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.
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.
- Drug:
- FORESEE
- Announced Date:
- November 22, 2024
- Indication:
- For the diagnosis and management of Leptomeningeal Metastases (LM)
Announcement
CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, Inc. will present data from the FORESEE trial showcasing the CNSide CSF Assay Platform's utility in diagnosing and guiding clinical decision making for breast cancer and non-small cell lung cancer patients with LM.
AI Summary
CNSide Diagnostics, LLC—a fully owned subsidiary of Plus Therapeutics, Inc.—will present important new data from the FORESEE trial. The study highlights the CNSide CSF Assay Platform’s effectiveness in diagnosing leptomeningeal metastases (LM) in breast cancer and non-small cell lung cancer patients. The trial’s data show that the assay influenced clinical management decisions in over 90% of LM cases and demonstrated 2.8 times higher diagnostic sensitivity compared to standard cytology. This advanced assay can not only detect tumor cells with improved sensitivity but also identify actionable mutations, such as HER2 amplification, helping guide treatment strategies. The findings suggest that the CNSide CSF Assay Platform could significantly enhance the diagnosis and ongoing management of LM, offering doctors a more reliable tool for patient evaluation and treatment planning.
Read Announcement- Drug:
- FORESEE
- Announced Date:
- August 13, 2024
- Indication:
- For the diagnosis and management of Leptomeningeal Metastases (LM)
Announcement
Plus Therapeutics, Inc. presented data from the FORESEE study of its CNSide platform for the diagnosis and management of LM. The data were presented in a podium presentation at the 2024 Society for NeuroOncology (SNO)/American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, 2024 in Denver, Colorado.
AI Summary
Plus Therapeutics recently presented encouraging data from its FORESEE study of the CNSide platform, a novel tool for diagnosing and managing leptomeningeal metastases (LM). The findings were shared during a podium presentation at the 2024 Society for NeuroOncology (SNO)/American Society for Clinical Oncology (ASCO) CNS Metastases Conference in Denver, Colorado, held from August 8-10, 2024.
The prospective, multi-center trial enrolled patients with LM from either breast or non-small cell lung cancer. Results showed that CNSide more than doubled the sensitivity for detecting tumor cells compared to standard CSF cytology. Moreover, the test influenced clinical management decisions in over 90% of cases and identified actionable mutations in the CSF, offering a more personalized approach to treatment. These key findings suggest that CNSide may lead to earlier diagnosis and more precise management of LM, potentially improving patient outcomes.
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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.
- Drug:
- ReSPECT-GBM
- Announced Date:
- September 18, 2024
- Indication:
- In adults with recurrent glioblastoma after standard surgical, radiation, and/or chemotherapy treatment.
Announcement
Plus Therapeutics announced that will present data at the 2024 Congress of Neurological Surgeons (CNS) Annual Meeting September 28 - October 2, in Houston, Texas.
AI Summary
Plus Therapeutics recently announced that it will present important clinical data at the 2024 Congress of Neurological Surgeons (CNS) Annual Meeting. The meeting will take place in Houston, Texas, from September 28 to October 2, 2024. The company’s presentation will focus on its Phase 2 trial update for recurrent glioblastoma, a serious brain cancer. The trial uses a method called Convection Enhanced Delivery (CED) to administer Rhenium (186Re) Obisbemeda, a novel injectable radiotherapy developed to target and destroy tumor tissue. The presentation is scheduled for Monday, September 30, 2024, from 7:00 to 8:30 a.m. CDT at the George R. Brown Convention Center in Room 310C. This event marks a significant opportunity for Plus Therapeutics to share advancements in treatment options for patients with this challenging form of cancer.
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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.
- Drug:
- ReSPECT-LM
- Announced Date:
- February 26, 2025
- Indication:
- For the treatment of leptomeningeal metastases
Announcement
Plus Therapeutics, Inc. announced the completion of the ReSPECT-LM Phase 1 single-dose escalation trial, having determined an RP2D.
AI Summary
Plus Therapeutics, Inc. announced they completed the ReSPECT-LM Phase 1 single-dose escalation trial, successfully determining the Recommended Phase 2 Dose (RP2D). The trial evaluated the safety, tolerability, and potential effectiveness of a single dose of Rhenium (186Re) Obisbemeda administered directly into the cerebrospinal fluid in patients with leptomeningeal metastases. Notably, at the Cohort 4 dose (44.1 mCi), no severe toxic reactions were found, and one patient achieved a complete response with tumor cells disappearing from the cerebrospinal fluid.
