Takeda's New Drug Application Accepted by FDA for Priority Review
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 10 2026
0mins
Should l Buy TAK?
Takeda announced that the FDA accepted its new drug application and granted Priority Review for oveporexton for the treatment of narcolepsy type 1. Oveporexton is an investigational oral orexin receptor 2-selective agonist designed to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. The FDA has set a Prescription Drug User Fee Act goal date in the third quarter of this calendar year. Takeda remains on track to potentially bring the first approved orexin agonist treatment to people living with NT1.
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Analyst Views on TAK
Wall Street analysts forecast TAK stock price to fall
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 18.540
Low
18.00
Averages
18.00
High
18.00
Current: 18.540
Low
18.00
Averages
18.00
High
18.00
About TAK
Takeda Pharmaceutical Co Ltd is a Japan-based company mainly engaged in the research and development, manufacture, sale and licensing of pharmaceuticals. The Company focuses on the main business areas of gastrointestinal diseases, rare diseases, plasma derivatives (immune diseases), oncology (cancer), and neuroscience (neuropsychiatric diseases). The Company focuses on three research and development areas: innovative biopharmaceuticals with the focus on gastrointestinal and inflammatory diseases, neuroscience, and oncology, plus plasma derivatives and vaccines. Most of the pharmaceuticals treat rare diseases in the focus disease areas and the plasma derivatives area. The Company operates in Japan, the United States, Europe, and China.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Massive Market Potential: The global neuropsychiatric drug market is projected to exceed $150 billion by the end of the decade, and as awareness and acceptance of new serotonin-based therapies increase, NSAs are poised to secure a meaningful slice of this market, driving long-term growth for the company.
- Leadership Transition: Helus Pharma has appointed Michael Cola as CEO, whose extensive experience in neuroscience and global commercialization is expected to accelerate the development of next-generation mental health therapies and expedite the release of clinical data and market entry.
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- Clinical Data Impact: NSAs are designed to act faster than traditional antidepressants, effectively treating complex conditions such as depression, PTSD, anxiety, and addiction, which is anticipated to significantly improve patient outcomes and attract increased investor interest.
- Leadership Change: Helus Pharma has appointed Michael Cola as CEO, who brings over 30 years of experience in neuroscience and specialty pharmaceuticals, expected to drive the company towards key clinical milestones, including the upcoming Phase 2 data for HLP004 and Phase 3 data for HLP003.
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- Technological Advantage: Iambic's AI models and fully automated lab capabilities are set to accelerate drug development timelines, with traditional drug discovery taking around six years, while Iambic's approach aims to compress this to under two years, significantly enhancing R&D efficiency and reducing costs.
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- Financial Gains: Under the terms, Iambic is set to receive upfront research costs and technology access fees, along with milestone payments that could exceed $1.7 billion, providing robust support for the company's financial stability and future investments.
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