Amy­lyx picks up ALS drug ap­proval in Cana­da af­ter FDA asks for more time to re­view the da­ta

Though the FDA ear­li­er this month told Amy­lyx Phar­ma­ceu­ti­cals the agency would need a lit­tle bit longer to re­view its ALS drug’s ap­pli­ca­tion, one coun­try is forg­ing ahead with a green light.

Cana­da ap­proved Amy­lyx’s ALS drug AMX0035 ear­ly Mon­day morn­ing, giv­ing the biotech its first green light and ALS pa­tients in the coun­try on­ly the third ther­a­py avail­able to treat the dis­ease. The de­ci­sion al­so marks a win for Amy­lyx, a one-drug biotech that went all-in on ALS — one of the most chal­leng­ing dis­eases for drug R&D — and whose for­tunes ap­peared murky af­ter the FDA raised con­cerns over its da­ta at an ad­vi­so­ry com­mit­tee meet­ing in March.

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