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Plus Therapeutics (PSTV) FDA Events

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FDA Events for Plus Therapeutics (PSTV)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Plus Therapeutics (PSTV). Over the past two years, Plus Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as FORESEE, ReSPECT-GBM, ReSPECT-LM, REYOBIQ™, and Rhenium. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Plus Therapeutics' Drugs in FDA Review

FORESEE - FDA Regulatory Timeline and Events

FORESEE is a drug developed by Plus Therapeutics for the following indication: For the diagnosis and management of Leptomeningeal Metastases (LM). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ReSPECT-GBM - FDA Regulatory Timeline and Events

ReSPECT-GBM is a drug developed by Plus Therapeutics for the following indication: In adults with recurrent glioblastoma after standard surgical, radiation, and/or chemotherapy treatment. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ReSPECT-LM - FDA Regulatory Timeline and Events

ReSPECT-LM is a drug developed by Plus Therapeutics for the following indication: For the treatment of leptomeningeal metastases. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

REYOBIQ™ - FDA Regulatory Timeline and Events

REYOBIQ™ is a drug developed by Plus Therapeutics for the following indication: For Patients with Leptomeningeal Metastases. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Rhenium (186Re) - FDA Regulatory Timeline and Events

Rhenium (186Re) is a drug developed by Plus Therapeutics for the following indication: For the treatment of recurrent glioblastoma (rGBM). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Plus Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Plus Therapeutics (PSTV) has reported FDA regulatory activity for the following drugs: Rhenium (186Re), REYOBIQ™, ReSPECT-LM, FORESEE and ReSPECT-GBM.

The most recent FDA-related event for Plus Therapeutics occurred on July 8, 2025, involving REYOBIQ™. The update was categorized as "Provided Update," with the company reporting: "Plus Therapeutics, Inc. announced the treatment of its initial patients in the Company's ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM)."

Current therapies from Plus Therapeutics in review with the FDA target conditions such as:

  • For the treatment of recurrent glioblastoma (rGBM) - Rhenium (186Re)
  • For Patients with Leptomeningeal Metastases - REYOBIQ™
  • For the treatment of leptomeningeal metastases - ReSPECT-LM
  • For the diagnosis and management of Leptomeningeal Metastases (LM) - FORESEE
  • In adults with recurrent glioblastoma after standard surgical, radiation, and/or chemotherapy treatment. - ReSPECT-GBM

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:PSTV) was last updated on 7/9/2025 by MarketBeat.com Staff
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