---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-006964"
form_type: "8-K"
ticker: "AYTU"
cik: "0001385818"
company_name: "AYTU BIOPHARMA, INC"
filed_at: "2023-04-27T23:59:59+00:00"
generated_at: "2026-06-16T08:40:59.260635+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Aytu BioPharma gets FDA approval for Adzenys site transfer; 15% margin improvement expected

## Summary
- FDA approved Prior Approval Supplement to transfer Adzenys XR-ODT manufacturing to contract manufacturer in 2023.
- Cotempla XR-ODT bioequivalence study completed; site transfer PAS submission expected mid-2023 with approval by late 2023 or early 2024.
- Upon completion of both site transfers, Aytu expects 15% margin improvement for ADHD product line.
- Manufacturing of Adzenys and Cotempla at contract facility expected to begin late 2023 and early 2024 respectively.

## SEC filing metadata
- accession: 0001558370-23-006964
- form_type: 8-K
- ticker: AYTU
- cik: 0001385818
- company_name: AYTU BIOPHARMA, INC
- filed_at: 2023-04-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1385818/000155837023006964/0001558370-23-006964-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1385818/000155837023006964/aytu-20230427x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-006964
- JSON: https://secwatch.observer/filing/0001558370-23-006964.json
- Plain text: https://secwatch.observer/filing/0001558370-23-006964.txt

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