Buckle up, traders, because today’s market is serving up some serious action, and one stock is stealing the spotlight! Plus Therapeutics, Inc. (Nasdaq: PSTV) is screaming higher, with shares surging as of this writing, thanks to a game-changing announcement that’s got investors buzzing. The U.S. Food and Drug Administration (FDA) just gave the green light to the company’s Investigational New Drug (IND) application for REYOBIQ™, a cutting-edge treatment aimed at tackling pediatric brain cancers like high-grade glioma and ependymoma. This is big news, folks, and it’s sending PSTV’s stock price into overdrive. Let’s dive into what’s driving this move, why it matters, and what it means for traders looking to navigate this wild market.

The Catalyst: FDA Clearance for REYOBIQ™

This morning, Plus Therapeutics dropped a bombshell: the FDA cleared its IND application for REYOBIQ™ (Rhenium Re186 Obisbemeda), paving the way for a Phase 1/2a clinical trial called ReSPECT-PBC. This trial, backed by a hefty $3 million grant from the U.S. Department of Defense, will test REYOBIQ™ in kids aged 6 to 21 (and potentially up to 25) with aggressive brain tumors that have come back or stopped responding to standard treatments. We’re talking about rare but devastating cancers like high-grade glioma and ependymoma, which strike about 3.3 out of every 100,000 kids and have a grim five-year survival rate as low as 22% for some cases.

REYOBIQ™ is no ordinary drug. It’s a radiotherapeutic, meaning it delivers targeted beta radiation directly to the tumor, zapping cancer cells while sparing healthy tissue. What’s cool about this approach? It uses something called convection-enhanced delivery (CED), which bypasses the blood-brain barrier—a major roadblock for many brain cancer treatments. Think of it like a precision-guided missile for tumors, and early data from Plus Therapeutics’ adult trials for glioblastoma (another brutal brain cancer) is already showing promise, with patients who got high doses doubling their survival time compared to standard care.

Dr. Ashley S. Plant, the trial’s lead investigator at Ann & Robert H. Lurie Children’s Hospital of Chicago, summed it up perfectly: “Surgery and external radiation have been the mainstays for these kids, but outcomes haven’t budged in decades. This novel therapy could be a game-changer.” That kind of hope, paired with FDA backing, is why the market is going nuts for PSTV today.

Why the Stock Is Soaring

As of this writing, PSTV is up over 100%—a monster move for a small-cap biotech like this. Why the frenzy? First off, FDA clearances are like rocket fuel for biotech stocks. Getting the IND approved means Plus Therapeutics can start enrolling patients in the ReSPECT-PBC trial, a major milestone that de-risks the program and brings REYOBIQ™ closer to potential commercialization. Plus, the $3 million DoD grant means the company isn’t footing the entire bill, which is music to investors’ ears for a firm with a market cap hovering around $3 million before today’s surge.

Second, pediatric brain cancer is an area with massive unmet need. There aren’t many effective treatments out there, and the emotional weight of helping kids with cancer resonates with investors and the public alike. If REYOBIQ™ shows even a hint of success in this trial, it could attract attention from bigger players in the pharma world, potentially leading to partnerships or even a buyout down the road.

Finally, let’s talk sentiment. Posts on X are lighting up with chatter about PSTV, with traders calling it “squeezy” and hyping the FDA news. This kind of social media buzz can amplify price moves, especially for low-float stocks like PSTV, where fewer shares are available to trade, making it easier for demand to outstrip supply and send prices soaring.

The Risks: Don’t Get Blinded by the Hype

Now, hold your horses before you dive headfirst into PSTV. Biotech stocks are a rollercoaster, and today’s big winner can be tomorrow’s big loser. Here’s the deal: Plus Therapeutics is a clinical-stage company, meaning it’s not selling drugs yet and is burning cash to fund trials. Its latest financials show a cash balance of $9.9 million as of Q1 2025, but with a net loss of $17.4 million in that quarter, the runway isn’t infinite. The company has leaned on grants (like the DoD’s $3 million and a $17.6 million CPRIT grant for other trials) and equity financings ($15 million raised in March 2025) to keep the lights on, but dilution is a real concern. Just yesterday, PSTV announced a restructuring to cancel 1.5 billion shares’ worth of potential dilution, which is a positive move, but future fundraising could still weigh on the stock.

Then there’s the clinical risk. The ReSPECT-PBC trial is early-stage (Phase 1/2a), focused on finding the right dose and checking safety before digging into efficacy. Even if the trial goes smoothly, it’s years away from FDA approval, and plenty can go wrong along the way—unexpected side effects, disappointing results, or even regulatory hurdles. Biotech trials are like high-stakes poker: you need a strong hand and a lot of luck to win.

