Takeda Pharm Stock Price, News & Analysis

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) has received recognition from the International Society for Pharmaceutical Engineering (ISPE) with two awards for the 2021 Facility of the Year Awards. The new solid pharmaceutical packaging building in Hikari, Japan, won in the ‘Process Intelligence and Innovation’ category, while the Grange Castle facility in Ireland was honored for ‘Facility Integration’. These accolades highlight Takeda's commitment to advanced manufacturing and digital technologies, ensuring high-quality production and efficient supply chains for its oncology treatments.

Takeda Pharmaceutical Company announced that the FDA has granted priority review for its New Drug Application (NDA) for mobocertinib (TAK-788). This oral therapy targets EGFR Exon20 insertion mutations in metastatic non-small cell lung cancer (mNSCLC) patients who have previously undergone platinum-based chemotherapy. Mobocertinib has already received Orphan Drug Designation and Breakthrough Therapy Designation from the FDA. The NDA is based on a Phase 1/2 trial involving 114 patients and is part of the FDA's accelerated approval program, facilitated by Project Orbis.

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced a conference call on April 6, 2021, to discuss updates on its Wave 1 pipeline portfolio, which includes several New Molecular Entities (NMEs) with regulatory filings expected by year-end FY2021. The agenda features key presentations on innovative treatments, including Maribavir (TAK-620) for post-transplant CMV infection and Soticlestat (TAK-935) for Dravet Syndrome. Takeda emphasizes its focus on organic and sustainable revenue growth over the coming years.

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) has finalized the sale of a portfolio of around 130 OTC and prescription products to Orifarm Group for up to $670 million USD. This portfolio, which generated FY2020 net sales of approximately $240 million USD, includes key products from various therapeutic areas mainly sold in Europe. Proceeds will be used to reduce debt, aiming for a 2x net debt/adjusted EBITDA target by 2023. The transaction has also involved transitioning approximately 600 employees to Orifarm.

Takeda Pharmaceutical Company has completed the sale of its Consumer Healthcare division to Blackstone for JPY 242 billion. The divestiture includes numerous OTC products generating over JPY 60 billion in revenue. Following the sale, TCHC will operate as Alinamin Pharmaceuticals. Takeda aims to use the proceeds to reduce debt and achieve a net debt/EBITDA ratio of 2x by FY2023. With this transaction, Takeda has surpassed its $10 billion divestiture target, totaling $12.9 billion since January 2019. A pre-tax gain of JPY 140 billion will boost reported net profit for FY2020.

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced that the European Medicines Agency (EMA) accepted its regulatory filings for the dengue vaccine candidate, TAK-003. This vaccine is aimed at preventing dengue in individuals aged four to 60. Takeda plans to submit filings in multiple countries including Argentina, Brazil, and Mexico in 2021. The company is also participating in EMA’s parallel assessment assessment process. The pivotal Phase 3 trial demonstrated safety and efficacy over 36 months, highlighting the urgent need for dengue vaccination globally.

Takeda Pharmaceutical presented at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation the results from the Phase 3 SOLSTICE trial of TAK-620 (maribavir). The study demonstrated a significant increase in CMV viremia clearance among transplant recipients with resistant infections, achieving 62.8% with maribavir against 20.3% with conventional therapies. Maribavir also exhibited lower rates of treatment-related toxicities compared to traditional antiviral options, highlighting its potential as a transformative treatment for CMV infections in transplant patients.

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) has partnered with IDT Biologika to temporarily use its manufacturing capacity for the COVID-19 vaccine developed by Janssen Pharmaceuticals. This arrangement allows Takeda to support global vaccination efforts while ensuring that its dengue vaccine candidate, TAK-003, can resume production shortly after. The company remains dedicated to addressing both COVID-19 and dengue, acknowledging the significant public health needs associated with these diseases.

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) has submitted a New Drug Application (NDA) for lanadelumab, a monoclonal antibody therapy, to the MHLW in Japan. This treatment targets hereditary angioedema (HAE), a rare genetic disorder affecting 2,000-3,000 people in Japan, of whom only 450 are diagnosed. Lanadelumab proved effective in reducing monthly HAE attacks by up to 87% in clinical trials. If approved, it will be available as a pre-filled syringe, enhancing treatment access for patients with unmet medical needs.