EU com­mit­tee like­ly to rec­om­mend against ap­prov­ing Amy­lyx ALS drug, com­pa­ny says

Amy­lyx Phar­ma­ceu­ti­cals’ ALS drug is seem­ing­ly head­ed for a rock­i­er path in the EU than it faced in the US and Cana­da.

The biotech an­nounced Tues­day morn­ing that the bloc’s drug re­view com­mit­tee, known as CHMP, is ex­pect­ed to is­sue a “neg­a­tive opin­ion” and rec­om­mend against ap­prov­ing the drug next month. If that neg­a­tive opin­ion comes to pass, Amy­lyx ex­pects to ap­peal in a “for­mal re-ex­am­i­na­tion,” per a com­pa­ny press re­lease.

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