---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-26-001543"
form_type: "8-K"
ticker: "AYTU"
cik: "0001385818"
company_name: "AYTU BIOPHARMA, INC"
filed_at: "2026-01-20T23:59:59+00:00"
generated_at: "2026-05-16T09:31:15.426711+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Aytu BioPharma launches EXXUA for MDD; reports $32.6M cash, reduced launch budget to $6-8M

## Summary
- EXXUA (gepirone) is first FDA-approved 5HT1a agonist for MDD; full commercial launch underway after Dec 15, 2025 initial availability.
- Cash $32.6M as of 9/30/25; TTM adjusted EBITDA $6.7M; launch budget reduced from $10M to $6-8M.
- Commercialization deal with Fabre-Kramer: $3M upfront, 28% base royalty plus 3% on COGS, milestones starting at $100M net sales.
- Pivotal trials showed significant HAM-D17 improvement vs placebo (P=0.018 and P=0.032); no sexual dysfunction or weight gain warning.
- Targeting 5,500 high-value psychiatry prescribers; 40+ person sales force; virtual team to deliver 20,000 contacts in launch phase.

## SEC filing metadata
- accession: 0001437749-26-001543
- form_type: 8-K
- ticker: AYTU
- cik: 0001385818
- company_name: AYTU BIOPHARMA, INC
- filed_at: 2026-01-20T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1385818/000143774926001543/0001437749-26-001543-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1385818/000143774926001543/aytu20260118_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-26-001543
- JSON: https://secwatch.observer/filing/0001437749-26-001543.json
- Plain text: https://secwatch.observer/filing/0001437749-26-001543.txt

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