Welcome to our dedicated page for Takeda Pharm news (Ticker: TAK), a resource for investors and traders seeking the latest updates and insights on Takeda Pharm stock.
Takeda Pharmaceutical Company Limited reports news as a Japan-based, R&D-driven biopharmaceutical company whose American depositary shares trade under TAK. Its updates center on medicines and pipeline programs in gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines, including ENTYVIO, GAMMAGARD LIQUID ERC, HYQVIA, TAK-881, zasocitinib, rusfertide and oveporexton.
Recurring developments include pivotal clinical trial data, U.S. FDA regulatory actions involving new drug applications, prescription product availability, collaboration updates, and financial reports. Takeda also reports on launch preparation, generic competition affecting established products, operating-cost discipline, foreign-exchange effects, corporate transformation initiatives and governance matters tied to its global pharmaceutical business.
Takeda announced that the primary analysis data from the Phase 2 OPTIC trial will be presented at the 57th ASCO and 26th EHA Annual Meetings. The trial evaluated response-based dosing of ICLUSIG (ponatinib) in patients with resistant chronic-phase CML. Key findings indicate the optimal starting dose is 45 mg, with a subsequent reduction to 15 mg upon achieving ≤1% BCR-ABL1IS. The trial demonstrated a good safety profile with manageable rates of arterial occlusive events. This data supports ICLUSIG as a viable option for patients intolerant to prior TKI therapies.
Takeda Pharmaceutical Company Limited (NYSE: TAK) reported financial results for FY2020, ending March 31, 2021, revealing a total revenue of JPY 3,197.8 billion, a decline of 2.8% year-on-year, but an underlying growth of 2.2%. The operating profit surged by 407.2% to JPY 509.3 billion, driven by non-core asset sales. The company aims for mid-single-digit revenue growth, targeting JPY 5 trillion by FY2030, while anticipating FY2021 as a critical year with increased R&D investments and potential for four regulatory approvals. Net profit rose by 749.9% to JPY 376 billion.
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.