Humanigen, Inc. - HGEN STOCK NEWS

Humanigen, Inc. (NASDAQ: HGEN), a biopharmaceutical firm, announced that its CEO, Cameron Durrant, will present at two healthcare conferences in January 2022. These virtual events will feature updates on regulatory interactions in the US, UK, and EU, as well as the ACTIV-5/BET-B clinical trial for lenzilumab in COVID-19 patients. Durrant will discuss the Emergency Use Authorization amendment strategies and the company’s clinical pipeline, including CAR-T therapy and other inflammatory conditions. Key details include participation in the H.C. Wainwright and JP Morgan Healthcare conferences.

Humanigen (NASDAQ:HGEN) announced promising results from the LIVE-AIR Phase 3 study, indicating that elevated baseline C-Reactive Protein (CRP) levels can predict progression to invasive mechanical ventilation (IMV) or death in COVID-19 patients. Patients with CRP<150 mg/L who received lenzilumab had over 2.5 times higher survival rates without IMV compared to placebo. This analysis underscores a biomarker-driven approach for improved outcomes in COVID-19 treatments. Future studies, including ACTIV-5/BET-B, will explore these findings further.

Humanigen, Inc. (NASDAQ: HGEN) announced that CEO Cameron Durrant will present at the 40th annual J.P. Morgan Healthcare Conference in San Francisco on January 13, 2022. The presentation aims to update on ACTIV-5/BET-B enrollment and regulatory discussions. Durrant emphasized the significance of lenzilumab, a therapy targeting cytokine storm in COVID-19 patients, despite ongoing concerns over variants. The investigational therapy is currently under review by health authorities, with potential implications for its future market authorization.

Humanigen, Inc. (Nasdaq: HGEN) announced a conference call and webcast on December 2, 2021, at 8am EST to discuss publications in The Lancet Respiratory Medicine and provide a corporate update. The peer-reviewed paper highlights Humanigen's focus on preventing cytokine storms, with its leading candidate lenzilumab showing promise in treating COVID-19. The company seeks Conditional Marketing Authorization for lenzilumab in the UK. Access details for the conference call and further information on Humanigen's product strategies are provided.

Humanigen announced positive results from the LIVE-AIR Phase 3 trial of lenzilumab, a therapy targeting immune responses in hospitalized COVID-19 patients. The study indicated a statistically significant 54% relative improvement in survival without invasive mechanical ventilation (SWOV). Published in The Lancet Respiratory Medicine, these findings indicate lenzilumab's potential to improve outcomes for patients, with a safety profile akin to placebo. However, lenzilumab is currently not authorized or approved in any country.

Humanigen, Inc. (HGEN) announced the presentation of three abstracts at the British Thoracic Society Winter Meeting, highlighting significant findings from the Phase 3 LIVE-AIR study of lenzilumab in hospitalized COVID-19 patients. Abstract #S48 reports a 54% improved likelihood of survival without invasive ventilation in lenzilumab-treated patients. Abstract #S49 shows a 3-fold improvement in patients under 85 years with baseline CRP<150 mg/L. Abstract #S51 indicates that lenzilumab requires fewer treatments to prevent a death compared to other therapies.

Humanigen, Inc. (Nasdaq: HGEN) announced that its presentation at the Jefferies London Healthcare Conference is rescheduled to 9:20am EST on November 17, 2021. Timothy Morris, COO and CFO, will present, and a livestream will be accessible via the provided link. The company is focused on treating 'cytokine storm' with its lead candidate, lenzilumab, currently under review for potential Conditional Marketing Authorization in the UK. Humanigen aims to explore lenzilumab's efficacy for various inflammatory conditions.

Humanigen, Inc. (HGEN) reported financial results for Q3 and nine months ending September 30, 2021, with a net loss of $66.7 million or $1.12 per share for Q3, compared to $30.8 million or $0.71 per share in 2020. The company continues efforts for lenzilumab's Conditional Marketing Authorization in the UK, having submitted final modules to the MHRA. Lenzilumab was selected by the European Commission as a promising COVID-19 treatment. R&D expenses surged to $60.8 million in Q3 due to increased manufacturing efforts. Cash and equivalents stand at $76.5 million.

Humanigen (HGEN) will support a Phase 2/3 clinical trial, dubbed RATinG, aimed at evaluating lenzilumab for treating acute graft versus host disease (aGvHD) following hematopoietic stem cell transplantation (HSCT) in the UK. The study will initiate enrollment in the first half of 2022 across up to 22 sites. Lenzilumab neutralizes GM-CSF, a key player in aGvHD, impacting 30-50% of HSCT patients. The trial's initial phase will assess safety and efficacy before progressing to a double-blind randomized study involving 220 patients. Results may enhance treatment options for high-risk aGvHD patients.