Plus Therapeutics (NASDAQ: PSTV) stock skyrocketed 170% in regular trading Thursday after the company revealed that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name REYOBIQ™ for its lead radiotherapeutic candidate, rhenium Re186 obisbemeda.
The drug is currently under clinical investigation for central nervous system (CNS) cancers, including Leptomeningeal Metastases (LM) and Recurrent Glioblastoma (GBM).
This FDA approval marks a key milestone for Plus Therapeutics (NASDAQ: PSTV) as it prepares to file a New Drug Application (NDA) for marketing approval.
Russ Havranek, Vice President of Corporate Strategy and New Product Planning at Plus Therapeutics, highlighted the importance of the branding, saying,
“The establishment of the REYOBIQ™ brand will enable investigators, investors, and potential patients to connect with our rhenium-based radiotherapeutic beyond its chemical identity.”.
He added that the company aims to build familiarity with the new REYOBIQ™ name and logo to strengthen stakeholder engagement.
REYOBIQ™ is a novel injectable radiotherapy specifically formulated to deliver high-dose, targeted radiation directly to CNS tumors, offering a safer, more effective, and convenient treatment approach that optimizes patient outcomes. By providing a more targeted and potent radiation dose, REYOBIQ™ has the potential to minimize off-target risks and enhance outcomes for CNS cancer patients compared to currently approved therapies. Rhenium-186, the key radioisotope in REYOBIQ™, is well-suited for CNS applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging.
The drug is being evaluated in two clinical trials: ReSPECT-GBM for recurrent glioblastoma and ReSPECT-LM for leptomeningeal metastases. ReSPECT-GBM is backed by the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH). Meanwhile, ReSPECT-LM is funded by a $17.6 million, three-year grant from the Cancer Prevention & Research Institute of Texas (CPRIT).
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