Japan's Takeda Pharmaceutical Company announced that its experimental drug, Soticlestat (TAK-935), did not meet the primary endpoint in Phase 3 trials for treating Dravet Syndrome and Lennox-Gastaut Syndrome. The SKYLINE study in Dravet Syndrome narrowly missed its primary endpoint of reducing convulsive seizure frequency with a p-value of 0.06. Despite multiple key secondary efficacy endpoints showing significant results with p-values ≤ 0.008, the drug failed to achieve its main goal. Ovid Therapeutics, a partner in the development of Soticlestat, saw a significant pre-market stock drop of 42% and a 66% drop overall following the announcement. Takeda plans to discuss the totality of the data with regulators to determine the path forward.
Takeda drug for rare types of epilepsy misses goal in late-stage trial https://t.co/PnU4lkYQCh $TAK @ByJonGardner
Takeda Drug Fails Pivotal Tests in 2 Rare Epilepsies; Path Forward Depends on Regulatory Flexibility https://t.co/aj9I4UycIu
Japanese drugmaker Takeda said on Monday its experimental drug being tested for two epileptic disorders failed to reduce frequency of seizures in patients across late-stage studies. https://t.co/H3C69PX51F https://t.co/H3C69PX51F
$STOK chances are that Takeda now wants to do the type of $300M upfront for 50:50 US rights deal they've done with $ARWR and $PTGX. #Dravets
$OVID Will #soticlestat be approved for #Dravets based on p2 ELEKTRA and p3 p=0.06 and safety without additional studies?
Takeda's seizure drug fails to meet main goal in late-stage studies https://t.co/ROu6Zr79xv https://t.co/WDtzkTWPin
$OVID -66% on partner Takeda soticlestat fail...brutal: Phase II in Dravet highly stat sig Phase III (today) narrowly missed with p=0.06 'multiple key secondary efficacy endpoints all with p-values ≤ 0.008'. --> Takeda will discuss 'totality of data' with regulators. MC now…
Japan's Takeda said on Monday its experimental drug to treat epileptic disorders failed to meet the main goal in two late-stage studies. https://t.co/qqakaEUCtz https://t.co/qqakaEUCtz
$STOK important to remember that the selling point of Stoke's approach is not just reducing seizure frequency, but also improving behavior and neurodev in general. Takeda's was (another) seizure-targeted treatment: https://t.co/JODD1NhVZD
$OVID -42% 📉 pre-market Ovid Therapeutics Reports on Takeda's Announcement of Phase 3 Topline Study Results for Soticlestat - OVID • BioPharmCatalyst @MattBiotech https://t.co/8mqnioLOXu
Ovid Therapeutics Reports on Takeda’s Announcement of Phase 3 Topline Study Results for Soticlestat $OVID https://t.co/YogXNUMqAc
Takeda Announces Phase 3 Topline Results for Soticlestat (TAK-935) in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome $TAK https://t.co/cY9PMYSUQ4
Takeda Announces Phase 3 Topline Results for Soticlestat (TAK-935) in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome https://t.co/ddbdDFuqXP https://t.co/xKtYTVgXAx
Takeda Announces Phase 3 Topline Results for Soticlestat (TAK-935) in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome. $TAK SKYLINE Study in Dravet Syndrome Narrowly Missed its Primary Endpoint of Reduction in Convulsive Seizure Frequency
Takeda Signs Option Agreement with Ascentage Pharma to Enter into Exclusive Global License for Olverembatinib, a Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI) https://t.co/3MhRP8qASR https://t.co/Ih3QvsPnfu
Japan's Takeda nears breakthrough in treating narcolepsy https://t.co/DQUcwtXS4b