Takeda Pharm Stock Price, News & Analysis

Takeda announced that its dengue vaccine, QDENGA (TAK-003), has been approved by the Indonesia National Agency for Drug and Food Control (BPOM) for individuals aged 6 to 45. This makes QDENGA the only dengue vaccine in Indonesia that does not require pre-vaccination testing. The approval marks the first commercialization of QDENGA outside Japan. Dengue poses a significant health threat in Indonesia, with over 63,000 cases and nearly 600 deaths reported in the first half of 2022. Takeda aims to provide this vaccine globally and is also seeking EU regulatory approval.

NextRNA Therapeutics announces the appointment of Dominique Verhelle, PhD, MBA, as CEO, effective immediately. Verhelle, a co-founder of the company, has spearheaded its scientific and corporate strategy since its inception. Under her leadership, NextRNA secured $56M in financing to advance its unique platform aimed at developing small molecule drugs targeting non-coding RNA interactions. Additionally, Jason Katz has been appointed as VP and Head of Drug Discovery, bringing extensive drug discovery experience from IFM Therapeutics and Merck.

Takeda reported its Q1 FY2022 financial results with core revenue growth of +8.3% at constant exchange rates (CER) and a core operating profit growth of +17%. Reported revenues reached 972.5 billion yen, representing a +2.4% rise, while the operating profit was 150.5 billion yen, down -39.4% due to a prior year one-time gain. Key business areas, particularly Growth & Launch Products, saw a significant revenue boost of +26% at CER. Takeda remains on track to meet its FY2022 management guidance amidst a challenging macroeconomic environment.

Takeda announced that its Phase 3 clinical trial, ADVANCE-1, evaluating HYQVIA for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), met its primary endpoint. The treatment reduced relapse rates significantly compared to placebo (9.7% vs 31.4%; p-value = 0.0045). The trial involved 132 adult patients previously on IVIG therapy. Takeda plans to submit regulatory applications in the US and EU for HYQVIA in fiscal year 2022.

Takeda Pharmaceutical Company Limited has submitted its Corporate Governance Report to the Tokyo Stock Exchange, adhering to TSE regulations. This report, rooted in the revised Corporate Governance Code effective as of June 11, 2021, highlights a diverse Board of Directors with a composition of 4 internal and 11 independent external directors. The report emphasizes increased transparency and independence in governance, with advisory committees staffed entirely by external directors. The full report can be accessed on Takeda’s website and the Japan Exchange Group’s platform.

Takeda reported positive results from the Phase 3 SPRING study of TAKHZYRO, a treatment for hereditary angioedema (HAE) in children aged 2 to <12 years. The study demonstrated a 94.8% reduction in HAE attacks over 52 weeks compared to baseline. Notably, 76.2% of patients were attack-free during the treatment, with an average of 99.5% attack-free days. The results align with the efficacy and safety profile seen in adults. Takeda plans to initiate global regulatory filings in fiscal year 2022 to expand TAKHZYRO's indication for younger patients.

Takeda (TAK) and Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced promising results from the Phase 2 AROAAT-2002 study of fazirsiran for liver disease due to alpha-1 antitrypsin deficiency (AATD). Key findings include a 58% fibrosis regression in treated patients, an 83% median reduction in Z-AAT accumulation in the liver, and a 69% reduction in histologic globule burden. Fazirsiran aims to tackle AATD's liver manifestations, with plans for a Phase 3 study on the horizon. The collaboration has received Breakthrough Therapy and Orphan Drug designations from the FDA.

Takeda has signed a 15-year lease with BioMed Realty for 600,000 square feet of R&D and office space in Kendall Square, Massachusetts. The new facility will enhance Takeda's research capabilities and support the company's shift towards flexible workspaces. Construction is set to begin in 2023, with occupation expected by 2026. This move aligns with Takeda's goal of achieving net-zero greenhouse gas emissions and reflects its commitment to innovation and sustainability while expanding its presence in a prominent life sciences hub.

Takeda's dengue vaccine candidate TAK-003 has demonstrated significant efficacy, preventing 84% of hospitalizations and 61% of symptomatic dengue cases over 4.5 years. The results from the Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) indicate no important safety risks. TAK-003 is currently under regulatory review for potential licensure in the European Union and select dengue-endemic countries. The study, involving over 20,000 children and adolescents, aims to address the urgent need for effective dengue prevention.