---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-011769"
form_type: "8-K"
ticker: "AYTU"
cik: "0001385818"
company_name: "AYTU BIOPHARMA, INC"
filed_at: "2023-07-10T23:59:59+00:00"
generated_at: "2026-06-13T10:30:51.405872+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Aytu submits Cotempla XR-ODT site transfer PAS to FDA; expects 15% margin improvement on ADHD brands

## Summary
- Submitted Cotempla XR-ODT Prior Approval Supplement to FDA; expects six-month review with approval by late 2023/early 2024.
- Adzenys XR-ODT site transfer PAS already approved; production shifting to contract manufacturer.
- Upon completion of both site transfers, expects ~15% margin improvement for ADHD product line.
- CEO states outsourced manufacturing of Adzenys and Cotempla expected to begin by late 2023/early 2024.

## SEC filing metadata
- accession: 0001558370-23-011769
- form_type: 8-K
- ticker: AYTU
- cik: 0001385818
- company_name: AYTU BIOPHARMA, INC
- filed_at: 2023-07-10T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- 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/1385818/000155837023011769/0001558370-23-011769-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1385818/000155837023011769/aytu-20230710x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-011769
- JSON: https://secwatch.observer/filing/0001558370-23-011769.json
- Plain text: https://secwatch.observer/filing/0001558370-23-011769.txt

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