Takeda Pharm Stock Price, News & Analysis

Takeda announced a positive opinion from the European Medicines Agency's CHMP for its dengue vaccine candidate, TAK-003. This recommendation supports the vaccine's use in individuals aged four and older across Europe and dengue-endemic countries. The decision is based on over 4.5 years of safety and efficacy data from a pivotal Phase 3 trial involving more than 20,000 participants. Marketing authorization in Europe is anticipated soon, with further regulatory reviews expected in Latin America and Asia.

Takeda has announced that the FDA has accepted a supplemental Biologics License Application (sBLA) for the expanded use of TAKHZYRO (lanadelumab-flyo) to prevent hereditary angioedema (HAE) attacks in pediatric patients aged 2 to <12 years old. Currently, no approved prophylactic treatments exist for children under 6. If approved, TAKHZYRO would be the first treatment available for this demographic. The FDA has granted priority review, with a decision expected in the first half of 2023.

Takeda and UNITAR have launched a joint initiative to enhance healthcare systems for plasma and plasma-derived therapies. This partnership aims to address the rising global demand for these therapies due to increasing patients with rare diseases. The initiative seeks to create a UN-based platform to unite experts, policymakers, and stakeholders, improving access and quality of life for patients. Takeda will contribute its expertise and funding, working collaboratively with countries to develop solutions tailored to their healthcare challenges.

Takeda and Enel North America have signed a 12-year virtual power purchase agreement (VPPA) to advance Takeda's sustainability goals. The agreement is expected to generate approximately 350,000 Megawatt Hours (MWh) of renewable energy credits annually, covering around 20% of Takeda’s current Scope 1 and 2 GHG emissions. The VPPA facilitates the purchase of electricity from Enel’s 79 MW Seven Cowboy wind project in Oklahoma, ensuring a sustainable energy source for Takeda’s U.S. facilities. This aligns with Takeda's target to reduce GHG emissions by 40% by 2025 and achieve net-zero emissions by 2035.

Takeda announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval for maribavir, a treatment for cytomegalovirus (CMV) in adults post-transplant. This would be the first CMV-specific UL97 protein kinase inhibitor in the EU. The recommendation stems from the Phase 3 SOLSTICE study, which showed maribavir's superiority over conventional therapies at week 8. CMV affects 16%-70% of transplant recipients, necessitating effective treatment options.

Takeda has launched the CDPATH™ program, a personalized prognostic tool designed for Crohn's disease patients in the U.S. This tool predicts the risk of developing serious complications within three years using blood tests, and it's offered at no cost to eligible adult patients. The program aims to facilitate shared decision-making between patients and healthcare providers by integrating patient-specific markers with clinical assessments. CDPATH is available through over 2,500 locations nationwide, enhancing patient-centered care for over three million people affected by inflammatory bowel disease.

Takeda has launched four new partnerships under its Global Corporate Social Responsibility (CSR) Program, contributing a total of JPY 19.7 billion (approximately USD 140.7 million) since its inception in 2016. The new partners include Ipas, Plan International, Pure Earth, and UNFPA, focusing on improving healthcare for marginalized populations in various countries. Notably, funds will aid in enhancing sexual and reproductive health services, combatting gender-based violence, and addressing childhood lead poisoning across Ethiopia, Somalia, Colombia, and more.

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.