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 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.
Atossa Therapeutics (NASDAQ: ATOS) announced full results from its Phase 2 KARISMA-Endoxifen trial, showing significant reductions in mammographic breast density (MBD) in premenopausal women. The randomized, double-blind study of 240 women aged 40-55 tested 1mg and 2mg doses of (Z)-endoxifen against placebo over six months.
The 1mg dose reduced MBD by 17.3 percentage points and the 2mg dose by 23.5 percentage points (both p0.01), compared to 0.27 points for placebo. The 1mg dose showed no significant difference in adverse events versus placebo, while the 2mg dose had higher rates of side effects. Plasma concentrations were 4.8 ng/mL and 9.7 ng/mL for 1mg and 2mg doses respectively.
Atossa Therapeutics (ATOS) presented pharmacokinetic and tolerability data from its Phase 2 EVANGELINE trial at SABCS 2024. The trial investigates (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+/HER2-negative breast cancer. Key findings include: 50% of patients receiving 80mg (Z)-endoxifen with goserelin met target steady-state plasma concentrations, while 38% reached target levels without goserelin. The 80mg dose achieved tissue levels double that of plasma levels in 90% of patients.
The treatment showed substantial tumor suppression across all dosing levels, with Ki-67 response rates above 85%. Quality of life data indicated the treatment was generally well-tolerated. Based on these results, EVANGELINE will proceed with an amended protocol comparing 40mg/day (Z)-endoxifen plus OFS to exemestane plus OFS, with recruitment expected to begin in 2025.
Atossa Therapeutics (NASDAQ: ATOS) presented research on the anti-cancer activity of (Z)-endoxifen and its byproducts at the AACR Special Conference. The study investigated four (Z)-endoxifen byproducts for treating estrogen receptor-positive (ERα+) breast cancer, including endocrine-resistant tumors.
Two compounds, AT416E and AT402E, showed strong anti-proliferative activity, with AT416E demonstrating enhanced inhibition of cell migration and invasion. All four byproducts exhibited greater anti-proliferative effects than (Z)-endoxifen in estrogen-deficient conditions, while (Z)-endoxifen proved most effective at inducing cell cycle arrest and apoptosis.
The company plans future in vivo studies to validate these compounds' potential in overcoming current endocrine therapy limitations.
Atossa Therapeutics (NASDAQ: ATOS) announced its upcoming presentation at the AACR Special Conference in Cancer Research in Toronto, December 9-11, 2024. The company will present a poster titled 'Anti-cancer Activity of (Z)-Endoxifen-Related Compounds in ERα+ Breast Cancer' on December 10, 2024.
The research focuses on optimizing therapeutic efficacy and tolerability through modifications to (Z)-endoxifen chemistry in treating estrogen receptor alpha-positive breast cancer. The presentation aims to demonstrate how these compounds could enhance potency and reduce adverse effects in cancer treatment outcomes.
Atossa Therapeutics (ATOS) announced that five abstracts featuring data on (Z)-endoxifen have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. The presentations will showcase findings from various studies evaluating (Z)-endoxifen in breast cancer prevention and treatment, including phase 2 trials and combination therapy research. Key presentations include studies on breast cancer prevention, quality of life outcomes in premenopausal patients, pharmacokinetic profiles, synergistic treatment combinations, and a non-inferiority trial comparing (Z)-endoxifen to existing treatments.
Atossa Therapeutics (NASDAQ: ATOS) announced Q3 2024 financial results and corporate updates. Key highlights include positive topline results from KARISMA-Endoxifen Phase 2 study showing significant mammographic breast density reductions of 19.3% and 26.5% in 1mg and 2mg treatment arms. The I-SPY 2 trial met its primary endpoint with 95% of patients completing treatment, showing 69% reduction in Ki-67 and 30.4% reduction in tumor volume. The company ended Q3 with $74.8 million in cash and no debt. Operating expenses decreased to $6.4 million in Q3 2024 from $7.5 million in Q3 2023.