BioCentury
ARTICLE | Finance

Regulatory milestones

January 11, 2010 8:00 AM UTC

Actelion Ltd. (SIX:ATLN) gained CHF1.70 to CHF56.90 last week after FDA posted briefing documents ahead of Tuesday's meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss an sNDA for Zavesca miglustat to treat progressive neurological manifestations in patients with Niemann-Pick type C disease, an Orphan lysosomal storage disease.

The agency noted Zavesca missed the primary endpoint of the single Phase III trial supporting the application, but that the complete body of data showed some patients given Zavesca did improve (see Online Links, A31)...