In­smed shares soar as PhI­II lung dis­ease study proves pos­i­tive, point­ing to quick FDA pitch

Shares of In­smed $IN­SM rock­et­ed up 133% in pre­mar­ket trad­ing on Tues­day af­ter the biotech re­port­ed that its Phase III study had hit the pri­ma­ry end­point it be­lieves will per­suade the FDA to hand over a break­through ap­proval. The da­ta on ef­fec­tive­ness in im­prov­ing pa­tients’ abil­i­ty to walk, though, is lack­ing and could cloud the up­com­ing shot at an OK.

Re­searchers in the study say that the in­haled drug Arikayce — now re­ferred to as ALIS — added to stan­dard of care elim­i­nat­ed ev­i­dence of a lung in­fec­tion known as Non­tu­ber­cu­lous My­cobac­te­r­i­al (NTM) dis­ease in 29% of pa­tients, com­pared to on­ly 9% in the stan­dard of care group.

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