Analysts were unfazed by the news that Takeda will cease development of soticlestat after Phase III failures, while responding positively to the announcement that Julie Kim will take the helm of the Japanese giant in 2026.
In a news rush Thursday, Takeda announced it is stopping development and no longer seeking FDA approval for its epilepsy drug soticlestat, while naming a new chief executive alongside its third-quarter earnings report.
In an SEC filing, the company stated that Phase III studies of soticlestat in Dravet syndrome and Lennox-Gastaut syndrome (LGS)—two forms of epilepsy—both missed their primary endpoints of baseline reduction of seizure frequency compared to placebo.
Takeda had previously discontinued the LGS program. Regarding Dravet syndrome, “The FDA informed Takeda that the current clinical data package would not be capable of demonstrating substantial evidence of effectiveness,” according to the filing. Takeda took a ¥21.5 billion ($139.3 million) investment hit for the drug in the quarter that ended June 30th, 2024.
Takeda’s decision to end the program also means that its development partner Ovid will lose out on a potential $26 million milestone payment.
In an investor note focused on Ovid, William Blair analyst Sarah Scramm wrote that the news is “not a surprise given results of the pivotal SKYLINE study, and we believe investors had ascribed little value for the program given a largely muted reaction to the news.”
On a macro scale, Takeda announced that Julie Kim will take over as the company’s CEO and representative director in June 2026, assuming the reigns from current CEO and president Christophe Weber, who will retire.
Jefferies analysts welcomed the news. “Investors and analysts following Takeda are well aware of [Kim’s] track record of success as the head of Takeda’s plasma business, and since April 2022, as President of Takeda’s US business unit,” they wrote in a Thursday investor note.
These announcements came as Takeda reported its Q3, 2024 earnings, which buoyed interest from analysts.
Overall sales for the quarter beat consensus by 5.1%. Jefferies noted that sales of off-patent ADHD treatment Vyvanse were stronger than expected, offsetting weak sales of irritable bowel treatment Entyvio.
“Entyvio sales were hurt by one-off factors, but the company maintains that underlying trends are strong, ” the analysts wrote.
Looking forward, Takeda raised its full-year 2025 revenue guidance by 2.5% to ¥110 billion (approximately $712.3 million).
