HUMANIGEN, INC.
Associated tags: Health, Biotechnology, COVID-19, Pharmaceutical, Clinical Trials, Pharmaceutical industry, Research, Patient
미 FDA, 휴머니젠의 코로나19 환자용 치료제 렌질루맙 긴급사용승인(EUA) 거부
휴머니젠 2021년 2분기 재무 결과 보고
Humanigen Reports Second Quarter 2021 Financial Results
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.
- 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.
렌질루맙 치료제, 인공 호흡기 없는 상황에서 아프리카계 미국인 코로나19 입원 환자들의 생존률을 높일 것으로 예상
미국 국립보건원, 코로나-19 치료용 렌질루맙의 ACTIV-5/BET-B 임상 평가 임상 2상에서 임상 2/3상 진척
Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients
In the overall population with CRP
- 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
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.
- 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.
영국 의약품규제청, 코로나 사태 속 신속한 정기 검토를 위한 휴머니젠의 렌질루맙 마케팅 승인 신청을 승인
UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review
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.
- 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.