Following these promising results, Plus Therapeutics is moving forward with a Phase 2 trial to further study the single-dose treatment and a new Phase 1 trial using a fractionated multiple-dose approach of the same RP2D. The company remains committed to advancing these trials and working closely with the FDA to define the next steps for a pivotal trial pathway.
Read Announcement- Drug:
- ReSPECT-LM
- Announced Date:
- August 12, 2024
- Indication:
- For the treatment of leptomeningeal metastases
Announcement
Plus Therapeutics, Inc. presented data in a podium presentation updating the progress of its ReSPECT-LM clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM).
AI Summary
Plus Therapeutics, Inc. has shared encouraging results from its ongoing ReSPECT-LM clinical trial during a recent podium presentation at the 2024 Society for Neuro-Oncology/ASCO CNS Metastases Conference. The trial evaluates the safety and feasibility of using intrathecal dosing of up to 44 mCi of Rhenium (186Re) Obisbemeda, a radiolabeled nanoliposome designed to deliver targeted radiation to treat leptomeningeal metastases (LM).
In the Phase 1 dose-escalation study’s initial four cohorts, 16 patients were treated without any dose limiting toxicities, and the maximum tolerated dose was not reached. The data showed that higher doses resulted in a linear increase in radiation exposure in the spinal fluid and cranial regions, a mean reduction of 53% in circulating tumor cells within 28 days, and a median overall survival of 12 months. These findings support the continued clinical promise of this treatment approach in LM patients.
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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.
- Drug:
- REYOBIQ™
- Announced Date:
- July 8, 2025
- Indication:
- For Patients with Leptomeningeal Metastases
Announcement
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).
AI Summary
Plus Therapeutics, Inc. announced that its ReSPECT-LM dose optimization trial for REYOBIQ™ (rhenium Re186 obisbemeda) has begun treating its first patients. The trial targets leptomeningeal metastases (LM), a serious condition that affects the central nervous system and currently has limited treatment options. By administering multiple doses through an intraventricular catheter, the study aims to identify the optimal dosing regimen that maximizes both safety and effectiveness. In alignment with FDA guidance, the trial is set up to carefully determine the maximum tolerated dose and the minimum effective dose in patients with LM stemming from various solid tumors. With an anticipated rapid enrollment in the initial cohort, this study represents an important step forward in seeking safer and improved treatment alternatives for patients affected by LM.
Read Announcement- Drug:
- REYOBIQ™
- Announced Date:
- June 30, 2025
- Indication:
- For Patients with Leptomeningeal Metastases
Announcement
Plus Therapeutics, Inc announces the initiation of the ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM).
AI Summary
Plus Therapeutics, Inc. has initiated the ReSPECT-LM dose optimization trial to refine the dosing regimen of REYOBIQ™ (rhenium Re186 obisbemeda) for treating leptomeningeal metastases (LM). This study aims to identify the optimal balance between maximum safety and efficacy in patients with LM from various solid tumors. The trial, following promising single-dose escalation results, will test multiple-dose regimens using the recommended Phase 2 dose of 44.1 mCi. Administered via an intraventricular catheter (Ommaya reservoir), the dosing schedule will be examined at intervals ranging from 14 to 56 days across different patient cohorts. The study’s design aligns with the FDA’s Project Optimus guidelines and seeks to determine both the maximum tolerated and minimum effective doses, providing essential data to support a future registrational trial.
Read Announcement- Drug:
- REYOBIQ™
- Announced Date:
- April 15, 2025
- Indication:
- For Patients with Leptomeningeal Metastases
Announcement
Plus Therapeutics, Inc. announces the online availability of new data on its lead compound REYOBIQ™ (rhenium Re186 obisbemeda) in an abstract for both an oral presentation and a poster to be presented at the Nuclear Medicine and Neurooncology conference to be held May 9-10, 2025 in Vienna, Austria.
AI Summary
Plus Therapeutics, Inc. has announced that new data on its lead compound, REYOBIQ™ (rhenium Re186 obisbemeda), is now available online. This data is featured in an abstract set for both an oral presentation and a poster at the upcoming Nuclear Medicine and Neurooncology conference in Vienna, Austria, on May 9-10, 2025. The abstract, titled "Rhenium Obisbemeda (REYOBIQ) in Leptomeningeal Metastases," covers findings from a Phase 1 dose escalation trial. The study reports a dose-dependent increase in the average radiation dose absorbed by the cranial and spinal subarachnoid space, along with promising neuroimaging responses and clinical benefit rates, even as the treatment was well tolerated. This new information boosts confidence in the potential of REYOBIQ™ as a targeted radiotherapeutic for patients suffering from leptomeningeal metastases. Additional details will be shared following the conference.
