Plus Therapeutics, Inc. announced on March 6, 2025, that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Rhenium (186Re) Obisbemeda for the treatment of leptomeningeal metastases (LM) in patients with lung cancer.
This ODD status provides significant benefits to the drug developer, including seven potential years of market exclusivity upon approval, tax credits for qualified clinical trials, and exemptions from substantial regulatory fees. This designation follows a previously granted Fast Track designation.
The company recently completed the ReSPECT-LM Phase 1 single-dose trial, establishing the recommended Phase 2 dose. This ODD strengthens the pathway toward delivering an innovative, targeted radiotherapeutic solution for this highly underserved patient population.
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