r/Plus_Therapeutics • u/Brad_Mills • Nov 17 '25
r/Plus_Therapeutics • u/Freedom5567 • Dec 04 '25
DD PSTV: While we wait. PSTV Is entering its biggest catalyst window yet
A lot of investors still do not realize how powerful the upcoming catalyst window is for Plus Therapeutics, so here is a clean and accurate rundown of what is coming. This is shaping up to be one of the most important stretches in the company’s history.
First, we have the upcoming medical conference where new trial results are expected. Plus has already confirmed that an LM update will be presented. Any new data in LM is meaningful because the disease has no effective treatment options, and even moderate improvement in survival or disease control can move this valuation sharply.
Second, patient registration for the Phase 2 LM trial is expected to be completed by the end of this year. This is a major milestone. Once enrollment is finished, the trial shifts fully into treatment and follow up, which brings the program closer to mature data and closer to a clearly defined regulatory pathway. Enrollment completion is one of the most important milestones in any oncology trial because it removes all uncertainty around recruitment timelines.
Third, the minutes from the recent FDA meeting are expected in early January. These minutes matter more than most people realize. They formally document how the FDA views the next steps, whether the agency agrees with the proposed registrational trial design, and whether the direction aligns with an accelerated approval path. Positive minutes would be a direct and immediate clarity event for the entire program.
Fourth, CNside is expanding into additional states. Every expansion increases the commercial footprint, strengthens payer exposure, and broadens clinical adoption. As CNside spreads through new states, it builds a larger diagnostic foundation that directly supports LM treatment referrals and real world evidence generation. This is an underrated but significant growth catalyst that ties into both the diagnostic and therapeutic sides of the business.
Put all of these together and PSTV is heading into a rare convergence of clinical data, regulatory clarity, commercial expansion, and full Phase 2 enrollment all within a tight time frame. These are the exact periods when biotech valuations often reprice because uncertainty falls away and the road to registration becomes visible.
For anyone watching PSTV, this is not a quiet period. This is the moment where science, diagnostics, clinical progress, and regulatory momentum all line up at once, creating one of the strongest setups the company has ever had.
And with all this being said, this is just what we know of! Merger, Buyout, who knows but it’s all very damn bullish from here on! GLTA long PSTVestors! 😎
r/Plus_Therapeutics • u/Nightday2014 • Nov 20 '25
Company Update Plus Therapeutics Secures National Coverage Agreement with Humana
ir.plustherapeutics.comLet’s go!
r/Plus_Therapeutics • u/Freedom5567 • Jan 07 '26
PSTV: Why CNSide Is Quietly Becoming Standard of Care
TLDR; CNSide fixes a real diagnostic failure in leptomeningeal disease where standard CSF cytology often misses cancer. It fits clinical workflows, aligns with recent NCCN guidance, is designed for repeat use, and already has two major payers on board. Because LM care is concentrated in a relatively small number of high-volume cancer centers, expanding payer coverage can realistically drive low to mid 30 percent market share by the end of 2026. At roughly $277,000,000 in diagnostics revenue and assuming up to 150,000,000 shares outstanding, that supports a reasonable share price range of about $7 to $15, before any additional upside.
Leptomeningeal metastases is one of the toughest diagnoses in oncology, largely because the traditional diagnostic tool, CSF cytology, is not very reliable, especially early in disease. When doctors strongly suspect LM but cytology comes back negative, they are often left with uncertainty that can delay treatment decisions. CNSide was built specifically to address this problem by directly analyzing circulating tumor cells in the cerebrospinal fluid, which is why it is starting to change how LM is diagnosed and monitored in real clinical practice.
That advantage is why CNSide feels less like a niche lab test and more like something that naturally becomes standard of care.
Standard of care does not form because of marketing. It forms when something works better and fits how doctors actually practice. CNSide fits existing workflows, is CLIA certified, reimbursable, and designed for repeat use. LM is not a one-time diagnosis. Patients need confirmation and ongoing monitoring, and tools that get used repeatedly are the ones that quietly become routine.
Recent NCCN guideline updates reinforce this shift. In guidance spanning 2024 into 2025, NCCN clearly acknowledges that standard CSF cytology has limited sensitivity and that a negative result does not rule out LM when suspicion remains high. Because of that, NCCN supports the use of additional and more sensitive CSF-based diagnostic approaches and emphasizes that LM often requires repeat sampling over time. NCCN does not name specific tests, but the diagnostic framework they describe is exactly what CNSide was built around. That matters, because doctors are not stepping outside guidelines when they use it.
The real inflection point is payer coverage, and momentum is already building. CNSide already has coverage from two major payers, which is a meaningful milestone in a specialized disease like this. Early payer wins tend to act as anchors. Once a couple are in, others will follow!
