Denali touts more biomarker data with accelerated approval in mind

He­paran sul­fate, a po­ten­tial new sur­ro­gate bio­mark­er for neu­rode­gen­er­a­tive dis­eases, is get­ting a lot of love from biotechs this week.

De­nali Ther­a­peu­tics on Wednes­day pre­sent­ed new da­ta for its lead pro­gram, aim­ing to prove how re­duc­tions in he­paran sul­fate, a car­bo­hy­drate whose ex­cess and tox­ic buildup is caused by ge­net­ic mu­ta­tions, can re­li­ably pre­dict a clin­i­cal ben­e­fit for pa­tients. The com­pa­ny’s up­date came one day af­ter Ul­tragenyx re­vealed da­ta for an ex­per­i­men­tal drug in a dif­fer­ent dis­ease for which he­paran sul­fate may al­so be a po­ten­tial sur­ro­gate bio­mark­er.

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