Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 160

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 160
---
 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.

<div align='center'>100</div>

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 rare infectious disease indications. To qualify, we will demonstrate that:

| ● | The target                                                                  
 condition has a prevalence of fewer than 5 in 10,000 individuals in the EU; |

| ● | Nano-Mupirocin offers significant                                                                   
 benefit over existing therapies, such as improved systemic activity or a novel mechanism of action; |

| ● | There is a plausible scientific                               
 rationale for its clinical effect in the proposed indication. |

| ● | Upon OMPD approval, the product 
 will benefit from:              |

| ● | 10 years of market exclusivity 
 in the orphan indication;      |

| ● | Protocol assistance (free or     
 reduced-cost scientific advice); |

| ● | Fee reductions for various 
 regulatory activities.     |

As part of our development strategy, we also
intend to submit a Pediatric Investigation Plan (PIP), as required under EU regulation for all new marketing authorization applications,
including orphan drugs. Given the increasing incidence of multidrug-resistant infections in pediatric populations, especially in neonatal
and pediatric intensive care settings, Nano-Mupirocin may offer an important pediatric therapeutic alternative. We plan to engage early
with EMA’s Pediatric Committee (PDCO) to define an age-appropriate development plan or, where justified, request a waiver or deferral
based on disease prevalence and clinical feasibility.

Depending on the strength of