Plus Therapeutics Introduces REYOBIQ™, FDA-Accepted Proprietary Name for Lead Drug Candidate
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.
Plus Therapeutics (Nasdaq: PSTV) annuncia l'accettazione condizionata da parte della FDA del nome commerciale REYOBIQ™ per il suo principale candidato terapeutico. REYOBIQ™ (rhenium Re186 obisbemeda) è attualmente sotto indagine clinica per il trattamento delle Metastasi Leptomeningeal (LM) e del Glioblastoma Ricorrente (GBM), entrambi tumori del sistema nervoso centrale (CNS).
L'azienda deve presentare una richiesta di revisione del nome commerciale al momento della presentazione della domanda di commercializzazione (NDA). Questa iniziativa di branding mira ad aiutare i ricercatori, gli investitori e i potenziali pazienti a connettersi meglio con il radioterapico a base di rhenio oltre la sua composizione chimica.
Plus Therapeutics (Nasdaq: PSTV) anuncia la aceptación condicional de la FDA del nombre comercial REYOBIQ™ para su principal candidato terapéutico. REYOBIQ™ (rhenio Re186 obisbemeda) se encuentra actualmente bajo investigación clínica para el tratamiento de Metástasis Leptomeníngeas (LM) y Glioblastoma Recurrente (GBM), ambos cánceres del sistema nervioso central (CNS).
La empresa debe presentar una solicitud de revisión del nombre comercial al presentar la solicitud de comercialización (NDA). Esta iniciativa de marca tiene como objetivo ayudar a investigadores, inversores y pacientes potenciales a conectarse mejor con el radioterapéutico a base de rhenio más allá de su composición química.
Plus Therapeutics (Nasdaq: PSTV)는 FDA가 자사의 주요 치료 후보에 대한 상표명 REYOBIQ™를 조건부로 승인했다고 발표했습니다. REYOBIQ™ (rhenium Re186 obisbemeda)는 현재 지주막 전이 (LM) 및 재발성 교모세포종 (GBM) 치료를 위한 임상 연구 중에 있습니다. 두 가지 모두 중추신경계 (CNS) 암입니다.
회사는 마케팅 신청서 (NDA)를 제출할 때 상표명 검토 요청을 제출해야 합니다. 이 브랜딩 이니셔티브는 연구자, 투자자 및 잠재적 환자들이 화학적 조성을 넘어 rhenium 기반 방사선 치료제와 더 잘 연결될 수 있도록 돕는 것을 목표로 합니다.
Plus Therapeutics (Nasdaq: PSTV) annonce l'acceptation conditionnelle par la FDA du nom commercial REYOBIQ™ pour son principal candidat thérapeutique. REYOBIQ™ (rhenium Re186 obisbemeda) est actuellement en cours d'investigation clinique pour le traitement des Métastases Leptomeningeales (LM) et du Glioblastome Récurrent (GBM), deux cancers du système nerveux central (CNS).
L'entreprise doit soumettre une demande de révision du nom commercial lors du dépôt de la demande de mise sur le marché (NDA). Cette initiative de branding vise à aider les chercheurs, les investisseurs et les patients potentiels à mieux se connecter avec le radiothérapeutique à base de rhenium au-delà de sa composition chimique.
Plus Therapeutics (Nasdaq: PSTV) gibt die bedingte Annahme des FDA für den Handelsnamen REYOBIQ™ für seinen führenden therapeutischen Kandidaten bekannt. REYOBIQ™ (Rhenium Re186 obisbemeda) wird derzeit klinisch untersucht zur Behandlung von Leptomeningeale Metastasen (LM) und wiederkehrendem Glioblastom (GBM), beides Tumore des zentralen Nervensystems (CNS).
Das Unternehmen muss bei der Einreichung des Antrags auf Marktzulassung (NDA) einen Antrag auf Überprüfung des Handelsnamens einreichen. Diese Branding-Initiative zielt darauf ab, Forschern, Investoren und potenziellen Patienten zu helfen, sich besser mit dem rhenium-basierten Radiotherapeutikum über seine chemische Zusammensetzung hinaus zu verbinden.
- FDA conditional acceptance of proprietary name represents progress toward commercialization
- Drug candidate targets two different CNS cancer indications (LM and GBM)
- 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
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/.
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FAQ
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