Plus Therapeutics (PSTV) announces that the U.S. Food and Drug Administration has granted Orphan Drug Designation to Rhenium Obisbemeda for the treatment of leptomeningeal metastases in patients with lung cancer. 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 while actively engaging the FDA to define the optimal pivotal trial strategy.
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