This section highlights FDA-related milestones and regulatory updates for drugs developed by Atossa Genetics (ATOS).
Over the past two years, Atossa Genetics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Endoxifen, endoxifen-Z, and EVANGELINE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Endoxifen - FDA Regulatory Timeline and Events
Endoxifen is a drug developed by Atossa Genetics for the following indication: Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Endoxifen
- Announced Date:
- December 11, 2024
- Indication:
- Breast Cancer
Announcement
Atossa Therapeutics, Inc announced full results from its Phase 2 KARISMA-Endoxifen trial conducted at the Karolinska Institute in Stockholm, Sweden.
AI Summary
Atossa Therapeutics, Inc. announced the full results from its Phase 2 KARISMA-Endoxifen trial, which was conducted at the Karolinska Institute in Stockholm, Sweden. The study evaluated low-dose (Z)-endoxifen as a potential preventative therapy for premenopausal women at risk of developing breast cancer. In the trial, 240 premenopausal women were randomized in a double-blind, placebo-controlled study to receive either placebo, 1 mg, or 2 mg of oral (Z)-endoxifen daily for six months. The results showed that the 1 mg dose lowered mammographic breast density by 17.3 percentage points, while the 2 mg dose reduced it by 23.5 percentage points, compared to almost no change in the placebo group. Notably, the 1 mg dose was well-tolerated with no significant differences in adverse events compared to placebo, highlighting its potential as a safe and effective option for breast cancer prevention.
Read Announcement- Drug:
- Endoxifen
- Announced Date:
- July 22, 2024
- Indication:
- Breast Cancer
Announcement
Atossa Therapeutics, Inc. announced that the 12-patient 80mg pharmacokinetic (PK) run-in cohort of the Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study has fully enrolled.
AI Summary
Atossa Therapeutics, Inc. announced that the 12-patient 80mg pharmacokinetic (PK) run-in cohort for its Phase 2 EVANGELINE study has fully enrolled. This study focuses on pre-menopausal women with Grade 1 or 2 Estrogen Receptor positive (ER+)/Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. During this initial phase, each patient will receive 80mg of (Z)-endoxifen daily for four weeks. After this period, those participants whose tumors show a reduction, indicated by Ki-67 levels below 10%, will continue the treatment for an additional five months before undergoing surgery.
This milestone is an important step in evaluating the optimal dose and safety profile of (Z)-endoxifen. The study will eventually expand to about 175 patients at up to 25 sites across the United States as the treatment cohort begins once the ideal dosing is confirmed.
Read Announcement- Drug:
- Endoxifen
- Announced Date:
- June 28, 2024
- Indication:
- Breast Cancer
Announcement
Atossa Therapeutics, Inc. announced protocol changes in the previously initiated study to evaluate Atossa's proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company.
AI Summary
Atossa Therapeutics, Inc. announced important protocol changes in its study evaluating the combination of its proprietary (Z)-endoxifen with abemaciclib (VERZENIO®). This study focuses on neoadjuvant treatment for women with newly diagnosed ER+/HER2- breast cancer. Based on promising safety, efficacy, and pharmacokinetic data from the ongoing Phase 2 EVANGELINE study, the (Z)-endoxifen dose has been increased from 40 mg to 80 mg once daily. This change aims to achieve optimal drug concentrations to target PKCβ1 inhibition and further enhance the antitumor effects of (Z)-endoxifen.
The updated study protocol will enroll approximately 80 participants across two cohorts of 40 each. One cohort will include premenopausal women receiving ovarian function suppression, allowing for a direct comparison of safety and efficacy between treatment groups. These modifications are expected to deepen understanding of the combination’s safety profile and clinical benefits, helping to guide future conversations with regulators and potential partners.
Read Announcement- Drug:
- Endoxifen
- Announced Date:
- May 7, 2024
- Indication:
- Breast Cancer
Announcement
Atossa Therapeutics, Inc announced its support of new guidelines released by the U.S. Preventive Services Task Force (USPSTF) recommending that women begin breast cancer screening starting at age 40
AI Summary
Atossa Therapeutics, Inc. announced its support for new guidelines from the U.S. Preventive Services Task Force (USPSTF) that recommend women begin breast cancer screening at age 40. The updated recommendation highlights the importance of earlier detection, which could lead to earlier treatment and improved outcomes for women diagnosed with the disease.
By aligning with these guidelines, Atossa Therapeutics emphasizes its commitment to advancing women's health. The company believes that starting screening at a younger age can help catch cancer in its early stages, potentially reducing mortality rates and improving overall survival. This decision supports wider efforts to boost cancer awareness and preventative care practices across the country. The move is seen as a positive step towards promoting proactive health measures, ensuring that women receive timely screening and intervention when necessary.
Read Announcement- Drug:
- Endoxifen
- Announced Date:
- April 15, 2024
- Indication:
- Breast Cancer
Announcement
Atossa Therapeutics, announced the initiation of a new study to evaluate Atossa's proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, in women with ER+/HER2- breast cancer.
