Takeda Pharm Stock Price, News & Analysis

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced FDA approval for the supplemental New Drug Application (sNDA) of ICLUSIG® (ponatinib) for adults with chronic-phase chronic myeloid leukemia (CML) who are resistant or intolerant to at least two prior kinase inhibitors. The updated regimen features a starting dose of 45 mg, reducing to 15 mg upon achieving ≤1% BCR-ABL1^IS. The approval is based on data from the OPTIC and PACE trials. The revised label is expected to optimize treatment for patients with resistant CML, providing significant clinical benefits.

Prime Therapeutics has secured an agreement with Takeda Pharmaceuticals for its hemophilia A treatment, ADVATE. This collaboration aims to evaluate clinical outcomes and costs associated with hemophilia A treatments, which have become increasingly expensive. The agreement introduces a health plan remuneration model linked to quantifiable medical costs from ineffective treatments under a total cost of care framework. Hemophilia A affects around 80% of the 18,000 people living with the disorder in the U.S., presenting an opportunity for improved patient and cost outcomes.

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced that the FDA has accepted its New Drug Application for TAK-721, a treatment for eosinophilic esophagitis (EoE), granting it Priority Review. If approved, TAK-721 will be the first FDA-approved therapy for EoE. The product had previously received Breakthrough Therapy and Orphan Drug designations. The NDA filing is based on successful Phase 3 trials demonstrating its safety and efficacy. EoE affects approximately 1 in 2,000 people in the U.S., leading to significant quality of life impacts due to related symptoms.

Takeda Pharmaceutical Company Limited (TAK) has completed the sale of a portfolio of 18 pharmaceutical and OTC products to Celltrion Inc. for $278 million, including milestone payments. This divestment, part of Takeda's strategy to focus on core areas, is expected to aid in reducing debt and accelerating deleveraging to achieve a net debt/adjusted EBITDA target of 2x by FY 2023. The sale comes after Takeda exceeded its $10 billion non-core asset divestiture target, totaling ~$11.3 billion in agreements since January 2019.

On November 11, 2020, Takeda announced a strategic partnership with OrigiMed to create a genomic-based precision medicine platform. This collaboration aims to enhance R&D and commercialization of innovative medicines in China, addressing unmet medical needs. Takeda plans to introduce over 15 innovative drugs to the Chinese market within five years, benefiting approximately 10 million patients. OrigiMed will leverage its genomic datasets and advanced sequencing technology to support these developments.

Seqster PDM Inc. and Takeda Pharmaceutical Company Limited have extended their partnership to enhance patient outcomes by leveraging Seqster's healthcare technology. The collaboration will provide Takeda with immediate access to Seqster's secure platform, which integrates electronic health records, genomic data, and wearable information. This will facilitate real-time data visualization, improving patient engagement and compliance during clinical trials. The implementation will enable Takeda to activate 12 use cases across its business rapidly, aiming to enhance clinical development and patient services.

Takeda Pharmaceuticals reported Q2 FY2020 results, showing resilience amidst COVID-19 challenges. Revenue reached JPY 1,590.8 billion, reflecting a 0.5% underlying growth despite a 4.2% decline. Operating profit surged by 97.7% to JPY 215.6 billion, with net profit up 15.8% to JPY 86.5 billion. The company confirmed its full-year guidance, upgrading forecasts for free cash flow and earnings per share. Takeda's ongoing divestitures, exceeding $11 billion since January 2019, are strengthening its balance sheet and reducing debt, with an aim to achieve a net debt/EBITDA ratio of 2x by FY2021-FY2023.

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) presented four abstracts at the Thrombosis and Hemostasis Summit of North America, focusing on advancements in personalized care for bleeding disorders. Key studies include evaluating rurioctocog alfa pegol in hemophilia A and B, implementing a Goal Attainment Scaling instrument for hemophilia, and insights into population pharmacokinetics of recombinant von Willebrand factor. These presentations emphasize personalized treatment strategies aimed at enhancing patient care in hemophilia and von Willebrand's disease.

Takeda Pharmaceutical Company and Arrowhead Pharmaceuticals have formed a collaboration to co-develop ARO-AAT, an investigational RNA interference therapy for alpha-1 antitrypsin-associated liver disease (AATLD). Under a profit-sharing agreement, they will share U.S. commercialization efforts 50/50, while Takeda will lead global commercialization outside the U.S. Arrowhead receives a $300 million upfront payment and may earn up to $740 million in milestone payments. This partnership aims to address the significant unmet medical need for AATLD, a serious condition with no current approved therapies.