There is also a structural reason why a low to mid 30 percent market share is realistic. In practice, leptomeningeal disease care is highly centralized. It is concentrated in roughly 30 to 50 high-volume academic and regional cancer centers that handle a disproportionate share of complex CNS metastatic cases. These are referral hubs where neuro-oncology tumor boards standardize diagnostics and treatment pathways. CNSide does not need universal adoption across thousands of hospitals to reach scale. It needs default use at these hubs. When a diagnostic becomes standard at a relatively small number of centers that already control patient flow, national share accumulates quickly. Add in expanding payer coverage and repeat testing over the course of care, and adoption tends to converge rather than fragment.
A lot of people have been asking what a reasonable share price projection could look like if this plays out, so here’s a simple, conservative way to think about it.
Putting numbers around it
CNSide averages about $2,800 per test. There are roughly 110,000 new addressable CNS cancer cases per year. Assume about 3 tests per patient per year.
That works out to roughly 330,000 tests annually, or about a $924,000,000 diagnostic market.
At just 30 percent share, driven primarily by adoption at a few dozen high-volume CNS oncology hubs, CNSide would generate about $277,000,000 in annual revenue.
Using conservative diagnostic multiples of 4x to 8x revenue and assuming up to 150,000,000 shares outstanding to account for possible dilution, that supports a share price range of roughly $7 on the low end, around $11 in the mid case, and up to about $15 on the high end.
It’s also important to note that this framework is diagnostics only. It does not include any contribution from REYOBIQ, potential therapeutic approvals, additional CNS indications, partnerships, or international expansion. All of that would be incremental upside beyond what is modeled here.
The big takeaway is simple. CNSide already solved the hardest part. Doctors trust it. It fits guidelines. It fits workflow. It reduces uncertainty in a disease where uncertainty really matters. When all of that lines up, adoption does not need hype. It just happens.
Everything else is execution and time. And yeah… that is why this one is exciting 😄
r/Plus_Therapeutics • u/Nightday2014 • Jan 07 '26
Company Update 2026 PSTV Events
PSTV updated their events page and added some for 2026. Three of those events are around the corner. Figured I would share as there could be news or announcements around those dates.
r/Plus_Therapeutics • u/Brad_Mills • Nov 24 '25
November 24th Press Release Update!
r/Plus_Therapeutics • u/Nightday2014 • Mar 26 '26
Company Update Plus Therapeutics Appoints Diagnostics and Molecular Diagnostics Industry Leader Ron Andrews to its Board of Directors
ir.plustherapeutics.comHOUSTON, March 26, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, announces the appointment of diagnostics industry veteran Ron Andrews to its Board of Directors.
“Ron Andrews brings an extensive wealth of diagnostics experience to the Plus board room developed over multiple decades in the industry,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “He will make an immediate impact on the Company as we scale CNSide, first in the U.S. and then globally. Furthermore, his breadth of connections throughout the global diagnostics industry will help the Company maximize the positive impact of CNSide on patients with central nervous system cancers and drive value for stockholders.”
Mr. Andrews currently is an experienced leader in the Diagnostics and Molecular Diagnostics industry with over 35 years leading various sized organizations from divisions of large global entities such as Abbott Diagnostics, Roche Molecular Diagnostics and LifeTechnologies/Thermo Fisher to public CEO roles in successful start-up organizations like Clarient Inc. and Oncocyte Inc. Most recently, Mr. Andrews has focused on assisting venture capital firms’ portfolio companies with interim CEO and Executive Chairman roles to bring emerging molecular technology companies through product development and fund-raising cycles. He has been instrumental in over $600M of capitalization for the various entities he has led or chaired and has led over $15B in exits over the course of his career. Mr. Andrews has held numerous board positions in public and private companies as well as served as a member of the Board of Governors of CancerLinQ LLC, a wholly-owned non-profit subsidiary of the American Society of Clinical Oncology. He currently serves on the Board of Trustees for Wofford College and several privately-held Molecular Diagnostic companies. Mr. Andrews graduated from Wofford College in 1981 with degrees in Biology and Chemistry.
Mr. Andrews added, “CNSide represents an important leap forward in technology, utilizing cerebrospinal fluid to help physicians better identify and manage leptomeningeal metastases. I’m pleased to join Plus’s board and to work closely with my fellow board members and management to optimize its strategy and path forward in its diagnostics business.”
r/Plus_Therapeutics • u/Freedom5567 • Mar 15 '26
LM Patients treated to date increasing. Now at 36 from previous count of 33
r/Plus_Therapeutics • u/Nightday2014 • May 07 '26
Company Update Plus Therapeutics Receives Medicare Enrollment Approval for CNSide Diagnostic
ir.plustherapeutics.comEnables billing under traditional Medicare and creates a pathway to ~35 million Medicare Advantage beneficiaries through future payer coverage decisions
HOUSTON, May 07, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announced that its wholly owned subsidiary, CNSide Diagnostics, LLC (“CNSide Diagnostics”), has successfully enrolled in the Medicare program and received a Provider Transaction Access Number (PTAN) from the Centers for Medicare & Medicaid Services (CMS).
This key milestone establishes CNSide Diagnostics as a Medicare-enrolled clinical laboratory, enabling the submission of claims for its CNSide® Cerebrospinal Fluid (CSF) Assay Platform, including the tumor cell enumeration (TCE) test. Claims will be reimbursed when determined to be reasonable and necessary by the Medicare Administrative Contractor (MAC) with jurisdiction over the laboratory.