AI Summary
Atossa Therapeutics has initiated a new study to evaluate its proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®) for women with estrogen receptor-positive (ER+), HER2-negative breast cancer. This study, part of the I-SPY TRIAL framework, will enroll about 20 women with newly diagnosed invasive disease. Participants will receive a daily 40mg dose of (Z)-endoxifen along with 150mg of abemaciclib twice daily for 24 weeks before surgery.
The research team aims to assess the benefits of this combination therapy as a neoadjuvant treatment, potentially offering improved outcomes by targeting both estrogen receptor activity and the cell division process. This study could help determine which patients might benefit more from a combination approach, ultimately guiding more effective treatment strategies in both early-stage and advanced breast cancer settings.
Read Announcement- Drug:
- Endoxifen
- Announced Date:
- April 9, 2024
- Indication:
- Breast Cancer
Announcement
Atossa Therapeutics, Inc announced promising safety and efficacy data from the Company's Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) clinical trial. The EVANGELINE study is evaluating (Z)-endoxifen as a neoadjuvant treatment for pre-menopausal women with Grade 1 or 2 Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
AI Summary
Atossa Therapeutics, Inc. announced promising safety and efficacy data from its Phase 2 EVANGELINE trial, which is testing (Z)-endoxifen as a neoadjuvant treatment for pre-menopausal women with Grade 1 or 2 ER+/HER2- breast cancer. In this study, seven women received a 40mg daily dose for 28 days. The majority (six out of seven) achieved a significant reduction in their Ki-67 levels—a marker for tumor growth—bringing the levels below 10% and allowing them to continue treatment for an extra five months, while one patient discontinued treatment.
MRI assessments later showed that all six patients had reductions in tumor size, including one complete response and one partial response, with the remaining patients showing stable disease. These early results suggest that (Z)-endoxifen is well tolerated and may offer a promising alternative treatment approach by effectively slowing or reducing tumor growth.
Read Announcement
endoxifen-Z - FDA Regulatory Timeline and Events
endoxifen-Z is a drug developed by Atossa Genetics for the following indication: for Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- endoxifen-Z
- Announced Date:
- May 14, 2025
- Indication:
- for Breast Cancer
Announcement
Atossa Therapeutics, today reported full results from the Phase 2 Endocrine Optimization Pilot (EOP) sub‑study within the I‑SPY 2 TRIAL evaluating low‑dose oral (Z)‑endoxifen (10 mg daily) as a neoadjuvant treatment in 20 women with stage II/III estrogen‑receptor–positive (ER+), HER2‑negative breast cancer.
AI Summary
Atossa Therapeutics today announced full results from the Phase 2 Endocrine Optimization Pilot (EOP) sub‑study within the I‑SPY 2 Trial. The study tested low‑dose oral (Z)‑endoxifen (10 mg daily) as a neoadjuvant treatment in 20 women with stage II/III estrogen‑receptor–positive, HER2‑negative breast cancer. The trial achieved its feasibility endpoint, with 95% of participants completing at least 75% of the planned dosing. Early signs of treatment effect were observed as the key cancer cell marker Ki‑67 dropped from 10.5% at baseline to 5% by Week 3, with 65% of patients reaching Ki‑67 levels at or below 10%. Additionally, MRI scans showed significant tumor shrinkage, confirming the drug’s anti‑proliferative activity. The low‑dose (Z)‑endoxifen was well tolerated, with mostly mild side effects, paving the way for further studies using higher doses and combination therapies.
Read Announcement
EVANGELINE - FDA Regulatory Timeline and Events
EVANGELINE is a drug developed by Atossa Genetics for the following indication: for premenopausal women with estrogen receptor-positive (ER+)/HER2-negative breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EVANGELINE
- Announced Date:
- December 10, 2024
- Indication:
- for premenopausal women with estrogen receptor-positive (ER+)/HER2-negative breast cancer.
Announcement
Atossa Therapeutics, Inc. announced that three posters involving pharmacokinetic and tolerability data from the Phase 2 EVANGELINE trial will be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS 2024).
AI Summary
Atossa Therapeutics, Inc. announced that three posters from their Phase 2 EVANGELINE trial will be showcased at the 2024 San Antonio Breast Cancer Symposium (SABCS 2024). The posters present new pharmacokinetic and tolerability data for (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with estrogen receptor-positive, HER2-negative breast cancer.
One poster details the pharmacokinetic run-in phase where (Z)-endoxifen doses of 40 mg and 80 mg—with or without goserelin—were evaluated, showing promising plasma and tissue concentration levels. Another focuses on patient-reported outcomes and quality of life measures, demonstrating that (Z)-endoxifen is generally well-tolerated with mostly low-grade side effects. The third poster outlines the design and rationale for a randomized trial comparing (Z)-endoxifen plus ovarian function suppression to exemestane plus ovarian function suppression. This data highlights a clear plan for further advancing treatment options in breast cancer.
Read Announcement
