Retrieved on:
Tuesday, October 27, 2020
Oncology,
Health,
Infectious diseases,
Clinical trials,
Pharmaceutical,
Biotechnology,
Branches of biology,
Cytokines,
Cell biology,
Growth factors,
Glycoproteins,
Macrophage colony-stimulating factor,
Proteoglycans,
Granulocyte-macrophage colony-stimulating factor,
Infection Key Points:
- A live webcast of the presentation may be accessed on the Events section of the Humanigen website https://www.humanigen.com/events .
- Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms.
- We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
- You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.
Retrieved on:
Tuesday, October 13, 2020
Research,
Infectious diseases,
Clinical trials,
Biotechnology,
Other Health,
Health,
Pharmaceutical,
Other Science,
Science,
Branches of biology,
Cytokines,
Medical specialties,
Cell biology,
Granulocyte-macrophage colony-stimulating factor,
Lenzilumab,
Coronavirus disease,
Vaccine,
NIHS,
National Institutes of Health,
Activ,
Macrophage colony-stimulating factor,
ACTIV,
ACTIV-5/BET,
Humanigen, Inc. Humanigen is providing lenzilumab for the study, which is fully funded by NIH.
Key Points:
- Humanigen is providing lenzilumab for the study, which is fully funded by NIH.
- ACTIV-5/BET is being conducted in collaboration with the NIHs public-private partnership Accelerating COVID-19 Therapeutic Innovations and Vaccines ( ACTIV ) program.
- We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
- You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.
FDA,
Health,
Infectious diseases,
Clinical trials,
Pharmaceutical,
Biotechnology,
Health,
Food and Drug Administration,
Clinical research,
Clinical trial,
Design of experiments,
Pharmaceutical industry,
Eua,
Articles The Company also announced several updates on its Phase 3 registration study with lenzilumab which is continuing to enroll in the U.S. and Brazil, and now has been approved to expand to Mexico.
Key Points:
- The Company also announced several updates on its Phase 3 registration study with lenzilumab which is continuing to enroll in the U.S. and Brazil, and now has been approved to expand to Mexico.
- View the full release here: https://www.businesswire.com/news/home/20201002005106/en/
FDA was very helpful and provided clear guidance on our EUA submission plan, said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.
- We are encouraged by our Type B meeting and remain confident in our program and preparedness plans in advance of a potential EUA.
- Program clinical trial investigators in Brazil stressed the importance of this program and urgency for enrollment during a recent investigator meeting.
Health,
Infectious diseases,
Hospitals,
Clinical trials,
Pharmaceutical,
Biotechnology,
Respiratory diseases,
Medical specialties,
Pulmonology,
Respiratory physiology,
Zoonoses,
Coronavirus disease,
Occupational safety and health,
Acute exacerbation of chronic obstructive pulmonary disease,
Chronic obstructive pulmonary disease,
Severe acute respiratory syndrome,
Acute respiratory distress syndrome,
Bronchodilator The case report, titled COVID-19 associated chronic ARDS successfully treated with lenzilumab is available at: https://osf.io/xusr9/ .
Key Points:
- The case report, titled COVID-19 associated chronic ARDS successfully treated with lenzilumab is available at: https://osf.io/xusr9/ .
- The patient tested positive for SARS-CoV-2 and was admitted to the ICU in March 2020 for COVID-19 and put on respiratory isolation.
- The patient was treated with steroids, broad spectrum antibiotics for community acquired pneumonia and bronchodilators for possible COPD exacerbation and hydroxychloroquine with zinc.
- You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.
Retrieved on:
Wednesday, September 23, 2020
Biotechnology,
Pharmaceutical,
Other Manufacturing,
Health,
Infectious diseases,
Chemicals,
Plastics,
Manufacturing,
Clinical trials,
Life sciences,
Articles,
Biotechnology,
Thermo Fisher Scientific,
Lenzilumab,
Biopharmaceutical,
Thermo Thermo Fisher will begin the technical transfer of the lenzilumab bulk drug substance process and commercial scale production could begin before the end of this year.
