Latest news with #REGEN-007
Yahoo
14-07-2025
- Business
- Yahoo
ProKidney Just Set a New 52-Week High. Should You Buy, Sell, or Hold PROK Stock Here?
Chronic kidney disease (CKD) is a silent epidemic. In this high-stakes space, biotechnology companies focused on reversing or slowing CKD progression are racing for a breakthrough. Successful clinical trials are not only scientific wins, but the catalysts that can ignite sector-wide rallies. Especially when the weapon isn't another pill, but cell therapy — an approach that could redefine kidney care as we know it. One such player that just jolted the market is ProKidney (PROK), a biotech making noise with bold science and even bolder stock moves. Once backed by SPAC king Chamath Palihapitiya, this overlooked biotech stock just pulled off a 515% surge thanks to impressive top-line data from its Phase 2 REGEN-007 trial. Its autologous cell therapy, rilparencel (REACT), significantly slowed kidney function decline. Shopify Stock is a Bargain - How to Make a 3.2% One-Month Yield with SHOP Tariffs, Inflation and Other Key Things to Watch this Week Stocks Set to Open Lower as Trump Ratchets Up Tariff Threats, U.S. Inflation Data and Big Bank Earnings Awaited Get exclusive insights with the FREE Barchart Brief newsletter. Subscribe now for quick, incisive midday market analysis you won't find anywhere else. While some on Wall Street are optimistic, raising price targets and seeing real potential for accelerated approval, others remain skeptical, pointing to trial design gaps and warning that PROK stock may have sprinted too far, too fast. So, should investors ride the wave of optimism and snag shares? Or is this rally already baked into the price? Founded in 2015, ProKidney is a clinical-stage biotech tackling CKD with regenerative cell therapy. In 2022, it went public through a $2.6 billion SPAC merger with Social Capital Suvretta Holdings, backed by Chamath Palihapitiya. Its lead candidate, rilparencel, is a first-in-class minimally invasive autologous cell therapy designed to preserve or even improve kidney function, potentially delaying or eliminating the need for dialysis. Now in a Phase 3 trial, ProKidney is drawing attention as it reimagines what's possible for CKD patients. ProKidney went public at around $10 per share, but the stock soon lost momentum, slipping into penny territory. For a while, it stayed quiet. That was until July 2025 flipped the narrative. Following strong Phase 2 trial results for its CKD therapy, PROK stock skyrocketed more than 600% in just five days, hitting a 52-week high of $7.13 on July 9 before cooling to $4.34 — still a massive leap from $0.61 just two days earlier. Despite the breather, PROK stock is up 169% on a year-to-date (YTD) basis. The rally pushed its market capitalization from $177 million to over $1 billion. Plus, on July 8 alone, over 343 million shares changed hands, signaling aggressive buying interest. On May 12, ProKidney dropped its fiscal first-quarter 2025 numbers, and Wall Street liked what it saw. The stock jumped 15.8% in the next trading session — not bad for a clinical-stage biotech still chasing its first product approval. While technically still pre-revenue, the company logged $230,000 at the top line, with a per-share loss of $0.13, beating the Street's expectations and improving by nearly 19% year-over-year (YOY). R&D spending held steady at $27.3 million, with hiring and facility costs nudging higher, offset by lower clinical trial expenses due to the winding down of earlier-phase programs. General and administrative costs rose to $14.4 million, mainly from increased salaries and professional fees, typical for a company scaling up for a pivotal Phase 3. Importantly, ProKidney ended the quarter with a solid $328.5 million in cash, giving it runway through mid-2027. That's enough to push its lead therapy through late-stage testing. But if trial costs balloon, talks of dilution or partnerships could heat up. Analysts tracking the company anticipate its per-share losses to shrink by 21% YOY to $0.49 in fiscal 2025, then narrow another 4% to $0.47 in fiscal 2026. ProKidney's recent rally was more than just market noise. It was a reaction to meaningful clinical signals. The company's Phase 2 REGEN-007 trial revealed that rilparencel significantly slowed kidney function decline in patients with CKD and diabetes, and that's a big deal. Importantly, the U.S. Food and Drug Administration had previously indicated that rilparencel could qualify for accelerated approval if a validated surrogate endpoint showed strong results. That bar was seemingly met in Group 1 of the trial as it saw an annual improvement of 78% in 'eGFR slope' (the rate of kidney function decline), strengthening the case for regulatory momentum. With a critical FDA meeting scheduled this summer, Wall Street caught wind of the momentum, and the stock blasted off on renewed optimism. However, enthusiasm must be tempered. The trial had a small sample size, and while Group 1 showed promise, the 50% improvement in eGFR slope in Group 2 was 'not statistically significant,' raising questions about consistency and durability. Regulators may demand harder endpoints in Phase 3 instead of relying only on eGFR improvements. Meanwhile, competition is also heating up, with contenders like Eli Lilly (LLY) and Novo Nordisk (NVO) racing forward in the same space. And as a small-cap biotech, with no product revenue yet, ProKidney remains highly volatile and vulnerable to both hype and setbacks. Wall Street is split on ProKidney's explosive run, with some eyeing a true biotech breakout while others question the substance behind the surge. Citi sees promise and took the bullish lane. The firm kept a 'Buy' rating and hiked PROK stock's price target from $6 to $9, calling the early Phase 2 data better than expected. Citi now sees a 