Today is the meeting of the FDA panel for the review of Benlysta, a monoclonal antibody that promises to be the first novel treatment for Lupus in over 50 years. The antibody was developed by Human Genome sciences (HGSI) in partnership with Glaxo Smith-Klein (GSK) and met its primary Phase III endpoints developed under a special protocol assessment (SPA) with the FDA.
Trading of HGSI stock has been halted pending the panel meeting's conclusion.
(Disclaimer: I am long HGSI.)
Update: Human Genome presentation complete, addressed key concerns in FDA briefing without negative comment from panel. Currently on break, FDA will present next.