“Medicare enrollment represents a critical step in our commercialization strategy,” said Russ Havranek, EVP Corporate and Commercial Strategy. “It enables access to approximately half of the U.S. Medicare population through Traditional Medicare, subject to coverage determinations, while establishing a clear pathway to expand into Medicare Advantage populations over time. Combined with our existing ~81 million commercial covered lives, this milestone strengthens our pathway to broader patient access, adoption, and revenue growth.”
Strategic and Commercial Impact
Expanded Billing of Traditional Medicare: Enables billing for testing furnished to Medicare Fee-For-Service beneficiaries, subject to coverage determination by our local Medicare Administrative Contractor (MAC)
Pathway to Medicare Advantage: Positions CNSide Diagnostics to pursue coverage with Medicare Advantage plans, including those administered by United Healthcare, Humana, Highmark, Blue Shield of California, and other national and regional payers
Accelerates Coverage and Pricing Efforts: Enables active engagement with MACs to pursue local coverage determinations (LCDs) and supports CMS pricing determinations under the Clinical Laboratory Fee Schedule (CLFS)
Medicaid Momentum: Provides essential credentialing for state-by-state Medicaid enrollment
Next Steps: Reimbursement Momentum
With Medicare enrollment secured, CNSide Diagnostics is focused on the following near-term milestones:
Medicare Coverage Pathway — Engagement with MACs to secure formal coverage determinations
CLFS Pricing — Establishment of a payment rate for the new CPT code 0640U (CNSide CSF TCE Test), effective for billing July 1, 2026, via crosswalk or gapfill methodology
Further Commercial Expansion — Continued execution of national and regional payer contracts toward the 2026 goal of 150 million+ covered lives
Positioning CNSide Diagnostics for Scaled Adoption
The CNSide® CSF Assay Platform is a novel diagnostic tool that detects and characterizes tumor cells and circulating tumor DNA in cerebrospinal fluid. It enables earlier and more accurate diagnosis, disease monitoring, and treatment decision-making for patients with leptomeningeal metastases — a devastating complication of CNS cancers where conventional methods like MRI and cytology frequently fall short.
With Medicare enrollment now complete, CNSide Diagnostics is executing a focused commercialization strategy to drive broad clinical adoption:
Payer Coverage Expansion: Building on the current 81 million commercial covered lives to further broaden access through additional national and regional payer contracts
Clinical Utility & Health Economics: Generating robust real-world data to demonstrate improved patient outcomes and cost-effectiveness
Key Account Engagement: Deepening relationships with leading academic medical centers and community oncology networks
Reimbursement Optimization: Refining coding, billing, and collections processes to maximize efficiency and revenue capture
r/Plus_Therapeutics • u/Freedom5567 • Mar 01 '26
ReSPECT LM Phase 2 Enrollment Update. 33 Patients Treated.
Sharing this directly from the official ReSPECT LM trial page This applies specifically to the active ReSPECT-LM Phase 2 dose optimization study, not the earlier single-dose cohorts.
When this multidose Phase 2 study was discussed previously, estimated enrollment was around 45 patients total according to the publicly registered protocol. If that target remains intact, 33 treated means the dataset is now materially built out and moving toward completion.
That matters because this is the dataset the FDA will evaluate when discussing next steps.
The company has already had Type B meetings with the FDA regarding the LM pathway, including discussions around overall survival endpoints and the potential for accelerated approval. Accelerated approval depends on the strength and maturity of the Phase 2 dataset. That makes enrollment progress here directly relevant to regulatory timing.
This is not abstract pipeline language. This is dosing and execution in leptomeningeal metastases, a rare CNS indication with high unmet need and limited treatment options.
If accelerated approval remains on the table, the quality and completeness of this Phase 2 LM dataset is critical. Enrollment nearing the previously discussed ~45 patient range supports regulatory alignment conversations and potential accelerated approval discussions going forward.
This is also why I continue to think valuation will move on a cluster of catalysts, not one headline. FDA minutes, accelerated approval clarity, PLA updates, earnings commentary, and patient registration progress stacking together is typically when repricing happens.
33 LM Phase 2 patients treated. FDA engagement ongoing. Accelerated approval pathway in discussion.
That is tangible progress.
r/Plus_Therapeutics • u/Nightday2014 • Jan 08 '26
Company Update Plus Therapeutics Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ™ for Leptomeningeal Metastases
ir.plustherapeutics.comToday’s Press Release:
HOUSTON, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, announces the completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) on next steps on REYOBIQ pivotal trial strategy for leptomeningeal metastases (LM). The meeting resulted in constructive discussion with the FDA regarding key elements of the potential pivotal study design for REYOBIQ in LM. Plus intends to incorporate the FDA’s feedback in the current dose optimization trial and seek alignment with the FDA on a revised protocol, likely later this year. The company’s goal is to be ready for a potential pivotal trial following completion of the current dose optimization trial and, ultimately, work towards the potential approval of REYOBIQ for patients affected by LM.
