This section highlights FDA-related milestones and regulatory updates for drugs developed by RenovoRx (RNXT).
Over the past two years, RenovoRx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
RenovoCath, TAMP, and TIGeR-PaC. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
RenovoCath FDA Regulatory Timeline and Events
RenovoCath is a drug developed by RenovoRx for the following indication: Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RenovoCath
- Announced Date:
- May 6, 2025
- Indication:
- Solid Tumors
Announcement
RenovoRx, Inc announced that it has received an Issue Notification from the U.S. Patent and Trademark Office (USPTO) indicating that U.S. patent NO. 12,290,564, becomes effective today, May 6, 2025.
AI Summary
RenovoRx, Inc. announced a significant milestone for its oncology innovations today. The company received an Issue Notification from the U.S. Patent and Trademark Office, confirming that U.S. patent No. 12,290,564, titled “Methods for Treating Tumors,” becomes effective on May 6, 2025. This patent expands the protection for RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP™) therapy platform by safeguarding methods for locally delivering drugs near tumors with its proprietary RenovoCath device. The protection provided by the patent extends until November 2037, further strengthening RenovoRx’s intellectual property portfolio. This development supports the company's efforts to advance and scale the commercialization of the RenovoCath device, positioning it as a key player in targeted oncology treatments.
Read Announcement- Drug:
- RenovoCath
- Announced Date:
- April 16, 2025
- Indication:
- Solid Tumors
Announcement
RenovoRx, Inc announced that it is increasing production of its FDA-cleared RenovoCath catheter-based device in order to meet increased demand for the targeted delivery of diagnostic and/or therapeutic agents from oncologists and interventional radiologists.
AI Summary
RenovoRx, Inc. announced it is ramping up production of its FDA-cleared RenovoCath catheter-based device to meet rising demand from oncologists and interventional radiologists. The device is designed for the targeted delivery of diagnostic and therapeutic agents, providing doctors with a precise way to treat patients. Manufactured by Medical Murray Inc. in North Barrington, IL, RenovoCath isolates blood flow to deliver fluids to specific sites within the peripheral vascular system.
The company expects that increased production will help boost revenue, with early projections indicating low six-figure earnings in the first quarter of 2025 and ongoing growth thereafter. RenovoRx’s move reflects its commitment to addressing market needs and capturing a share of an estimated $400 million peak annual U.S. sales opportunity, while continuing to support innovative, targeted oncology therapies made in America.
Read Announcement- Drug:
- RenovoCath
- Announced Date:
- April 1, 2025
- Indication:
- Solid Tumors
Announcement
RenovoRx, Inc. provided business updates
AI Summary
RenovoRx, Inc. announced key business updates for Q4 2024 and the full year, highlighting initial revenue generation from its FDA-cleared RenovoCath device. The company reported approximately $43,000 in standalone sales during Q4 and expects revenues to grow sequentially in 2025, driven by new customer purchase orders and repeat orders from early adopters. RenovoRx stressed that its current commercial strategy can be executed without significantly increasing capital expenditures, regardless of whether it self-commercializes or partners with a larger organization. Additionally, the company noted a robust cash position of $7.2 million as of December 31, 2024, bolstered by an additional $12.1 million gross proceeds from a recent public offering. These funds will support ongoing expansion initiatives, including scaling RenovoCath sales and advancing the Phase III TIGeR-PaC clinical trial toward key milestones.
Read Announcement- Drug:
- RenovoCath
- Announced Date:
- March 28, 2025
- Indication:
- Solid Tumors
Announcement
RenovoRx, Inc announced today that a new human pharmacokinetic (PK) data abstract was presented at the Society of Surgical Oncology (SSO) 2025 Annual Meeting on March 27 – 29, 2025 in Tampa, FL: ePoster P379.
AI Summary
RenovoRx, Inc. announced that a new human pharmacokinetic (PK) data abstract was presented at the Society of Surgical Oncology (SSO) 2025 Annual Meeting in Tampa, FL, held from March 27–29, 2025. The abstract, showcased as ePoster P379, focused on the company’s Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, which is engineered for targeted chemotherapy delivery.