60% probability of success for rilparencel. With statistically and clinically meaningful results, analysts believe the therapy could fast-track toward approval if Phase 3 holds up. But not everyone's buying the breakout. Bank of America stayed firmly in the skeptic camp, maintaining its 'Underperform' rating and $1 price target. The firm's concerns run deep — no sham comparator in the REGEN-007 trial, limited weight from open-label eGFR data, and uncertainty over which patients drove the results. Even more, the bank flagged ambiguity around the regulatory path and warned the Phase 3 timeline could stretch beyond ProKidney's cash runway. Analysts also questioned whether the market for rilparencel is large enough without exceptionally strong data. Evercore ISI struck a more measured tone. Analyst Jonathan Miller called the top-line results 'very intriguing,' but said they're still holding off on buying the stock. While the ongoing Phase 3 trial could be a major catalyst in kidney care, results are not expected any sooner. PROK stock has a consensus 'Moderate Buy' rating overall. Out of seven analysts covering the biotech stock, four recommend a 'Strong Buy,' two give a 'Hold,' and one analyst gives a 'Moderate Sell' rating. Amid the sharp climb this week, PROK stock has edged past its average price target. Meanwhile, Citi's Street-high target of $9 suggests shares could rally as much as 98%. ProKidney just lit up the biotech radar with a massive stock surge and promising trial data, but the hype comes with high-stakes risk. PROK stock's ride from penny status to a $1 billion valuation was fast, volatile, and fueled by future hopes, not current revenue. Analysts remain split, and FDA approval is still a ways off. If investors are in, they'll need to brace for turbulence as this is not a classic steady climber. The potential is real, but so are the risks. On the date of publication, Sristi Suman Jayaswal did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Forbes
09-07-2025
- Business
- Forbes
ProKidney: What's Happening With PROK Stock?
Turmeric capsules are on display on a table in Lisbon, Portugal, on May 15, 2025. (Photo by Luis ... More Boza/NurPhoto via Getty Images) ProKidney Corp. (NASDAQ: PROK) has seen significant volatility following encouraging Phase 2 clinical trial outcomes for its REGEN-007 study, which assesses rilparencel in patients suffering from chronic kidney disease (CKD) and diabetes. The study indicated considerable enhancements in kidney function: These findings mark a significant clinical milestone, as chronic kidney disease impacts millions globally and available treatment options are still limited. The positive trial results prompted a substantial market response, with the stock skyrocketing over 500% on July 8. Nevertheless, this surge should be viewed in context: despite this recent jump, the stock still sits over 70% below its 2023 peak of roughly $13. Current consensus price targets from analysts hover around $4.00, implying that the stock may be fairly valued at its present levels. Although peak sales forecasts of $900 million indicate potential for growth, these remain speculative until commercialization is approved. If you're seeking upside with a smoother experience than a single stock, consider the High Quality portfolio, which has outperformed the S&P and achieved over 91% returns since its inception. Additionally, see – WOLF Stock To $20? ProKidney currently holds a relatively stable financial standing. The company boasts a robust cash balance of $358 million, which represents 81% of its total assets. In addition, it carries a minimal debt load of merely $3.2 million, yielding a debt-to-equity ratio below 1%, reflecting a conservative capital structure. Nonetheless, specific financial issues require scrutiny. ProKidney has incurred operating expenditures totaling $185 million over the past year, and as a clinical-stage firm, it has no commercial products that generate revenue. The existing cash burn rate, while normal for companies at this development phase, will necessitate continuous observation. Beyond the financials, investing in ProKidney entails notable risks that potential investors must carefully evaluate. A significant concern is the uncertainty related to its Phase 3 trial; succeeding in Phase 2 does not ensure success in Phase 3 or subsequent regulatory approvals. The company also encounters competitive risks from other organizations developing therapies for chronic kidney disease. ProKidney's limited pipeline, which heavily relies on rilparencel and lacks alternative programs, introduces additional risk. Moreover, as a penny stock, it is vulnerable to substantial price fluctuations. For context, PROK stock plummeted 91% from a high of $13.78 on March 13, 2023, to $1.21 on November 17, 2023. Finally, its valuation is speculative, based on anticipated projections rather than verified commercial performance. While ProKidney's Phase 2 outcomes signify authentic scientific advancement, the stock's considerable increase has likely already absorbed much of the favorable news. The company faces typical hurdles associated with clinical-stage biotechnology firms, including regulatory unpredictability, significant cash outflow, and reliance on a solitary experimental treatment. In light of the high-risk profile and existing valuation levels, individual investors should proceed with utmost caution. Now, we utilize a risk assessment framework while constructing the Trefis High Quality (HQ) Portfolio which, consisting of 30 stocks, has a record of comfortably outperforming the S&P 500 over the previous four-year timeframe. Why is that? Collectively, HQ Portfolio stocks have provided superior returns with reduced risk compared to the benchmark index; offering a less volatile experience, as demonstrated in HQ Portfolio performance metrics.
