Atossa requests FDA Type C meeting to accelerate low-dose (Z)-endoxifen for breast cancer risk reduction

ATOSSA THERAPEUTICS, INC.

Company requested a Type C FDA meeting; expects update by year-end 2025.
Favorable outcome could shorten approval timeline by years and avoid tens of millions in trial costs.
Cash position of $57.9M with no debt as of June 30, 2025; potential multi-billion-dollar market highlighted.
Annual U.S. tamoxifen prescriptions estimated at 1.6-2.1 million; 4.3M women live with breast cancer history.
(Z)-endoxifen avoids CYP2D6 metabolism issues affecting ~20% of tamoxifen patients.

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