Takeda Pharmaceutical Files 6-K Report

TL;DR

Takeda filed its monthly 6-K, confirming its Tokyo HQ and 20-F reporting status.

AI Summary

Takeda Pharmaceutical Company Limited filed a Form 6-K on June 17, 2024, reporting as a foreign private issuer. The filing indicates Takeda's principal executive offices are located in Tokyo, Japan. This report is for the month of June 2024 and Takeda is submitting its annual reports under Form 20-F.

Why It Matters

This filing is a routine report for foreign private issuers, providing an update on Takeda's regulatory status and location of its principal executive offices.

Risk Assessment

Risk Level: low — This is a standard, routine filing for a foreign private issuer and does not contain new financial or operational information.

Key Players & Entities

• TAKEDA PHARMACEUTICAL COMPANY LIMITED (company) — Filer
• 0001395064-24-000071 (filing_id) — Accession Number
• 001-38757 (company_id) — SEC File Number
• 20240617 (date) — Filing Date
• Tokyo, Japan (location) — Principal Executive Offices

FAQ

Filing Documents

• form6k_061724.htm (6-K) — 52KB
• 0001395064-24-000071.txt ( ) — 53KB

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. TAKEDA PHARMACEUTICAL COMPANY LIMITED Date June 17, 2024 By s Norimasa Takeda Norimasa Takeda Chief Accounting Officer and Corporate Controller News Release Takeda Announces Phase 3 Topline Results for Soticlestat (TAK-935) in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome 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 OSAKA, Japan and CAMBRIDGE, Massachusetts, June 17, 2024 – Takeda (TSE4502NYSETAK) today announced topline data from its SKYLINE and SKYWAY studies. SKYLINE (TAK-935-3001) was a multicenter, randomized, double-blind Phase 3 study that evaluated soticlestat (TAK-935) plus standard of care versus placebo plus standard of care in patients with refractory Dravet syndrome (DS). 1 Soticlestat narrowly missed the primary endpoint of reduction from baseline in convulsive seizure frequency as compared to placebo (p-value 0.06). Among the six key secondary endpoints, soticlestat showed clinically meaningful and nominally significant results in the responder rate, measures of caregiver and clinician global impression of improvement, and seizure intensity and duration scales over the 16-week treatment period (all p-values 0.008). SKYWAY (TAK-935-3002) was a multicenter, randomized, double-blind Phase 3 study that evaluated soticlestat plus standard of care versus placebo plus

Forward-Looking Statements

Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could", "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States competitive pressures and developments changes to applicable laws and regulations, including global health care reforms challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof uncertainty of commercial success for new and existing products manufacturing difficulties or delays fluctuations in interest and currency exchange rates claims or concerns regarding the safety or efficacy of marketed products or product candidates the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business the timing and impact of post-merger integration efforts with acquired companies the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s) and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda

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View this 6-K filing on SEC EDGAR