Neu­ro­crine flesh­es out its PhI­II case for val­be­nazine; Avro­bio adds to gene ther­a­py pipeline

Neu­ro­crine has al­ready post­ed the key late-stage da­ta that it took to the FDA in build­ing a case for In­grez­za (val­be­nazine) as a new ther­a­py for tar­dive dysk­i­ne­sia. But now it’s pub­lished the full set of da­ta in its fa­vor, in­clud­ing a note that its drug scored for 40% of the pa­tients in the drug arm who reg­is­tered at least a 50% im­prove­ment in AIMS dysk­i­ne­sia score, com­pared to 8.7% of those on place­bo. Neu­ro­crine is fac­ing a head-to-head fight with a new drug from Te­va, and a num­ber of an­a­lysts think the small­er biotech has a clear shot at dom­i­nat­ing the sec­tor. The PDU­FA date for the break­through ther­a­py is April 11.

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