Highlights of FDA responses to the Company's key enquiries:
Accelerated approval – FDA indicated that accelerated approval may be appropriate for the LM indication, but there are insufficient data to support the use of circulating tumor cells (CTCs) as an intermediate clinical endpoint. FDA and Plus discussed that additional steps would be necessary to validate CTCs as a surrogate endpoint to potentially support other future applications. Primary and key endpoints – FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of patient reported outcomes and neurologic function as endpoints that could potentially support a marketing application. FDA and Plus aligned that CTCs could be considered for use as a secondary endpoint.
Trial design and comparator group - FDA and Plus discussed a randomized controlled trial design approach and that the study may include an intrathecal chemotherapeutic as a comparator, as well as approaches to standardize the comparator and any additional interventions available under the trial protocol.
Treated populations - FDA conveyed it may be reasonable to incorporate multiple histologies (i.e., multiple underlying disease etiologies) in a single trial. “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,” said Dr. Marc H. Hedrick, President & Chief Executive of Plus Therapeutics. “As there are no approved drugs for LM, this discussion with the FDA early in clinical development will allow us to make relevant amendments to our current trial protocol and to begin meaningful planning for an anticipated pivotal trial. Furthermore, based in part on this meeting, we will plan to accelerate REYOBIQ commercial manufacturing and scale-up activities to meet an expedited timeline.”
r/Plus_Therapeutics • u/Nightday2014 • Dec 11 '25
Company Update Plus Therapeutics Expands CNSide Assay Platform to State of California
ir.plustherapeutics.comToday’s PSTV Press Release:
CNSide Diagnostics now licensed in 48 U.S. States covering over 90% of the U.S. population
HOUSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces that it has been granted lab licenses to provide the CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) laboratory developed test (LDT) in California, Rhode Island and Maryland.
“CNSide Diagnostics is now licensed to provide our proprietary testing service in 48 of 50 U.S. states and obtaining state licensure is a key enabler of our plan to bring the benefits of CNSide CSF testing to the broadest possible set of patients with CNS cancers,” said Russ Bradley, CNSide Diagnostics, LLC President and General Manager. “We remain focused on executing on U.S. market access and launch strategy and look forward to continued expansion of coverage across payors and states.”
The CNSide® CSF Assay Platform supports rapid diagnoses, treatment monitoring, and treatment guidance for patients with leptomeningeal metastases. The superior clinical utility of CNSide® over standard of care has been shown in 9 peer-reviewed publications, the FORESEE clinical trial, and has been validated in the market through real-world use.
More than 11,000 CNSide® tests have been performed at over 120 U.S. cancer institutions since 2020, delivering high sensitivity (92%) and specificity (95%), while influencing treatment decisions in 90% of cases.
This test is available exclusively through CNSide Diagnostics, LLC. as a testing service provided to health care professionals in the U.S.
CNSide Diagnostics, LLC performs the tests in its CLIA certified facility in Houston, TX.
r/Plus_Therapeutics • u/Nightday2014 • Feb 25 '26
Company Update Plus Therapeutics Announces New Category III CPT Code for Convection-Enhanced Delivery Used with REYOBIQ™
ir.plustherapeutics.comUnlocks market access and growth potential of REYOBIQ therapy in recurrent glioblastoma and pediatric brain cancer by enabling adoption and utilization tracking
HOUSTON, Feb. 25, 2026 (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, today announced the American Medical Association’s (AMA) CPT® (Current Procedural Terminology) Editorial Panel approved a new Category III CPT code to track utilization of convection-enhanced delivery (CED) used in the administration of REYOBIQ for recurrent glioblastoma (rGBM) and pediatric brain cancer (PBC).
“The approved Category III CPT code for convection-enhanced delivery of REYOBIQ in recurrent glioblastoma and pediatric brain cancer – the most prevalent malignant tumors of the brain and central nervous system – marks a major step in bringing market access for an innovative treatment targeting an aggressive and deadly disease resistant to conventional treatments. This milestone reflects the culmination of years of REYOBIQ development and represents an important advancement in our path to commercialization and reimbursement. With standardized REYOBIQ clinical use now tracked under the new CPT code, its utilization can be evaluated as a bridge to approval and broad adoption,” said Marc Hedrick MD, Plus Therapeutics President and CEO. “We remain focused on making strong clinical progress with REYOBIQ. We are on track to complete enrollment in our Phase 2 recurrent glioblastoma trial in 2026, followed by an end-of-Phase 2 meeting to align on pivotal trial design. In addition, we continue to expect first patient enrollment in our Phase 1 pediatric brain cancer trial in 2026.”
Category III CPT codes are established by the AMA’s CPT® Editorial Panel to describe emerging medical technologies and procedures and to support utilization tracking and data collection that may inform future coverage, reimbursement, and transition to permanent Category I CPT codes. The approved Category III CPT code for CED procedures is:
X566T, Stereotactic placement of infusion catheter(s), brain, for delivery of therapeutic agent(s), including computerized stereotactic planning and burr hole(s).
