FDA re­buffs lit­tle As­ser­tio Ther­a­peu­tic­s' long-act­ing ACTH for­mu­la­tion, shares sink

Tiny As­ser­tio Ther­a­peu­tics’ shares plunged pre-mar­ket on Tues­day, af­ter the FDA has spurned its man-made ver­sion of the hor­mone ACTH, which was be­ing re­viewed as a di­ag­nos­tic for pa­tients pre­sumed to have adreno­cor­ti­cal in­suf­fi­cien­cy.

The Lake For­est, Illi­nois-based drug­mak­er said its de­vel­op­ment part­ner West Ther­a­peu­tic De­vel­op­ment had re­ceived a com­plete re­sponse let­ter from the US reg­u­la­tor, which in­di­cat­ed that that cer­tain “phar­ma­co­dy­nam­ic pa­ra­me­ters were not ad­e­quate­ly achieved” for the prod­uct.

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