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Humanigen, Inc. (Nasdaq: HGEN) has appointed Ken Trbovich as the SVP of Investor Relations, effective immediately. Trbovich brings over 20 years of Wall Street experience as a Managing Director and Senior Analyst from notable investment banks. He will play a key role in engaging with investors while Humanigen prepares for potential Emergency Use Authorization for its drug lenzilumab, aimed at treating cytokine storms in COVID-19 patients. Humanigen's focus also includes exploring lenzilumab's efficacy in various inflammatory conditions.
Humanigen, Inc. (Nasdaq: HGEN) announced its participation at the 2021 LD Micro Invitational XI from June 8-10, 2021. The company will present on June 8 during the 'Hall of Fame' session, discussing its lead drug candidate, lenzilumab, which aims to treat cytokine storms in COVID-19 patients. Lenzilumab has been submitted for Emergency Use Authorization by the FDA. The presentation will also cover launch preparations and updates on other development programs.
Humanigen, Inc. (Nasdaq:HGEN) announced the submission of an Emergency Use Authorization (EUA) application to the FDA for its lead drug candidate, lenzilumab, aimed at treating hospitalized COVID-19 patients. This follows encouraging results from the LIVE-AIR Phase 3 trial, where lenzilumab showed a 54% improvement in the likelihood of survival without ventilation. The drug's safety profile was comparable to placebo, and it is positioned to address a critical need for effective COVID-19 treatments. Humanigen is also pursuing further clinical studies for its therapies targeting cancers and other diseases.
Humanigen, Inc. (Nasdaq: HGEN) announced that data on GM-CSF gene-edited CAR-T cells will be presented at the ISCT 2021 Annual Meeting in New Orleans from May 26-28, 2021. Researchers from the Mayo Clinic highlighted that GM-CSF knock-out in CAR-T cells reduces activation-induced cell death and enhances T-cell expansion in vivo, promising improved anti-tumor activity. CEO Cameron Durrant emphasized the potential of GM-CSFKO CAR-T as a less toxic alternative to current therapies. The Mayo Clinic's presentation is scheduled for May 28, 2021, from 11:30 AM to 1:00 PM ET.
Humanigen, Inc. (Nasdaq: HGEN) announced its management team will participate in a fireside chat at the Jefferies Healthcare Conference from June 1-4, 2021. They will discuss the lead product, lenzilumab, which has completed a Phase 3 trial for COVID-19 patients. The chat will cover the submission for Emergency Use Authorization to the FDA and updates on commercial preparations. The live session is scheduled for June 2, 2021, at 4:00 PM ET. Additionally, the company plans to launch a Phase 2 study on lenzilumab combined with CD19 CAR-T therapies for lymphoma.
Humanigen (Nasdaq:HGEN) has partnered with Chime Biologics to produce its lead drug candidate, lenzilumab, for commercial sale outside the U.S. The agreement follows the positive results from the LIVE-AIR Phase 3 clinical trial. Chime will utilize its advanced KuBio facility in China, with an initial capacity of 56,000L for annual production. The planned commercial product availability is set for 2022, pending necessary regulatory approvals in regions like Europe, India, and Brazil. This collaboration aims to fulfill the anticipated demand for lenzilumab.
Humanigen announced its Q1 2021 financial results, reporting a net loss of $65.6 million or $1.25 per share, up from $2.5 million or $0.11 per share in Q1 2020. The loss was primarily due to increased R&D expenses of $59.9 million, mainly for lenzilumab manufacturing and clinical trials. The company successfully completed its Phase 3 LIVE-AIR study for lenzilumab, showing a 54% greater likelihood of survival for treated COVID-19 patients. Humanigen plans to submit for emergency use authorization (EUA) for lenzilumab by May 2021 and has raised $94.1 million from a recent public offering.
Humanigen, Inc. (Nasdaq: HGEN) announced the online publication of results from its Phase 3 study, LIVE-AIR, evaluating lenzilumab in hospitalized COVID-19 patients. This study supports lenzilumab's potential to treat cytokine storm, a severe immune response. Humanigen plans to initiate a Phase 2 study assessing lenzilumab's efficacy alongside CD19 CAR-T therapies for diffuse large B-cell lymphoma. The company is also advancing gene-edited CAR-T therapies and examining GM-CSF neutralization technologies to enhance treatment efficacy while controlling toxicity.
Humanigen, Inc. (Nasdaq: HGEN) has appointed Adrian Kilcoyne, MD, MBA, MPH, as its Chief Medical Officer, effective immediately. Dr. Kilcoyne previously held significant roles at AstraZeneca, overseeing multiple oncology launches, and brings expertise in clinical development across various therapeutic areas. His role will involve leading clinical and regulatory strategies for Humanigen's lead drug candidate, lenzilumab, aimed at treating conditions like acute GvHD and COVID-19. This strategic appointment is seen as a move to strengthen Humanigen's leadership in developing innovative therapies.
Humanigen, Inc. (Nasdaq: HGEN) reported promising data from the Phase 1b ZUMA-19 study, evaluating its drug, lenzilumab, in patients with diffuse large B-cell lymphoma (DLBCL) undergoing CAR-T therapy. At the recommended Phase 2 dose of 1,800 mg, the objective response rate (ORR) reached 100% with no severe cytokine release syndrome (CRS) or neurological toxicity. The company plans a larger, potentially registrational Phase 2 trial to assess lenzilumab with various CD19 CAR-T therapies, enrolling approximately 150 patients. The collaboration with Kite on ZUMA-19 has been terminated.