Radiopharmaceuticals developer Radiopharm said it has scheduled a meeting with the U.S. Food and Drug Administration to discuss the regulatory pathway for its investigational brain imaging agent RAD101.
The company did not specify the date of the meeting but stated that the discussion will focus on the clinical and non-clinical data required for potential approval. RAD101 is designed for imaging brain disorders, though the specific indications under review were not disclosed.
Radiopharm, which trades on the Nasdaq under the ticker RADP, did not provide further details on the timing or scope of the FDA interaction. The outcome of the meeting could influence the company’s development timeline and regulatory strategy for RAD101.
Shares of Radiopharm were not immediately active in after-hours trading following the announcement. The company has not previously disclosed financial guidance tied to RAD101’s development.
