Rigel steps back from sN­DA fil­ing plans for bleed­ing dis­or­der drug; NMD gives first look in­to myas­the­nia gravis pro­gram

In June, Rigel re­port­ed a Phase III fail for its on­ly ap­proved drug, fos­ta­ma­tinib, in warm au­toim­mune he­molyt­ic ane­mia, or wAI­HA for short, an au­toim­mune dis­ease in which healthy red blood cells are de­stroyed pre­ma­ture­ly. At the time, Rigel at­trib­uted the fail­ure to place­bo arm pa­tients in east­ern Eu­ro­pean coun­tries who had high­er rates of durable re­sponse than those in the ac­tive co­hort.

But af­ter hear­ing back from the FDA af­ter it sub­mit­ted its re­analy­sis, Rigel no longer plans to sub­mit an sN­DA for wAI­HA, it an­nounced Mon­day af­ter­noon.

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