US-based biotechnology company Atossa Therapeutics Inc (Nasdaq:ATOS) announced on Monday that it has requested a Type C meeting with the US Food and Drug Administration (FDA) to discuss a regulatory strategy aimed at accelerating development of low-dose (Z)-endoxifen for breast cancer risk reduction.

Atossa says that beginning in June 2025, it engaged an internationally recognised FDA law firm and senior regulatory affairs experts to review its extensive (Z)-endoxifen data and the considerable published scientific literature on (Z)-endoxifen. They evaluated whether existing evidence could support a faster regulatory path in breast cancer risk-reduction, specifically, in the adjuvant setting, in ductal carcinoma in situ (DCIS), and in high-risk women without cancer.

The experts recommended that Atossa rapidly schedule a Type C meeting with the FDA to align on the requirements needed to complete a New Drug Application (NDA). Atossa has now filed this meeting request and expects to update shareholders on the outcome of the meeting before the end of 2025, based on standard agency timelines. According to Atossa, while there can be no assurance of success, a favourable meeting outcome could shorten approval timelines by years and avoid tens of millions of dollars in clinical trial costs.

Atossa had approximately USD57.9m in cash and no debt as of 30 June 2025.