Amy­lyx shares rout­ed on skep­ti­cal ad­comm docs — but did the FDA leave an open door on un­met ALS need?

The FDA re­leased its brief­ing doc­u­ments for Wednes­day’s ad­vi­so­ry com­mit­tee to dis­cuss Amy­lyx Phar­ma­ceu­ti­cals’ ALS drug, and the ini­tial im­pres­sion ap­pears to bode poor­ly for the biotech — at least on the da­ta.

Agency sta­tis­ti­cians called in­to ques­tion the com­pa­ny’s ef­fi­ca­cy and sur­vival analy­ses, rais­ing the specter of a po­ten­tial vote against the drug, known as AMX0035. In the brief­ing doc­u­ments, re­leased Mon­day morn­ing, the FDA said da­ta out­lin­ing the drug’s ef­fec­tive­ness were “not per­sua­sive.”

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