And let’s not forget volatility. Small-cap biotechs like PSTV can swing wildly on news, and today’s 100%+ gain could easily reverse if the hype fades or if broader market conditions turn sour. Traders need to be nimble and disciplined, setting clear entry and exit points to avoid getting caught in a downdraft.

The Rewards: Why PSTV Has Potential

On the flip side, the rewards could be huge for those who play their cards right. If REYOBIQ™ delivers in the pediatric trial, it could transform Plus Therapeutics from a tiny biotech into a serious player in the central nervous system (CNS) cancer space. The company’s already got traction with REYOBIQ™ in adult trials, including a 76% clinical benefit rate in leptomeningeal metastases and doubled survival in glioblastoma patients at high doses. Add in FDA Fast Track and Orphan Drug designations for other indications, and you’ve got a pipeline with serious credibility.

Plus, the CNS cancer market is heating up. A recent report pegged the global brain cancer treatment market as rapidly growing, driven by rising cases and new tech like targeted therapies. If Plus Therapeutics can carve out a niche with REYOBIQ™, the upside could be massive—especially with a stock trading at such a low market cap. For context, successful biotech stocks can rocket from pennies to dollars on positive trial data, and PSTV’s current price (around $0.35 as of this writing) leaves plenty of room for growth if the stars align.

Lessons for Traders: Riding the News Wave

PSTV’s surge today is a textbook example of how news can move markets, and it’s a great chance to talk about trading strategy. Catalysts like FDA clearances, trial results, or big grants can light a fire under a stock, but smart traders know how to ride the wave without wiping out. Here’s the playbook:

1. Stay Informed: News moves fast, and you need to be in the know. Following reliable sources and keeping tabs on market chatter (like posts on X) can help you spot opportunities early. Want to stay ahead of the game? Tap here to get free daily stock alerts sent straight to your phone—no strings attached, just pure market insights.
2. Time Your Entry: Jumping into a stock up 100% mid-morning can be tempting, but it’s often a recipe for buying the top. Look for pullbacks or consolidation to find a better entry point, and always have a plan for where you’ll take profits or cut losses.
3. Manage Risk: Biotech stocks are volatile, so never bet the farm on one trade. Use position sizing to limit your exposure, and set stop-loss orders to protect your capital. A 100% gain can turn into a 50% loss faster than you can say “clinical trial.”
4. Know the Story: Stocks like PSTV move on narrative as much as fundamentals. The FDA clearance and DoD grant are powerful stories, but dig into the company’s financials, pipeline, and trial timelines to understand the bigger picture. Knowledge is your edge in this game.
5. Don’t Chase Hype: Social media can pump a stock into the stratosphere, but hype fades. If you’re late to the party, wait for the dust to settle rather than chasing a runaway train.

What’s Next for Plus Therapeutics?

Looking ahead, all eyes are on the ReSPECT-PBC trial. The Phase 1a/b portion will enroll about 24 kids to figure out the maximum tolerated dose, with safety checks along the way. If that goes well, Phase 2a will test efficacy in 32 more patients. Results from these early stages could be another catalyst for PSTV, especially if they echo the promising data from adult trials. The company also got other irons in the fire, like trials for leptomeningeal metastases and glioblastoma, plus a diagnostic platform called CNSide set to launch in Q3 2025.

On the financial front, Plus Therapeutics is walking a tightrope. The $9.9 million cash pile, grants, and recent financing give it some breathing room, but it’ll need to keep raising funds or score partnerships to reach the finish line. Yesterday’s restructuring to slash dilution risk shows management’s listening to shareholders, but traders should watch for any signs of more share offerings.

The Bottom Line

Plus Therapeutics is the talk of the town today, and for good reason. The FDA’s nod for REYOBIQ™ in pediatric brain cancer is a massive step forward, and the market’s eating it up with a triple-digit gain as of this writing. But this is biotech, folks—high risk, high reward. The potential for REYOBIQ™ to change lives and disrupt the CNS cancer space is real, but so are the hurdles of cash burn, trial risks, and market volatility. For traders, PSTV’s surge is a chance to learn how to play news-driven moves with discipline and smarts.

Want to keep your finger on the pulse of stocks like PSTV? Tap here to join over 250,000 traders getting free daily stock alerts sent right to their phones. No hype, just insights to help you navigate this crazy market. Stay sharp, trade smart, and let’s keep riding these waves!