Societal CDMO, Inc., a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, has been selected by Atossa Therapeutics to provide a range of its clinical trial services (CTS) offerings focused on Atossa’s proprietary selective estrogen receptor modulator (SERM), (Z)-endoxifen.

The agreement spans a range of activities including analytical method transfer/development and validation, cleaning verification method validation, manufacturing of multiple R&D engineering batches, and stability testing of the R&D engineering batches.

“Societal’s demonstrated expertise in the technology transfer of established drug products, along with our long track record of successfully formulating and manufacturing innovative small molecules, positions us well to align with Atossa and support the ongoing clinical development of the company’s proprietary oral formulation of (Z)-endoxifen,” said David Enloe, CEO of Societal CDMO. “We are eager to initiate this important work and deliver exceptional results for Atossa. It is important to highlight that we are continuing to see growing demand for the CTS portion of our business, which is helping to both grow our overall revenue and diversify our expanding customer base.”