The Phase 3 results, "along with data regarding additional endpoints and further analysis from the study, support the submission of applications for emergency use authorization to the U.S. FDA & conditional marketing authorization in the UK & the EU"
$HGEN
ir.humanigen.com/news/news-deta…
$HGEN
ir.humanigen.com/news/news-deta…
$HGEN plans to:
-Submit an EUA application to the FDA during May 2021
-Initiate a rolling CMA submission to UK before the end of Q2 2021
-Submit for CMA to the EMA for EU
-Review the possibility of similar submissions for approval or compassionate use in other countries worldwide
-Submit an EUA application to the FDA during May 2021
-Initiate a rolling CMA submission to UK before the end of Q2 2021
-Submit for CMA to the EMA for EU
-Review the possibility of similar submissions for approval or compassionate use in other countries worldwide
$HGEN is scheduled to conduct a Phase 2 Trial studying the efficacy of lenzilumab in combination with azacitadine. The study, (“PREcision Approach to Chronic Myelomonocytic Leukemia”) is anticipated to begin enrollment in Q3 2021 & to include 4 sites
#CMML
sec.gov/Archives/edgar…
#CMML
sec.gov/Archives/edgar…
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