---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-114101"
form_type: "8-K"
ticker: "OGN"
cik: "0001821825"
company_name: "Organon & Co."
filed_at: "2024-11-05T23:59:59+00:00"
generated_at: "2026-05-30T05:27:09.809001+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA extends VTAMA sNDA review for atopic dermatitis to March 12, 2025

## Summary
- FDA extended target action date by 3 months to March 12, 2025; original date was December 12, 2024.
- FDA requested final datasets and clinical study report from long-term extension study, deemed a major amendment.
- No concerns raised regarding safety, efficacy, or approvability of VTAMA for atopic dermatitis.
- Organon expects VTAMA full-year 2025 revenue of ~$125M; impact of ~75 bps headwind to Adjusted EBITDA margin.
- Updated guidance provided as a supplement to prior Q3 2024 earnings call commentary.

## SEC filing metadata
- accession: 0001104659-24-114101
- form_type: 8-K
- ticker: OGN
- cik: 0001821825
- company_name: Organon & Co.
- filed_at: 2024-11-05T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1821825/000110465924114101/0001104659-24-114101-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1821825/000110465924114101/tm2427489d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-114101
- JSON: https://secwatch.observer/filing/0001104659-24-114101.json
- Plain text: https://secwatch.observer/filing/0001104659-24-114101.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.