Atossa Therapeutics

ATOS

Market cap $78.2M

SEATTLE, Jan. 6, 2026 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing innovative medicines for unmet medical needs, today announced that the U.S. Food and Drug Administration ("FDA") issued a "Study May Proceed" letter for the Company's study in metastatic breast cancer which was the subject of a recent investigational new drug application for (Z)-endoxifen. "This letter marks an important regulatory milestone for Atossa and to potentially expand the use of (Z)-endoxifen for metastatic ER+/HER2- Breast Cancer.

Recognized for Advancing (Z)-Endoxifen, a Precision-Engineered Endocrine Therapy with Potential Across Multiple Breast Cancer and Rare Disease Settings SEATTLE , Dec. 17, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, announces that it has been selected as a winner of the 2025 Clinical Trials Arena Excellence Awards. The Company was honored with the Research and Development Award in the Precision Endocrine Therapy category.

Studies highlight findings regarding the potential use of (Z)-endoxifen to advance breast cancer treatment and risk reduction SEATTLE , Dec. 15, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of high unmet need, presented four clinical trial updates on (Z)-endoxifen at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12, 2025, in San Antonio, TX. "Clinical trial updates and data presented at SABCS 2025 reinforce our focus on the therapeutic value of (Z)-endoxifen across the breast care continuum," said Steven Quay, M.D.

Designation expands (Z)-Endoxifen program into rare pediatric neuromuscular disease and may qualify Atossa for a future Priority Review Voucher upon approval SEATTLE , Dec. 11, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announced that the U.S. Food and Drug Administration ("FDA") has granted Rare Pediatric Disease ("RPD") designation to (Z)-Endoxifen for the treatment of Duchenne Muscular Dystrophy ("DMD"). RPD designation is granted to drug candidates intended to treat serious or life-threatening diseases that primarily affect individuals from birth to 18 years of age.

New patent further strengthens global intellectual property estate supporting Atossa's lead program across the breast cancer spectrum and other hormone-driven conditions SEATTLE , Dec. 9, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies in areas of significant unmet need in breast cancer, today announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,479,790 B2, titled, "Methods for Making and Using Endoxifen.

Company positioned to pursue expedited regulatory pathways in metastatic, neoadjuvant, and risk-reduction settings SEATTLE , Dec. 4, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment and prevention, announced the completion of a Type C meeting with the U.S. Food and Drug Administration ("FDA") on November 17, 2025, to review regulatory strategy for advancing (Z)-endoxifen. During the meeting, the FDA provided the Company feedback on potential expedited regulatory pathways and development options across metastatic disease, neoadjuvant treatment, and breast cancer risk-reduction settings.

CAMBRIDGE, Mass. , Dec. 2, 2025 /PRNewswire/ -- Insilico Medicine ("Insilico"), a global leader in AI-powered drug discovery, and Atossa Therapeutics ("Atossa") (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel treatments for breast cancer and other serious conditions, announce the publication of a joint study evaluating the potential of (Z)-endoxifen for glioblastoma multiforme (GBM).

Published article outlines rationale for multi-pathway efficacy for (Z)-endoxifen in Duchenne Muscular Dystrophy (DMD); November scientific presentation to spotlight potential in Duchenne carrier–associated pathologies SEATTLE , Nov. 17, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, announces a growing body of scientific work supporting the potential role of its investigational therapy (Z)-endoxifen in DMD, a severe, progressive, and ultimately fatal neuromuscular disease, in addition to Duchenne carrier–associated pathologies (D-CAPs) that affect a subset of female carriers. The momentum is anchored by a newly published, peer-reviewed hypothesis article and an upcoming invited scientific presentation.

Company reports progress to file planned IND for (Z)-endoxifen in mBC with CRO selection and streamlined development programs for potential 2026-NDA enabling activities, including a Type C meeting with the FDA, to potentially accelerate (Z)-endoxifen in breast cancer risk reduction Appointed key leadership to drive (Z)-endoxifen development and evolve pathway to commercialization SEATTLE , Nov. 12, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing proprietary innovative medicines in areas of significant unmet medical need in oncology, today announces its financial results for the third quarter ended September 30, 2025 and provides an update on recent corporate developments. "We continue to make meaningful and measurable progress across our (Z)-endoxifen development strategy in oncology," stated Dr. Steven Quay, Atossa Therapeutics' Chairman and CEO.

Studies highlight findings in the use of (Z)-endoxifen to advance breast cancer treatment and prevention SEATTLE , Nov. 6, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, announces that four abstracts featuring data on (Z)-endoxifen have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS), being held on December 9-12, 2025, in San Antonio, TX. "We continue to add to our body of clinical evidence.