Plus Therapeutics announced on March 6, 2025, that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Rhenium (186 Re) Obisbemeda. This designation is for the treatment of leptomeningeal metastases (LM) in patients with lung cancer.
ODD status provides significant benefits to drug developers, including seven potential years of market exclusivity, tax credits for qualified clinical trials, and exemptions from substantial regulatory fees. This designation strengthens the pathway toward delivering an innovative therapeutic solution.
This milestone follows the recent completion of the ReSPECT-LM Phase 1 single-dose trial, which established the recommended Phase 2 dose. The company is now advancing a Phase 2 single-dose expansion trial and a Phase 1 multiple-dose trial.
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