Clinical Trial SuccessThe company reported positive top-line data from the P3 study, achieving its primary endpoint of increase in time to catheter failure.
Commercialization PotentialCitius has achieved a critical milestone in future Lymphir commercialization and patient support with the assignment of a unique, permanent HCPCS J-code by the CMS.
Regulatory GuidanceThe FDA provided clear, constructive, and actionable guidance for a future New Drug Application submission for Mino-Lok, supporting its pathway to regulatory approval.