---
title: Groundbreaking Rare Disease Drug Approval OGSIVEO | Halloran Consulting Group
description: Explore how effective regulatory strategy and program management resulted in the approval of OGSIVEO (nirogacestat) for a rare disease. Read our case study.
---

[Insights ](https://hallorancg.com/insights)

# [Groundbreaking Rare Disease Drug Approval OGSIVEO | Halloran Consulting Group](https://hallorancg.com/insights/rare-disease-drug-approval-case-study)

 Written by [Halloran Consulting Group](https://hallorancg.com/insights/author/halloran-consulting-group) | Jan 9, 2025 5:00:00 AM

## Rare Disease Drug Approval (OGSIVEO [nirogacestat])

SpringWorks Therapeutics, a biopharmaceutical company that applies a precision medicine approach to developing and delivering life-changing medicines, acquired Pfizer’s asset to begin their pivotal clinical study in desmoid tumors. They needed to refine their late-stage regulatory strategy considering Pfizer’s previous development (plus compelling results from an investigator-initiated trial putting them at End of Phase 2 (EOP2)), define a clear development roadmap to approval, and submit a New Drug Application (NDA). Halloran provided team direction to collaborate through a shared vision and alignment. Read our case study, written in collaboration with our colleagues at SpringWorks. 

 

[View full post](https://hallorancg.com/insights/rare-disease-drug-approval-case-study)

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