KRMD News & Events

KORU Medical "announced that the Company received U.S. Food and Drug Administration clearance for use of the KORU Medical FreedomEDGE(R) infusion system to deliver RYSTIGGO, a therapy commercialized globally by UCB, Brussels, Belgium. The clearance for the FreedomEDGE(R) label includes indicated administration by a healthcare professional, increasing flexibility and access for patients living with generalized myasthenia (gMG). RYSTIGGO(R) is a novel biologic approved to treat adults with generalized myasthenia gravis (gMG), a rare, chronic autoimmune disorder that affects communication between nerves and muscles. RYSTIGGO(R) is administered as a weekly infusion of 3mL-6mL of drug over 15-30 minutes for 6 weeks, with subsequent treatment cycles based on clinical evaluation."

Reports preliminary FY25 revenue $41.1M, consensus $40.69M. "We delivered strong fourth quarter results and enter 2026 with solid momentum, driven by continued strength in our core immunoglobulin business and growth in our recurring patient base," said Linda Tharby, President and CEO of Koru Medical. "Our international expansion strategy is on track, and our recent 510(k) submission for clearance of the Freedom Infusion System for use with Phesgo(R) represents a key milestone in expanding beyond Ig into oncology. With continued disciplined execution on all aspects of our strategy, we are positioned well for sustainable growth in 2026 and beyond."

Koru Medical announced the submission of a 510(k) premarket notification to the FDA seeking clearance for the use of Koru Medical's FreedomEDGE infusion system to subcutaneously administer Phesgo, a co-formulated therapy for HER2+ breast cancer.