PSTV Stock on November 25, 2025: FDA Meeting, Nasdaq Extension and Humana Deal Put Plus Therapeutics Back in Focus

As traders log in on Tuesday, November 25, 2025, Plus Therapeutics (NASDAQ:PSTV) is back on the radar thanks to a cluster of late‑November catalysts: an FDA Type B meeting for lead radiotherapeutic REYOBIQ™, a fresh 180‑day Nasdaq bid‑price extension, and a national coverage agreement with Humana for its CNSide® cancer diagnostic.

As of the latest completed trading session on Monday, November 24, PSTV last changed hands at $0.5752, up roughly 8% on the day, after trading between $0.50 and $0.59 on volume of about 8.4 million shares. Even after that bounce, the stock still sits well below its 52‑week high of $2.31 and above its 52‑week low of $0.16, underscoring how volatile this micro‑cap biotech has been over the past year. ^[1]

Below is a closer look at what’s driving PSTV stock today, 11‑25‑2025, and the key storylines traders are watching.

How PSTV stock is setting up today

• Latest price (Nov 24 close/late trade): $0.5752
• Intraday range (Nov 24): $0.5002 – $0.5865
• Approximate daily gain (Nov 24): +7.96%
• Volume (Nov 24): ~8.45 million shares traded
• Market cap (recent): around $70–75 million, based on recent trading around $0.50–0.60 per share. ^[2]

MarketBeat data show Plus Therapeutics shares have swung between $0.16 and $2.31 over the last 12 months, marking the company as a highly volatile penny‑stock‑range biotech. ^[3] For short‑term traders, that volatility can be the attraction; for longer‑term investors, it’s a warning sign that position sizing and risk management matter.

Heading into today’s U.S. session, the latest available quote is still from Monday’s trading, so early‑day moves on November 25 may shift these levels in real time.

Catalyst #1: FDA Type B meeting on REYOBIQ for leptomeningeal metastases

The most immediate headline for PSTV stock is regulatory rather than financial.

On November 24, Plus Therapeutics announced that it completed a Type B meeting with the U.S. FDA on November 7 to discuss future clinical development plans for REYOBIQ™ (rhenium Re‑186 obisbemeda) in leptomeningeal metastases (LM), including the design of a planned pivotal or registrational trial. ^[4]

Key points from that update:

• The meeting focused on pivotal trial design for REYOBIQ in LM — a necessary step before Plus can run a registrational study. ^[5]
• Management described the discussion as “constructive” and said it builds on prior positive FDA interactions around REYOBIQ’s clinical development and manufacturing. ^[6]
• The company expects to receive meeting minutes and provide guidance on next steps in early 2026, and plans to make targeted amendments to its LM trial to align with FDA recommendations. ^[7]

Why LM matters

Leptomeningeal metastases are a rare but devastating complication of advanced cancers where tumor cells spread to the fluid‑lined structures of the central nervous system. Roughly 5% of patients with metastatic cancer develop LM, with breast, lung and melanoma being the most common primaries. Median survival is often just 2–6 months, and effective treatment options remain limited. ^[8]

That high unmet need is the backdrop for Plus Therapeutics’ LM program:

• In August 2025, data from the ReSPECT‑LM Phase 1 trial showed that REYOBIQ produced a clinical benefit rate above 75% across three clinically relevant outcome measures, alongside biomarker changes (RNA sequencing and circulating tumor cell reductions) consistent with tumor cell death. No dose‑limiting toxicities were observed at the tested doses, including the recommended Phase 2 dose. ^[9]

For PSTV stock, the FDA meeting itself is not an approval — it’s a planning step. But it signals that:

1. The LM program is advanced enough to discuss pivotal trial design, and
2. The company expects clearer regulatory guidance in 2026, a natural future catalyst for the share price.

Until investors see the final pivotal design, timelines, and endpoints, though, regulatory risk remains high.

Catalyst #2: Nasdaq gives PSTV more time to fix its bid price

The other major November headline is about PSTV’s listing status.

On November 17, Plus Therapeutics reported that Nasdaq granted the company an additional 180‑day extension to regain compliance with the exchange’s $1.00 minimum bid price requirement under Listing Rule 5550(a)(2). ^[10]

What the extension means in plain English:

• PSTV now has until May 11, 2026 to get its closing bid price to at least $1.00 for 10 consecutive business days. ^[11]
• The notice does not immediately affect its Nasdaq Capital Market listing; the stock continues to trade under the PSTV ticker. ^[12]
• The company emphasized that no near‑term reverse stock split is required to meet the rule, although it also warned there is no guarantee it will regain compliance. ^[13]

With PSTV last around $0.58, the stock would need roughly a 74% price increase just to hit $1.00, and then it must hold that level for at least 10 straight trading days. ^[14] That’s a tall order for any micro‑cap, let alone a clinical‑stage biotech that still reports losses.