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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.
- Drug:
- Rhenium (186Re)
- Announced Date:
- June 25, 2025
- Indication:
- For the treatment of recurrent glioblastoma (rGBM)
Announcement
Plus Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQTM (Rhenium Re186 Obisbemeda) for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma.
AI Summary
Plus Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQ™ (Rhenium Re186 Obisbemeda). This clearance marks an important step toward evaluating a novel radiotherapeutic for pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma—aggressive brain tumors with few treatment options.
The IND clearance enables clinical testing of REYOBIQ™, a therapy designed to target tumors with high doses of beta radiation while limiting exposure to healthy tissue. In the upcoming trial, the treatment will be assessed for safety, tolerability, and potential effectiveness using precise delivery methods that bypass the blood-brain barrier. This innovative approach could offer new hope for pediatric patients facing these challenging conditions.
Read Announcement- Drug:
- Rhenium (186Re)
- Announced Date:
- March 20, 2025
- Indication:
- For the treatment of recurrent glioblastoma (rGBM)
Announcement
Plus Therapeutics, Inc. announces the U.S. Food and Drug Administration (FDA) has conditionally accepted the Company's new proprietary name, REYOBIQ™, for its lead therapeutic candidate.
AI Summary
The U.S. Food and Drug Administration (FDA) has conditionally accepted Plus Therapeutics’ new proprietary name, REYOBIQ™, for its lead therapeutic candidate. This step is key as the company gears up for the upcoming marketing application and future commercialization. Once the New Drug Application (NDA) is submitted, a full proprietary name review will follow.
REYOBIQ™, the brand name for rhenium Re186 obisbemeda, represents a promising targeted radiotherapeutic currently under clinical investigation for the treatment of leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The new branding aims to create a more recognizable identity, helping investigators, investors, and potential patients connect with the innovative therapy beyond its chemical description. The establishment of the REYOBIQ™ name and logo is expected to boost stakeholder engagement and support the drug’s development success in treating central nervous system cancers.
Read Announcement- Drug:
- Rhenium (186Re)
- Announced Date:
- March 7, 2025
- Indication:
- For the treatment of recurrent glioblastoma (rGBM)
Announcement
Plus Therapeutics, Inc. announces the publication of results in a peer-reviewed manuscript titled, "Treatment of Recurrent Glioma by Rhenium (186Re) Obisbemeda (186RNL): a Phase 1 clinical trial" in the peer-reviewed medical journal Nature Communications.
AI Summary
Plus Therapeutics, Inc. announced that its Phase 1 clinical trial results have been published in the peer-reviewed journal Nature Communications. The manuscript, titled "Treatment of Recurrent Glioma by Rhenium (186Re) Obisbemeda (186RNL): a Phase 1 clinical trial," highlights the safety and potential effectiveness of using Rhenium (186Re) Obisbemeda for treating recurrent glioblastoma. In the trial, 21 patients were treated, and those who received more than 100 Gy showed a median overall survival of 17 months, a significant improvement compared to lower doses. There were no dose-limiting toxicities, and most adverse events were unrelated to the treatment, reinforcing its safety profile. This peer-reviewed study serves as strong validation of the clinical program and has paved the way for the ongoing ReSPECT-GBM Phase 2 trial, providing hope for a much-needed treatment option for this aggressive brain cancer.
Read Announcement- Drug:
- Rhenium (186Re)
- Announced Date:
- March 6, 2025
- Indication:
- For the treatment of recurrent glioblastoma (rGBM)
Announcement
Plus Therapeutics, Inc announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Rhenium (186Re) Obisbemeda for the treatment of leptomeningeal metastases (LM) in patients with lung cancer.
AI Summary
Plus Therapeutics, a clinical-stage pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its treatment Rhenium (186Re) Obisbemeda. This designation is for the treatment of leptomeningeal metastases (LM) in lung cancer patients, a rare condition affecting fewer than 200,000 people in the U.S. ODD status provides benefits such as up to seven years of market exclusivity, tax credits for clinical trials, and exemptions from certain regulatory fees. This milestone is crucial as patients with LM currently have very limited treatment options, and the incidence of LM in lung cancer is growing. The FDA's decision supports Plus Therapeutics’ effort to develop a targeted radiotherapy that could offer a new, more focused treatment approach for a highly underserved patient population.
Read Announcement- Drug:
- Rhenium (186Re)
- Announced Date:
- December 17, 2024
- Indication:
- For the treatment of recurrent glioblastoma (rGBM)
Announcement
Plus Therapeutics, Inc presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM) with a specific focus on breast cancer patients.
