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Monotherapy Phase 2 study designed with FDA input; IND expected in Q4 2025 Topline results anticipated in 2026 Positions Atossa for transition into registrational Phase 3 development SEATTLE, Aug. 20, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, announced today it has selected PSI, a leading global contract research organization (CRO), to operationalize and manage its planned (Z)-endoxifen monotherapy dose-ranging study in women with metastatic breast cancer (mBC). The study was designed following guidance from the U.S. Food and Drug Administration (FDA)
FDA Provides Positive Feedback, Clears Path for Atossa to File IND for (Z)-Endoxifen in Metastatic Breast Cancer; FDA Indicates No Additional Toxicity Studies Required Strong I-SPY2 Results Reinforce Efficacy of Atossa's Monotherapy at 3-weeks SEATTLE, Aug. 12, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the second quarter ended June 30, 2025 and provided an update on recent company developments. "Atos
SEATTLE, July 29, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, today announced positive written feedback from the U.S. Food and Drug Administration (FDA) regarding the company's proposed dose optimization trial of (Z)-endoxifen for the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer. With the FDA's feedback, Atossa is energized and moving quickly to advance (Z)-endoxifen in metastatic breast c
10-Q - ATOSSA THERAPEUTICS, INC. (0001488039) (Filer)
8-K - ATOSSA THERAPEUTICS, INC. (0001488039) (Filer)
SCHEDULE 13G/A - ATOSSA THERAPEUTICS, INC. (0001488039) (Subject)
4 - ATOSSA THERAPEUTICS, INC. (0001488039) (Issuer)
4 - ATOSSA THERAPEUTICS, INC. (0001488039) (Issuer)
4 - ATOSSA THERAPEUTICS, INC. (0001488039) (Issuer)
Announced positive topline results from KARISMA-Endoxifen Phase 2 study which demonstrated that low doses of (Z)-endoxifen significantly reduced mammographic breast density (MBD), addressing a key breast cancer risk factorReleased a preliminary analysis from I-SPY 2 Endocrine Optimization Pilot (EOP) Phase 2 trial of (Z)-endoxifen which met the primary endpoint with 95 percent (19/20 patients) receiving > 75 percent of planned treatmentAnnounced the dosing of the first patient in a clinical trial conducted in partnership with Quantum Leap Healthcare Collaborativeä evaluating Atossa's proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO)Received a new patent (U.S. Patent No. 12
SEATTLE, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), today announced the appointment of Claudia Lopez, DVM, MSc, as its new Vice President, Clinical Product Development. Dr. Lopez brings more than two decades of clinical development and strategic expertise to Atossa, including leadership roles in global clinical programs across immunology, oncology, and metabolic disease. Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer. Dr. Lopez most recently served as Vice President of Clinical Development at Landos Biopharma, where she oversaw global clinical strategies, trial
SEATTLE, Aug. 20, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) today announced the appointment of Michael Parks as Vice President of Investor and Public Relations. Mr. Parks brings nearly 30 years of investor relations and corporate communications experience working globally within the biopharmaceutical and healthcare industries. He will oversee corporate, executive, and digital communications, investor relations, thought leadership, and branding for the Company. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer. "We are excited to welcome Michael t
SC 13G/A - ATOSSA THERAPEUTICS, INC. (0001488039) (Subject)
SC 13G/A - ATOSSA THERAPEUTICS, INC. (0001488039) (Subject)
SC 13G/A - ATOSSA THERAPEUTICS, INC. (0001488039) (Subject)
FDA Provides Positive Feedback, Clears Path for Atossa to File IND for (Z)-Endoxifen in Metastatic Breast Cancer; FDA Indicates No Additional Toxicity Studies Required Strong I-SPY2 Results Reinforce Efficacy of Atossa's Monotherapy at 3-weeks SEATTLE, Aug. 12, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the second quarter ended June 30, 2025 and provided an update on recent company developments. "Atos
Announced strategic plan to advance (Z)-endoxifen for metastatic breast cancer indication Enhanced (Z)-endoxifen intellectual property portfolio with three new U.S. patents, expanding IP portfolio to more than 200 patent claims related to (Z)-endoxifen Ended first quarter 2025 with $65.1 million in cash and cash equivalents and no debt SEATTLE, May 13, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the first quarter ended March 31, 2025 and provided an update on recent company developments.
Ended 2024 with $71.1 million of cash and cash equivalents and no debt Conference Call and Webcast Scheduled for Tuesday, March 25, 2025, at 8:30 a.m. Eastern Time SEATTLE, March 25, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the full year ended December 31, 2024 and provided an update on recent company developments. Fourth Quarter and Early 2025 Highlights Strategic Decision to Pursue Metastatic Breast Cancer Indication: Atossa plans to advance its lead program, (Z)-endoxifen, to target metastatic bre
4 - ATOSSA THERAPEUTICS, INC. (0001488039) (Issuer)
4 - ATOSSA THERAPEUTICS, INC. (0001488039) (Issuer)
4 - ATOSSA THERAPEUTICS, INC. (0001488039) (Issuer)