzilumab targets cytokine storms, a leading cause of COVID-19 mortality, affecting up to 89% of such patients. The agreement provides Humanigen with immediate access to EVERSANA’s comprehensive services, including marketing and medical education, optimizing the launch of lenzilumab. This collaboration is aimed at ensuring prompt patient access to the treatment.
FAQ
What is the market cap of Humanigen (HGEN)?
What does Humanigen, Inc. specialize in?
What is lenzilumab?
What is the RATinG trial?
What are the key partnerships supporting Humanigen's research?
What other conditions is lenzilumab being investigated for?
What is ifabotuzumab?
Is Humanigen a publicly traded company?
How can I stay updated with Humanigen's latest news?
What challenges does Humanigen face?
What is Humanigen's approach to antibody development?
