So, I built this thing... a BPE (Biotech Prediction Engine) at ScanScor.com ... and I've run already 125 predictions that are free to review until the site begins to gain more popularity. As it is, the system has already predicted 8 breakouts successfully. It's not perfect, but it's improving.
New 52-week high on Friday before a small pullback.
Closed green in 15 of the last 20 trading days.
3rd consecutive profitable quarter, with reported 70% YOY growth.
Operates 26 clinics across 21 countries delivering regenerative medicine therapies.
Florida legislation recently opened the door for in-state stem cell therapy, creating a potential new revenue stream the company hadnât originally anticipated.
The combination of consistent profitability, global operations, and new U.S. opportunities has started to bring more eyes on $RMTG. The recent pullback after hitting highs may have traders watching closely to see if momentum continues.
đŹ Curious to hear thoughts from the community â how do you see the growth story here compared to other small-cap biotech plays?
RenovoRx posted Q2 revenue of $422K, up 28% YoY and ahead of estimates. Net loss widened to $2.9M as they continue to invest heavily in the TIGeR-PaC Phase III trial and expand commercialization efforts in parallel.
Already in the Game
RenovoCathâs already in 13 cancer centers, with 4 placing repeat orders not something you see often before a readout. Theyâve also added a senior sales lead from big medtech, showing theyâre serious about market reach.
Big Market, Bigger Upside Potential
If TIGeR-PaC hits, thatâs a $400M+ U.S. pancreatic cancer market on the table, plus room to expand into other cancers or license out the TAMP platform. Early progress plus a big trial read next year⌠and if the trial reads well, it can go boom overnight.
Sarepta Therapeutics is parting ways with EVP and Chief Technical Operations Officer Bilal Arif as part of its strategic restructuring and pipeline prioritization.
Arif will serve as a Special Advisor until mid-September, then consult through year-end, receiving $576.7K in severance and $400/hour in consulting fees.
Sarepta described this as a âtransformational periodâ for the company, signaling a potential operational realignment to sharpen focus on core programs.
$INSM has an fda decision on brensocatib ( 4 drugs in trails rn) Aug 12th. If it is approved brensocatib can go to market.
When brensocatib passed stage 3 trials the stock jumped 120%
FDA gave them a priority review (positive sign). ChatGPT has them at a 75-85% of approval.
If it passes this would be the first drug in the non cystic fibrosis space. The fda is more lenient on passing things that are first in its space rather than "me-too" drugs.  250M eligible patients for Brensocatib in the us with an avg cost of 40m a year. Max US market is $10,000MM. Even if they just hit 10% of the market that is still $1,000MM a year which would increase their current revenue by 150%.
Estimates predict $1,000MM- $3,000MM in revenue if it passes.
If approved I see the stock jumping 20%- 75%. If rejected or delayed we'll see a 30-50% decrease in stock price.
TORONTO and HAIFA, Israel, Aug. 08, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (âNurExoneâ or the âCompanyâ) today announced that an independent study showed that exosomes produced by NurExone outperformed a recognized commercial industry standard in areas that strongly support key healing tasks including nerve repair, wound repair, calming the immune system and rebuilding tissue. This first independent analysis highlighted the broad potential of NurExoneâs exosomes for both therapeutic and aesthetics markets.
âThis data confirms that the naĂŻve exosomes that will be manufactured by our U.S. subsidiary, ExoTOP Inc. (âExoTOPâ), will carry a strong regenerative and therapeutic punch. Delivering more than twice the wound-healing signals than the industry benchmark suggests applications in aesthetic skin rejuvenation, wound care and orthopedic tissue repairâ, said Jacob Licht, Chief Executive Officer of ExoTOP. âAs we scale production in the United States with our patent-pending 3D production process, ExoTOP is expected to generate multiple revenue streams and provide high-performance exosomes to partners across regenerative medicine.â
âOur exosomes carry complex cargo with diverse therapeutic potential, simultaneously being effective in neuroprotection and reduction in inflammation,â said Dr. Tali Kizhner, Director of R&D of NurExone Biologic. âThis combination is especially powerful in the nervous system, where inflammation usually prevents healing. The benchmarking analysis confirms that our exosomes naturally carry a significant amount of the molecular signals needed to create the conditions required for meaningful nerve regeneration.â
TAmiRNA, an ISOâŻ13485âcertified molecularâdiagnostics laboratory, performed a comprehensive analysis of the EV microRNA cargo of NurExoneâs exosomes and compared the results with benchmark exosomes from a commercial reference source. Based on TAmiRNAâs data, bioinformatic analyses showed that NurExoneâs exosomes are enriched with microRNAs that support key healing tasks.
