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

AYTU BIOPHARMA, INC

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.

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