Harmony Biosciences’ Wakix fails PhIII hypersomnia study; Florida gene therapy startup downsizes

Plus Phase II da­ta on ABION’s MET ty­ro­sine ki­nase in­hibitor, and 60 De­grees Phar­ma­ceu­ti­cals giv­ing up on re­pur­pos­ing its an­ti­malar­i­al drug for Covid-19.

Har­mo­ny Bio­sciences’ drug failed the pri­ma­ry goal in a Phase III study and in­vestors re­act­ed by shed­ding the biotech’s share price $HRMY by about 30% Fri­day morn­ing. The Penn­syl­va­nia drug­mak­er said its treat­ment can­di­date pitolisant did not achieve sta­tis­ti­cal sig­nif­i­cance on ex­ces­sive day­time sleepi­ness in the ran­dom­ized with­draw­al phase of the IN­TUNE study, which in­cludes pa­tients with the rare and chron­ic dis­ease id­io­path­ic hy­per­som­nia. The FDA ap­proved the tablets, sold as Wak­ix, in 2019 to treat ex­ces­sive day­time sleepi­ness in adults with nar­colep­sy. — Kyle LaHu­cik

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