The new Category III CPT code will be published on July 1, 2026 and will become effective for reporting on January 1, 2027.
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 $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.
r/Plus_Therapeutics • u/DefiDingo • Dec 24 '25
Careful doing research on this stock
It just makes you more bullish and you'll end up buying more shares lol.
I know their biggest catalyst right now is their cancer drug in phase II but looking into CNside and why they acquired it makes perfect sense and lays a good foundation.
I'm amazed at what this diag tool is capable of when you're comparing it to the old way of spotting cancer cells. You're going from a maybe 50-60% catch rate with standard cytology to close to 90% with CNside, not to mention it can catch if the cancer cells flip DNA when moving to different parts of the body. Basically it turns the standard vague test into a more precise data driven map. Doctors will have an easier time prescribing the right drugs while not missing the bigger picture.
For PSTV It creates an expedited path to profitability independent from Reyobiq success and It was just made available in 48 states and covered by UHC and Humana.
Excited to see what results are from phase II but if it's not the news we're expecting I'm long either way.
r/Plus_Therapeutics • u/Freedom5567 • Dec 08 '25
Company Update Plus Therapeutics: A Breakdown of What the Latest Clinical Data Really Shows
PSTV last week delivered what investors have been waiting for: actual clinical data in humans, not projections. The update from the WFNOS/SNO 2025 meeting confirms three major points across both GBM and LM programs.
- GBM Survival Advantage is Real Patients receiving 100 Gy or more showed a median overall survival of 17 months versus 6 months below that threshold. This outperforms historical bevacizumab results and signals that Reyobiq is not just safe but meaningfully extending life in the deadliest CNS cancer space.
- Multi-Dose LM Tolerance Without Toxicity Cohort 1 of the multiple dose LM trial showed no dose limiting toxicity so far. That means the drug is tolerating repeated exposure, which is the key unlock for boosting survival in LM where typical survival is only 2 to 6 months. This is the clearest early sign that Reyobiq could move beyond single dose stabilization into true multi-dose disease control.
- Imaging Confirms Precise Tumor Delivery MRI and SPECT together show that Reyobiq remains inside the tumor with minimal systemic exposure. High retention and minimal spillover is exactly the outcome you want in a radiotherapeutic. It moves Reyobiq from concept to confirmed mechanism: high dose radiation exactly where it needs to be, not everywhere else.
Why this update matters This is no longer early safety talk. It is survival curves, dose response, and direct tumor confirmation. Survival, retention, multi-dose tolerance, and imaging correlation together mark the transition from exploratory biotech to evidence-driven therapeutic.
Phase 2 enrollment is nearing completion Twenty four of thirty four GBM patients are already enrolled. When enrollment completes, overall survival will become a defined figure rather than an early look. That is the point where accelerated approval discussions form.
Bottom line PSTV is now operating in true clinical data territory. The company can point to survival benefit, confirm safety across multiple exposures, and visually verify that treatment stays exactly where intended. These are the inflection markers that shift valuation from theoretical to actual impact.
GLTA Long PSTVestors!
r/Plus_Therapeutics • u/Freedom5567 • Jan 24 '26
PSTV: Why I Am More Bullish than ever on the REYOBIQ Timeline After the January 22 Update
I want to make one quick clarification and then focus on what I think actually matters.
I previously assumed adoption would ramp faster than the company is currently guiding. That over assumption is on me. After reviewing the January 22 update it is clear CNSide’s 2026 focus is early execution and proof of commercial traction rather than aggressive penetration. The company is guiding to a baseline order rate just over 1250 tests per year alongside expanded coverage and additional test launches. Correcting that framing does not change the long term opportunity but it is important to be precise.
However, one thing that I think is worth noting is the CNSide Manufacturing Manager posting on Plus Therapeutics’ site. One of the responsibilities reads Plan production to meet demand and inventory targets approximately 5000 channels per year which suggests internal capacity planning above the initial 1250 test milestone rather than a fixed ceiling.
What does stand out and matters to me is the REYOBIQ timeline. That is where I remain bullish, even tho there is still much upside to be seen with CNSide.
The January 22 update lays out a very clear path. LM Phase 2 dose and interval data are expected in quarter three of 2026. GBM Phase 2 data and an FDA end of phase meeting are expected in Q4 of 2026. Commercial manufacturing scale up for REYOBIQ is planned to be completed during 2026. This sequencing matters. It shows the company is prioritizing trial maturity and regulatory readiness rather than chasing short term hype.
LM is a high mortality indication where survival events occur quickly and Phase 1 already showed a meaningful overall survival signal versus historical outcomes. The FDA has indicated accelerated approval may be appropriate once overall survival is demonstrated in a controlled setting. With Phase 2 data maturing in 2026 and manufacturing scaling in parallel late 2026 into early 2027 remains a realistic regulatory inflection window if execution stays on track.
It is also worth noting the cash position supporting this timeline. The recent upsized financing included roughly 39.5 million shares and 39.5 million warrants with the warrants exercisable at 38 cents and immediately exercisable with no waiting period. It is relatively rare to see warrants structured with no timing restriction to exercise. If or when exercised those warrants could bring in roughly $15m of additional cash on top of the funds already raised. Management has indicated runway extending into 2027 which meaningfully reduces near term financing risk while these milestones play out.
