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. (HGEN) has commenced its Phase 3 clinical trial of lenzilumab at MedStar Washington Hospital Center for COVID-19 patients. The trial aims to investigate lenzilumab's efficacy in accelerating recovery for hospitalized patients, particularly those at risk of cytokine storm, a serious inflammatory condition. This site is among 18 locations across the U.S. approved to enroll participants. CEO Cameron Durrant emphasized the swift collaboration with the hospital to initiate patient enrollment amid rising COVID-19 cases in the area.
Humanigen, Inc. (Nasdaq: HGEN) announced that the first patient has been dosed in the ACTIV-5/BET trial at Emory University, evaluating lenzilumab alongside remdesivir for COVID-19 treatment. This randomized, double-blind study, involving up to 200 patients across 40 centers, aims to assess the efficacy of these therapies. Lenzilumab targets cytokine storms, which affect nearly 90% of hospitalized COVID-19 patients. Humanigen's CEO expressed optimism about lenzilumab's potential to accelerate recovery times in these patients.
Humanigen, Inc. (Nasdaq: HGEN) announced participation in several virtual investor conferences focusing on COVID-19 therapeutics. Key events include:
- ROTH Capital Healthcare Event on October 28, 2020.
- Bryan, Garnier & Co European Healthcare Conference on November 16-17, 2020.
- Stifel Virtual Healthcare Conference on November 16-18, 2020.
- Jefferies London Healthcare Conference on November 17-19, 2020.
Live webcasts will be available on the Humanigen website, with archived presentations for 30 days post-event.
Humanigen, Inc. (Nasdaq: HGEN) announced that the National Institute of Allergy and Infectious Diseases (NIAID) has launched the ACTIV-5 “Big Effect Trial” to evaluate its lead drug candidate, lenzilumab, in combination with remdesivir for hospitalized COVID-19 patients. The study will involve approximately 100 patients per treatment arm across 40 US sites, with Humanigen supplying lenzilumab. This trial is part of a larger public-private partnership aimed at identifying promising COVID-19 treatments. The collaboration underscores lenzilumab's potential in treating severe immune responses.
Humanigen, Inc. (NASDAQ:HGEN) announced a promising case report involving its drug lenzilumab for treating severe COVID-19. A 77-year-old patient, hospitalized for 13 weeks, showed rapid improvement in oxygenation and mobility after receiving the drug under an emergency IND approval. This case aligns with a separate Mayo Clinic study exhibiting an 80% reduction in the risk of invasive mechanical ventilation and death among patients treated with lenzilumab. Humanigen continues to evaluate lenzilumab in ongoing Phase 3 trials aimed at improving outcomes for critical COVID-19 patients.
Humanigen, Inc. (NASDAQ:HGEN) announced key updates regarding its lead drug candidate, lenzilumab, aimed at treating the cytokine storm in COVID-19 patients. Following a Type B meeting with the FDA, the company received positive feedback indicating that its submission may suffice for Emergency Use Authorization (EUA) pending Phase 3 trial results. The Phase 3 trial is now expanded to Brazil and Mexico, with 24 active sites in the U.S. and 7 in Brazil currently enrolling patients. Top-line data is expected in Q4 2020.
Humanigen, Inc. (NASDAQ:HGEN) announced a strategic collaboration with Thermo Fisher Scientific to enhance manufacturing capacity for its COVID-19 therapeutic candidate, lenzilumab. This partnership is aimed at supporting a potential Emergency Use Authorization (EUA) in 2020. The partnership follows similar collaborations with Lonza and Catalent, highlighting Humanigen's commitment to rapid production and delivery of lenzilumab, currently in a Phase 3 registration study. Production could start before year-end, positioning the company to address severe COVID-19 cases by reducing the risk of ventilation or death.
Humanigen, Inc. (NASDAQ:HGEN) announced that management will present a company overview at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 23, 2020, at 10:50 a.m. EDT. The event will be virtual, with a live webcast available at this link. Humanigen focuses on developing therapies for cancer and infectious diseases using GM-CSF neutralization and gene-editing technologies, particularly targeting cytokine release syndrome associated with SARS-CoV-2.
Humanigen, Inc. (Nasdaq:HGEN) has successfully completed its underwritten public offering, raising approximately $72.8 million through the sale of 9.2 million shares, including 1.2 million shares from the over-allotment option. The funds will be used for the manufacturing and commercial preparation of lenzilumab, aimed at treating COVID-19 patients, along with general corporate purposes. The offering was conducted via a shelf registration statement declared effective by the SEC. Major financial institutions involved include J.P. Morgan and Jefferies.
Humanigen has priced an underwritten public offering of 8,000,000 shares of common stock at $8.50 per share, generating approximately $68 million in gross proceeds. The offering is expected to close around September 22, 2020. Additionally, underwriters have a 30-day option to purchase up to 1,200,000 shares at the public offering price. The funds will be allocated to support manufacturing, production, and commercial preparation of lenzilumab for treating COVID-19, alongside general corporate needs. Humanigen's stock will begin trading on Nasdaq under the symbol HGEN starting September 18, 2020.
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?
