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 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.
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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.
Takeda presented interim real-world data from the Phase 4 EMPOWER study, showing significant improvements in Hereditary Angioedema (HAE) treatment outcomes with TAKHZYRO (lanadelumab). New users experienced an average 83% reduction in monthly attack rates, while established users reported enhanced treatment satisfaction. Key metrics included improvements in the Angioedema Quality of Life Questionnaire and a notable percentage of users extending treatment intervals from every 2 weeks to 4 weeks. Full data is expected in 2024.
Takeda has announced promising six-month interim results from the INSPIRE study, which evaluated the effectiveness of Alofisel (darvadstrocel) in patients with complex Crohn’s perianal fistulas. Clinical remission was observed in 65% of participants, with a clinical response rate of 73% for the All Treated group. The study has enrolled 230 patients as of September 2021. While adverse events were noted in 20% of participants, no serious incidents such as deaths or ectopic tissue formation were reported. These findings align with previous Phase 3 study results, supporting Alofisel's potential as a viable treatment option.
Takeda reported strong Q3 FY2021 results, achieving a +11% year-to-date revenue growth, amounting to 2,695.7 billion yen ($23.4B). The operating profit surged by +28.9% to 462.5 billion yen ($4.0B), with an underlying core operating profit margin of 29.4%. Their 14 global brands accounted for 42% of total core revenue, reflecting a +12% underlying growth. Takeda also upgraded its FY2021 financial forecasts, expecting a free cash flow between 700 billion yen and 800 billion yen.
VONVENDI ([von Willebrand Factor (Recombinant)]) has received FDA approval for routine prophylaxis to reduce bleeding episodes in adults with severe Type 3 von Willebrand disease (VWD) on on-demand therapy. This marks it as the first treatment specifically for this purpose. VWD affects up to 3 million people in the U.S., impacting blood clotting due to a deficiency or dysfunction of von Willebrand factor. Clinical studies showed a 54.7% reduction in annualized bleeding rates. The approval reflects Takeda's commitment to improving care for individuals with VWD.