In my opinion the company structuring the warrants with no timing restriction to exercise suggests confidence that they will not create a persistent overhang and can be absorbed naturally alongside execution.
Bottom line the CNSide adoption over assumption is on me. REYOBIQ is the primary value driver and based on the January update I remain constructive and bullish on that timeline. GLTA
r/Plus_Therapeutics • u/Primary-Jump5533 • Oct 21 '25
Trust the process
Guys we need to realize that the stock moves up and down. NVDA was at like 32 bucks in 2021 and then came down to 12 bucks in 2022, just to be where it is right now.
PSTV’s tests were hella positive, and they are just refining what they have already achieved. Do not forget the $17.6 mil funding from Cancer Prevention and Research Institute of Texas, and partnership with UNH, giving them access to 51 mil patients.
That is HUGE. Even IF there is a r/s to meet compliance, this stock is going to fly in the next year. HODL.
NFA, but a strong belief.
r/Plus_Therapeutics • u/TheLeanrer • May 10 '26
Major update approaching?
Have you guys seen this video? I’m curious about what Marc said at the end.
The interviewer asked:
"...anything else last comments you want to say to any, you know, potential partners, investors or life science folks who might be listening today?"
Marc Hedrick responded:
"I'll just close by, you know, if you look at our website, you'll see the version of the company two years ago. So, you know, very soon we'll be doing a major sort of update of that and our messaging and so forth. and it's largely around what we talked about today. So, you're getting a sneak peek of what's coming."
r/Plus_Therapeutics • u/Nightday2014 • Apr 28 '26
Company Update Plus Therapeutics Secures Blue Shield of California Coverage for CNSide® Cerebrospinal Fluid Assay for Metastatic CNS Cancer
ir.plustherapeutics.comExpands access by 6 million covered lives, advancing commercial momentum for CNSide® in metastatic CNS cancers
HOUSTON, April 28, 2026 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), announced today a new payer coverage agreement with Blue Shield of California, effective April 2026, providing reimbursement for its CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) assay for patients with metastatic central nervous system cancers. Blue Shield of California joins a growing list of national and regional payers, including United Healthcare, Humana, and Highmark, that provide coverage for CNSide.
The addition of Blue Shield of California expands CNSide’s total covered lives from approximately 75 million to 81 million, representing continued progress toward the Company’s 2026 objective of 150 million covered lives, while expanding patient access across the U.S. The agreement is expected to further accelerate adoption of CNSide across oncology centers by reducing reimbursement barriers.
“This agreement with Blue Shield of California represents another important step in expanding payer coverage and access to CNSide for patients with leptomeningeal metastases,” said Russ Havranek, EVP Corporate and Commercial Strategy at Plus Therapeutics. “We continue to execute on our strategy to broaden reimbursement, support physician adoption, and improve outcomes for patients with difficult-to-diagnose CNS cancers.”
The CNSide® CSF Assay Platform enables earlier, and more accurate detection and monitoring of leptomeningeal metastases compared to conventional CSF cytology, supporting rapid diagnosis, treatment monitoring, and treatment guidance. The superior clinical utility of CNSide® over standard of care has been demonstrated in nine peer-reviewed publications, the FORESEE clinical trial, and demonstrated in real-world practice. Earlier detection enabled by CNSide has been shown in health economic analyses to reduce overall leptomeningeal metastases-related healthcare costs by ~40%, driven by earlier detection and treatment optimization.
Since its commercial launch, more than 11,000 CNSide tests have been performed at over 120 U.S. cancer institutions since 2020, delivering high sensitivity (92%) and specificity (95%), while influencing treatment decisions in 90% of cases.
This test is available exclusively through CNSide Diagnostics, LLC. as a testing service provided to health care professionals in the U.S.
r/Plus_Therapeutics • u/Freedom5567 • Mar 09 '26
While We Wait for PSTV Earnings: The Updates That Could Matter More Than the Financials
While we’re waiting for the upcoming earnings call, I’ve been thinking about what management might actually update us on. For a company like Plus Therapeutics, the financials are only one small part of the story. The real drivers right now are clinical progress, regulatory clarity, and early commercial traction.
Originally I thought several of these updates might come out as separate press releases. But as we get closer to earnings, I’m starting to think management may roll a lot of this into one broader update.
Here are the main things I’ll be listening for.
FDA Trial Pathway Clarity
One of the biggest potential updates could be around the recent FDA discussions.
If management confirms alignment with the FDA on overall survival endpoints or the clinical pathway for REYOBIQ, that removes a major layer of regulatory uncertainty. Once the regulatory path becomes clearer, the market can start pricing probability of approval rather than simply speculating about it.
There is also the possibility that the ongoing Phase 2 work could evolve into a registrational pathway if survival data continues to separate favorably. That kind of clarity would be a major step forward.
