Takeda Pharm Stock Price, News & Analysis

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.

Takeda announced the completion of the SHP643-301 study, a Phase 3 trial evaluating TAKHZYRO (lanadelumab) for preventing acute attacks of hereditary angioedema (HAE) in pediatric patients aged 2 to <12 years. The study met its primary and secondary objectives, demonstrating a safety profile consistent with previous trials in older patients, with no serious adverse events reported. Takeda plans to initiate a global regulatory filing for this age group within the fiscal year.

Takeda proposes new candidates for independent external directors at its upcoming shareholders' meeting on June 29, 2022. The candidates, Kimberly A. Reed and John Maraganore, will replace retiring directors Toshiyuki Shiga and Shiro Kuniya. Additionally, Masami Iijima is nominated as the new chair of the Board Meetings, succeeding Masahiro Sakane. This move aims to enhance governance and diversity within the board. All current members will also be proposed for re-election.

Takeda has received approval from Japan's Ministry of Health, Labour and Welfare for TAKHZYRO (lanadelumab) subcutaneous injection in adults and pediatric patients aged 12 and older for preventing attacks of hereditary angioedema (HAE). This decision is primarily based on results from the global Phase 3 HELP Study and a Japan-specific Phase 3 trial, where 41.7% of patients did not experience attacks over 26 weeks. The drug is already approved in over 50 countries and aims to enhance treatment options for the HAE patient community.