StockNews.AI

Plus Therapeutics Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ™ for Leptomeningeal Metastases

StockNews.AI • 2 days

PSTVbluebird bio (BLUE)NantKwest (NK)Zymeworks (ZYME)
High Materiality8/10

Information

HOUSTON, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Co...

Original source

AI Summary

Plus Therapeutics has successfully completed a Type B meeting with the FDA regarding the trial strategy for REYOBIQ, particularly for leptomeningeal metastases. The FDA indicated that accelerated approval may be feasible, contingent on further validation of endpoints. The company aims to incorporate FDA feedback into its trial protocols and advance towards potential drug approval.

Trading Thesis

Positive FDA interactions could enhance PSTV's stock performance amid drug development progress.

Market-Moving

  • FDA's willingness to consider accelerated approval creates bullish sentiment.
  • REYOBIQ's potential market impacts can significantly affect PSTV's valuation.
  • Accelerated timelines for clinical trials can lead to quicker market entries.
  • Construction of a robust trial protocol may attract investor interest.
  • Validating new endpoints could unlock further regulatory approvals.

Key Facts

  • REYOBIQ aims to treat leptomeningeal metastases in CNS cancer.
  • FDA indicated insufficient data exists for CTCs as endpoints.
  • Leptomeningeal metastases affect 5% of metastatic cancer patients.
  • Median survival for LM patients typically ranges from 2-6 months.
  • REYOBIQ utilizes rhenium-186 for targeted cancer radiotherapy.

Companies Mentioned

  • FDA (N/A): Engagement with the FDA supports clinical development plans for PSTV.
  • National Cancer Institute (NCI) (N/A): NCI supports REYOBIQ's clinical trials, indicating institutional backing.
  • Cancer Prevention & Research Institute of Texas (CPRIT) (N/A): CPRIT funds key trials, highlighting state-backed interest in PSTV's success.
  • Department of Defense (DoD) (N/A): DoD grants support PSTV's pediatric cancer initiatives, broadening their market potential.

Corporate Developments

The ongoing engagements with the FDA signify vital progress for Plus Therapeutics' REYOBIQ, an essential development in the oncology landscape. Enhanced regulation interactions generally correlate with higher investor confidence and potential stock appreciation, particularly within biopharma sectors focused on unmet medical needs.

FAQ

Why Bullish?

The FDA's consideration for accelerated approval indicates positive regulatory support. Historical examples show FDA engagements often result in increased stock performance for biotech firms, such as bluebird bio during pivotal discussions.

How important is it?

The article's focus on FDA meetings and pivotal trials directly concerns PSTV's market trajectory. Given that REYOBIQ addresses a significant unmet medical need, strategic developments in trial protocols can substantially influence investor sentiment and market value.

Why Long Term?

Outcomes from FDA engagements will align trial protocols and timeline forecasts, potentially realizing long-term value as product pipelines advance.

Related Companies

PSTVbluebird bio (BLUE)NantKwest (NK)Zymeworks (ZYME)

Plus Therapeutics Makes Progress on REYOBIQ for Leptomeningeal Metastases

On January 8, 2026, Plus Therapeutics, Inc. (Nasdaq: PSTV), a pioneering healthcare company focusing on precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, announced the completion of a Type B meeting with the U.S. Food and Drug Administration (FDA). The meeting was centered on the pivotal trial strategy for the company’s promising treatment, REYOBIQ, aimed at addressing leptomeningeal metastases (LM).

Key Outcomes from the FDA Meeting

The discussions with the FDA revealed several important considerations for the upcoming pivotal trial. Plus Therapeutics plans to incorporate this feedback into their current dose optimization trial, aiming to create a revised protocol later this year. The ultimate goal is to prepare for a pivotal trial once the dose optimization is complete, thereby advancing towards potential approval for REYOBIQ in LM patients.

Highlights of FDA Feedback

  • Accelerated Approval: The FDA indicated that an accelerated approval pathway may be feasible for LM, although there is presently insufficient data to validate circulating tumor cells (CTCs) as an intermediate clinical endpoint.
  • Primary Endpoints: The FDA recommended evaluating endpoints demonstrating established clinical benefits, such as overall survival, while suggesting further studies on patient-reported outcomes and neurologic function.
  • Trial Design: A randomized controlled trial design was discussed, potentially including intrathecal chemotherapeutics as comparators to standardize interventions.
  • Treated Populations: The agency conveyed that incorporating multiple disease histologies within a single trial may be a reasonable approach.

Statements from Leadership

Dr. Marc H. Hedrick, President & CEO of Plus Therapeutics, expressed optimism regarding the FDA discussions. “Our recent FDA end-of-phase meeting was constructive, and we hope will help us speed up our clinical development timelines and facilitate faster submission of an application for the approval of REYOBIQ for patients with LM,” he stated. Dr. Hedrick further noted that the absence of approved drugs for LM makes this early dialogue crucial for refining their trial protocol and preparing for future pivotal trials.

Understanding Leptomeningeal Metastases

Leptomeningeal metastases are a severe complication experienced by approximately 5% of patients with metastatic cancer. This condition affects the essential fluid-lined structures of the CNS, and is most commonly linked to breast cancer, lung cancer, and melanoma. With a median survival rate typically spanning only 2-6 months, the need for innovative treatments like REYOBIQ is urgent.

About REYOBIQ™ and its Clinical Trials

REYOBIQ (rhenium Re186 obisbemeda) represents a novel injectable radiotherapy tailored for delivering high-dose targeted radiation in CNS tumors. With its unique formulation, it aims to optimize patient outcomes while minimizing off-target effects associated with conventional therapies. The potential of rhenium-186 for CNS applications is underscored by its short half-life and effective radiation properties.

REYOBIQ is being assessed in several clinical trials, including:

  • ReSPECT-GBM: Targeting recurrent glioblastoma
  • ReSPECT-LM: Focusing on leptomeningeal metastases
  • ReSPECT-PBC: Concentrating on pediatric brain cancer

These trials are backed by significant funding, with ReSPECT-LM receiving a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT).

About CNSide Diagnostics, LLC

CNSide Diagnostics, a subsidiary of Plus Therapeutics, focuses on developing proprietary laboratory tests like CNSide®, to detect tumor cells that have migrated to the CNS in patients with carcinomas and melanomas. Their innovative CSF Assay Platform aids in the quantitative analysis of cerebrospinal fluid, providing critical insights for better management of patients with LM.

About Plus Therapeutics

Based in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical entity devoted to developing targeted radiotherapeutics specifically designed for challenging CNS cancers. The company’s efforts are bolstered by strategic partnerships aimed at enhancing the development and manufacturing of their promising pipeline products, including REYOBIQ.

Forward-Looking Statements

This article includes statements that may be considered “forward-looking statements” under U.S. securities laws. These statements reflect the current expectations of Plus Therapeutics regarding potential developments in the study design for REYOBIQ for LM and plans for commercial manufacturing expansion. Actual results may differ due to various factors, including market conditions and competition in the cancer treatment field.

Related News