Welcome to our dedicated page for Atossa Therapeutics news (Ticker: ATOS), a resource for investors and traders seeking the latest updates and insights on Atossa Therapeutics stock.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company whose news flow centers on the development of its lead investigational therapy, (Z)-Endoxifen. Company announcements frequently cover progress in breast cancer programs, regulatory interactions, intellectual property developments, and emerging opportunities in other serious diseases.
Investors following ATOS news can expect regular updates on clinical trials involving (Z)-Endoxifen, including studies in metastatic ER+/HER2- breast cancer, neoadjuvant treatment for premenopausal ER+/HER2- patients, breast cancer risk reduction strategies focused on mammographic breast density, and participation in the RECAST DCIS platform trial for hormone receptor–positive ductal carcinoma in situ. These releases often summarize trial design, early findings, and the potential implications for future registration strategies.
Atossa’s news also highlights regulatory milestones, such as FDA Type C meetings, Investigational New Drug (IND) submissions, and “Study May Proceed” letters. Additional coverage includes the FDA’s Rare Pediatric Disease designation for (Z)-Endoxifen in Duchenne Muscular Dystrophy, as well as AI-enabled research collaborations identifying new oncology indications like glioblastoma.
Another recurring theme in ATOS news is the company’s intellectual property position, including newly issued patents for enteric oral (Z)-Endoxifen formulations and methods of use in hormone-dependent breast disorders and estrogen-related conditions. Corporate updates, such as financial results, leadership appointments, and Nasdaq listing communications, provide context on Atossa’s operational and strategic direction.
By monitoring this news page, readers can review a chronological record of Atossa’s clinical, regulatory, scientific, and corporate announcements related to (Z)-Endoxifen and the company’s broader oncology and rare disease programs.
Atossa Therapeutics (NASDAQ: ATOS) has been granted a new U.S. Patent (No. 12,275,684) by the USPTO for enteric oral formulations of (Z)-endoxifen and related treatment methods. The patent specifically covers formulations and their use in treating hormone-dependent breast and reproductive tract disorders.
This development strengthens Atossa's intellectual property portfolio for its proprietary (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM). The company's patent estate now includes multiple U.S. patents with over 100 claims related to (Z)-endoxifen formulations and clinical applications, reinforcing their position in developing targeted therapies for hormone receptor-positive breast cancer.
Nona Biosciences and Atossa Therapeutics (Nasdaq: ATOS) have announced a research collaboration to develop next-generation therapeutic antibodies for breast cancer. The partnership will utilize Nona's proprietary H2L2 Harbour Mice® platform, which generates fully human monoclonal antibodies without requiring additional engineering or humanization.
The platform combines transgenic mice technology with single B cell cloning, offering an efficient approach to therapeutic antibody development. The Harbour Mice® platform has been implemented in over 250 drug discovery programs across multiple therapeutic areas and has gained widespread recognition from global partners.
Atossa Therapeutics (NASDAQ: ATOS) has released its full year 2024 financial results, ending with $71.1 million in cash and no debt. The company announced a strategic shift to focus on metastatic breast cancer for its lead program, (Z)-endoxifen.
Key highlights include positive data from the Phase 2 EVANGELINE trial, showing tumor suppression rates above 85% across dose levels. The trial will continue with amended protocol comparing 40mg (Z)-endoxifen with OFS to exemestane plus OFS. The Phase 2 KARISMA-Endoxifen study demonstrated significant mammographic breast density reduction, with 1mg and 2mg doses achieving 17.3 and 23.5 percentage point reductions respectively.
Financial results show total operating expenses decreased by $3.8 million to $27.6 million in 2024, compared to $31.4 million in 2023. Interest income was $4.1 million, down $0.2 million from the previous year.
Atossa Therapeutics (NASDAQ: ATOS), a clinical-stage biopharmaceutical company focused on breast cancer medicines, has scheduled its fourth quarter and full year 2024 financial results conference call for Tuesday, March 25, 2025, at 8:30 a.m. ET.
The company will host both a conference call and live audio webcast to discuss corporate and financial results. Investors can access the webcast through the investor relations section of Atossa's website. For telephone access, U.S. callers should dial 1-800-836-8184, while international participants can dial 1-646-357-8785. The conference call name is 'Atossa Therapeutics Business Update'. A 30-day replay will be available on the company's website following the call.
Atossa Therapeutics (NASDAQ: ATOS) has announced its strategic focus on developing (Z)-endoxifen for metastatic breast cancer treatment, while simultaneously pursuing additional indications with FDA guidance.
