Takeda Pharm - TAK STOCK NEWS

Takeda has shared long-term data from the Phase 3 ADVANCE-CIDP 3 clinical trial, evaluating HYQVIA for treating chronic inflammatory demyelinating polyneuropathy (CIDP). The study, the longest of its kind, demonstrated HYQVIA's safety, tolerability, and low relapse rate, supporting its use as maintenance therapy. Presented at the PNS Annual Meeting, HYQVIA is the first facilitated subcutaneous immunoglobulin for CIDP, approved by the FDA and European Commission. The trial involved 85 patients over 33 months, reporting consistent safety profiles with no new concerns. Adverse events were mostly mild or moderate, with serious events in three patients. Results indicated stable disease maintenance with a low annualized relapse rate of 4.5%.

Takeda has released topline results from two Phase 3 studies for its drug soticlestat (TAK-935) targeting Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). The SKYLINE study for DS narrowly missed its primary endpoint of reducing convulsive seizure frequency but showed significant effects in multiple secondary endpoints. The SKYWAY study for LGS missed its primary endpoint of reducing Major Motor Drop seizures. Despite the mixed results, soticlestat was well tolerated in both studies. Takeda plans to discuss the data with regulatory authorities and assess the financial impacts, including potential impairment losses.

Takeda has signed an option agreement with Ascentage Pharma for an exclusive global license to olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI) for treating chronic myeloid leukemia (CML) and other hematological cancers.

The agreement gives Takeda the option to license and commercialize olverembatinib outside of mainland China, Hong Kong, Macau, Taiwan, and Russia. Ascentage Pharma will continue late-stage clinical development before Takeda exercises the option.

Ascentage Pharma will receive a $100 million option payment, a potential option exercise fee, and additional milestone and royalty payments. Takeda will also make a minority equity investment in Ascentage Pharma. Olverembatinib has shown promising clinical results, addressing a significant unmet need for CML patients resistant to current TKIs.

Takeda has announced an expanded partnership with Partners In Health (PIH) to support a new initiative aimed at addressing social determinants of health and improving access to care in Massachusetts. This initiative builds on Takeda's global partnership with PIH, which began in 2017 and has provided screening and diagnostic services to over 8 million people. The expanded collaboration will focus on establishing Health Equity Communities of Practice, expanding local health departments' capacity, and increasing opportunities for community health workers. This effort aims to dismantle systemic barriers to health equity and strengthen the health workforce in diverse communities across Massachusetts.

Takeda presented positive Phase 2b trial results for TAK-861, an oral orexin receptor 2 agonist, in treating narcolepsy type 1 (NT1) at SLEEP 2024. The trial showed statistically significant and clinically meaningful improvements across primary and secondary endpoints over 8 weeks, including increased sleep latency and reduced cataplexy. TAK-861 was generally safe and well tolerated, with no serious adverse events. The Phase 3 trials are set to commence in the first half of FY 2024. The FDA has granted Breakthrough Therapy designation to TAK-861 for excessive daytime sleepiness in NT1.

Takeda and Pfizer announced positive four-year results from the Phase 3 HD21 trial. The trial evaluated ADCETRIS® (brentuximab vedotin) in combination with chemotherapy for treating newly diagnosed Stage IIb/III/IV classical Hodgkin lymphoma. Conducted by the German Hodgkin Study Group (GHSG), the study showed that the ADCETRIS combination significantly improved progression-free survival (PFS) and had a better safety profile compared to the standard eBEACOPP regimen. The results will be presented at the ASCO and EHA 2024 meetings. After 48 months, the ADCETRIS combination showed a 94.3% PFS rate versus 90.9% for eBEACOPP. Additionally, the ADCETRIS regimen was associated with fewer acute and long-lasting toxicities. Takeda and Pfizer are responsible for regulatory filings and commercialization in different regions.

Takeda has received a positive opinion from the EMA's CHMP for recombinant ADAMTS13 (rADAMTS13) for treating congenital thrombotic thrombocytopenic purpura (cTTP).

If approved, rADAMTS13 will be the first enzyme replacement therapy for cTTP in the EU. cTTP is an ultra-rare blood clotting disorder with a high mortality rate if untreated.

This recommendation is based on comprehensive evidence, including results from a Phase 3 trial, published in May 2024. The European Commission will now consider this opinion for potential marketing authorization in the EU.

Takeda (TSE: 4502/NYSE:TAK) announced its participation in the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO) from May 31-June 4, 2024, in Chicago. The company will present data on its oncology pipeline and product portfolio, covering various cancers such as colorectal, lung, lymphoma, multiple myeloma, and leukemia. Presentations will include both clinical and real-world data aimed at enhancing treatment approaches. Key highlights will feature data on Hodgkin lymphoma and colorectal cancer, emphasizing Takeda’s commitment to combining internal innovations with external partnerships. Takeda continues its mission to provide transformative medicines and improve patient care.

Takeda announced its FY2023 full year results, showing +5.9% revenue growth at AER and +1.5% at CER, with a -13.3% core operating profit change at CER due to generic impact and R&D investment. The company aims for a 100-250 basis points core operating profit margin improvement each year from FY2025. Takeda's financial performance exceeded expectations, with three new therapy approvals from the U.S. FDA in FY2023 and up to six NMEs in phase 3 development in FY2024. The company plans to implement an efficiency program in FY2024 to drive organizational agility, procurement savings, and leverage data, digital, and technology capabilities.