Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"HGEN just was told No-Go on their EUA."
HGEN said this in its release:
"the U.S. FDA has declined its request for emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients. In its letter, 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."
"We believe the ongoing ACTIV-5/BET-B trial*, which has been advanced to enroll up to 500 patients, may provide additional safety and efficacy data sufficient to support our efforts to obtain an EUA to treat hospitalized COVID-19 patients."


Their trial (520 participants, completed in March) is worth a look for general comparison of inclusions, exclusions, outcome measures.
https://clinicaltrials.gov/ct2/show/record/NCT04351152?term=humanigen&draw=2&rank=1


*https://clinicaltrials.gov/ct2/show/NCT04583969?term=ACTIV-5%2FBET-B&draw=2&rank=1