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Investing.com -- Disc Medicine Inc (NASDAQ:IRON) stock surged 19.7% in after-hours trading Thursday after the company announced it received a Commissioner’s National Priority Voucher (CNPV) from the U.S. Food and Drug Administration for its drug bitopertin.
The voucher was granted for bitopertin’s application in treating erythropoietic protoporphyria (EPP), including X-linked protoporphyria (XLP). Disc Medicine submitted a New Drug Application for bitopertin in September 2025 following the FDA’s accelerated approval pathway for patients aged 12 years and older with EPP. The drug has already received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA.
The Commissioner’s National Priority Voucher program, launched in June 2025, aims to accelerate development and review of drugs addressing U.S. national health priorities. The program offers benefits including reduced drug application review times of just 1-2 months, enhanced communications, and rolling review processes.
EPP is a rare genetic disease that causes severe reactions when patients are exposed to sunlight, including excruciating pain, edema, and burning sensations. The condition can also lead to serious liver complications in 20-30% of patients.
"We are honored to have received this voucher which underscores the potential impact of bitopertin and reinforces the immense need EPP patients have for a new therapy that may address the underlying cause of their disease," said John Quisel, Chief Executive Officer and President of Disc Medicine.
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