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 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.
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Takeda Pharmaceutical Company announced its growth strategy and revenue potential at the J.P. Morgan Healthcare Conference. The company is optimistic about generating incremental revenue of JPY 500 billion (approximately $4.5 billion) by FY2025, supported by 14 global brands projected to grow by 14-16%. Takeda's pipeline includes 40 clinical-stage therapies, targeting oncology and rare diseases, aiming for significant regulatory approvals. The company is also committed to maintaining strong cash flow and reducing debt.
Takeda Pharmaceutical Company Limited has announced its acquisition of Adaptate Biotherapeutics, enhancing its immuno-oncology portfolio. This acquisition follows a successful partnership and marks Takeda's third oncology 'build-to-buy' initiative in under a year. The deal focuses on Adaptate's antibody-based γδ T-cell engager platform aimed at cancer therapies, complementing previous acquisitions. This strategic move positions Takeda at the forefront of γδ T cell research, expected to finalize in Q1 of Takeda's fiscal year 2022, pending regulatory reviews.
Takeda Pharmaceutical Company Limited (NYSE: TAK) has received a Complete Response Letter (CRL) from the U.S. FDA regarding its New Drug Application for TAK-721 (budesonide oral suspension) aimed at treating eosinophilic esophagitis (EoE). The FDA indicated that the application could not be approved in its current state and recommended further clinical studies. Takeda expressed disappointment, noting that patients will continue to lack an FDA-approved treatment option.
Takeda Pharmaceutical Company Limited announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of vedolizumab for the treatment of adults with moderately to severely active chronic pouchitis. If approved, vedolizumab would be the first authorized treatment for this condition in Europe, which affects patients post-surgery for ulcerative colitis. The positive opinion was based on findings from the EARNEST trial, showing significant clinical remission rates.