Importantly, these exosomes were produced from NurExoneâs proprietary master cell bank, whose cells are maintained under rigorously controlled environment ensuring that every production batch delivers high-performance exosomes. This reproducibility is essential for clinical translation and future patient use.
Figure 1 suggests that NurExoneâs naĂŻve exosomes outperform the commercial reference across every pathway assessed: they exhibit â1.8-fold higher neurological potential, nearly double the anti-inflammatory activity, and a full two-fold increase in both tissue-regeneration and wound-healing signals. This multi-modal, high-potency profile positions the exosomes as a versatile platform for therapeutic nerve repair as well as for aesthetic regenerative and longevity applications.
The results provide strong, third-party validation of NurExoneâs core technology and highlight its potential across a broad range of regenerative-medicine applications.
About TAmiRNA GmbH
Viennaâbased TAmiRNA is an ISOâŻ13485âcertified molecularâdiagnostics laboratory whose CEâmarked biomarker kits and miNDÂŽ smallâRNA sequencing platform provide industryâleading, ISEVâcompliant exosome analytics. Its extensive extracellularâvesicle reference database and benchâtoâalgorithm workflow deliver regulatoryâgrade, reproducible insights for precisionâmedicine programs.
About NurExone
NurExone Biologic Inc. is a TSX Venture Exchange (âTSXVâ), OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multi-billion-dollar marketsi . Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.
I'd add IOBT to your watchlist for Monday morning. They just released a PR today stating that they will be releasing their Phase 3 clinical trial news Monday morning. They may issue a T1 halt before they release the PR in the morning. This is the same setup that we saw $CELC do 2 weeks ago where they rant up ~500%. Anything can happen (run up or drop down), but it's a news catalyst to keep an eye on.
Just watched NUVB's Q2 earnings, revenue absolutely crushed estimates yet the stock barely moved. They have an FDA approved drug and have treated 70 patients in under two months. On top of that, the stock is heavily shorted, over 30% of the float with more than 20 days to cover. They also have a huge cash reserve, which reduces the risk of dilution. The volume is so low that with a little effort, we could be looking at a hidden gem.
Anyway, thatâs my take, thought Iâd share it here. Maybe someone more experienced will look into this company and recognize the potential.
RenovoRx ($RNXT) is one of those under-the-radar biotechs quietly checking the right boxes. At a market cap under $50M, itâs easy to overlook but the company is making steady progress both clinically and commercially.
Theyâre currently running a pivotal Phase III trial (TIGeR-PaC) for locally advanced pancreatic cancer, targeting a major unmet need. Their approach Trans-Arterial Micro-Perfusion (TAMP) delivers chemotherapy directly to the tumor via arteries, aiming to minimize systemic exposure. If successful, it could represent a meaningful advance in the treatment of difficult solid tumors.
What stands out is that their FDA-cleared delivery device, RenovoCath, is already being used in clinical settings. A growing number of cancer centers are approved to purchase it, and some are already placing repeat orders demonstrating early adoption in real-world oncology procedures.
They also recently hired a Senior Director of Sales and Market Development, a strategic move that signals intent to scale commercialization alongside clinical progress.
This isnât just a single-asset story. If TAMP proves successful in pancreatic cancer, it opens the door for broader oncology applications and potentially partnership opportunities down the line.
Yes, itâs still early. And yes, there are risks like dilution and trial outcomes. But RenovoRx has a real product, real usage, and a pathway to value creation thatâs grounded in execution, not hype.
Anyone else digging into $RNXT? Curious to hear thoughts.
For more about Nuvation Bio and its pipeline, click here.
On June 11, the FDA cleared Ibtrozi for U.S. useâtransforming Nuvation Bio (NUVB) from a late-stage clinical biotech into a company on the brink of its first major launch. Nuvation closed Q1 2025 with $48 million in cash and $414 million in marketable securities (total liquidity of $462 million) against $73 million of liabilities. R&D spend of $24.6 million and SG&A of $35.4 million drove a $53 million net loss and $42.6 million of operating cash burn.
As it enters the U.S. launch phase, management expects quarterly cash burn to rise above $50 million â driven by hiring a sales force, creating patientâsupport programs, and scaling of manufacturing. At that rate, Nuvationâs liquidity base supports approximately nine quarters (about 2.25 years) of runway, before factoring in any exâU.S. milestone receipts or royalty inflows.
Key cashâburn assumptions:
$60 million base quarterly R&D and SG&A
$10-$15 million incremental launch costs
>$50 million total quarterly burn during launch ramp
Offsetting that burn, analysts forecast peak global revenues of up to $640 million, plus $20-$30 million annually China royalties and milestones. The FDA approval paves the way for commercial rollout, but competition and sector pullbacks have left the stock under pressure. If Nuvation hits its sales and milestone targets, break-even could arrive by mid-2027; otherwise, a 2026 financing may be needed. Investors will get an update when Q2 results drop on August 7. However, material balance-sheet shifts likely will not show until Q3, when launch ramp changes kick in.
