RenovoRx Achieves Major Milestone with Full Enrollment in Phase III TIGeR-PaC Trial for Locally Advanced Pancreatic Cancer
Rhea-AI Summary
RenovoRx (Nasdaq: RNXT) announced full enrollment of its Phase III TIGeR-PaC trial for locally advanced pancreatic cancer, evaluating intra-arterial gemcitabine (IAG) delivered via the FDA-cleared RenovoCath device using the TAMP™ platform versus standard intravenous gemcitabine plus Abraxane. Patient enrollment closed as of August 7, 2026.
According to the company, the study’s primary endpoint is overall survival, with trial completion expected in the first half of 2027 after 86 events (patient deaths); 78 events had occurred as of August 11, 2026. Initial topline data are anticipated in the second half of 2027. The trial has passed two independent interim analyses (after the 26th event in 2023 and 52nd in 2025) with recommendations to continue. RenovoRx reported approximately $1.1 million in RenovoCath sales in 2025 and a record $563,000 in Q1 2026, and RenovoCath with gemcitabine has Orphan Drug Designation for pancreatic and bile duct cancer.
Positive
- Phase III TIGeR-PaC fully enrolled in August 2026, de-risking recruitment
- Trial completion and data timeline: completion expected H1 2027, topline readout H2 2027
- Two interim DMC reviews after 26 and 52 events recommended trial continuation
- RenovoCath commercial traction: about $1.1 million sales in 2025
- Record RenovoCath revenue: $563,000 in Q1 2026
- Orphan Drug Designations for pancreatic and bile duct cancer support potential exclusivity
Negative
- None.
News Explained
The enrollment milestone does not change the product’s regulatory status: RenovoCath is FDA-cleared for specified delivery uses, while the intra-arterial gemcitabine combination remains under investigation and is not approved for commercial sale.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 28 | Orphan drug designation | Positive | +6.2% | FDA granted orphan designation for intra-arterial oxaliplatin in pancreatic cancer. |
| Apr 14 | Clinical imaging data | Positive | +1.0% | Clinical imaging data supported localized gemcitabine delivery through the TAMP platform. |
| Mar 26 | Phase III enrollment milestone | Positive | +5.5% | Trial surpassed 100 randomized patients while approaching enrollment completion. |
| Feb 26 | Clinical abstract acceptance | Neutral | -5.0% | Clinical data abstract was accepted for presentation at the 2026 SIR meeting. |
| Feb 04 | Technical clinical data | Neutral | -4.5% | Clinical data described pressure measurement performance during RenovoCath procedures. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-specific clinical-trial news produced three aligned positive reactions and two divergent negative reactions, averaging a 0.64% move.
Key Terms
overall survival medical
investigational new drug application regulatory
21 cfr 312 regulatory
orphan drug designation regulatory
phase iii medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Completion of Trial Expected in First Half 2027 With Topline Data Readout Expected Second Half 2027
MOUNTAIN VIEW, Calif., Aug. 11, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or “the Company”) (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, is pleased to announce completion of enrollment in the Company’s Phase III TIGeR-PaC trial in locally advanced pancreatic cancer (LAPC).
As of August 7, 2026, TIGeR-PaC trial investigators have been notified by RenovoRx that patient enrollment is closing. Completion of the trial is expected during the first half of 2027, after 86 events (i.e., patient deaths) have been observed. As of August 11, 2026, 78 events have occurred. Following completion of the trial, initial top line trial data is expected to be available during the second half of 2027.
This significant milestone reflects successful patient recruitment, clinical execution, and collaboration among investigators and study teams evaluating intra-arterial gemcitabine (IAG) via RenovoCath delivered through RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP™) platform as a novel drug-device product candidate for difficult-to-treat LAPC. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx’s patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to the standard of care (systemic (intravenous) chemotherapy gemcitabine + Abraxane).
Pancreatic cancer continues to represent a major unmet medical need, with limited treatment options and current standards of care centered largely on systemic chemotherapy, which can cause significant toxicity and related side effects for patients. TAMP is designed to deliver chemotherapy directly near the tumor site while potentially reducing systemic exposure.
“The TIGeR-PaC Phase III study represents an exciting step forward in the treatment of LAPC,” said Hassan Hatoum, MD Associate Professor of Medicine Medical Director, GI Oncology Disease Site Chair, GI Oncology Disease Site Group Stephenson Cancer Center University of Oklahoma Health Sciences Center and principal investigator at the University of Oklahoma Health for the TIGeR-PaC trial. “For far too long, patients with LAPC have had limited options beyond systemic chemotherapy. This novel treatment approach offers hope by adding an innovative, locoregional and targeted intervention that has the potential to improve outcomes beyond the current standard of care. The preliminary results of this study have been encouraging and reinforce the importance of continuing to explore new strategies for this challenging disease.”
