Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 162

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 162
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 regulatory programs
are intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs.

Basis for Potential Eligibility:

Based on early-stage preclinical data and
the indications we are targeting, we believe that certain of our product candidates may meet the preliminary criteria for expedited development
programs. For example:

| ● | Nano-Mupirocin may be eligible for Fast Track designation or QIDP status due to its potential to address serious, multidrug-resistant Gram-positive infections, including MRSA. |

| ● | Nano-Candesartan may qualify for Breakthrough Therapy designation if future clinical data demonstrate substantial improvement over available therapies in oncology settings. |

However, these beliefs are based on our current
development plans and nonclinical data, and actual eligibility for any FDA designation is subject to further evaluation by the FDA following
submission of the relevant data.

Limitations and Regulatory Uncertainty:

While these designations can provide potential
benefits, including more frequent interactions with the FDA, eligibility for rolling submissions, and in some cases shorter review timelines,
they do not guarantee a faster development or approval process. Moreover, they do not increase the likelihood that a product candidate
will ultimately receive marketing approval. Because our product candidates are in early stages of development, there can be no assurance
that the FDA will grant any such designation or accept any application under an expedited program.

Furthermore, even if one or more of our product
candidates receive such designations, the FDA may later rescind them if subsequent data fail to confirm the initial qualifying criteria.

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European Union

We intend to pursue marketing authorization
for Nano-Mupirocin via the European Medicines Agency (EMA) under the centralized procedure, which ensures access across all EU member
states and is required for novel antimicrobial therapies. Nano-Mupirocin, a novel liposomal formulation of mupirocin for systemic (parenteral)
use, is designed to treat serious, resistant bacterial infections, addressing critical unmet needs in the context of antimicrobial resistance
(AMR). However, this program remains at a preclinical stage, and there can be no assurance that Nano-Mupirocin will demonstrate safety
or efficacy in humans, or that it will receive regulatory approval in the EU or elsewhere.

Given the severity and limited treatment options
for certain resistant infections, particularly those affecting vulnerable populations, we plan to seek Orphan Medicinal Product Designation
(OMPD) for relevant