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Humanigen announced that the independent Data Safety Monitoring Board (DSMB) unanimously recommended the continuation of its Phase 3 trial of lenzilumab for COVID-19 without modifications after an interim analysis. This recommendation is based on safety and futility assessments, confirming the trial's progression as planned. The company is on track to complete enrollment of 300 patients by the end of the month, with topline data expected in Q4. This marks a significant milestone towards a potential Emergency Use Authorization (EUA) for lenzilumab.
Humanigen, Inc. announced a 1-for-5 reverse stock split set to take effect on September 11, 2020, following shareholder approval on July 29, 2020. This split will reduce the outstanding shares from approximately 211 million to about 42 million, maintaining the current authorized shares at 225 million. The move aims to satisfy Nasdaq listing requirements and make additional shares available for future issuance. Trading under the symbol HGEN will continue, with the new CUSIP number assigned. No fractional shares will be issued; cash payments will be provided for such shares.
Humanigen, Inc. (OTCQB:HGEN) has announced an investor call and webcast on September 3, 2020, at 11:00 a.m. EDT, to discuss lenzilumab data published in Mayo Clinic Proceedings regarding COVID-19 patients. The call will feature Dr. Zelalem Temesgen from the Mayo Clinic. Participants can join via telephone or access the event online. The company focuses on GM-CSF neutralization technologies aimed at combating cytokine release syndrome in severe SARS-CoV-2 cases and is exploring lenzilumab's efficacy in various cancer treatments.
Humanigen, a clinical-stage biopharmaceutical company, announced significant findings from a case-control study of its drug, lenzilumab, in severe COVID-19 patients. The results indicate an 80% reduction in the risk of invasive mechanical ventilation and/or death compared to controls. Patients treated with lenzilumab saw their median recovery time from acute respiratory distress syndrome (ARDS) decrease from eight to one day. Additionally, hospital discharge times halved. This study is part of a broader investigation into lenzilumab's efficacy, with ongoing Phase III trials underway.
Humanigen, Inc. (OTCQB:HGEN) has appointed Edward P. Jordan as Chief Commercial Officer to facilitate the potential Emergency Use Authorization of lenzilumab. Jordan, who has over 20 years in commercial operations, previously served at DBV Technologies, where he prepared for a pediatric biologic launch. His expertise in sales, marketing, and operations is expected to enhance Humanigen's commercialization strategies, particularly for COVID-19 treatment. The company aims to leverage GM-CSF neutralization technology to address severe complications from SARS-CoV-2.