Dr. Hatoum continued, “What makes this approach particularly promising is its adaptability. Because the FDA-approved RenovoCath device administers chemotherapy directly near the tumor, it can continue to be integrated with a systemic therapy protocol regardless of how standard systemic treatment evolves in the future, this provides a versatile platform that can remain relevant as new chemotherapy regimens and targeted therapies emerge.”
“I am proud to be part of the Phase III trial evaluating IAG, working alongside an exceptional multidisciplinary team committed to advancing care for patients with LAPC. Together, we are developing innovative treatment strategies that have the potential to improve outcomes and quality of life for our patients. Beyond pancreatic cancer, this novel platform also offers hope for expanding targeted regional chemotherapy delivery to other cancers, potentially opening new therapeutic opportunities across multiple solid tumors,” concluded Dr. Hatoum.
“Completing enrollment in the Phase III TIGeR-PaC trial marks a major milestone for RenovoRx,” said Ramtin Agah, M.D., Executive Chairman, Chief Medical Officer, and Founder of RenovoRx. “TIGeR-PaC is the cornerstone of our clinical development program, and we are now closer than ever in our efforts to validate IAG and its efficacy through rigorous, long-term evaluation. We thank the participating clinical sites, the patients and their families for their dedication, support, and trust in this important study. With enrollment complete, we are now focused on advancing toward completion and data analysis. We believe TIGeR-PaC will provide meaningful additional validation of our TAMP therapy platform in an area with significant unmet need and limited therapeutic progress. The validation of this approach both in terms of tolerability and efficacy should provide additional tools for clinicians to offer patients in this challenging disease.”
The study’s enrollment was supported by participation from nationally recognized cancer centers and academic medical institutions across the United States, including Johns Hopkins Medicine, University of Pittsburgh Medical Center, UT Southwestern Medical Center, University of Nebraska Medical Center, Baptist Health South Florida, Stephenson Cancer Center at the University of Oklahoma, and more.
The study has also progressed through two independent interim analyses triggered following the 26th event in 2023 and the 52nd event in 2025, with the study’s independent Data Monitoring Committee (DMC) recommending continuation of the trial on both occasions. Together, these accomplishments reflect the successful execution of RenovoRx’s lead clinical program and support continued evaluation of its proprietary TAMP therapy platform.
About RenovoCath
Based on its FDA clearance, RenovoCath® 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 (“IFU”), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.
About the TIGeR-PaC Clinical Trial
TIGeR-PaC is an ongoing Phase III randomized multi-center trial evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). RenovoRx’s first investigational drug-device combination product candidate, using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath® device, is designed for the intra-arterial administration of chemotherapy, gemcitabine (IAG).
About RenovoRx, Inc.
RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) 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 therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s 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.
RenovoRx is actively commercializing its TAMP technology and FDA-cleared RenovoCath as a standalone device. For its first full year of commercial efforts in 2025, RenovoRx generated approximately
RenovoRx is also evaluating its novel drug-device combination oncology product candidate intra-arterial gemcitabine delivered via RenovoCath, (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 FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. Full enrollment in the TIGeR-PaC trial was achieved in August 2026, with completion of the trial currently expected during the first half of 2027. Initial topline data readout is expected during the second half of 2027.
The IAG combination product candidate, 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.
For more information, visit www.renovorx.com. Follow RenovoRx on LinkedIn, X and Facebook.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection therewith described herein contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding (i) our clinical trials and studies, including the anticipated timing for completion of and data readout from the Phase III TIGeR-PaC trial as described herein, (ii) the potential for our product candidates (including IAG) to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iii) our efforts to commercialize RenovoCath and our TAMP technology. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, intellectual property development, clinical trials, our TAMP therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These statements may be identified using words such as “may,” “expects,” “plans,” “aims,” “anticipates,” “believes,” “forecasts,” “aim,” “goal,” “estimates,” “intends,” and “potential,” or derivatives of these terms or other comparable terminology regarding RenovoRx’s statements about the future, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: (i) the risk that our commercial sales efforts for RenovoCath and our TAMP technology may not lead to viable, revenue-generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding; (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of our preclinical studies, clinical trials and our research programs (including, most importantly, the timing for completion of and data readout from our Phase III TIGeR-PaC trial); (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate; (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals, including any New Drug Applications (including for IAG) which may be submitted to the FDA in the future); (x) our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements, needs for additional financing, our ability to obtain additional capital and our ability to maintain the listing of our common stock on Nasdaq; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xviii) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xix) the pricing, coverage and reimbursement of our product candidates, if approved; and (xx) developments relating to our competitors and our industry, including competing product candidates and therapies. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that we file from time to time with the Securities and Exchange Commission, which can be accessed at https://ir.renovorx.com/sec-filings.
Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.
Investor Contact:
KCSA Strategic Communications
Valter Pinto or Jack Perkins
T: 212-896-1254
RenovoRx@KCSA.com
Media Contact:
STiR Communications
Hannah Williams
T: 803-521-1214
hannah@stir-communications.com