The data presented at the meeting demonstrated that localized, intra-arterial delivery of gemcitabine using the FDA-cleared RenovoCath® device resulted in lower systemic drug levels compared to standard intravenous delivery. This finding indicates that the TAMP™ platform may help reduce the toxic side effects typically associated with systemic chemotherapy. The new PK data supports the potential safety and efficacy benefits of this innovative treatment option for patients with challenging tumors.
Read Announcement- Drug:
- RenovoCath
- Announced Date:
- March 19, 2025
- Indication:
- Solid Tumors
Announcement
RenovoRx, Inc. announce a presentation of a new pre-clinical clinical data abstract at the upcoming Society of Surgical Oncology (SSO) 2025 Annual Meeting.
AI Summary
RenovoRx, Inc. announced that they will present a new pre-clinical clinical data abstract at the Society of Surgical Oncology (SSO) 2025 Annual Meeting in Tampa, FL. The abstract, titled “Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial,” details new human pharmacokinetic (PK) and pre-clinical data. This data supports RenovoRx’s innovative Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, which is designed to deliver targeted therapy directly near the tumor site while aiming to reduce toxicity compared to standard intravenous treatments.
The presentation is a key part of the company's ongoing efforts to demonstrate the effectiveness and safety of their TAMP therapy. This work may contribute to their overall approach to improving treatment options for patients battling locally advanced pancreatic cancer.
Read Announcement- Drug:
- RenovoCath
- Announced Date:
- February 26, 2025
- Indication:
- Solid Tumors
Announcement
RenovoRx, Inc. announced continuing momentum with the Company's RenovoCath commercial strategy, with new purchase orders received from several esteemed, high volume National Cancer Institute-designated centers.
AI Summary
RenovoRx, Inc. is showing strong progress in its RenovoCath commercial strategy. The company announced new purchase orders from several high volume National Cancer Institute-designated centers, highlighting the growing acceptance of its FDA-cleared drug delivery device. These orders come on top of repeat purchases from initial customers, demonstrating that RenovoCath is gaining trust and usage in key oncology centers across the country.
With this continued momentum, RenovoRx expects to begin generating initial revenues from RenovoCath sales this quarter and anticipates further growth into 2025. The company is expanding its network of medical institutions interested in the device, which addresses significant unmet medical needs. CEO Shaun Bagai is optimistic that these partnerships will not only boost revenue but also improve outcomes by enabling targeted therapeutic delivery in oncology treatment.
Read Announcement- Drug:
- RenovoCath
- Announced Date:
- February 13, 2025
- Indication:
- Solid Tumors
Announcement
RenovoRx, Inc abstract published promising pre-clinical datafrom the use of RenovoRx's patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform, which aims to optimize local and targeted drug delivery in difficult-to-treat cancers.
AI Summary
RenovoRx, Inc. presented promising pre-clinical data at SIO 2025 that highlights its patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform. The study, conducted on a pig model, showed that using the RenovoCath device with dual occlusion balloons could improve targeted drug delivery in tumors with poor blood supply. By adjusting the distance between the occlusion balloons, researchers successfully isolated blood vessels, reducing off-target drug delivery and ensuring better penetration into the tumor’s microvasculature. The findings were confirmed using micro-CT imaging, which tracked how a radiopaque imaging agent filled the targeted areas. These results suggest that TAMP could optimize local drug delivery for difficult-to-treat cancers, potentially enhancing the effectiveness of treatments while minimizing side effects.
Read Announcement- Drug:
- RenovoCath
- Announced Date:
- January 27, 2025
- Indication:
- Solid Tumors
Announcement
RenovoRx, Inc announced an abstract presentation highlighting promising pharmacokinetic (known as PK) datafrom the use of RenovoRx's patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform in treating locally advanced pancreatic cancer (LAPC).
