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, Inc. (Nasdaq: ATOS) reported its fiscal year 2021 results, highlighting a cash position of $136 million. The company initiated a Phase 2 trial for its oral Z-endoxifen in Sweden, targeting premenopausal women with breast cancer. Notably, operating expenses rose by 40% to $20,521, driven by increased R&D costs of $9,210. The company aims to submit an IND for a U.S. study comparing Endoxifen to standard care and plans further development for its COVID-19 therapy, AT-H201, with completion expected in mid-2022.
Atossa Therapeutics (Nasdaq: ATOS) has emphasized its commitment to addressing significant health challenges, particularly in breast cancer and COVID-19. The company reported a successful Phase 2 study of Endoxifen, showing a 65.1% reduction in Ki-67, indicating reduced tumor activity. Atossa also initiated a Phase 2 study targeting women with increased mammographic breast density and advanced its AT-301 nasal spray and AT-H201 inhalation therapy for COVID-19. In 2021, Atossa raised over $110 million to further its clinical programs.
Atossa Therapeutics (Nasdaq: ATOS) announced the advancement of its Phase 1/2a clinical study of AT-H201, targeting lung function improvement in hospitalized COVID-19 patients and long-haul patients with post-infection pulmonary disease. After successfully completing Part A of the study, the Australian Human Research Ethics Committee approved the initiation of Part B, which will include 60 participants. AT-H201, a nebulized combination therapy, aims to address the urgent need for additional COVID-19 treatments amidst rising hospitalizations due to the Omicron variant.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced the enrollment initiation of its Phase 2 clinical study of oral Z-Endoxifen in Sweden, targeting premenopausal women with elevated mammographic breast density. This milestone aims to assess the dose-response relationship between daily Z-Endoxifen doses and breast density reduction, alongside safety evaluations. The study, led by Dr. Per Hall, will involve around 240 participants over six months. With significant public health implications, this initiative strives to address a condition affecting over 10 million women in the U.S.
Physician-Scientist Steven Quay, MD, PhD, has published a significant e-print on the coronavirus BANAL-236, which exhibits high homology to SARS-CoV-2 and can infect human cells. This research, reported by the Institut Pasteur, indicates that BANAL-236 evolved to infect human cells through a previously unknown mechanism. Quay emphasizes the urgency for an international effort to investigate this virus due to its potential transmissibility and implications for current therapeutic strategies.
Atossa Therapeutics (Nasdaq: ATOS) announced a significant milestone with the completion of a pre-investigational new drug (PIND) meeting with the FDA regarding its proprietary Z-endoxifen for treating breast cancer in the neoadjuvant setting. The FDA's feedback will aid in preparing a request to open an IND for a Phase 2 study, focusing on pre-menopausal women with ER+/HER2- breast cancer. Atossa plans to initiate the IND request in Q2 2022 and conduct a pharmacokinetic study alongside the Phase 2 trial, seeking to compare Z-endoxifen against standard treatment options.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces a live Q&A session on November 30, 2021, at 8 AM Pacific/11 AM Eastern. CEO Dr. Steven Quay and CFO Kyle Guse will address questions regarding Atossa's research initiatives focused on breast cancer and COVID-19. The event, hosted by Tribe Public, is complimentary, with registration available here. For more details about Atossa, visit atossatherapeutics.com.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported its financial results for Q3 2021, ending September 30, with cash reserves of approximately $140 million. The company has no sustainable revenue and incurred operating expenses of about $5.16 million for Q3 2021, a 47% increase year-over-year. Key developments include initiating a clinical study for AT-H201 targeting COVID-19 patients and receiving Swedish regulatory approval for a Phase 2 trial of Endoxifen in women with mammographic breast density. The company anticipates ongoing increases in R&D expenses as trials progress.
Atossa Therapeutics (Nasdaq: ATOS) CEO Dr. Steven Quay addressed the significant decline in mammograms during the global pandemic in a recent video for Breast Cancer Awareness Month. He emphasized that many women have not been seeking mammograms since COVID-19 began, which is particularly concerning for women of color and those in lower income brackets, as highlighted in a peer-reviewed article. Atossa continues to focus on innovative treatments for oncology and COVID-19, aiming to address these urgent medical needs.
Atossa Therapeutics has begun enrolling participants in a clinical study for its nebulized formulation, AT-H201, aimed at improving lung function in both moderately to severely ill hospitalized COVID-19 patients and those suffering from post-infection pulmonary issues. The study will include 60 participants and is being conducted in Australia. AT-H201 combines two FDA-approved drugs and has shown to be significantly more potent than existing treatments like Remdesivir. Successful completion of this study and obtaining regulatory approval is crucial for commercialization.
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