FDA Grants Priority Review for Takeda (TAK) and Protagonist's Rusfertide in PV Treatment

Takeda Pharmaceutical Company Limited (NYSE:TAK) is one of the most promising stocks under $20. On March 2, Takeda and Protagonist Therapeutics announced that the US FDA accepted the New Drug Application and granted Priority Review for rusfertide. This investigational, first-in-class hepcidin mimetic is intended to treat adults with polycythemia vera/PV, a rare blood cancer characterized by the dangerous overproduction of red blood cells.

Given its potential to address significant unmet needs, the FDA has set a Prescription Drug User Fee Act action date for Q3 2026. The regulatory submission is supported by data from the Phase 3 VERIFY study, along with long-term results from the Phase 2 REVIVE and THRIVE trials. Clinical findings showed that rusfertide, when added to the standard of care, more than doubled response rates compared to standard treatments alone. Key benefits included sustained control of hematocrit levels below 45%, a significant reduction in the need for painful phlebotomy procedures, and improvements in patient-reported symptoms such as fatigue.

Under the 2024 collaboration agreement, Takeda is managing the regulatory strategy and future global filings, while Protagonist maintains an option to co-commercialize the drug in the US through a profit-sharing structure. Rusfertide works by mimicking the hormone hepcidin to regulate iron homeostasis, effectively targeting the underlying mechanism of the disease. If approved, it would provide a novel subcutaneous treatment option for patients who currently struggle to manage blood thickness and the associated risk of life-threatening thrombotic events like strokes or embolisms.

Takeda Pharmaceutical Company Limited (NYSE:TAK) researches, develops, manufactures, markets, and out-licenses pharmaceutical products in Japan and internationally. It offers pharma products for gastroenterology, rare diseases, plasma-derived therapies, immunology, oncology, and neuroscience.

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