Key Points:
- Thermo Fisher will begin the technical transfer of the lenzilumab bulk drug substance process and commercial scale production could begin before the end of this year.
- Thermo Fisher provides biologics manufacturing expertise and scalable capacity to further support our production and growth trajectory."
- Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms.
- You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.
Retrieved on:
Tuesday, September 22, 2020
Biotechnology,
Infectious diseases,
Health,
Pharmaceutical,
Oncology,
Branches of biology,
Cytokines,
Cell biology,
Proteins,
Growth factors,
Granulocyte-macrophage colony-stimulating factor,
Medtech,
Macrophage colony-stimulating factor,
NASDAQ,
Zimmer Biomet Robotics Humanigen, Inc. , (Nasdaq: HGEN) (Humanigen), announced today that management will present a company overview and business update at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit at 10:50 a.m. EDT, Wednesday, September 23, 2020.
Key Points:
- Humanigen, Inc. , (Nasdaq: HGEN) (Humanigen), announced today that management will present a company overview and business update at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit at 10:50 a.m. EDT, Wednesday, September 23, 2020.
- Archived replay will be available on the Company website for 30 days following the event.
- We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
- You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release.
Retrieved on:
Monday, September 14, 2020
The DSMB assessed the Phase 3 trial data for safety, futility, sample size and power assumptions.
Key Points:
- The DSMB assessed the Phase 3 trial data for safety, futility, sample size and power assumptions.
- After completing their analysis, the DSMB unanimously recommended that the trial continue according to the existing trial protocol without modification.
- We consider the decision to continue according to the existing protocol as a signal that the trial is progressing to plan."
- Humanigen expects to complete the targeted enrollment of 300 patients this month with topline data available in the fourth quarter.
Retrieved on:
Friday, September 4, 2020
FDA,
Health,
Infectious diseases,
Clinical trials,
Pharmaceutical,
Biotechnology,
Financial markets,
Finance,
Stock market,
Financial economics,
Corporate finance,
Equity securities,
Reverse stock split,
Stock split,
Common stock,
Stock,
Par value,
Share When the reverse stock split becomes effective, every 5 shares of the companys issued and outstanding common stock will be automatically combined into one issued and outstanding share of common stock without any change in the par value per share or the total number of authorized shares.
Key Points:
- When the reverse stock split becomes effective, every 5 shares of the companys issued and outstanding common stock will be automatically combined into one issued and outstanding share of common stock without any change in the par value per share or the total number of authorized shares.
- No fractional shares will be issued in connection with the reverse stock split.
- Stockholders of record otherwise entitled to receive a fractional share as a result of the reverse stock split will receive a cash payment in lieu of such fractional shares.
- Following the approval of the reverse stock split, the Humanigen Board of Directors no longer expects to pursue the proposed amendment to the companys charter to increase the number of authorized shares of common stock, which will remain at 225,000,000.
Retrieved on:
Wednesday, September 2, 2020
Biotechnology,
Infectious diseases,
Health,
Pharmaceutical,
Oncology,
Branches of biology,
Health sciences,
Health,
Drug discovery,
Infectious diseases,
Therapy,
Cancer,
Macrophage colony-stimulating factor ET on Wednesday, September 16, 2020
Key Points:
- ET on Wednesday, September 16, 2020
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit at 10:50 a.m. on Wednesday, September 23, 2020
The conferences are being held in a virtual format.
- Webcast information for these events will be available on the Humanigens investor page at https://www.humanigen.com/investor-materials .
- Archived replays will be available on the Company website for 30 days following each event.
- Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms.
Retrieved on:
Tuesday, September 1, 2020
Humanigen will host the conference call and webcast Thursday, September 3, 2020 at 11:00 a.m. EDT.
Key Points:
- Humanigen will host the conference call and webcast Thursday, September 3, 2020 at 11:00 a.m. EDT.
- To participate on the conference call, please dial toll free (833) 714-0938 or toll number (778) 560-2680.
- The conference ID number is 1158096.
- In addition, a replay of the webcast will be available on the company website for 30 days following the event.
