We are pleased to announce that Lithea has been officially granted Small and Medium-sized Enterprise (SME) status by the European Medicines Agency (EMA).
This milestone is an important step forward as Lithea advances its mission to develop innovative treatments for patients with solid tumours. The SME designation from the EMA provides a valuable framework of support, including:
“Securing SME status is a strong signal of our commitment to regulatory excellence and our long-term presence in the European market,” said Ludvig Sjöberg, CEO of Lithea. “This recognition will allow us to navigate the regulatory landscape more efficiently as we bring our solid tumour treatment programs closer to clinical reality.”
The EMA’s SME programme is designed to support high-potential biotech and medtech innovators by easing the path to market for new therapies, particularly in complex and underserved areas like oncology.