Plus Therapeutics Introduces REYOBIQ™, FDA-Accepted Proprietary Name for Lead Drug Candidate

Rhea-AI Summary

Plus Therapeutics (Nasdaq: PSTV) announces FDA's conditional acceptance of REYOBIQ™ as the proprietary name for its lead therapeutic candidate. REYOBIQ™ (rhenium Re186 obisbemeda) is currently under clinical investigation for treating Leptomeningeal Metastases (LM) and Recurrent Glioblastoma (GBM), both central nervous system (CNS) cancers.

The company must submit a request for proprietary name review when filing the marketing application (NDA). This branding initiative aims to help investigators, investors, and potential patients better connect with the rhenium-based radiotherapeutic beyond its chemical composition.

Positive

• FDA conditional acceptance of proprietary name represents progress toward commercialization
• Drug candidate targets two different CNS cancer indications (LM and GBM)

Negative

• Marketing application (NDA) not yet submitted
• Final name approval still pending FDA review
• Product still in clinical investigation phase with no revenue generation

 REYOBIQ™ (rhenium Re¹⁸⁶ obisbemeda) continues to be under clinical investigation for Leptomeningeal Metastases (LM) and Recurrent Glioblastoma (GBM)

HOUSTON, March 20, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announces the U.S. Food and Drug Administration (FDA) has conditionally accepted the Company’s new proprietary name, REYOBIQ™, for its lead therapeutic candidate. A request for proprietary name review for REYOBIQ™ must be submitted once the marketing application (NDA) is submitted. All communications regarding the USAN-adopted and INN-recommended rhenium Re¹⁸⁶ obisbemeda generic name will now utilize the proprietary name REYOBIQ™.

"Branding is an important part of preparing for commercialization, and the establishment of the REYOBIQ™ brand will enable investigators, investors, and potential patients to connect with our rhenium-based radiotherapeutic beyond its chemical identity," said Russ Havranek, Plus Therapeutics VP of Corporate Strategy and New Product Planning. "We are looking forward to building familiarity with the new REYOBIQ™ name and logo, as we believe it will foster stronger stakeholder engagement and reinforce the promising progress we are making in developing targeted radiotherapeutics for LM and GBM.”

About REYOBIQ™ (rhenium Re¹⁸⁶ obisbemeda)
REYOBIQ™ (rhenium Re¹⁸⁶ obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ™ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ™ is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://plustherapeutics.com/.

Investor Contact
Jules Abraham
Managing Director, Communications
CORE IR
Julesa@coreir.com

FAQ

What is REYOBIQ and what conditions does it treat?

REYOBIQ (rhenium Re186 obisbemeda) is Plus Therapeutics' lead therapeutic candidate being investigated for Leptomeningeal Metastases (LM) and Recurrent Glioblastoma (GBM), both CNS cancers.

What stage of development is PSTV's REYOBIQ currently in?

REYOBIQ is currently in the clinical investigation stage and has not yet submitted its marketing application (NDA) to the FDA.

Has the FDA fully approved REYOBIQ as the drug's brand name?

No, the FDA has only conditionally accepted REYOBIQ as the proprietary name. Final approval requires a review during the marketing application (NDA) submission.

What type of technology does REYOBIQ use to treat cancer?

REYOBIQ uses rhenium-based radiotherapeutic technology specifically targeted for central nervous system (CNS) cancers.