Atossa Therapeutics Supports FDA’s New Mammography Rule
SEATTLE – Atossa Therapeutics, Inc. (NASDAQ: ATOS) supports the U.S. Food and Drug Administration’s updated mammography regulations. The change requires mammography facilities to tell patients, in clear language, whether they have dense breasts. The goal is simple and practical: give patients information they can use to talk about risk and next steps.
Why Breast Density Matters for Detection
The FDA’s revisions are a meaningful step toward better awareness and earlier detection. Breast density is a known risk factor for developing breast cancer. It can also make tumors harder to see on a mammogram, which can complicate diagnosis and delay timely care. When patients receive understandable density information, they’re better positioned to ask about supplemental screening—such as ultrasound or MRI—and to decide, with their clinicians, whether those options make sense. That conversation matters most for women with dense breast tissue, who may face higher risk and greater challenges with standard imaging.
Expert View on the Rule
Dr. Steven Quay, Atossa’s President and CEO, called the rule an important step forward: “The rule implemented by the FDA is a commendable initiative that advances patient outcomes through early detection and diagnosis. With the new requirements, patients can take proactive steps in managing their breast health, particularly regarding Estrogen Receptor-positive (ER+) breast cancers, where breast density plays an essential role in risk assessment.”
Atossa’s Work Focused on Early Detection and Prevention
Atossa is focused on improving how breast cancer is detected and prevented, which aligns with the spirit of the FDA’s action. The company is studying its potential therapy, (Z)-endoxifen, across multiple phase 2 clinical trials. One example is the Karisma-Endoxifen study, which is evaluating whether (Z)-endoxifen can reduce mammographic breast density in premenopausal women. Results from this trial are expected before the end of the year, and the findings could inform how clinicians think about breast density as a modifiable factor.
Backing Research That Personalizes Screening
Atossa is also participating in the SMART (Stockholm MAmmography Risk stratified Trial). This study is designed to validate an artificial intelligence–enabled model for assessing breast cancer risk and to build an individualized, imaging-based screening approach. The aim is straightforward: identify women at the highest risk so screening can be better tailored. If the model proves effective, it could lay the groundwork for future phase 3 trials evaluating the use of (Z)-endoxifen in breast cancer prevention.
What to Know About (Z)-Endoxifen
(Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) developed to inhibit estrogen receptor activity. It’s being evaluated for its potential to overcome tumor resistance to hormonal therapies and to target PKC?1, an oncogenic protein, while showing minimal endometrial proliferative effects compared with tamoxifen. Atossa is developing a distinct oral formulation that does not rely on liver metabolism, a design intended to support consistent drug exposure and enhance therapeutic effect.
Clinical Program and Path Ahead
(Z)-endoxifen is currently being studied in five phase 2 clinical trials across different settings in women with breast cancer. Atossa holds four U.S. patents related to this program and has additional applications pending. Through this work, the company aims to establish (Z)-endoxifen as a new option for both treatment and prevention.
About Atossa Therapeutics
Atossa Therapeutics, Inc. develops therapies intended to improve outcomes for women facing breast cancer. Its ongoing research with (Z)-endoxifen reflects a commitment to earlier detection, smarter prevention, and better care decisions. For more information, please reach out using the contact details below.
Contact Information
Michael Parks, VP Investor and Public Relations
484-356-7105
michael.parks@atossainc.com
Frequently Asked Questions
What exactly did the FDA change in the mammography rules?
The updated rule requires mammography facilities to tell patients, in plain language, whether they have dense breasts. The intent is to give patients clear, usable information about breast density and risk.
How can breast density affect my screening results?
Dense breast tissue is a risk factor for breast cancer and can make tumors harder to detect on a mammogram. Knowing your density can help you and your clinician discuss whether additional imaging, such as ultrasound or MRI, is appropriate.
What is (Z)-endoxifen, in simple terms?
(Z)-endoxifen is a SERM designed to inhibit estrogen receptor activity. It’s being developed in an oral form that doesn’t require liver metabolism and is under study for its potential to address resistance to hormonal therapies while targeting PKC?1 with minimal endometrial effects compared to tamoxifen.
Which studies is Atossa running right now?
Atossa is evaluating (Z)-endoxifen in five phase 2 clinical trials. One, the Karisma-Endoxifen study, is testing whether the drug can reduce mammographic breast density in premenopausal women, with results expected before the end of the year. The company also participates in the SMART trial, which is validating an AI-driven risk assessment model to personalize screening.
Could this research lead to larger prevention trials?
Yes. If the SMART study’s risk model proves effective, it could support future phase 3 trials that examine the use of (Z)-endoxifen in breast cancer prevention.