The company’s latest Form 10‑Q for the quarter ended September 30 flagged “substantial doubt” about its ability to continue as a going concern, citing cumulative losses, negative cash flow, and ongoing funding needs — even after a recent cash rebuild. ^[15] So while the extension removes immediate delisting pressure, it doesn’t eliminate the longer‑term listing risk.

For PSTV stock watchers, the bid‑price extension is a double‑edged sword:

• Positive: More time to execute clinically and commercially without rushing into a reverse split.
• Negative: The extension underscores the fact that the share price is still well below Nasdaq’s threshold and might require dilutive financings or corporate actions to fix if organic appreciation doesn’t materialize.

Catalyst #3: Humana and UnitedHealthcare expand CNSide coverage to 67 million lives

While REYOBIQ is the high‑profile drug asset, Plus also owns CNSide Diagnostics, LLC, a wholly owned subsidiary that markets the CNSide® cerebrospinal fluid (CSF) tumor cell enumeration test for metastatic CNS cancer, including LM. ^[16]

CNSide is a lab‑developed test (LDT) that measures tumor cells and molecular markers in CSF to support LM diagnosis, treatment selection and ongoing monitoring.

Two payor deals in 2025 have dramatically expanded its covered population:

1. UnitedHealthcare national coverage (September 15, 2025)
   • Effective mid‑September, Plus signed a national agreement with UnitedHealthcare covering more than 51 million people in the U.S. for the CNSide CSF Tumor Cell Enumeration test. ^[17]
2. Humana national coverage (October 29, 2025)
   • On November 20, the company announced a national coverage agreement with Humana, effective October 29, adding coverage for approximately 16 million additional people.
   • Together with UnitedHealthcare and other policies, this brings total CNSide CSF TCE policy coverage to about 67 million lives. ^[18]

Plus and CNSide also highlight that:

• >11,000 CNSide tests have been performed at over 120 U.S. cancer centers since 2020.
• Internal and published data show about 92% sensitivity and 95% specificity, with the test influencing clinical treatment decisions in roughly 90% of cases. ^[19]

From an investment perspective, the CNSide platform does three things:

1. Potential revenue stream: Reimbursed diagnostic testing can generate recurring revenue if utilization grows across the 67 million covered lives.
2. Strategic synergy: CNSide’s ability to measure LM disease burden and molecular changes dovetails with REYOBIQ’s development in the same indication.
3. Validation signal: National coverage from UnitedHealthcare and Humana serves as a third‑party vote of confidence in the clinical utility of the test, even though actual revenue ramp and margins are still uncertain. ^[20]

What Plus Therapeutics actually does: radiotherapeutics + diagnostics

At a high level, Plus Therapeutics is building a CNS‑focused radiopharma + diagnostics platform:

• REYOBIQ™ (rhenium Re‑186 obisbemeda)
  • A Rhenium‑186 radiolabeled nanoliposome therapy designed to deliver high‑dose, localized radiation to brain and CNS tumors while sparing healthy tissue. ^[21]
  • Disease targets include recurrent glioblastoma (GBM), leptomeningeal metastases (LM), and pediatric brain cancers. ^[22]
  • Delivery methods:
    • Convection‑enhanced delivery (CED) directly into brain tissue for GBM and pediatric brain tumors.
    • Intraventricular delivery via Ommaya reservoir for LM, placing drug directly into the CSF compartment where tumor cells circulate. ^[23]
• 188RNL‑BAM (Rhenium‑188 NanoLiposome Biodegradable Alginate Microsphere)
  • A radioembolization candidate that loads Rhenium‑188 nanoliposomes into biodegradable alginate microspheres, intended for primary and metastatic liver cancers. This program is earlier‑stage than REYOBIQ. ^[24]

The company’s core platform relies on chelation of Rhenium into nanoliposomes using its proprietary BMEDA chemistry, allowing radiolabeled particles to remain in the tumor region for days rather than hours, and enabling live imaging thanks to gamma emissions. ^[25]

For PSTV stock, the bull case hinges on whether this combination of precision radiotherapeutics plus a companion‑like diagnostic (CNSide) can translate into regulatory approvals, real‑world adoption, and durable revenue streams in rare but high‑value CNS cancer niches.

Financial picture: more cash, but losses and going‑concern warning

Biotech investors care just as much about cash as they do about clinical data. For Plus Therapeutics, recent quarters show a mixed but improving picture.

