FDA Calendar for Human Genome Sciences (HGSI)

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Human Genome Sciences (HGS) is a commercially focused biopharmaceutical company. The Company has three products in late-stage clinical development: BENLYSTA for systemic lupus erythematosus (SLE), ZALBIN for chronic hepatitis C, and raxibacumab for inhalation anthrax. In July and November 2009, the Company reported that BENLYSTA successfully met its primary endpoints in two Phase III clinical trials in patients with systemic lupus. In March 2009, the Company reported that ZALBIN successfully met its primary endpoint in the second of two Phase III clinical trials in chronic hepatitis C. HGS submitted a biologics license application (BLA) for ZALBIN in the United States in November 2009, and Novartis submitted a marketing authorization application (MAA) under the brand name JOULFERON in Europe in December 2009. The Company received confirmation from the United States Food and Drug Administration (FDA) in February 2010, that the BLA submission was accepted for filing.


Drug Pipeline

Drug NameType Of DrugFDA StatusDrug Phase
Zalbin STD UnknownNDA
Benlysta (belimumab) Other Pending DecisionPhase 3


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HGSI

$10.16
0.02 +0.20%
2/3/2012 4:00:00 PM

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