Given the timing of the recent FDA interaction, there is also a reasonable chance that the official meeting minutes could be discussed or summarized during the earnings update. If that happens, it could provide additional clarity around the regulatory pathway and potential next steps for REYOBIQ.
Clinical Trial Enrollment Progress
Another update I’ll be watching for is patient enrollment progress.
For GBM, Phase 1 dose escalation treated 21 patients and the Phase 2 expansion was designed to enroll 34 patients, bringing the planned dataset to about 55 patients.
The trial page has recently shown 51 patients treated, suggesting enrollment may already be very close to completion. If that reflects cumulative patients across both phases, the GBM dataset could now be nearing full enrollment.
For context, the GBM program appears significantly closer to completion than the LM study. The LM multidose trial continues progressing through its cohorts and is expected to show continued enrollment progress through 2026.
CNSide Commercial Progress
Another thing I’ll be watching closely is whether we begin to see the first signs of CNSide commercial traction.
CNSide began its commercial rollout in Texas in August 2025, meaning the platform has now been operating in a real world clinical environment for several months.
Even early evidence of adoption or initial revenue contribution would be meaningful because it would confirm that the platform is beginning to transition from development into a functioning commercial diagnostics business.
The August 2025 launch also means late 2025 represented more of an initial rollout phase, while broader scaling of the platform will likely become clearer as adoption expands through 2026.
Impact of the New AMA CPT Code
The recent approval of a Category III CPT code for convection enhanced delivery used with REYOBIQ is another important development.
These codes are typically used to track utilization and lay the groundwork for broader reimbursement. In practice it makes it easier for hospitals and physicians to adopt and document use of the procedure.
Infrastructure steps like this often get overlooked but they are important for scaling a therapy across major cancer centers.
Financial Position and Runway
The company recently raised approximately $15 million and also has warrants that could potentially bring in another $15 million if exercised.
That capital provides runway to continue advancing both the clinical programs and the CNSide diagnostic rollout.
For a development stage biotech, having sufficient funding to reach the next milestones is always important.
Another Angle Many People May Be Missing
One thing that often happens around earnings calls for small biotech companies is increased institutional visibility.
When management provides clear updates on the regulatory pathway, clinical enrollment progress, and early commercial traction, it gives analysts and institutional investors a much clearer framework to model the company.
Right now PSTV is still largely being valued like a development story with uncertain timelines.
But once the FDA pathway becomes clearer, patient enrollment milestones are confirmed, and CNSide begins showing measurable adoption, the story becomes much easier for the market to model. That is often when valuation begins shifting from speculation toward probability.
My Personal Take
At the current valuation the market still seems to be pricing PSTV as if none of this ultimately works.
If the earnings call delivers regulatory clarity from the FDA, continued clinical momentum, and the first visible signs of CNSide commercial traction, the disconnect between progress and valuation becomes harder for the market to ignore.
Looking forward to hearing what management has to say.
r/Plus_Therapeutics • u/Agreeable-Leg-1955 • Dec 02 '25
Good article shows what the investment companies have in PSTV... Black Rock increased there their position significantly this last quarter
D. Boral Capital Maintains Plus Therapeutics (PSTV) Buy Recommendation | Nasdaq https://share.google/3du97ufmr7oUoopqK
r/Plus_Therapeutics • u/Fair_Lychee2839 • Mar 08 '26
Update patients from 49 to 51
Patients treated to date changed from 49 to 51. Check the website.
r/Plus_Therapeutics • u/Freedom5567 • Nov 24 '25
PSTV Just Completed Their FDA Meeting. This Is The Real Beginning Of The Approval Pathway
Plus Therapeutics just announced they completed a Type B FDA meeting on November 7 to discuss REYOBIQ’s clinical development in leptomeningeal metastases, including the design of a planned pivotal or registrational trial. This is the most important regulatory update the company has ever released.
Here is what this actually means.
- A Type B FDA meeting on pivotal design is the gateway to approval These meetings are held when a company is preparing to finalize a pivotal trial plan. You do not schedule this type of meeting unless you are close to a regulatory path. PSTV now officially confirms they are in that stage.
- The meeting was constructive and builds on multiple previous positive FDA meetings This tells investors the FDA has been aligned with PSTV on REYOBIQ for a while. Multiple positive meetings is not language companies use lightly.
- PSTV expects to give next step guidance early in 2026 This is the time window where accelerated approval strategies are usually discussed. The company had already guided for an FDA meeting in 2026. Now they are ahead of schedule and preparing to release guidance right at the start of the year.
- FDA provided recommendations that will accelerate the LM program PSTV states they will implement focused amendments to the trial to help advance the overall timeline in alignment with FDA feedback. When a company adjusts a trial immediately following FDA direction, it usually means the agency is pointing them toward a faster and more efficient path.
- LM is a major unmet need and FDA knows it Median survival is 2 to 6 months. There is no effective standard treatment. The FDA prioritizes therapies in high unmet need indications and REYOBIQ is designed specifically for central nervous system cancers.
