Nxera Pharma Files South Korean Marketing Application for Vamorolone in DMD; Shares Rise 7.9%

Nxera Pharma (SOLTF) said it has submitted a Marketing Authorization Application to South Korea's Ministry of Food and Drug Safety for vamorolone to treat Duchenne muscular dystrophy, a rare genetic disorder causing progressive muscle degeneration. Shares were trading at $8.43, up 7.87%. The filing follows South Korea's grant of Orphan Drug Designation and Global Innovative Products on Fast Track (GIFT) status, a pathway meant to speed review of medicines for serious and rare diseases. Vamorolone is a dissociative corticosteroid designed to preserve anti-inflammatory effects while reducing systemic side effects of long-term conventional steroid treatment. The drug is already approved for DMD in the U.S., European Union, U.K. and China. Nxera acquired exclusive rights from Santhera Pharmaceuticals in January 2026 to develop, manufacture and commercialize vamorolone in Japan, South Korea, Australia and New Zealand. The company targets South Korean approval in 2027 and a commercial launch in 2028.