AI Summary
RenovoRx, Inc. recently announced a promising abstract presentation from the TIGeR-PaC Phase III clinical trial on its Trans-Arterial Micro-Perfusion (TAMP™) therapy platform for treating locally advanced pancreatic cancer. The study, presented by Dr. Paula Novelli at the ASCO Gastrointestinal Cancers Symposium, focused on pharmacokinetic data comparing intra-arterial versus intravenous delivery of gemcitabine. The results showed that using the TAMP system to deliver gemcitabine directly into the artery near the tumor can increase the drug's local effect while reducing the overall amount of the drug entering the bloodstream. This targeted approach may lead to improved treatment effectiveness and fewer side effects compared to the standard intravenous method, suggesting that TAMP could offer a safer and more potent option for patients with this challenging form of pancreatic cancer.
Read Announcement- Drug:
- RenovoCath
- Announced Date:
- November 20, 2024
- Indication:
- Solid Tumors
Announcement
RenovoRx, Inc. announced today that the Northwell Health Cancer Institute ("NHCI") in New Hyde Park, NY is enrolling patients with locally advanced pancreatic cancer (LAPC) in the Company's ongoing pivotal Phase III TIGeR-PaC clinical trial.
AI Summary
RenovoRx, Inc. announced that the Northwell Health Cancer Institute in New Hyde Park, NY, is now enrolling patients with locally advanced pancreatic cancer for its ongoing pivotal Phase III TIGeR-PaC clinical trial. This study is testing the company’s innovative TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform, which uses its FDA-cleared RenovoCath® device to deliver chemotherapy directly at the tumor site. The targeted intra-arterial infusion is designed to improve treatment efficacy by focusing the drug where it’s needed most while potentially reducing side effects compared to traditional systemic treatments. RenovoRx aims to complete full patient enrollment by the first half of 2025. The participation of the Northwell Health Cancer Institute, a respected cancer center, underscores the importance of the trial in advancing new treatment options for pancreatic cancer patients.
Read Announcement- Drug:
- RenovoCath
- Announced Date:
- September 25, 2024
- Indication:
- Solid Tumors
Announcement
RenovoRx, Inc. announced that it is increasing the production of its FDA-cleared RenovoCath catheter-based delivery system due to increased demand for targeted delivery of diagnostic and/or therapeutic agents from oncologists and interventional radiologists.
AI Summary
RenovoRx, Inc. announced it is ramping up production of its FDA-cleared RenovoCath catheter-based delivery system due to increased demand from oncologists and interventional radiologists. The RenovoCath device is used for the targeted delivery of diagnostic and therapeutic agents. This boost in production comes as the company strengthens its partnership with Medical Murray, its main manufacturing partner, by signing a new project work order. RenovoRx will also offer Medical Murray a warrant to purchase shares if certain manufacturing goals are met. The increased production supports the company's plans to explore more commercial opportunities for RenovoCath as a stand-alone device. This strategic move aims to meet the growing clinical demand while potentially improving patient outcomes through more precise targeted therapies.
Read Announcement
TAMP FDA Regulatory Events
TAMP is a drug developed by RenovoRx for the following indication: For the treatment of locally advanced pancreatic cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TAMP
- Announced Date:
- September 19, 2024
- Indication:
- For the treatment of locally advanced pancreatic cancer
Announcement
RenovoRx, Inc. announced that Ripal Gandhi, M.D., FSIR, FSVM will present at the Symposium on Clinical Interventional Oncology ("CIO") which is being held September 20-22, 2024, at the Loews Hotel in Miami Beach, Florida. Dr. Gandhi's presentation will highlight RenovoRx's TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer ("LAPC") and recent publications of clinical data.
AI Summary
RenovoRx, Inc. announced that Dr. Ripal Gandhi, a noted professor of Interventional Radiology, will present at the Symposium on Clinical Interventional Oncology (CIO). This event is scheduled for September 20-22, 2024, at the Loews Hotel in Miami Beach, Florida. Dr. Gandhi will serve as a Course Director for the Symposium and will focus on RenovoRx's TAMP (Trans-Arterial Micro-Perfusion) therapy platform.
