Nxera Pharma Co.,Ltd. [4565.T]
TOKYO, Jun 02 (Pulse News Wire) – Nxera Pharma CO.,LTD. (4565.T) announced today that the Korean Ministry of Food and Drug Safety (MFDS) granted Orphan Drug Designation (ODD) and Global Innovative Products on Fast Track (GIFT) designation to its drug candidate vamorolone for the treatment of Duchenne Muscular Dystrophy (DMD).
The ODD recognizes DMD as a rare disease lacking established therapies, while the GIFT program could potentially shorten the review process from 120 business days to as few as 90. Vamorolone's approval application in South Korea is scheduled for submission in 2026.
MinBok Lee, CEO of Nxera Pharma Korea Co., Ltd., stated, “We are pleased to achieve these designations swiftly, reflecting the urgent need for innovative treatments for DMD patients in South Korea.” The company expects these regulatory approvals to contribute positively to its long-term revenue and enterprise value, although the impact on the fiscal year ending December 2026 is expected to be minor.
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