Humanigen Inc (HGENQ)

[cowtown jay]

It's been 133 days since we initiated the submission of a Marketing Authorization for lenzilumab in the UK.

It's been 150 days since we applied for an EUA in the US.

In April 2020, the FDA approved Emergency IND Use of Humanigen’s Lenzilumab for Compassionate Use in COVID-19 Patients.

https://ir.humanigen.com/English/news/news-details/2020/FDA-Approves-Emergency-IND-Use-of-Humanigens-Lenzilumab-for-Compassionate-Use-in-COVID-19-Patients/default.aspx

About two weeks ago, this type of patient-by-patient use became the basis for the Managed Access Program Clinigen is administering for us in Europe. I hope that "LenzMAP" will be hugely successful.

Here's a timeline of Humanigen's effort to gain regulatory approval, which I hope we can begin to see this week.

"May 28, 2021
Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19

Two weeks later:

Jun 14, 2021
Humanigen Initiates Submission for Lenzilumab Marketing Authorization in COVID-19, to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)

Jul 09, 2021
UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review

Sep 09, 2021 (104 days after EUA application submitted)
FDA has declined Humanigen’s Emergency Use Authorization (EUA) Request for Lenzilumab in Hospitalized COVID-19 Patients

Sep 28, 2021
Humanigen Announces the European Medicines Agency Has Appointed a Rapporteur and Co-rapporteur as Part of the Process Related to the Planned Submission of a Marketing Authorization Application (MAA) for Lenzilumab

Oct 01, 2021
Humanigen Submits All Planned Modules for Potential Conditional Marketing Authorization from the UK’s MHRA

Oct 08, 2021
Humanigen Signs Contract With Clinigen for Lenzilumab Managed Access Program in Europe"


https://ir.humanigen.com/English/news/default.aspx