Af­ter dis­ap­point­ing Wall Street last year, De­nali touts new bio­mark­er da­ta hop­ing to forge clear path to FDA

Look­ing to build out a case for its drugs that can bet­ter pen­e­trate the blood-brain bar­ri­er, De­nali Ther­a­peu­tics tout­ed new in­ter­im Hunter syn­drome da­ta Wednes­day morn­ing. And ex­ecs are sharp­en­ing their reg­u­la­to­ry pitch.

The South San Fran­cis­co biotech re­port­ed longer-term re­sults from a Phase I/II study eval­u­at­ing DNL310, say­ing the safe­ty pro­file re­mained sim­i­lar to the cur­rent stan­dard of care — en­zyme re­place­ment ther­a­py — af­ter 85 weeks. Ad­di­tion­al­ly, a larg­er group of pa­tients gives the com­pa­ny more con­fi­dence that ear­ly bio­mark­er re­sults from Ju­ly 2021 in­di­cate the drug is pos­i­tive­ly af­fect­ing Hunter syn­drome pa­tients.

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