Humanigen, Inc. - HGEN STOCK NEWS

Humanigen (NASDAQ: HGEN), a clinical-stage biopharmaceutical company, announced participation in several investor conferences in November 2021. CEO Cameron Durrant will present at the Credit Suisse 30th Annual Healthcare Conference on November 9 and participate in the Reuters Total Health Global Conference on November 18. COO and CFO Timothy Morris will present at the Jefferies London Healthcare Conference on November 17. Humanigen is developing lenzilumab to treat cytokine storm related to COVID-19 and other inflammatory conditions, with a rolling review submitted to the UK regulatory authority.

Humanigen announced the dosing of the first patient in the PREACH-M clinical trial, aiming to improve outcomes for Chronic Myelomonocytic Leukemia (CMML) patients with specific mutations. This trial focuses on patients with RAS pathway mutations, assessing the combination of lenzilumab and azacitidine. Current response rates for CMML are around 18%, with hopes to improve this to 30%-50%, potentially increasing median survival from 30 months to over three years. The study involves 72 patients across five sites in Australia, with results tracked over two years.

Humanigen, Inc. (NASDAQ: HGEN) announced that its lead drug candidate, lenzilumab, has been recognized by the European Commission as one of the “10 most promising treatments for COVID-19.” This decision followed an assessment of 82 therapeutics by an independent panel of experts. Lenzilumab was chosen for its potential therapeutic value and favorable safety profile. The company aims to submit a marketing authorization application to the European Medicines Agency for lenzilumab’s use in COVID-19 as part of its ongoing efforts.

Humanigen (NASDAQ: HGEN) announced that Phase 1 results of ifabotuzumab in glioblastoma will be presented at EANM'21, showcasing tumor-specific targeting without normal tissue uptake. A follow-on Phase 1b study in non-CNS solid tumors is set to begin in early 2022. Principal Investigator Prof. Andrew Scott emphasized the potential of ifabotuzumab as an antibody-drug conjugate. The study demonstrated reproducible targeting and is supported by preclinical success. Humanigen aims to advance ifabotuzumab's therapeutic options while continuing its COVID-19 treatment development.

Humanigen (NASDAQ:HGEN) presented data from its LIVE-AIR Phase 3 study at the CHEST Annual Meeting 2021, indicating that baseline C-reactive protein (CRP) <150 mg/L enhances the efficacy of lenzilumab in hospitalized COVID-19 patients. Results show lenzilumab improved survival without ventilation by over 3-fold and reduced mortality by more than 2-fold compared to standard treatments. The study achieved its primary endpoint, demonstrating that early intervention may prevent progression to a cytokine storm, particularly in patients with elevated CRP levels.

Humanigen, Inc. (NASDAQ: HGEN) announces the availability of a manuscript detailing a budget impact model for lenzilumab treatment in COVID-19 hospitalized patients. Evidence indicates lenzilumab offers significant clinical and economic benefits, particularly among specific patient groups. The average cost for ICU care of a COVID-19 patient can exceed $100,000, making effective treatment options crucial. Lenzilumab is not yet authorized or approved globally and is under evaluation for various conditions, including acute Graft versus Host Disease and eosinophilic asthma.

Humanigen has partnered with Clinigen Group to launch a Managed Access Program (LenzMAP) for their investigational treatment, lenzilumab, aimed at hospitalized COVID-19 patients across 16 European countries. The program allows access on a case-by-case basis where no alternatives are available. Currently, lenzilumab is not authorized in any country, and Humanigen continues to pursue regulatory approvals, including a Marketing Authorization Application with the European Medicines Agency.

Humanigen, Inc. (Nasdaq: HGEN) has announced participation in various virtual investor conferences in October 2021, focusing on their treatment for cytokine storms. Key events include a discussion at the Guggenheim Vaccines and Infectious Diseases Conference on October 5, and a presentation on the Phase 3 LIVE-AIR study at the Cytokines 2021 meeting on October 17. The company is advancing lenzilumab, an antibody targeting GM-CSF, which is pivotal in managing severe inflammation in COVID-19 and other conditions.

Humanigen, Inc. (Nasdaq: HGEN) announced the submission of a Conditional Marketing Authorization application for lenzilumab to the UK’s MHRA, aimed at treating COVID-19 in hospitalized patients. The submission included all planned modules, a risk management plan, and a pediatric investigation plan. The live AIR Phase 3 study, which enrolled 520 patients, demonstrated significant benefits in preventing 'cytokine storm' with lenzilumab, achieving its primary endpoint. The UK continues to face high COVID-19 hospitalization rates, emphasizing the urgency of lenzilumab's potential deployment.