The presentation will cover how the TAMP therapy can be used to treat locally advanced pancreatic cancer (LAPC) by targeting tumors more precisely and potentially reducing the side effects commonly seen with systemic chemotherapy. Dr. Gandhi will also discuss recent clinical data and publications, highlighting the platform's promise as a new targeted oncology option for LAPC patients.
Read Announcement
TIGeR-PaC FDA Regulatory Timeline and Events
TIGeR-PaC is a drug developed by RenovoRx for the following indication: o provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TIGeR-PaC
- Announced Date:
- April 29, 2025
- Indication:
- o provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT).
Announcement
RenovoRx, Inc announced that Johns Hopkins Medicine is now initiated to enroll patients with locally advanced pancreatic cancer (LAPC) in RenovoRx's ongoing Phase III TIGeR-PaC clinical trial.
AI Summary
RenovoRx, Inc. announced that Johns Hopkins Medicine will now enroll patients with locally advanced pancreatic cancer (LAPC) in its ongoing Phase III TIGeR-PaC clinical trial. The enrollment will take place at the Sibley Memorial Hospital campus, adding to a network of leading U.S. cancer centers participating in the trial. This study evaluates the intra-arterial delivery of gemcitabine using RenovoRx’s FDA-cleared RenovoCath device and its Trans-Arterial Micro-Perfusion (TAMP™) technology. Johns Hopkins Medicine’s involvement will help drive patient recruitment, with full enrollment expected to be reached by 2025. Dr. Valerie Lee, a medical oncologist with expertise in gastrointestinal cancers, has been appointed as the local Principal Investigator for the trial. Her role supports the effort to advance new, targeted treatment methods for pancreatic cancer, offering hope for improved outcomes in this challenging patient population.
Read Announcement- Drug:
- TIGeR-PaC
- Announced Date:
- December 11, 2024
- Indication:
- o provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT).
Announcement
RenovoRx, Inc. announced today that SCRI Oncology Partners in Nashville, TN, is now enrolling patients with locally advanced pancreatic cancer (LAPC) in the Company's ongoing pivotal Phase III TIGeR-PaC clinical trial. SCRI Oncology Partners joins esteemed clinical sites throughout United States participating in the study.
AI Summary
RenovoRx, Inc. announced that SCRI Oncology Partners in Nashville, TN, is now enrolling patients with locally advanced pancreatic cancer (LAPC) in its pivotal Phase III TIGeR-PaC clinical trial. The study is evaluating the TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform, a novel approach that delivers gemcitabine directly to tumors via the FDA-cleared RenovoCath device. This targeted intra-arterial infusion aims to improve overall survival and reduce the systemic side effects often seen with standard intravenous chemotherapy. SCRI Oncology Partners joins other respected U.S. clinical sites in this trial, supporting RenovoRx's goal of accelerating patient enrollment. The collaboration is expected to help the study reach enrollment completion in the first half of 2025, potentially offering new hope in the treatment of LAPC.
Read Announcement- Drug:
- TIGeR-PaC
- Announced Date:
- August 14, 2024
- Indication:
- o provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT).
Announcement
RenovoRx, Inc. announced that that the first patient has been enrolled at the University of Nebraska Medical Center ("UNMC") in RenovoRx's ongoing pivotal Phase III TIGeR-PaC clinical trial for Locally Advanced Pancreatic Cancer (LAPC).
AI Summary
RenovoRx, Inc. announced that the first patient has been enrolled at the University of Nebraska Medical Center (UNMC) in its pivotal Phase III TIGeR-PaC clinical trial for Locally Advanced Pancreatic Cancer. This important step is part of the study testing RenovoGem, the company’s novel drug-device combination. RenovoGem uses a targeted intra-arterial approach with the TAMP therapy platform, designed to deliver the chemotherapy drug gemcitabine directly near the tumor. This method aims to overcome the challenge of scar tissue around tumors that can limit the effectiveness of standard intravenous chemotherapy. By enrolling at UNMC, a center with a high number of pancreatic cancer patients, RenovoRx hopes to improve treatment outcomes, offering potential benefits such as higher drug concentration at the tumor site with fewer side effects.