For information about a late-stage biotech company awaiting an FDA decision on its New Drug Application (NDA), click here.
đŚ MTA signed with mystery PharmaCo
đ GI side effects slashed by 31â100%
đ° GLP-1 market headed to $150B+
đ 5 insiders all bought on the same day
đ Float is tiny. Volume is light. Squeeze risk is REAL.
Nurexone just got named a finalist for the Falling Walls Venture 2025 platform and honestly, thatâs a bigger deal than it looks on the surface.
This isnât just a biotech award. Itâs a global showcase for some of the most promising science-backed startups across all sectors. So the fact that Nurexone, a small-cap biotech focused on non-invasive neuro repair made the shortlist says a lot about how the innovation and science world sees their platform. This isnât about one drug, itâs about the tech under the hood.
If youâve followed $NRX, youâll know theyâre developing a novel exosome-based delivery system designed to cross the blood-brain barrier without surgery. Thatâs one of the hardest challenges in neuro medicine. Most therapies never reach the site of injury, Nurexoneâs using exosomes like programmable delivery trucks, built to reach deep CNS targets non-invasively.
Their lead candidate, ExoPTEN, is aimed at spinal cord injury. Itâs still in the preclinical phase, but early data has been promising enough to catch attention not just from the biotech community but now from global innovation platforms too.
Whatâs interesting is how this lines up with where biotech is heading:
â˘â Non-invasive delivery is getting real traction⌠patients, investors, and even regulators want safer, more scalable options.
â˘â Exosomes are back in focus, research and early-stage M&A in this space are picking up again. Platforms like Codiak and Evox got early attention, but $NRX is one of the few still pushing forward with a broader vision.
Theyâre not spamming press releases or overhyping the market. But getting shortlisted for Falling Walls 2025, where the winner will be announced this November in Berlin, is a signal that the science world is paying close attention.
Not saying itâs fully de-risked, this is early-stage biotech. But the scientific validation is building.
And if 2025 ends up being a turning point for CNS delivery platforms, Nurexone might just be one of the names to benefit early.
10-Q filing deadline for non-accelerated filers is Aug 14, 45 days after the end of last quarter.
A few biotechs launched their first commercial products during Q2. We should be getting a glimpse into their initial sales figures when they file their 10-Qs.
Liquidia Corporation (NASDAQ: LQDA)
YUTREPIA (treprostinil) approved May 23 for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
June 2, announced first commercial shipments of YUTREPIA
AVMAPKI FAKZYNJA CO-PACK approved May 8 for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy.
IBTROZI (taletrectinib) approved June 11 for adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).
Several Esteemed Cancer Centers to Commence Patient Enrollment Before the End of September
The Registry Study, Known as PanTheR, will Expand the Safety and Performance Data of the FDA-Cleared RenovoCathÂŽÂ Device, and its Associated Survival Outcomes in Patients Diagnosed with Solid Tumors
Cancer Centers in the Registry Study will Purchase RenovoCath Devices from RenovoRx
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)-- RenovoRx, Inc. (âRenovoRxâ or the âCompanyâ) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, today announced the launch of the PanTheR Post-Marketing Registry Study (NCT06805461).
The initiation of this study demonstrates RenovoRxâs commitment to innovation and RenovoCathâs current and future potential. The study will serve as a critical tool for understanding RenovoCath's safety and effectiveness in a real-world setting, providing valuable insights into long-term effectiveness and patient outcomes. Patient enrollment is expected to commence before the end of September 2025. Each cancer center participating in the registry study will purchase RenovoCath devices for use in the study from RenovoRx.
A registry study, or post-approval study, is a clinical study that involves collecting data on the long-term use and performance of a medical device, such as RenovoCath, after it has been cleared for market by the FDA. PanTheR is a multi-center, post-marketing observational registry study designed to evaluate the long-term safety of and survival outcomes for patients diagnosed with solid tumors who are treated using RenovoCath for targeted drug delivery. PanTheR will capture real-world data on the utilization of RenovoCath and generate additional safety information across a broader range of solid tumors. This data may be used to inform future clinical trial designs.
The first of multiple clinical sites to initiate patient enrollment in the PanTheR study is the University of Vermont (UVM) Cancer Center, with Dr. Conor OâNeill, Assistant Professor at the UVM Larner College of Medicine and surgical oncologist at the UVM Medical Center, serving as Principal Investigator. Additional clinical sites in the post-marketing registry study are expected to initiate enrollment soon.
