Takeda Pharm Stock Price, News & Analysis

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.

Takeda Pharmaceutical and Seagen announced that their Phase 3 ECHELON-1 trial for ADCETRIS (brentuximab vedotin) achieved key survival metrics in patients with advanced Hodgkin lymphoma. Data showed a 41% reduction in the risk of death compared to standard treatment ABVD, with a 93.9% six-year overall survival rate for the ADCETRIS combination. The results will be presented at the ASCO and EHA Annual Meetings. The safety profile of ADCETRIS remained consistent with prior studies, showing no new safety signals. This trial marks a significant advancement in treatment options for advanced-stage Hodgkin lymphoma patients.

Takeda reported strong FY2021 results, achieving an underlying revenue growth of 7.4% and a reported revenue increase of 11.6%. Key highlights include a robust free cash flow of JPY 943.7 billion ($7.8B) and significant product approvals across regions. FY2022 guidance predicts continued growth with core operating profit expected to reach JPY 1.1 trillion and reported net profit projected to rise by 26.9%. Takeda's innovative pipeline features approximately 40 clinical stage assets.

Takeda announced its presentation of four abstracts at the 2022 Tandem Meetings and ECCMID, focusing on LIVTENCITY (maribavir) for post-transplant cytomegalovirus (CMV) infections. Key findings include a 34.8% reduction in hospitalizations and a 53.8% decrease in hospital stay duration for LIVTENCITY-treated patients compared to conventional therapies. Additionally, subgroup analyses indicate quicker CMV DNA level clearance with LIVTENCITY. These presentations support LIVTENCITY's role as a new treatment option for CMV infections resistant to conventional therapies.

Takeda has received approval from the Japan Ministry of Health for its recombinant protein-based COVID-19 vaccine, Nuvaxovid, for individuals aged 18 and older. The approval covers both primary and booster immunization, based on positive efficacy and safety data from clinical trials conducted in Japan and internationally. Takeda will manufacture the vaccine at its Hikari facility and begin distribution shortly. The financial impact of Nuvaxovid on Takeda's fiscal year ending March 31, 2023, will depend on distribution schedules, with forecasts to be revealed in May 2022.

Takeda has launched the TAKHZYRO® (lanadelumab-flyo) injection in a single-dose prefilled syringe format in the U.S. to prevent hereditary angioedema (HAE) attacks in patients aged 12 and older. Approved by the FDA in February 2022, this user-friendly option aims to enhance patient experience by simplifying the administration process. TAKHZYRO has been available since 2018 and shows proven efficacy in preventing HAE attacks, supported by one of the largest clinical studies in the field. Patients and specialty pharmacies will receive guidance for the transition to this new format.

Takeda Pharmaceutical Company Limited has completed its share buyback program as outlined in the Board of Directors’ resolution from October 28, 2021. In April 2022, Takeda repurchased 6,907,500 shares of common stock at a total cost of JPY 24,992,962,200. This acquisition is part of a broader plan to buy back up to JPY 100 billion worth of shares (up to 35 million shares). The program aims to enhance shareholder value and optimize capital structure.