other material
confidence high
sentiment positive
materiality 0.60
Aytu submits Cotempla XR-ODT site transfer PAS to FDA; expects 15% margin improvement on ADHD brands
AYTU BIOPHARMA, INC
- 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.