Plus Therapeutics Announces Completion of U.S. FDA Meeting on Future Clinical Development Plans for REYOBIQ™ in Leptomeningeal Metastases
Plus Therapeutics (Nasdaq: PSTV) announced completion of a Type B meeting with the U.S. Food and Drug Administration on November 7, 2025 to discuss clinical development plans for REYOBIQ in leptomeningeal metastases (LM), including design of a planned pivotal/registrational trial. The company described the meeting as constructive and said it will receive FDA meeting minutes, provide an update and guidance on next steps early in 2026, and implement focused amendments to its LM trial to align the development timeline with FDA recommendations.
Plus Therapeutics (Nasdaq: PSTV) ha annunciato il completamento di un incontro di tipo B con la U.S. Food and Drug Administration il 7 novembre 2025 per discutere i piani di sviluppo clinico per REYOBIQ nelle metastasi leptomeningeali (LM), inclusa la progettazione di uno studio chiave registrazionale pianificato. L'azienda ha descritto l'incontro come costruttivo e ha detto che riceverà i verbali dell'FDA, fornirà un aggiornamento e indicazioni sui prossimi passi all'inizio del 2026, e attuerà emendamenti mirati al proprio trial LM per allineare la timeline di sviluppo con le raccomandazioni della FDA.
Plus Therapeutics (Nasdaq: PSTV) anunció la finalización de una reunión de tipo B con la Administración de Alimentos y Medicamentos de Estados Unidos (FDA) el 7 de noviembre de 2025 para discutir los planes de desarrollo clínico de REYOBIQ en metastasis leptomeníngeas (LM), incluida la diseño de un ensayo pivotal/registracional planificado. La empresa describió la reunión como constructiva y dijo que recibirá las actas de la FDA, proporcionará una actualización y orientación sobre los próximos pasos a principios de 2026, y implementará enfoques enfocados de enmiendas a su ensayo LM para alinear la cronología de desarrollo con las recomendaciones de la FDA.
Plus Therapeutics (Nasdaq: PSTV)는 2025년 11월 7일에 미국 식품의약국(FDA)과의 Type B 회의가 완료되어 REYOBIQ를 수막하 전이(LM)에서의 임상 개발 계획 및 계획된 결정적/등록 시험의 설계에 대해 논의했다고 발표했습니다. 회사는 회의를 건설적이었다고 설명했고 FDA 회의 의사록을 받게 되며 2026년 초에 업데이트와 향후 단계에 대한 지침을 제공하고, LM 시험의 개발 일정을 FDA 권고에 맞추기 위해 집중적인 수정사항을 구현할 것이라고 밝혔습니다.
Plus Therapeutics (Nasdaq: PSTV) a annoncé l’achèvement d’une réunion de type B avec la Food and Drug Administration des États-Unis le 7 novembre 2025 pour discuter des plans de développement clinique de REYOBIQ dans les métastases leptoméningées (LM), y compris la conception d’un essai pivot/registrational prévu. L’entreprise a décrit la réunion comme constructive et a indiqué qu’elle recevra les procès-verbaux de la FDA, fournira une mise à jour et des directives sur les prochaines étapes au début de 2026, et mettra en œuvre des amendements ciblés à son essai LM afin d’aligner le calendrier de développement sur les recommandations de la FDA.
Plus Therapeutics (Nasdaq: PSTV) gab bekannt, dass am 7. November 2025 ein Type-B-Meeting mit der US-amerikanischen Lebensmittel- und Arzneimittelbehörde (FDA) abgeschlossen wurde, um die klinischen Entwicklungspläne für REYOBIQ bei leptomeningealen Metastasen (LM) zu besprechen, einschließlich der Gestaltung einer geplanten pivotalen/registrierungsrelevanten Studie. Das Unternehmen beschrieb das Treffen als konstruktiv und sagte, es werde die FDA-Meeting-Minuten erhalten, ein Update sowie Anleitungen zu den nächsten Schritten früh im Jahr 2026 geben und fokussierte Änderungen an seinem LM-Trial vornehmen, um den Entwicklungszeitplan mit den Empfehlungen der FDA in Einklang zu bringen.
Plus Therapeutics (Nasdaq: PSTV) أعلنت عن إتمام اجتماع من النوع B مع إدارة الغذاء والدواء الأمريكية في 7 نوفمبر 2025 لمناقشة خطط التطوير السريري لـ REYOBIQ في النقائل السحائية النخاعية (LM)، بما في ذلك تصميم تجربة حاسمة/تسجيلية مخطط لها. قالت الشركة إن الاجتماع كان بنّاءً، وأنها ستحصل على محاضر اجتماع FDA، وتقدم تحديثاً وتوجيهات بشأن الخطوات التالية في أوائل 2026، وتنفّذ تعديلات مركَّزة على تجربتها LM لتتوافق مخطط التطوير مع توصيات FDA.
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HOUSTON, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, announced it has completed a Type B meeting with the U.S. Food and Drug Administration (FDA) on November 7th to discuss its REYOBIQ clinical development plans for leptomeningeal metastases (LM) including the design of a planned pivotal or registrational trial.
“Our recent FDA meeting was very constructive, building on multiple previous positive meetings with the FDA on the clinical development and manufacturing of Reyobiq for CNS cancers,” said Dr. Marc H. Hedrick, President & Chief Executive of Plus Therapeutics. “Following receipt of the FDA meeting minutes, the Company expects to provide an update and guidance on next steps early in 2026. We also will implement certain focused amendments to our LM trial that should help advance the overall clinical development timeline in alignment with the FDA recommendations.”
About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately
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, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC 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 CNSide Diagnostic, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
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://www.plustherapeutics.com.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; risks related to a halt in trading or delisting of the Company’s common stock on Nasdaq; Medicare and private payors may not provide coverage and reimbursement or may breach, rescind or modify their contracts or reimbursement policies or delay payments; the risk that our products and services may not perform as expected; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
investor@plustherapeutics.com
FAQ
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