Takeda Pharm Stock Price, News & Analysis

Takeda's AURORA trial results indicate that maribavir achieved a 69.6% CMV clearance rate in hematopoietic stem cell transplant recipients, compared to 77.4% for valganciclovir, but did not meet non-inferiority criteria. However, at Week 16, maribavir showed a maintenance effect of 52.7% compared to 48.5% for valganciclovir. Maribavir demonstrated a favorable safety profile, with lower incidences of treatment-emergent neutropenia (21.2%) compared to valganciclovir (63.5%). Takeda continues to engage with regulatory authorities regarding these outcomes.

Nimbus Therapeutics has entered into a definitive agreement for Takeda to acquire its subsidiary, Nimbus Lakshmi, Inc., along with the TYK2 inhibitor NDI-034858. The deal includes $4 billion upfront and up to $2 billion in milestone payments. NDI-034858 is being developed for autoimmune diseases, showing promising Phase 2b results in psoriasis. The acquisition is set to close in the first half of 2023, pending antitrust reviews.

Takeda has announced its acquisition of NDI-034858 from Nimbus Therapeutics for $4B, aiming to enhance its late-stage pipeline in treating autoimmune diseases. NDI-034858, a selective TYK2 inhibitor, has shown promising Phase 2b results in psoriasis, with expected Phase 3 trials commencing in 2023. This strategic move aligns with Takeda's focus on immune-mediated diseases, potentially leading to significant portfolio expansion and improved patient outcomes. The deal includes milestone payments of $1B upon reaching specified sales targets. Takeda anticipates closing the transaction by FY2022.

Takeda will present 15 company-sponsored and nine collaborative abstracts at the 64th American Society of Hematology Annual Meeting from December 10-13, 2022, in New Orleans. Highlighted presentations include updates from the Phase 3 OPTIC trial of ICLUSIG (ponatinib) and a first-in-human study of Modakafusp Alfa (TAK-573). The research aims to enhance outcomes in patients with hematologic diseases, emphasizing novel treatment mechanisms and the importance of addressing unmet needs in this field.

The European Commission has approved QDENGA (TAK-003), a dengue vaccine for individuals aged four years and older. This makes QDENGA the only dengue vaccine approved in the EU for use, regardless of prior dengue exposure.

Approval is based on extensive clinical studies involving over 28,000 participants, showing 80.2% efficacy in preventing symptomatic dengue and 90.4% in preventing hospitalizations at 18 months. The vaccine is crucial for reducing dengue incidence, which has significantly risen globally. No changes are expected in Takeda's fiscal outlook for FY 2022 due to this approval.

Takeda has announced that the FDA has accepted the Biologics License Application (BLA) for TAK-003, its investigational dengue vaccine. The vaccine is aimed at preventing dengue disease caused by any virus serotype in individuals aged 4 to 60. With increasing dengue incidence and 888 infections reported in the U.S. this year, 96% of which were travel-related, the vaccine could become a crucial preventive option. The BLA is supported by a pivotal Phase 3 trial showing 80.2% efficacy at 12 months. Approval in Indonesia has been achieved, with ongoing regulatory reviews in Europe and other regions.

Takeda announced the successful results of the Phase 3 PhALLCON trial, which compared ICLUSIG® (ponatinib) with imatinib in adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The trial met its primary endpoint, demonstrating superior rates of minimal residual disease (MRD)-negative complete remission for ICLUSIG. Given the urgency for effective therapies in this patient population, these findings highlight ICLUSIG’s potential in addressing treatment challenges associated with Ph+ ALL.

LIVTENCITY is now the first and only treatment for cytomegalovirus (CMV) infection approved by the European Commission (EC) for patients with post-transplant infections. CMV is a prevalent issue post-transplant, affecting 16-56% of solid organ transplant patients. The approval is based on the successful results of the Phase 3 SOLSTICE trial. LIVTENCITY targets the UL97 protein kinase, offering a novel option where previous therapies failed, enabling healthcare providers across the EU and EEA to manage refractory CMV cases effectively.

Takeda reported strong financial results for the first half of fiscal year 2022, with core revenue growth of 5.5% at constant exchange rates (CER) and reported revenue growth of 10.1%. Core operating profit grew 14.5% at CER, achieving a core operating profit margin of 31.7%. The company upgraded its peak sales outlook for ENTYVIO® to $7.5-9.0 billion and improved net debt to adjusted EBITDA to 2.6x. Takeda also reaffirmed its full-year guidance, reflecting strong performance in key business areas and ongoing product approvals.