Humanigen Inc (HGENQ)

[cowtown jay]

I ask again for a moderator to pin Humanigen's Covid-19 Resource Page.

https://www.humanigen.com/covid-19-1

This link provides the documented evidence of the company's accomplishments.

On the other side of the coin are tort lawyers' claims that the company violated the Securities Exchange Act of 1934. Here is a representative sample of what they state in their Class Action Alert.

https://flashalert.me/?symbol=HGEN&source=PR&referer=https://twitter.com/&url=https://www.globenewswire.com/news-release/2022/09/20/2519552/32719/en/Humanigen-Inc-Class-Action-Alert-Shareholders-with-Losses-in-Humanigen-Inc-HGEN-Are-Urged-to-Contact-Robbins-LLP-for-Information-About-Their-Rights.html&s3=HGEN/2022-09-20/12-10-18_000000/glob/b5d47280b778d04d823bc68147611edf/Humanigen-Inc-Class-Action-Alert-Shareholders-with-Losses-in-Humanigen-Inc-HGEN-Are-Urged-to-Contact-Robbins-LLP-for-Information-About-Their-Rights.html

"In May 2021, Humanigen submitted an application to the U.S. Food and Drug Administration requesting Emergency Use Authorization ("EUA") for lenzilumab for the treatment of patients hospitalized with COVID-19."

Keep in mind the EUA Application, "...follows positive results from the LIVE-AIR Phase 3 clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.

https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Submits-Application-to-FDA-for-Emergency-Use-Authorization-for-Lenzilumab-in-COVID-19-2021.pdf

The company's Covid-19 resource page lists various studies on the value in targeting GM-CSF and and CRP levels, in addition to peer reviews.

The Class Action Alert continues with, "On September 9, 2021, Humanigen announced that the FDA had rejected the lenzilumab EUA, advising that "in its letter, [the] FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19."

The EUA application was declined, not rejected, as claimed in the Class Action Alert. "FDA has declined Humanigen’s Emergency Use Authorization (EUA) Request for Lenzilumab in Hospitalized COVID-19 Patients
9/8/2021

FDA has committed to working with Humanigen in the development of lenzilumab and has invited Humanigen to submit additional data as it becomes available. NIH’s ACTIV-5/BET-B study is expected to provide further data that may support a new EUA request " The FDA did not reject the EUA. They only indicated that they wanted to see more data.

https://s28.q4cdn.com/539885110/files/doc_news/FDA-has-declined-Humanigens-Emergency-Use-Authorization-EUA-Request-for-Lenzilumab-in-Hospitalized-COVID-19-Patients-2021.pdf

The Class Action Alert continues. "Then, on July 13, 2022, Humanigen disclosed that lenzilumab had failed to show statistical significance on the primary endpoint of the ACTIV-5/BET-B study."

There's no need to rehash the points I made about ACTIV-5 using a more severe primary endpoint, tested against late stage covid patients, instead of the newly hospitalized covid patients tested in LIVE-AIR. I pointed these issues out previously.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169869278

But I would like to add that NIAID's ACTT trial on remdesivir not only tested patients on room air, their patients needed to have laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction collected < 72 hours prior to randomization. So these were newly infected patients.

inclusion criteria 5:

https://clinicaltrials.gov/ct2/show/NCT04280705

How likely was it, in the ACTIV-5 trial, to have patients progress to ordinal scales 6 or 7 within 72 hours of testing positive for covid? Maybe that is possible, but what is the norm?

In any event, the NIH/NIAID ACTIV-5 trial is no reflection of the LIVE-AIR trial. Our results are not diminished from what we reported, and what the peer-reviews confirmed. The Class Action is without merit, and Humanigen has every reason to expect that a review of ACTIV-5's patients in ordinal scale 5 should provide at least some additional confirmatory data to LIVE-AIR.