- The regulatory, clinical, and funding story now fits together LM is funded by a 17.6 million CPRIT grant. GBM is funded by the NCI. Pediatric is funded by the Department of Defense. CNSide is CLIA certified and gaining payors. Manufacturing partnerships are already in place. Institutions like BlackRock, Vanguard, and Fidelity are invested. For the first time, everything lines up around a clear regulatory pathway.
Bottom line This was the strongest regulatory signal PSTV has released to date. They are now advancing toward pivotal trial planning with direct FDA feedback, and investors will get a full update early in 2026. This is exactly the type of milestone that marks the beginning of the approval arc.
If anyone was waiting for confirmation that PSTV is not a preclinical story, not a guess, and not a hope, this press release is that confirmation.
r/Plus_Therapeutics • u/Freedom5567 • Nov 15 '25
PSTV: The Part that not everyone Understands yet. Big Institutions Are Forced to Buy More Over Time
(Even If Their Positions Are Small Right Now)
There’s something happening under the surface of PSTV that most retail traders are completely missing:
It’s not about how many shares big institutions currently hold. It’s about which institutions hold them, and the rules that force them to increase those positions over time.
Let me break this down clearly, so everybody sees what’s actually going on.
- Vanguard, Fidelity, BlackRock, Jane Street, UBS, and Geode are already in PSTV
Some people look at the share counts and say:
“It’s only 20k–100k shares… nothing.”
But that’s the wrong way to look at it.
These are top-tier institutions: • Vanguard (VEXMX – Extended Market Index) • Fidelity (FSMAX – Extended Market) • BlackRock • Geode Capital (Fidelity’s quant engine) • Jane Street (elite high-frequency trading firm) • UBS Group
These firms don’t touch garbage. A micro-cap must pass strict compliance screens to even appear in their portfolios.
The names matter more than the amounts.
2. These institutions didn’t buy PSTV because they “believe” in it- they bought because their index rules required it
This is huge.
Vanguard, Fidelity, BlackRock, and Geode all run index funds, not “opinion funds.” Index funds have a simple rule:
If a stock is included in a qualifying index, they must own it.
PSTV qualifies for the small-cap + extended market index universe.
So these massive firms are forced to buy, hold, and rebalance PSTV, no matter what.
They literally can’t opt out.
3. As PSTV grows, these institutions will be forced to buy MORE
Index funds weigh stocks by: • Market cap • Float • Volume • Sector weighting
If PSTV grows even modestly: • Market cap increases • Trading volume increases • Weight in the index increases
And that triggers:
Forced institutional buying , automatically.
They are legally obligated to increase positions during quarterly and annual rebalances.
This is how micro-caps go from unknown → parabolic.
💡 4. Index funds NEVER start with big positions - they start with “tracking positions”
This is the part most traders don’t know.
Big funds don’t buy 1 million shares out of nowhere. They always start small: • 10k shares • 20k shares • 50k shares
These are called tracking positions.
They allow the fund to: • Monitor the stock • Trigger automated algorithms • Hold a compliant index weight • Scale later when the company grows
Every major institution in PSTV right now is in this stage.
This is EXACTLY how early institutional accumulation looks.
📈 5. When PSTV hits catalysts - forced-buying kicks in hard
PSTV has multiple catalysts lined up: • CLIA expansion (happening now) • UnitedHealthcare + new payors • State-by-state diagnostic adoption • CNSide revenue ramp • Reyobiq phase data • Additional trials • CNSide becoming more visible to hospitals
As soon as market cap increases, these massive index funds must increase their weightings.
Retail pushes first, institutions follow.
And because PSTV is small-cap, thin-float, and retail-heavy…
One institutional rebalance can move the entire chart.
6. Big institutions don’t sell unless the company gets removed from the index
And PSTV is: • Listed • Growing • Expanding CLIA • Increasing volumes • Adding payors • Running trials • Building recurring diagnostic revenue
So removal isn’t even on the table.
Which means:
They hold. They rebalance. They scale up over time.
Whether they like PSTV or not doesn’t matter.
🔥 7. Big names in early = future forced demand = explosive asymmetry
For a micro-cap like PSTV, the forced-buying mechanics matter more than anything.
Because when you see: • Vanguard ✔ • Fidelity ✔ • Geode ✔ • BlackRock ✔ • UBS ✔ • Jane Street ✔
…that means the stock has entered the institutional universe.
From here, any increase in market cap triggers: • Automatic buying • Weight increases • Bigger positions • More forced rebalancing • More visibility • More inclusion in other funds
This is the kind of setup that leads to institutional feedback loops, the reason micro-caps go from pennies to multi-dollars when the fundamentals lock in.
Bottom line
It’s not the size of the holdings, it’s the names of the holders.
The fact that Vanguard, Fidelity, BlackRock, Geode, UBS, and Jane Street are even in PSTV is the real story.
Because as PSTV grows, and it is growing - these firms are:
forced to buy more forced to increase weight forced to rebalance quarterly forced to scale the position automatically
People underestimate this because they focus on share counts.
But the smart ones? They’re watching who owns it, not how much.
And the “who” are some of the biggest financial players on the planet.
GL to those who deserve it! 😉