Business Insider
09-07-2025
- Business
- Business Insider
Why Is ProKidney Stock (PROK) Up 60% Today?
ProKidney (PROK) stock rocketed higher on Tuesday after the clinical-stage cellular therapeutics company reported results from its Phase 2 REGEN-007 trial evaluating rilparencel in patients with chronic kidney disease (CKD) and diabetes. Don't Miss TipRanks' Half-Year Sale Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. CKD is a condition where the kidneys are damaged, causing poor blood filtering and the buildup of waste and fluid in the body. Diabetes is when the body doesn't produce enough insulin, which can result in high blood sugar levels. The big news here was top-line and statistically significant results from rilparencel. ProKidney said it has the potential to 'preserve kidney function in patients with advanced CKD and type 2 diabetes.' The company already has a Phase 3 clinical trial of the treatment underway, and it has a meeting with the Food and Drug Administration (FDA) that could accelerate the drug's approval. ProKidney Stock Movement Today PROK stock was up 58.29% during pre-market trading on Tuesday, following a 4.82% dip yesterday. Investors will note that the shares were down 64.11% year-to-date and have fallen 75.74% over the past 12 months. Today's rally came with heavy trading, as some 53 million shares traded, compared to a three-month daily average of about 1.27 million units. Is ProKidney Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for ProKidney is Moderate Sell, based on one Hold and one Sell rating over the past three months. With that comes an average PROK stock price target of $3, representing a potential 394.64% upside for the shares.
Business Insider
09-07-2025
- Business
- Business Insider
ProKidney price target raised to $9 from $6 at Citi
Citi raised the firm's price target on ProKidney (PROK) to $9 from $6 and keeps a Buy rating on the shares after the company reported results from the Phase 2 REGEN-007 study evaluating rilparencel in diabetes and chronic kidney disease. The firm says the initial data exceeded Citi's and management's expectations. REGEN-007 demonstrated statistically significant efficacy in group one, which may support accelerated approval in Phase 3 pending FDA confirmation, the analyst tells investors in a research note. Citi upped its probability of sucess for REGEN-007 to 60% from 50%. Don't Miss TipRanks' Half-Year Sale Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Yahoo
08-07-2025
- Business
- Yahoo
ProKidney Is Soaring on Trial Results. How Should You Play Penny Stock PROK Here?
ProKidney (PROK) shares soared as much as 660% this morning after the biotech firm said its Rilparencel showed promising results as a treatment of chronic kidney disease in a Phase 2 trial. The company's candidate treatment did not exhibit any serious adverse events during the course of the mid-stage trial either – its press release confirmed on Tuesday. This Analyst Just Raised His Broadcom Stock Price Target by 70%. Should You Buy AVGO Now? Why Alibaba Stock Looks Like a Screaming Buy After Falling 27% From Its 2025 Highs 2 ETFs Offering Juicy Dividend Yields of 20% or Higher Get exclusive insights with the FREE Barchart Brief newsletter. Subscribe now for quick, incisive midday market analysis you won't find anywhere else. Including today's meteoric run, ProKidney stock is trading at roughly 740% from its year-to-date low set in April. The REGEN-007 clinical trial update is significant for ProKidney investors since it clears the path for Rilparencel to advance into Phase 3 evaluation and eventually attempt to secure FDA approval. Positive mid-stage data often leads to a significant increase in a biotech firm's valuation, attract institutional interest, and raise the likelihood of strategic partnerships or future funding. This milestone position ProKidney, which targets chronic kidney disease, as a potential front-runner in renal regenerative medicine. That's why PROK shares are ripping massively to the upside on Tuesday. While the Rilparencel data reported this morning is positive for ProKidney, investors should note that it, nonetheless, is a penny stock with a market cap of just $177 million. ProKidney shares, therefore, remain inherently risky to own – especially after today's cosmic run – as penny stocks often suffer from low liquidity and high volatility. PROK stock is exposed to sharp price swings and speculative hype also because it's a pre-revenue company that's relying on continued positive trial updates and regulatory approvals that are not guaranteed. Investors should remain wary of buying ProKidney stock at current levels also because it's already trading near analysts' average price target. While the consensus rating on PROK shares remains at 'Moderate Buy,' the mean target of $4.33 is below its current trading price. On the date of publication, Wajeeh Khan did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on
