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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

Benzinga ·  Jun 17 18:48
  • SKYLINE Study in Dravet Syndrome Narrowly Missed its Primary Endpoint of Reduction in Convulsive Seizure Frequency and Showed Clinically Meaningful and Nominally Significant Effects in Multiple Key Secondary Efficacy Endpoints
  • SKYWAY Study in Lennox-Gastaut Syndrome Missed its Primary Endpoint of Reduction in Major Motor Drop Seizures
  • Soticlestat Showed a Consistent and Favorable Safety and Tolerability Profile in Both Studies
  • Takeda Will Move Forward to Discuss the Totality of the Data with Regulatory Authorities
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