Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 152

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 152
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 Designation: Allows for early and frequent FDA engagement. |

| ● | Breakthrough                                                                                 
 Therapy Designation: Contingent on significant clinical benefit signals during early trials. |

AMR-Orphan Indication program is structured
to target diseases with low prevalence in the United States, qualifying for Orphan Drug Designation (ODD). In our assessment, we identified
several antimicrobial-resistant (AMR) indications listed in the FDA’s orphan designation database that are suitable for development
based on the known spectrum of activity of mupirocin. These include infections where MRSA, VRE, and other resistant Gram-positive pathogens
are involved, and where liposomal delivery offers added benefit.

Focusing on these AMR-related orphan
indications supports a targeted clinical development plan with high unmet medical need, smaller trial sizes, and a strong alignment with
public health priorities. This also enhances the potential to access key regulatory incentives and pathways dedicated to antimicrobial
resistance.

Expedited Regulatory Pathways and Potential Designations

We intend to evaluate and, where appropriate,
pursue various expedited development and review pathways provided by the U.S. Food and Drug Administration (FDA), including Orphan Drug
Designation (ODD), Breakthrough Therapy designation (BTD), Fast Track designation, and Priority Review, for certain of our product candidates
such as Nano-Mupirocin, Nano-Candesartan (as an ARB cancer therapy adjuvant), and our liposomal vaccine platform. These 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 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.                                       |

| ● | Liposomal                                                                                         
 Vaccine Platform may be considered for Fast Track designation for emerging infectious             
 diseases such as West Nile Virus or pandemic threats like SARS-CoV-2, particularly in combination 
 with intranasal delivery and novel immunogenic strategies.                                        |

However