Atossa Therapeutics

ATOS

Market cap $38.1M

SEATTLE, Feb. 11, 2026 /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 need, today issued a letter to Shareholders from Steven Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer, providing an update on the Company's clinical programs and recent events.

Atossa's Rare Pediatric Disease Designation for (Z)-endoxifen in neuromuscular diseases qualifies for a future PRV upon FDA approval SEATTLE, Feb. 5, 2026 /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 reaffirmed its strong market position around its Duchenne Muscular Dystrophy (DMD) program following  yesterday's congressional announcement that it had passed a five-year reauthorization of the Rare Pediatric Disease Priority Review Voucher ("PRV") Program. The program extends the Company's ability to be eligible to receive a future PRV upon the U.S. Food and Drug Administration's ("FDA") approval following the FDA granting Rare Pediatric Disease ("RPD") designation to (Z)-endoxifen for the treatment of DMD late last year.

Recognized for Visionary Leadership and Advancing Innovative Therapies in Oncology and Healthcare Technology SEATTLE, Jan. 21, 2026 /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 Founder, Chairman, President, and Chief Executive Officer Steven Quay, M.D., Ph.D. has been selected as one of "The Top 50 Healthcare Technology CEOs of 2025" by The Healthcare Technology Report.

Designation further supports (Z)-Endoxifen program into rare pediatric neuromuscular disease along with previously received Rare Pediatric Disease Designation SEATTLE, Jan. 16, 2026 /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") Office of Orphan Products Development ("OOPD") has granted Orphan Drug Designation to (Z)-endoxifen for the treatment of Duchenne muscular dystrophy ("DMD"). "In addition to the previously received Rare Pediatric Disease designation, Orphan Drug Designation for (Z)-endoxifen in Duchenne muscular dystrophy is an important milestone for Atossa as we move forward developing (Z)-endoxifen for this serious and debilitating disease," noted Steven C.

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.