Takeda Pharm Stock Price, News & Analysis

Takeda announced significant results from the Phase 3 GRAPHITE study, demonstrating that vedolizumab significantly improved intestinal aGvHD-free survival at Day 180 after allo-HSCT, achieving a response rate of 85.5% compared to 70.9% for placebo (p<0.001). The study, presented at the 2023 Tandem Meetings, also showed no new safety signals with vedolizumab. This treatment addresses a critical unmet need in managing lower gastrointestinal aGvHD, a serious complication after stem cell transplantation. The study included 333 patients and marks an advancement in understanding vedolizumab's role in gastrointestinal inflammatory conditions.

Takeda has completed the acquisition of Nimbus Lakshmi, Inc., acquiring full shares from Nimbus Therapeutics for about 4 billion USD. This significant transaction, announced on December 13, 2022, and finalized on February 8, 2023, includes acquiring the promising asset TAK-279, a selective oral TYK2 inhibitor. Phase 2b data is scheduled for release in Q4 FY2022, with a Phase 3 study aimed at psoriasis expected to commence in 2023. The acquisition enhances Takeda's late-stage pipeline, with potential applications across various immune-mediated diseases, supporting long-term growth.

Nimbus Therapeutics has completed the acquisition of its subsidiary Nimbus Lakshmi, Inc. by Takeda, with an upfront payment of $4 billion. This acquisition includes Nimbus's TYK2 inhibitor program, featuring the oral drug TAK-279. Nimbus anticipates receiving up to an additional $2 billion in sales-based milestone payments. The drug, designed to treat immune-mediated diseases, has shown promising results in a Phase 2b trial for moderate-to-severe plaque psoriasis, meeting its primary efficacy endpoint. Nimbus retains its pipeline for other therapies targeting cancer and autoimmune diseases.

Takeda has received FDA approval for the expanded use of TAKHZYRO (lanadelumab-flyo) as the first prophylaxis treatment for children aged 2 to <6 years with hereditary angioedema (HAE). This approval is based on efficacy data from the Phase 3 HELP and SPRING studies, showing a reduction in HAE attacks by 94.8% in pediatric patients. Previously, children 2 to <6 years lacked approved prophylactic options. TAKHZYRO is already available in over 60 countries and aims to address the needs of HAE patients through ongoing research and clinical programs.

Takeda (NYSE: TAK) reported strong Q3 2022 results with a 13.9% increase in revenue and 4.5% core revenue growth at constant exchange rates. Net profit rose 18.4%, and EPS rose 19.6%. The company approved the dengue vaccine QDENGA® in the EU and received priority review from the U.S. FDA. Takeda also announced an agreement to acquire a TYK2 inhibitor from Nimbus Therapeutics for USD 4 billion, enhancing its pipeline in autoimmune diseases. Despite revenue increases in most segments, oncology revenue fell 13% due to generic competition for VELCADE®.

Takeda Pharmaceutical has secured an exclusive licensing agreement with HUTCHMED for the development and commercialization of fruquintinib outside China, Hong Kong, and Macau. Fruquintinib, an inhibitor targeting VEGFR-1, 2, and 3, is aimed at treating refractory metastatic colorectal cancer (CRC). Takeda will pay HUTCHMED $400 million upfront, with potential additional payments of up to $730 million based on regulatory and sales milestones. The drug has shown promise in clinical trials and received Fast Track designation from the FDA. This partnership aims to enhance Takeda's oncology portfolio and expand treatment options for CRC patients.

Takeda announced the approval of EXKIVITY (mobocertinib) in China for treating adults with EGFR Exon20 insertion+ NSCLC who have progressed on platinum-based chemotherapy. This approval follows a Phase 1/2 clinical trial involving 114 patients, revealing a confirmed overall response rate (ORR) of 28% and a median duration of response (DoR) of 15.8 months. EXKIVITY is the first targeted therapy available for this patient group in China, addressing a significant unmet need as lung cancer is prevalent in the region.

Takeda (TSE:4502/NYSE:TAK) and Arrowhead Pharmaceuticals (NASDAQ:ARWR) announced positive results from the Phase 2 SEQUOIA study for fazirsiran in treating liver disease due to alpha-1 antitrypsin deficiency (AATD-LD). Notable findings include a 50% fibrosis regression in patients and a 94% median reduction in liver Z-AAT accumulation. Adverse events were balanced between treatment and placebo groups. A Phase 3 study is set to begin this month, aiming to confirm these promising Phase 2 results.