Shares of clinical stage biopharmaceutical company Humanigen, Inc. (HGEN) are rising more than 5% Friday morning after the company announced expansion of its prevoious deal with the U.S. government to develop the company’s lead drug candidate, lenzilumab for the treatment of Covid-19.
The company today announced an expansion to the Cooperative Research and Development Agreement (CRADA) that it had previously entered into with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), to gain access to manufacturing capacity reserved by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.
The agreement supports development of lenzilumab in advance of a potential Emergency Use Authorization (EUA) for Covid-19.
The initial agreement, signed in November 2020, complements Humanigen’s development efforts for lenzilumab by providing access to a full-scale, integrated team of manufacturing and regulatory subject matter experts and statistical support in anticipation of applying for Emergency Use Authorization (EUA) and subsequently a Biologics License Application (BLA) for lenzilumab as a potential treatment for COVID-19.
Lenzilumab is currently in a Phase III study evaluating patients hospitalized with Covid-19.
“As we move closer to filing a potential EUA, the integrated support of BARDA and JPEO helps us with manufacturing capabilities as we ready operations to support access to lenzilumab,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.
HGEN, currently at $19.73, has traded in the range of $1.55- $33.95 in the last one year.
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