Read Announcement- Drug:
- TIGeR-PaC
- Announced Date:
- June 26, 2024
- Indication:
- o provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT).
Announcement
RenovoRx, Inc. announced that the University of Nebraska Medical Center (UNMC) is now enrolling patients with Locally Advanced Pancreatic Cancer (LAPC) in the Company's ongoing pivotal Phase III TIGeR-PaC clinical trial.
AI Summary
RenovoRx, Inc. announced that the University of Nebraska Medical Center (UNMC) has started enrolling patients with Locally Advanced Pancreatic Cancer (LAPC) in its Phase III TIGeR-PaC clinical trial. This trial is testing the company’s novel treatment approach using its patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform. Instead of standard systemic chemotherapy given intravenously, TAMP delivers the chemotherapy drug gemcitabine directly to the tumor through the arterial wall. This method aims to overcome the barrier of scar tissue surrounding pancreatic tumors, which often prevents effective drug penetration. UNMC’s participation in the trial is a key step forward in evaluating whether targeted intra-arterial delivery can improve overall survival and reduce side effects compared to traditional treatments. The study is seen as an important part of RenovoRx’s efforts to develop better treatment options for patients with pancreatic cancer.
Read Announcement- Drug:
- TIGeR-PaC
- Announced Date:
- June 26, 2024
- Indication:
- o provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT).
Announcement
RenovoRx, Inc. announced that the University of Nebraska Medical Center (UNMC) is now enrolling patients with Locally Advanced Pancreatic Cancer (LAPC) in the Company's ongoing pivotal Phase III TIGeR-PaC clinical trial.
AI Summary
RenovoRx, Inc. announced that the University of Nebraska Medical Center (UNMC) is now enrolling patients with Locally Advanced Pancreatic Cancer (LAPC) in its pivotal Phase III TIGeR-PaC clinical trial. The study uses RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform to deliver the investigational drug-device combination, RenovoGem, directly to the tumor. Unlike standard intravenous chemotherapy, TAMP uses pressure to help the drug bypass the scar tissue that typically blocks effective drug penetration in pancreatic tumors.
UNMC’s participation brings trusted expertise and innovative research to the trial, which aims to demonstrate improved survival and fewer side effects compared to conventional treatment. This enrollment step is a significant milestone as the trial progresses toward full patient enrollment next year, potentially offering better outcomes for patients suffering from this aggressive form of pancreatic cancer.
Read Announcement- Drug:
- TIGeR-PaC
- Announced Date:
- April 16, 2024
- Indication:
- o provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT).
Announcement
RenovoRx, Inc today highlights a presentation of a clinical data abstract at the recent 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, held March 23-27, 2024 in Salt Lake City, Utah. Clinical data was presented by David Sperling, MD, Associate Professor of Radiology at Columbia University Irving Medical Center in New York.
AI Summary
RenovoRx, Inc. presented new clinical data at the 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting in Salt Lake City, Utah. The data was shared by David Sperling, MD, Associate Professor of Radiology at Columbia University Irving Medical Center. His presentation focused on a sub-study from the Phase III TIGeR-PaC trial, which is investigating the use of RenovoRx’s TAMP™ (Trans-Arterial Micro-Perfusion) therapy for patients with locally advanced pancreatic cancer (LAPC).
The study examined baseline abdominal CT scans to detect Mesenteric Venous Thrombosis (MVT). Results showed that patients with MVT were more likely to experience thrombosis in the targeted artery, potentially leading to incomplete treatment. These findings aim to help doctors better identify appropriate candidates for TAMP therapy, improve treatment plans, and ultimately, enhance patient outcomes.
Read Announcement
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