Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 162

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 162
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igake designation. This program offers expedited review for innovative
therapies and is broadly comparable to the FDA’s Fast Track designation in the United States.

Novel ARB Combination Therapy Regulatory Strategy

United States

We may seek FDA approval for Nano-Candesartan
under the 505(b)(2) pathway, which is subject to FDA discretion, and there can be no assurance that this pathway will be available or
sufficient for approval. This approach could potentially allow us to reference existing safety and pharmacology data from the reference
product, Candesartan, as well as the regulatory precedent for the liposomal delivery platform used in FDA-approved products such as Doxil.
Nano-Candesartan is a PEGylated liposomal formulation of candesartan, a widely used angiotensin II receptor blocker (ARB) currently approved
for hypertension and heart failure (e.g., Atacand). Our novel formulation introduces a new route of administration and a potential therapeutic
use in oncology, while relying on components with demonstrated safety and prior regulatory acceptance. While this pathway may provide
a more efficient development route compared to traditional approaches, there can be no assurance that the FDA will approve it.

While the cardiovascular indications of candesartan
are well established, emerging evidence has demonstrated its potential in oncology, particularly through modulation of the tumor microenvironment
(TME). Candesartan has been shown to reduce tumor-associated fibrosis, lower interstitial pressure, and normalize abnormal tumor vasculature—mechanisms
that enhance the intratumoral delivery and efficacy of co-administered therapies such as chemotherapy and immune checkpoint inhibitors.

Encapsulation of candesartan in nano-liposomes
enables targeted delivery to tumor tissue, prolongs circulation time, and significantly reduces systemic exposure and side effects, such
as hypotension. This targeted approach enhances the drug’s therapeutic index and supports its repurposing for oncology indications,
including hard-to-treat cancers like pancreatic adenocarcinoma.

We believe that the 505(b)(2) pathway may be
scientifically and strategically appropriate for this product, subject to FDA discretion. This pathway could potentially permit reliance
on established safety and pharmacology data from the reference listed drug (Atacand), while requiring us to generate new data specific
to the novel liposomal formulation and its intended oncology use. This approach may help streamline development timelines, may reduce
costs, and could potentially accelerate market entry compared to the