Takeda Announced Topline Data From SKYLINE And SKYWAY Phase 3 Studies Of Soticlestat (TAK-935) Plus Standard Of Care Versus Placebo Plus Standard Of Care For Refractory Dravet Syndrome, Both The Studies Missed Their Primary Endpoints
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Takeda announced that its Phase 3 studies of Soticlestat (TAK-935) for Dravet Syndrome and Lennox-Gastaut Syndrome missed their primary endpoints. Despite this, the studies showed clinically meaningful effects in secondary endpoints and a favorable safety profile. Takeda plans to discuss the data with regulatory authorities.
June 17, 2024 | 10:48 am
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Takeda's Phase 3 studies of Soticlestat missed primary endpoints but showed positive secondary outcomes and a favorable safety profile. Takeda plans to discuss the data with regulatory authorities.
The failure to meet primary endpoints in Phase 3 studies is generally negative for a pharmaceutical company, as it may delay or complicate regulatory approval. However, the positive secondary outcomes and favorable safety profile provide some optimism. The overall impact is likely negative in the short term due to the missed primary endpoints.
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