KORU Medical shares surge 12.66% after-hours after FDA clears FreedomEDGE system to deliver RYSTIGGO for gMG.

KORU Medical (NASDAQ: KRMD) surged 12.66% in after-hours trading following the U.S. Food and Drug Administration (FDA) 510(k) clearance for its FreedomEDGE® infusion system to deliver RYSTIGGO® (rozanolixizumab-noli), a biologic therapy for generalized myasthenia gravis (gMG). This marks the company’s ninth subcutaneous drug clearance and expands the FreedomEDGE® label to include administration by healthcare professionals in clinical settings, broadening access for gMG patients. The clearance aligns with KORU’s strategy to enhance its Freedom Infusion System’s versatility across drug therapies and treatment environments. The system, which supports large-volume infusions and has a 97% adherence rate, now serves 45,000+ patients globally. The regulatory approval, reducing market entry risks and enabling faster revenue generation, directly correlates with the post-announcement price surge.