RenovoRx, Inc. (NASDAQ:RNXT) announced Tuesday that it has completed patient enrollment for its Phase 3 TIGeR-PaC study of its targeted drug delivery platform for locally advanced pancreatic cancer (LAPC).
The U.S. Food and Drug Administration (FDA)-cleared RenovoCath to isolate blood flow and deliver fluids within the peripheral vascular system, as well as for temporary vessel occlusion during procedures such as chemotherapeutic drug infusion.
RenovoRx is evaluating its novel drug-device combination oncology product candidate, intra-arterial gemcitabine delivered via RenovoCath (known as IAG), in the ongoing Phase 3 TIGeR-PaC trial.
TIGeR-PaC Trial Execution And Timeline
Patient enrollment closed on August 7.
The study evaluates intra-arterial gemcitabine (IAG) administered via the RenovoCath drug-delivery device through the company’s proprietary Trans-Arterial Micro-Perfusion (TAMP) platform.
The study’s primary endpoint is overall survival. TIGeR-PaC compares targeted delivery of gemcitabine directly to the tumor against standard systemic intravenous chemotherapy using gemcitabine and Abraxane.
The company noted that current systemic standards cause widespread toxicity.
TAMP is designed to administer treatments near the tumor site while lowering systemic exposure.
Interim Monitoring And Data Expectations
As of August 11, 78 of the required 86 events (patient deaths) have occurred.
The trial is expected to finish in the first half of 2027 after reaching 86 events, with initial topline trial data anticipated in the second half of 2027.
The study passed two independent interim analyses following the 26th event in 2023 and the 52nd event in 2025.
On both occasions, the Data Monitoring Committee advised continuing the trial as designed.
RenovoRx Commercializes TAMP Technology And RenovoCath
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 $1.1 million in RenovoCath sales.
Sales reached $563,000 in the first quarter of 2026.
The IAG combination product candidate, enabled by the RenovoCath device, is currently under investigation.
RNXT Stock Price Activity: RenovoRx shares were down 4.31% at $1.11 during premarket trading on Tuesday, according to Benzinga Pro data.
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