Humanigen, Inc. - HGEN STOCK NEWS

Humanigen, Inc. (NASDAQ: HGEN) announced that the United States Patent and Trademark Office has granted a patent for lenzilumab, aimed at treating cytokine storm and neurotoxicity in CAR-T cell therapy patients. This patent, issued on December 22, 2020, covers the prevention and treatment of cytokine release syndrome (CRS), a significant adverse effect linked to CAR-T therapy. Lenzilumab neutralizes GM-CSF, a key factor in triggering inflammation. CEO Cameron Durrant emphasized the drug's potential to enhance CAR-T therapies, highlighting Humanigen's commitment to addressing severe inflammatory responses.

Humanigen, Inc. (Nasdaq: HGEN) announced its participation in the J.P. Morgan Healthcare Conference from January 11 to 14, 2021. Key executives will discuss the progress of its Phase 3 clinical trial for lenzilumab in COVID-19 patients and potential commercial preparations for Emergency Use Authorization. The presentation is scheduled for January 13, 2021, at 8:20 AM ET. The company focuses on therapies targeting cytokine storms and has promising developments in cancer treatments.

Humanigen, Inc. (NASDAQ: HGEN) has completed enrollment in a Phase 1 bioimaging study featuring its anti-EphA3 monoclonal antibody ifabotuzumab, targeting recurrent glioblastoma multiforme (GBM). Conducted at the Olivia Newton-John Cancer Research Institute, this trial aims to evaluate safety and determine dosing for future phases. Initial results are anticipated in the first half of 2021. Despite GBM's low 5-year survival rate of only 10%, early signs indicate ifabotuzumab effectively targets tumors without impacting healthy tissue, representing a step forward in immuno-oncology treatments.

Humanigen, Inc. (Nasdaq: HGEN) announced management will present at the PNC Bank & Solebury Trout COVID Webinar and LD Micro Investor Conference on December 15, 2020. CEO Cameron Durrant will discuss company programs and provide updates on the Phase 3 clinical trial of lenzilumab for COVID-19 patients. The PNC webinar is scheduled from 12:00-1:00 PM EST, while the LD Micro conference presentation is from 2:20-2:40 PM EST. Humanigen focuses on therapies targeting cytokine storms to reduce severe lung dysfunction caused by SARS-CoV-2.

Humanigen, Inc. (NASDAQ: HGEN) establishes Humanigen Australia Pty Ltd to explore partnerships and advance clinical programs in the Asia-Pacific region. The first initiative involves a licensing agreement for lenzilumab in South Korea and the Philippines. Ongoing studies include lenzilumab for COVID-19 in cancer patients and refractory chronic myelomonocytic leukemia, backed by Australian government grants. Additionally, a Phase 1 trial of ifabotuzumab in glioblastoma multiforme is nearing completion. This expansion aims to utilize financial incentives while enhancing Humanigen's pipeline.

Humanigen, Inc. (HGEN) reported its Q3 2020 financial results, highlighting a net loss of $30.8 million, or $0.71 per share, significantly more than Q3 2019's loss of $2.4 million. The company raised $72.7 million through an underwritten public offering and expanded its manufacturing capabilities for lenzilumab, targeting COVID-19 treatment. Key achievements include participation in NIH's ACTIV-5 trial and positive interim Phase 3 data indicating a 37% improvement in patient recovery. Humanigen anticipates increased expenses as it prepares to submit an EUA in Q1 2021.

Humanigen, Inc. (HGEN) has entered a Cooperative Research and Development Agreement (CRADA) with the DoD to advance its drug candidate lenzilumab™, aimed at treating cytokine storm related to COVID-19. This collaboration, part of Operation Warp Speed, provides crucial regulatory support and access to manufacturing expertise, enhancing the path towards Emergency Use Authorization (EUA) and Biologics License Application (BLA). Lenzilumab is currently undergoing Phase 3 clinical trials, with the NIH evaluating it in a major study.

Humanigen, Inc. (Nasdaq: HGEN) reported positive interim Phase 3 data for lenzilumab, its investigational treatment for COVID-19, showcasing a 37% increase in patient recoveries compared to standard care. The data safety monitoring board recommended raising the target for recoveries from 257 to 402 to optimize study power. The trial's design allows for expanded enrollment, enhancing success probabilities for Emergency Use Authorization (EUA) and Biologics License Application (BLA). Currently, 300 patients have been enrolled across U.S. and Latin American sites.

Humanigen, Inc. (Nasdaq: HGEN) has executed its first licensing agreement in the Asia-Pacific region with Telcon RF Pharmaceutical, Inc. and KPM Tech Co., Ltd for the development and commercialization of lenzilumab for COVID-19 in South Korea and the Philippines. The agreement entails up to $20 million in payments, including $6 million upfront and $14 million tied to milestones. Following regulatory approval, Humanigen will receive double-digit royalties. This marks a significant step in Humanigen's expansion strategy in the region, amidst over 412,000 COVID-19 cases reported in these countries.