Aytu BioPharma Announces Approval Of The Cotempla XR-ODT Manufacturing Site Transfer Prior Approval Supplement
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Aytu BioPharma has received approval from the U.S. Food & Drug Administration for the Prior Approval Supplement (PAS) of Cotempla XR-ODT, enabling the transfer of its manufacturing to a third-party manufacturer. This follows a similar approval for Adzenys XR-ODT in April 2023. The company expects to report enhanced ADHD product margins following the completion of the manufacturing transfer. The initial ramp-up of contract manufacturing of Adzenys and Cotempla is expected to begin in late 2023, with margin improvements expected from 2024.
October 26, 2023 | 12:06 pm
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Aytu BioPharma's approval for the PAS of Cotempla XR-ODT and Adzenys XR-ODT is expected to enhance the company's ADHD product margins. The transfer of manufacturing to a third-party is expected to lower overhead costs and improve margins.
The FDA approval for the PAS of Cotempla XR-ODT and Adzenys XR-ODT allows Aytu BioPharma to transfer the manufacturing of these products to a third-party manufacturer. This is expected to lower the company's overhead costs and improve the margins of its ADHD products. The company expects to see enhanced margins from 2024, which could positively impact the company's financial performance and potentially its stock price.
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