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Atossa Therapeutics, Inc. (NASDAQ: ATOS) is a pioneering biopharmaceutical company headquartered in Seattle, Washington. Established in 2009, Atossa focuses on developing innovative and proprietary medicines targeting unmet medical needs in oncology, with a particular emphasis on breast cancer. The company is currently in the clinical stage, advancing several key programs designed to improve cancer treatment and prevention.
Atossa's core program is the development of (Z)-endoxifen, a potent metabolite of tamoxifen, crucial for treating and preventing breast cancer. Currently, (Z)-endoxifen is in Phase II clinical trials aimed at various breast cancer conditions, including estrogen receptor-positive breast cancer, ductal carcinoma in situ (DCIS), and mammographic breast density. The company is also exploring its efficacy in combination therapies with drugs like abemaciclib, a CDK 4/6 inhibitor.
In addition to breast cancer, Atossa has ventured into COVID-19 therapeutics with two potential treatments: AT-H201 for improving lung function in severe COVID-19 patients and AT-301, a nasal spray for at-home use.
Recently, Atossa has achieved several milestones, including the successful dosing of the first patient in the RECAST DCIS study, full enrollment of its Phase II Karisma-Endoxifen trial, and promising preliminary data from the 40mg cohort in the EVANGELINE study. The company also regained compliance with Nasdaq's minimum bid price requirement.
Atossa's collaborative efforts include partnerships with Quantum Leap Healthcare Collaborative and Weill Cornell Medicine, advancing studies in combination therapies and breast cancer risk assessment through innovative AI models. With a strong financial position, including $84 million in cash and no debt as of Q1 2024, Atossa is well-positioned to continue its groundbreaking work in oncology.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has received approval from the Swedish Medical Product Agency to launch a Phase 2 clinical trial of its oral Endoxifen aimed at reducing mammographic breast density (MBD), a significant public health concern affecting millions of women. The study will involve about 240 pre-menopausal women and aims to assess the dose-response relationship of Endoxifen over six months. The company plans to initiate the trial once COVID-19 restrictions in Stockholm are lifted, with potential for broader future studies to evaluate Endoxifen's impact on breast cancer incidence.
Atossa Therapeutics (Nasdaq:ATOS) reported final results from its Phase 2 study of oral Endoxifen for breast cancer. The primary endpoint was met, showing a 65.1% reduction in tumor cell activity, measured by Ki-67, dropping from 25.6% to 6%. All patients achieved a Ki-67 level below 25%, which correlates with improved long-term survival. Secondary endpoints confirmed Endoxifen's safety and tolerability, with no severe adverse events. Atossa plans to advance Endoxifen toward FDA approval, targeting the unmet need for effective treatments for ER+ breast cancer.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) will hold a webinar on June 9, 2021, at 8 am PT to discuss final data from its Phase 2 study of Endoxifen for breast cancer patients before surgery. The event will feature key executives, including Dr. Steven Quay, and will allow participants to engage with the management team. The company focuses on developing innovative therapies for oncology and infectious diseases, particularly breast cancer and COVID-19. Interested attendees can register via Tribe Public's platform.
Atossa Therapeutics, led by Dr. Steven Quay, published research challenging the claim that the Wuhan Institute of Virology had no COVID-19 cases. The study highlights a statistical improbability given the 4.4% prevalence of COVID-19 in Wuhan during early 2020. The researchers argue that proper testing would likely have revealed positive cases among the 590 staff members at WIV. This analysis raises serious questions about the integrity of WIV's reported COVID cases.
Physician-Scientist Dr. Steven C. Quay, CEO of Atossa Therapeutics (NASDAQ: ATOS), has been invited to brief U.S. Congress on his research concerning the origins of COVID-19. The virtual meeting will occur on May 24, 2021, where Dr. Quay will discuss evidence supporting the theory of a laboratory-origin virus from Wuhan, China. He contends existing data indicates a lab-leak scenario rather than natural zoonosis. The briefing aims to inform congressional members about these findings, which could influence future safety measures against pandemics.
Atossa Therapeutics (Nasdaq: ATOS) reported its Q1 2021 financial results, revealing no sustainable revenue and cash reserves of approximately $137.7 million. The company concluded a Phase 2 study for oral Endoxifen, which showed positive results, and received FDA clearance for expanded access treatment in an ovarian cancer patient. Operating expenses increased by 20% to $3.5 million, driven by a 47% rise in R&D costs. The company plans to expand clinical studies and explore new opportunities moving forward.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced its participation in the Investor Summit Conference on May 18, 2021. CEO Dr. Steven Quay and CFO Kyle Guse will present at 8:45 am ET. The company focuses on developing innovative medicines for unmet medical needs, particularly in oncology and infectious diseases, including breast cancer and COVID-19. Investors can request one-on-one meetings with management after the presentation. For more details, visit Atossa's website.
Atossa Therapeutics (Nasdaq: ATOS) urges stockholders to participate in voting for proposals in its proxy statement ahead of the annual stockholder meeting on May 14, 2021. As of March 24, 2021, approximately 17.3 million shares are under lock-up and voting agreements. The company focuses on developing innovative treatments for unmet medical needs in oncology and infectious diseases, particularly breast cancer and COVID-19. For more information on voting and proposals, stockholders can refer to the proxy statement linked in the announcement.
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical firm, announced participation by CEO Dr. Steven Quay in a panel discussion at Cello Health's Cancer Progress Virtual Conference on May 6, 2021, at 10:00 AM ET. The panel, titled 'Investing in the Emerald City of Oncology Innovation,' will include experts from various venture investment funds. Atossa focuses on developing innovative treatments for oncology and infectious diseases, particularly breast cancer and COVID-19. For registration, visit their official site.
Atossa Therapeutics (Nasdaq: ATOS) announces an ovarian cancer patient has started treatment with its proprietary oral Endoxifen, following FDA approval via the expanded access pathway. This patient, treated by Dr. Barbara Goff at the University of Washington, previously did not tolerate tamoxifen. Molecular testing indicated that Endoxifen combined with alpelisib yielded a significant tumor response. The FDA's expanded access allows use solely for this patient, and Atossa is considering additional clinical studies.
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