Bio­haven’s tro­r­ilu­zole re­ject­ed be­fore FDA re­view

Bio­haven said Thurs­day it re­ceived a re­fusal-to-file let­ter from the FDA over its NDA for tro­r­ilu­zole in an an­nounce­ment that sent its share price down more than 26% in mar­ket trad­ing.

The reg­u­la­tor re­port­ed­ly told the com­pa­ny it would not re­view the drug be­cause the pri­ma­ry end­point in the study it sub­mit­ted was not met. Bio­haven said in May 2022 that tro­r­ilu­zole missed the pri­ma­ry end­point in a Phase III last year that en­rolled 213 pa­tients with dif­fer­ent types of spin­ocere­bel­lar atax­ia (SCA).

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