Takeda Pharm - TAK STOCK NEWS

Takeda Pharmaceutical Company Limited announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of vedolizumab for the treatment of adults with moderately to severely active chronic pouchitis. If approved, vedolizumab would be the first authorized treatment for this condition in Europe, which affects patients post-surgery for ulcerative colitis. The positive opinion was based on findings from the EARNEST trial, showing significant clinical remission rates.

Takeda Pharmaceutical Company presented nine abstracts at the 63rd American Society of Hematology (ASH) Annual Meeting held from December 11-14, 2021. The presentations highlight their commitment to innovative treatments in hematology, including data on ADYNOVATE for severe hemophilia A and an analysis of joint health biomarkers. Notably, the design of a phase 3b study of TAK-755, a first-of-its-kind replacement therapy, was shared. This emphasizes Takeda's ongoing advancements in therapies for rare blood disorders.

Takeda Pharmaceutical Company released results from the pivotal Phase 3 SOLSTICE trial, showing that LIVTENCITY (maribavir) significantly outperformed conventional therapies in treating post-transplant CMV infections. The primary endpoint was met with 55.7% of patients on LIVTENCITY achieving CMV DNA levels below 137 IU/mL compared to 23.9% for conventional therapies. Additionally, the key secondary endpoint of symptom control was also significantly better for LIVTENCITY. Adverse events were similar between groups, but fewer LIVTENCITY patients discontinued due to adverse events.

Takeda Pharmaceutical Company (TSE:4502/NYSE:TAK) announced it will present 23 company-sponsored abstracts at the 63rd American Society of Hematology (ASH) Annual Meeting from December 11-14, 2021 in Atlanta, Georgia. The presentations focus on advancing treatments in oncology and hematology, featuring pipeline candidates like Modakafusp Alfa (TAK-573) and Subasumstat (TAK-981). A key highlight includes updates on TAK-755, a novel therapy for Sickle Cell Disease and Congenital Thrombotic Thrombocytopenic Purpura.

Takeda Pharmaceutical Company announced the U.S. launch of LIVTENCITY™ (maribavir), the first treatment for post-transplant cytomegalovirus (CMV) infection/disease resistant to conventional antivirals. Available since December 2, 2021, after receiving FDA approval on November 23, LIVTENCITY is designed for patients aged 12 and over weighing at least 35 kg. With an estimated incidence rate of 16%-70% in transplant recipients, CMV poses serious health risks, emphasizing the need for effective treatments. LIVTENCITY offers a new option for clinicians in managing this complex infection.

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced a $20 million commitment to enhance its Corporate Social Responsibility (CSR) program in the U.S. during its first year. The program focuses on health equity, climate resiliency, K-8 math literacy, and food security, partnering with 20 grant recipients who will share $16.6 million in total grants. The initiative aims to alleviate social disparities and improve overall community well-being across various sectors.

Takeda Pharmaceutical Company Limited announced FDA approval for LIVTENCITY™ (maribavir), the first treatment for adults and pediatric patients (12 years and older) with post-transplant cytomegalovirus (CMV) infection refractory to conventional therapies. In the Phase 3 SOLSTICE study, 56% of patients on LIVTENCITY achieved CMV DNA levels

Takeda Pharmaceutical Company Limited (NYSE: TAK) has announced new policy recommendations aimed at improving care for patients with rare diseases. This initiative includes three primary reforms focused on enhancing access to genetic screenings and specialized care, as well as improving data standardization. A recent Morning Consult survey revealed that two-thirds of voters lack understanding of rare diseases, emphasizing the need for greater awareness. Takeda's report aims to address significant barriers to timely diagnoses and treatment, which currently average six years from symptom onset.

Takeda Pharmaceutical Company applied for selection to the Prime Market of the Tokyo Stock Exchange (TSE). The decision was made during the Board of Directors Meeting on September 29-30, 2021, following the TSE's initial assessment on July 9, 2021, confirming compliance with listing requirements. The company also submitted its Corporate Governance Report based on an updated governance code. Enhancements to governance transparency include updated documents available on its corporate website. This move aims to maximize corporate value and strengthen stakeholder engagement.