Early clinical trials have shown promising results, with (Z)-endoxifen demonstrating:
- More than doubled median progression-free survival compared to tamoxifen (7.2 vs. 2.4 months) in CDK4/6i-naïve patients
- Clinical benefits in patients who progressed on tamoxifen, including partial responses and stable disease lasting 2-3 years
- Favorable safety profile comparable to tamoxifen
The company is also advancing additional indications including breast cancer prevention and neoadjuvant therapy. In early-stage patients, (Z)-endoxifen maintained a Ki-67 ≤10% response rate above 85% across all dose levels, suggesting effective tumor proliferation reduction.
Atossa Therapeutics (Nasdaq: ATOS) announces that board director Dr. Tessa Cigler and Weill Cornell Medicine have been awarded a $2.3 million CDC grant over five years. The grant aims to improve breast cancer care for young patients across New York City, focusing on equitable access, quality of life, and survival outcomes.
Dr. Cigler, who serves as Associate Professor of Clinical Medicine at Weill Cornell Medicine and co-principal investigator, will collaborate with Dr. Vered Stearns to enhance care coordination and provide culturally relevant resources. The initiative specifically targets patients from diverse racial, ethnic, and socio-economic backgrounds, implementing interventions to optimize physical, emotional, and mental well-being for both patients and caregivers.
Atossa Therapeutics (Nasdaq: ATOS) has responded to the Patent Trial and Appeal Board's (PTAB) final decision regarding U.S. Patent No. 11,572,334, which found all challenged claims unpatentable. While disappointed, the company states this ruling does not affect their current clinical development formulations.
Rather than pursuing an appeal due to time and cost considerations, Atossa will seek patent protection through a new Continuation Patent Application. The company also announced the issuance of a new patent (U.S. Patent No. 12,201,591) on January 21, 2025, for sustained release compositions of endoxifen.
Atossa's current patent portfolio includes multiple U.S. patents with numerous claims: No. 11,261,151 (21 claims), No. 11,680,036 (22 claims), No. 12,071,391 (44 claims), and the new No. 12,201,591 (31 claims), all covering their clinical development formulations.
Atossa Therapeutics (NASDAQ: ATOS) has released a shareholder letter highlighting significant progress in 2024 for their breast cancer prevention and treatment programs. The company completed the KARISMA-Endoxifen Phase 2 Study, which demonstrated significant reductions in mammographic breast density of 17.3% (1mg) and 23.5% (2mg) compared to placebo.
The EVANGELINE trial showed promising results in its pharmacokinetic run-in phase, with 50% of patients receiving 80mg (Z)-endoxifen with goserelin reaching target steady-state plasma concentrations. The I-SPY 2 Endocrine Optimization Pilot demonstrated 95% treatment compliance, with a 69% reduction in Ki-67 and 30.4% reduction in functional tumor volume after three weeks.
The company secured two additional U.S. patents for (Z)-endoxifen and maintains a strong financial position. For 2025, Atossa plans to focus on advancing (Z)-endoxifen into registrational trials and expanding global business development efforts.
Atossa Therapeutics (NASDAQ: ATOS) endorses the U.S. Surgeon General's Advisory highlighting alcohol as a major preventable cause of breast cancer. The Advisory reveals that alcohol contributes to nearly 100,000 cancer cases and 20,000 cancer deaths annually in the US, making it the third leading preventable cause of cancer after tobacco and obesity.
Breast cancer represents the largest portion of alcohol-related cancers in women, accounting for 44,180 cases annually (16.4% of all breast cancer diagnoses). The risk begins to rise with as little as one drink per day, yet less than 45% of Americans believe alcohol significantly affects cancer development.
The Advisory calls for updated health warning labels on alcoholic beverages, expanded public education efforts, and implementation of proven alcohol reduction strategies in cancer prevention initiatives.
Atossa Therapeutics (NASDAQ: ATOS) has announced groundbreaking research findings on compounds that work synergistically with (Z)-endoxifen for breast cancer treatment. The discovery, presented at the 2024 San Antonio Breast Cancer Symposium, utilized both insilico and chemical screening approaches to identify compounds that target specific enzymes and proteins involved in tumor survival.
The research demonstrated that combinations of these newly discovered compounds with (Z)-endoxifen induced enhanced cell death in MCF-7 breast cancer cells, particularly when using inhibitors of MEK, PI3K, and AKT. The findings suggest promising potential for combination therapies targeting topoisomerase, CDK, mTOR/PI3K, and AKT alongside (Z)-endoxifen, though further research is needed.
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