Takeda Pharm Stock Price, News & Analysis

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.

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.

Takeda Pharmaceutical Company presented nine abstracts at the 63rd American Society of Hematology (ASH) Annual Meeting held from December 11-14, 2021. The presentations highlight their commitment to innovative treatments in hematology, including data on ADYNOVATE for severe hemophilia A and an analysis of joint health biomarkers. Notably, the design of a phase 3b study of TAK-755, a first-of-its-kind replacement therapy, was shared. This emphasizes Takeda's ongoing advancements in therapies for rare blood disorders.