HUMANIGEN, INC.


Associated tags: Health, Biotechnology, COVID-19, Pharmaceutical, Clinical Trials, Pharmaceutical industry, Research, Patient

Humanigen Reports Second Quarter 2021 Financial Results

Retrieved on: 
목요일, 8월 12, 2021

Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate, lenzilumab, today provided a corporate and regulatory update and reported financial results for the second quarter and six months ended June 30, 2021.

Key Points: 
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm with its lead drug candidate, lenzilumab, today provided a corporate and regulatory update and reported financial results for the second quarter and six months ended June 30, 2021.
  • Second Quarter and Recent Highlights:
    Submitted an application to the FDA for an EUA for lenzilumab for the treatment of patients hospitalized with COVID-19.
  • Second Quarter and Six Months Ended June 30, 2021 Financial Results
    Net loss for the three months ended June 30, 2021 was $70.8 million or $1.20 per share as compared to $24.0 million or $0.79 per share for the three months ended June 30, 2020.
  • For the third quarter of 2021 the company anticipates the R&D expense related to lenzilumab production will be same level as the second quarter of 2021.

Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients

Retrieved on: 
수요일, 8월 4, 2021

In the overall population with CRP

Key Points: 
  • In the overall population with CRP
  • LIVE-AIR Phase 3 study met its primary endpoint of survival without ventilation demonstrating a 1.54-fold improvement overall and trended to a 2.68-fold improvement in Black and African-American patients.
  • This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients hospitalized with COVID-19 pneumonia.
  • The primary endpoint was the difference between lenzilumab treatment and placebo treatment in SWOV through day 28 following treatment.

Humanigen’s Partner in South Korea Receives Ministry of Food and Drug Safety (MFDS) Approval to Conduct Phase 1 Study of Lenzilumab

Retrieved on: 
목요일, 7월 22, 2021

Support for conditional approval would be based on data from this phase 1 study and the existing data from Humanigens Phase 3 LIVE-AIR study.

Key Points: 
  • Support for conditional approval would be based on data from this phase 1 study and the existing data from Humanigens Phase 3 LIVE-AIR study.
  • We are hopeful that these data, alongside data generated in Korea by our partners, will allow for the use of lenzilumab in South Korea.
  • Like many countries, South Korea is experiencing rising number of COVID-19 cases, particularly due to the spread of the Delta variant.
  • Humanigens Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.

UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review

Retrieved on: 
금요일, 7월 9, 2021

Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdoms (UKs) Medicines and Healthcare Products Regulatory Agency (MHRA) for expedited COVID-related rolling review, with assessment expected to occur more rapidly than a standard rolling review.

Key Points: 
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdoms (UKs) Medicines and Healthcare Products Regulatory Agency (MHRA) for expedited COVID-related rolling review, with assessment expected to occur more rapidly than a standard rolling review.
  • We are grateful this submission will receive expedited consideration by MHRA, said Cameron Durrant, CEO of Humanigen.
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm.
  • Humanigens Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.