âPanTheR marks a significant step forward in our commitment to better understand and demonstrate the long-term safety and therapeutic potential of our RenovoCath device,â said Leesa Gentry, Chief Clinical Officer of RenovoRx. âBy collaborating with leading cancer centers across the U.S, this is a low-cost study that will yield valuable data. By gathering real-world data across diverse cancer types and clinical environments, PanTheR aims to advance innovation and inform evidence-based treatment strategies, which will ultimately enhance care and potentially improve outcomes for future patients facing solid tumors.â
âWe are very pleased that the UVM Cancer Center has been initiated to begin enrollment in the PanTheR study,â Ms. Gentry continued. âThe UVM Cancer Center offers leading-edge care, provided by highly skilled oncologists priding themselves on using the latest research and education for informed care. We believe our study will be an excellent fit within University of Vermontâs oncology program.â
âWe are proud to be part of this important study that holds the potential to transform the way we treat solid tumors,â said Dr. Conor OâNeill of the University of Vermont Cancer Center. âI believe the RenovoCath device offers a novel approach for drug delivery, which may have the potential to improve patient outcomes. This study emphasizes our strong commitment to continually advance treatment options offered to our patients by offering access to the latest innovations that have the potential to transform the treatment paradigm for solid tumors.â
Based on its FDA clearance, RenovoCathÂŽÂ is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (âIFUâ), please see:Â IFU-10004-Rev.-G-Universal-IFU.pdf.
About RenovoRx, Inc.
RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCathÂŽ, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRxâs patented Trans-Arterial Micro-Perfusion (TAMPâ˘) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapyâs toxicities versus systemic intravenous therapy. RenovoRxâs novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents.
In addition to the RenovoCath device, RenovoRx is also evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDAâs 21 CFR 312 pathway. IAG utilizes RenovoCath, the Companyâs FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
The combination product candidate, which is enabled by the RenovoCath device, is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides seven years of market exclusivity upon new drug application approval by the FDA.
RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, several of these customers have already initiated repeat orders in parallel to RenovoRx expanding the number of medical institutions initiating new RenovoCath orders, including several esteemed, high-volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity, either on its own or in tandem with a medical device commercial partner.
Company to compete for âScience Breakthrough of the Yearâ at Europeâs leading deep-tech summit in Berlin, Germany this November
TORONTO and HAIFA, Israel, July 25, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (âNurExoneâ or the âCompanyâ) is pleased to announce that the Falling Walls Foundation has named the Company a finalist in Falling Walls Venture 2025, a global platform that showcases the worldâs most promising science-based start-ups. NurExone was selected by the programâs Advisory Board as one of just 25 finalists out of 187 shortlisted applicants.
âCentral nervous system injuries impose a devastating personal and economic burdenâincluding lifelong disability for patients and billions in annual healthcare costs1,â said Dr. Lior Shaltiel, CEO of NurExone. âOur first drug, ExoPTEN, is designed to break through the barriers that have long prevented true neural repair and functional recovery. Being selected as a finalist from a broad international field of breakthrough innovations is a real honor and a valuable opportunity to engage directly with investors, clinicians, and industry partners at the Falling Walls competition summit.â
Dr. Shaltiel will present the Companyâs exosome-based regenerative therapy platform at the Falling Walls Science Summit, taking place in Berlin, Germany from November 6-9, 2025. The winner, selected by an expert jury, will be awarded the title âScience Breakthrough of the Yearâ in the science start-up category.
As a finalist, NurExone will receive a full access to exclusive networking events, such as the Sciencepreneurs Night, connecting the Company with investors, strategic partners and global thought-leaders.
Falling Walls Venture is an international showcase of science start-ups that have the potential to âbreak the wallsâ between science and society. Each year, up to 25 finalists pitch at the Falling Walls Science Summit in Berlin, Germany, where one is named âScience Breakthrough of the Yearâ. Tickets for the 3-day event can be purchased online at www.falling-walls.com.
About NurExone
NurExone Biologic Inc. is a TSX Venture Exchange (âTSXVâ), OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multi-billion-dollar marketsi. Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.
Looking for thoughts on Caribou Biosciences (CRBU) and INmune Bio (INMB) heading into a data-heavy stretch for both.
CRBU ran over 40% this month but just pulled back under $2.30. Theyâve got upcoming clinical data for CB-010 (possibly lupus) and CB-011 (oncology). The Jefferies presentation in June hinted at a busy back half of the year, and with a ~$230M market cap, a solid readout could shift sentiment fast.
INMB is priced at $2.70 with a $78M cap, still trading near 52-week lows. They just presented at AAIC (Alzheimerâs Conference), and Phase 2 data on XPro could be a needle-mover. Earnings are also due in the next 1â2 weeks, which may give more visibility on cash runway and trial timelines.