Announced submission of a marketing authorization application for vamorolone in South Korea. ODD and GIFT designations already obtained. Targeting approval in 2027 and commercial launch in 2028. 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ODD and GIFT designations already obtained. Targeting approval in 2027 and commercial launch in 2028. Positioning South Korea expansion as a mid-to-long-term growth strategy; no impact on full-year results for the fiscal year ending December 2026.","jir_summary":"### Summary of the News\nNxera Pharma Co., Ltd. announced that it has submitted a marketing authorization application for vamorolone, a treatment for Duchenne muscular dystrophy (DMD), to the MFDS in South Korea. Orphan Drug Designation (ODD) and GIFT designation have already been obtained, and the company aims to secure approval in 2027 and achieve commercial launch in 2028.\n\n### Outlook in South Korea and Long-Term Strategy\nThe South Korea rollout of vamorolone is an important milestone to provide new treatment options for DMD patients. Leveraging approval experience in the United States, EU, United Kingdom, and China, the company will lead activities to obtain local approval. In the long term, the initiative is expected to improve business revenue and corporate value.","jir_financial_highlights":"Impact on consolidated full-year results for the fiscal year ending December 2026: Unknown (Unknown)","jir_category":"","jir_hashtags":"#NxeraPharma, #vamorolone, #KoreaMAA, #DMDtreatment","jir_key_figures":"Marketing authorization application: Marketing authorization application in South Korea (MFDS)\nODD and GIFT designations: ODD and GIFT designations obtained\nTarget launch timing: 2028","jir_meta_title":"Nxera Pharma: Notification of Vamorolone Marketing Authorization Application in South Korea | October 2026","jir_meta_description":"Nxera Pharma announced submission of a marketing authorization application for vamorolone in South Korea. ODD\/GIFT designations obtained; targeting approval in 2027 and launch in 2028. Key points on regulatory progress and business impact.","jir_og_title":"Nxera Pharma: Notification of Vamorolone Marketing Authorization Application in South Korea","jir_og_description":"Announcement of vamorolone marketing authorization application in South Korea. ODD\/GIFT designations obtained; aiming for 2027 approval and 2028 launch. Implications for mid-to-long-term business growth.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":16880,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-133427","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n