AI Summary
Plus Therapeutics, Inc. shared promising updates from its ReSPECT-LM Phase 1 clinical trial at the 2024 San Antonio Breast Cancer Symposium. The study focused on breast cancer patients with leptomeningeal disease and involved delivering a single intrathecal dose of Rhenium (186Re) Obisbemeda—an innovative radiolabeled nanoliposome designed to target cancer cells in the central nervous system. Among nine evaluable patients, the treatment demonstrated favorable outcomes, with 88% showing improved circulating tumor cell counts, alongside positive findings on MRI imaging and clinical evaluations. Notably, the maximum tolerated dose has not yet been reached, and only one instance of dose-limiting toxicity was reported. Based on these encouraging results, Plus Therapeutics plans to initiate a single-dose breast expansion trial in early 2025, with additional multiple-dose expansion studies scheduled for later in the year.
Read Announcement- Drug:
- Rhenium (186Re)
- Announced Date:
- December 4, 2024
- Indication:
- For the treatment of recurrent glioblastoma (rGBM)
Announcement
Plus Therapeutics, Inc. will present data at the 2024 San Antonio Breast Cancer Symposium, December 10-13, 2024 in San Antonio, Texas.
AI Summary
Plus Therapeutics, Inc. will present new clinical data at the 2024 San Antonio Breast Cancer Symposium, taking place from December 10-13, 2024, in San Antonio, Texas. The company will share findings from its Phase 1 dose escalation trial for Rhenium (186Re) Obisbemeda, a novel radiotherapeutic designed to treat leptomeningeal metastases in breast cancer patients. This presentation, titled “Rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases: Update on Phase 1 dose escalation,” will be given by Dr. Andrew Brenner on December 13, 2024, at 7:30 a.m. CST in the Stars at Night Ballroom at the Henry B. Gonzalez Convention Center.
The data highlights the potential of Rhenium (186Re) Obisbemeda in delivering targeted radiation therapy, which could provide a safer and more effective treatment option for cancer patients with complications involving the central nervous system.
Read Announcement- Drug:
- Rhenium (186Re)
- Announced Date:
- November 25, 2024
- Indication:
- For the treatment of recurrent glioblastoma (rGBM)
Announcement
Plus Therapeutics, Inc. presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM).
AI Summary
Plus Therapeutics, Inc. recently presented updated data from its ReSPECT-LM Phase 1 clinical trial at the 2024 Society for Neuro-Oncology Annual Meeting. The trial evaluates Rhenium (186Re) Obisbemeda—a rhenium nanoliposome—administered as a single intrathecal dose for patients with leptomeningeal disease (LM). Early data show a favorable response rate and promising median overall survival. The treatment delivers up to eight times the radiation dose in the CNS subarachnoid space compared to standard external beam radiation, while maintaining a supportive safety profile.
Encouraged by the consistent response data, including survival improvements seen in some compassionate use cases, the company is rapidly advancing its research to include dose expansion and multiple-dose trials. The FDA has agreed to initiate a Phase 1 multiple administration dose escalation trial, marking a significant step toward enhanced treatment options for LM patients.
Read Announcement- Drug:
- Rhenium (186Re)
- Announced Date:
- October 1, 2024
- Indication:
- For the treatment of recurrent glioblastoma (rGBM)
Announcement
Plus Therapeutics, Inc. presented an update on the ongoing ReSPECT-GBM Phase 1/2 clinical trial, evaluating the Company's lead asset Rhenium (186Re) Obisbemeda for the treatment of recurrent glioblastoma.
AI Summary
Plus Therapeutics, Inc. provided an update on its ongoing ReSPECT-GBM Phase 1/2 clinical trial during the 2024 Congress of Neurological Surgeons Annual Meeting. The trial evaluates the company’s lead asset, Rhenium (186Re) Obisbemeda, delivered via convection enhanced delivery (CED), for treating recurrent glioblastoma. The data, led by neurosurgeon Dr. John Floyd, demonstrated that the therapy continues to show a favorable safety profile while producing promising efficacy signals in a challenging patient population.
In the study, the average Phase 2 tumor absorbed radiation dose reached 300 Gy, with 89% of patients exceeding the minimal threshold of 100 Gy. Encouraging safety and response results have supported the expansion of trial sites to two additional leading U.S. academic centers in New York and the Upper Midwest, highlighting the potential of Rhenium (186Re) Obisbemeda as a promising option for recurrent glioblastoma treatment.
Read Announcement