Q2 2025: one‑time profitability

In its Q2 2025 earnings release, Plus reported:

• Net income:$5.2 million (about $0.02 per share), versus a $2.9 million loss a year earlier.
• Operating loss:$1.5 million, improved from $3.7 million in Q2 2024.
• Cash and investments:$6.9 million at June 30, 2025, up from $3.6 million at year‑end 2024.
• Grant revenue:$1.4 million in Q2 from the $17.6 million CPRIT grant supporting the LM program. ^[26]

However, management and third‑party summaries were clear that the net income figure was largely driven by a non‑cash gain (~$6.5 million) from revaluing derivative instruments, not from core operations. ^[27]

Q3 2025: back to a loss, but stronger balance sheet

By Q3 2025, the picture normalized:

• Net loss: about $4.4 million for the quarter.
• R&D expense: roughly $2.4 million.
• G&A expense: roughly $3.4 million.
• Grant revenue:$1.4 million.
• Cash and cash equivalents:$13.3 million at September 30, 2025.
• Working capital: about $4.0 million, versus a negative $10.3 million at December 31, 2024.
• Stockholders’ equity: around $5.1 million, positive after prior deficits.
• Financing cash inflows (year‑to‑date): approximately $27.5 million, including sales under a Lincoln Park equity facility and other capital raises. ^[28]

That improved equity position helped Plus regain compliance with Nasdaq’s equity requirements earlier in 2025, but — as the going‑concern language in the 10‑Q makes clear — the business is still not self‑funding. ^[29]

For PSTV shareholders, that means:

• Future dilution risk from additional stock or warrant issuances remains high.
• The company’s ability to finance late‑stage trials and commercialization without excessively diluting existing holders is still an open question.

What Wall Street is saying about PSTV stock

Despite its small size, PSTV does have some analyst coverage — and the published targets are aggressive.

• StockAnalysis aggregates four analysts with an average 12‑month price target of about $7.25, and describes consensus as “Strong Buy” — implying potential upside of more than 1,000% from recent prices, if those targets were ever reached. ^[30]
• MarketBeat reports a broader mix:
  • D. Boral Capital recently reaffirmed a Buy rating with a $5 price target. ^[31]
  • Ascendiant Capital has a Buy rating with a $19 target, trimmed from $21. ^[32]
  • HC Wainwright reportedly carries a Buy rating with a lower target (around $2). ^[33]
  • Other firms include at least one Sell and one Hold, leaving the overall MarketBeat consensus at “Moderate Buy” with an average target around $7.75. ^[34]

It’s important to remember:

• These price targets are opinions, not guarantees, and they can change quickly with new data or financing events.
• For a micro‑cap biotech with ongoing losses, analyst models often assume successful trial outcomes and commercial launches that are still years away and inherently uncertain.

Key things traders and investors will watch next

Going into the rest of 2025 and early 2026, PSTV stock is likely to trade around a relatively short list of catalysts:

1. FDA meeting minutes and pivotal trial design for REYOBIQ in LM
   • The company has signaled it will share more detailed next‑step guidance in early 2026 once it receives and digests the FDA’s written feedback. ^[35]
   • Investors will look for clarity on trial size, endpoints, statistical assumptions, and potential timelines toward a registrational readout.
2. Further CNSide commercial ramp
   • With UnitedHealthcare and Humana now on board, the focus shifts to test volumes, reimbursement dynamics, and revenue contribution as the U.S. rollout progresses. ^[36]
3. Additional clinical data
   • Updates from ReSPECT‑LM, ReSPECT‑GBM and the pediatric brain cancer program — including any early data under the FDA‑cleared pediatric IND — could move sentiment significantly in either direction. ^[37]
4. Capital raises and balance‑sheet moves
   • With roughly $13 million in cash at the end of Q3 and ongoing R&D and commercial spending, the market will watch closely for new equity, debt, or partnership deals, and how dilutive they might be. ^[38]
5. Progress toward Nasdaq’s $1 bid requirement
   • If PSTV’s share price remains under $1 as May 11, 2026 approaches, investors will start handicapping the odds of a reverse split, further extensions, or a potential move to an OTC venue.

Bottom line on PSTV stock today

As of November 25, 2025, PSTV is a headline‑driven micro‑cap biotech with:

• Real, externally‑validated clinical and diagnostic progress in a high‑need area (leptomeningeal metastases and CNS cancers). ^[39]
• Meaningful commercial setup for its CNSide diagnostic via two large national payors and tens of millions of covered lives. ^[40]
• Improved but still fragile finances, including a recent cash rebuild but ongoing losses and an explicit going‑concern warning. ^[41]
• Continued Nasdaq listing risk, now pushed out to a May 2026 deadline for the $1.00 bid‑price rule. ^[42]

For traders, that mix can create sharp, news‑driven price swings — both up and down — as each new data point or financing update lands. For long‑term investors, PSTV sits squarely in the high‑risk, high‑uncertainty bucket typical of early‑stage oncology names.

If you’re evaluating PSTV stock today, some practical questions to weigh include:

1. Clinical risk: How comfortable are you with the probability that REYOBIQ’s LM and GBM programs ultimately succeed in pivotal trials and gain approval?
2. Financing risk: Are you prepared for further dilution if the company needs to raise substantial capital before becoming cash‑flow positive?
3. Execution risk: Do you believe Plus can scale CNSide utilization and reimbursement fast enough to materially offset R&D spend?
4. Listing risk: How would a reverse split or potential delisting affect your strategy and risk tolerance?

And, as always:

This article is for informational and educational purposes only and does not constitute financial, investment, or trading advice. Always do your own research and consider speaking with a licensed financial professional before making investment decisions.

References

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