Takeda Pharm Stock Price, News & Analysis

Takeda announced that its Phase 3 clinical trial, ADVANCE-1, evaluating HYQVIA for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), met its primary endpoint. The treatment reduced relapse rates significantly compared to placebo (9.7% vs 31.4%; p-value = 0.0045). The trial involved 132 adult patients previously on IVIG therapy. Takeda plans to submit regulatory applications in the US and EU for HYQVIA in fiscal year 2022.

Takeda Pharmaceutical Company Limited has submitted its Corporate Governance Report to the Tokyo Stock Exchange, adhering to TSE regulations. This report, rooted in the revised Corporate Governance Code effective as of June 11, 2021, highlights a diverse Board of Directors with a composition of 4 internal and 11 independent external directors. The report emphasizes increased transparency and independence in governance, with advisory committees staffed entirely by external directors. The full report can be accessed on Takeda’s website and the Japan Exchange Group’s platform.

Takeda reported positive results from the Phase 3 SPRING study of TAKHZYRO, a treatment for hereditary angioedema (HAE) in children aged 2 to <12 years. The study demonstrated a 94.8% reduction in HAE attacks over 52 weeks compared to baseline. Notably, 76.2% of patients were attack-free during the treatment, with an average of 99.5% attack-free days. The results align with the efficacy and safety profile seen in adults. Takeda plans to initiate global regulatory filings in fiscal year 2022 to expand TAKHZYRO's indication for younger patients.

Takeda (TAK) and Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced promising results from the Phase 2 AROAAT-2002 study of fazirsiran for liver disease due to alpha-1 antitrypsin deficiency (AATD). Key findings include a 58% fibrosis regression in treated patients, an 83% median reduction in Z-AAT accumulation in the liver, and a 69% reduction in histologic globule burden. Fazirsiran aims to tackle AATD's liver manifestations, with plans for a Phase 3 study on the horizon. The collaboration has received Breakthrough Therapy and Orphan Drug designations from the FDA.

Takeda has signed a 15-year lease with BioMed Realty for 600,000 square feet of R&D and office space in Kendall Square, Massachusetts. The new facility will enhance Takeda's research capabilities and support the company's shift towards flexible workspaces. Construction is set to begin in 2023, with occupation expected by 2026. This move aligns with Takeda's goal of achieving net-zero greenhouse gas emissions and reflects its commitment to innovation and sustainability while expanding its presence in a prominent life sciences hub.

Takeda's dengue vaccine candidate TAK-003 has demonstrated significant efficacy, preventing 84% of hospitalizations and 61% of symptomatic dengue cases over 4.5 years. The results from the Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) indicate no important safety risks. TAK-003 is currently under regulatory review for potential licensure in the European Union and select dengue-endemic countries. The study, involving over 20,000 children and adolescents, aims to address the urgent need for effective dengue prevention.

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) will present significant oncology data at the ASCO and EHA congresses in June. Key highlights include positive Phase 3 PARADIGM study results involving colorectal cancer in Japanese patients and survival data from the Phase 3 ECHELON-1 trial on Hodgkin lymphoma. Additionally, Takeda will showcase advancements in its pipeline targeting innate immunity for cancer treatment. These presentations reflect Takeda's commitment to improving patient care through innovation and collaboration in oncology.

Moderna has announced that it will assume the role of marketing authorization holder for its COVID-19 vaccine Spikevax™ in Japan starting August 1, 2022. This transition includes taking over all related activities, such as import, regulatory compliance, development, quality assurance, and commercialization. In a collaborative effort, Takeda will continue to provide distribution support during a transitional phase of the national vaccination campaign. Both companies aim to ensure smooth operational implementation during this handover.

Moderna announces it will take over as the marketing authorization holder for its COVID-19 vaccine, Spikevax^TM, in Japan starting August 1, 2022. This transition from Takeda includes responsibilities for import, local regulations, development, quality assurance, and commercialization. Takeda will continue to provide distribution support during a transitional period. This move aims to strengthen Moderna's commercial organization in Japan as it continues to combat the COVID-19 pandemic.