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 (Nasdaq: ATOS) highlighted enrollment progress and biomarker strategy for the RECAST™ Phase 2 DCIS platform trial ahead of an Early Detection Research Conference presentation on October 21, 2025.
RECAST is a multi-arm, randomized neoadjuvant trial testing standard endocrine therapy and novel agents—(Z)-Endoxifen, elacestrant, Hav-088—with imaging, biomarker discovery, and quality-of-life endpoints. Enrollment began January 2024 with 50 of 400 patients enrolled across 17 active U.S. sites. The trial aims to identify patients suitable for long-term active surveillance and generate interim imaging and biomarker readouts to de-risk later-stage development.
Atossa Therapeutics (Nasdaq: ATOS) announced that Chairman & CEO Steven Quay, M.D., Ph.D. will present at the Maxim Growth Summit on October 22–23, 2025 at the Hard Rock Hotel, New York City.
The company invited new and existing investors to attend or request one-on-one meetings to discuss Atossa's clinical programs, development plans, and capital-allocation strategy focused on preparing data packages for potential regulatory submissions and commercialization.
Investors are directed to the Atossa investor website for presentations, SEC filings, FAQs, and meeting requests.
Atossa (NASDAQ: ATOS) appointed Mark Daniel, CPA, as Chief Financial Officer effective Oct 14, 2025 to lead finance, systems, and capital strategy as the company prepares for commercial launch of (Z)-endoxifen.
Mr. Daniel brings >25 years of life‑sciences finance experience, including weekly revenue forecasting with commercial teams, management of operating budgets >$200M, implementation and certification of SOX controls, programs delivering >$50M in cost savings, stewardship of a $400M cash and investments portfolio, and participation in nearly $1B of equity, convertible debt, and credit transactions.
Atossa Therapeutics (NASDAQ: ATOS) announced expansion of its global intellectual-property strategy for Z-endoxifen, including issuance of an Israeli patent (No. 304863) granted on July 2, 2025 and a Certificate of Patent Renewal confirming fee payment and active status.
The Israeli claims cover oral delayed-release enteric dosage forms with at least 90% Z-endoxifen, optional impurity limits (<2%), defined gastric/intestinal release characteristics, dose strengths (e.g., 1–4 mg and 8 mg), pharmacokinetic targets, and manufacturing methods that enrich the Z-isomer via crystallization and solvent control.
Atossa Therapeutics (NASDAQ: ATOS) amended its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal ER+/HER2– early breast cancer to a single-arm, open-label, non-registrational design. The amendment reduces planned enrollment from 214 to 40–65 patients, implements a Cohort A two-stage futility rule using Week-4 Ki-67 ≤10% for earlier go/no-go decisions, and retains unchanged patient-safety data collection and DSMC oversight. Run-in data showed a Week-4 Ki-67 ≤10% rate of 86%. The company says the change aims to cut future study costs, accelerate objective readouts, and prioritize NDA-enabling activities in 2026.
Atossa Therapeutics (NASDAQ:ATOS) has appointed Janet R. Rea, MSPH as Senior Vice President, R&D. This strategic hire brings over 20 years of clinical development and regulatory expertise to accelerate the development of (Z)-endoxifen, the company's lead product candidate for breast cancer treatment and prevention.
Ms. Rea, who previously served at Atossa, returns with significant experience in securing regulatory approvals, including her role in the approval of FluBlok® at Protein Sciences. Her prior work at Atossa involved securing regulatory clearance for (Z)-endoxifen clinical studies in Australia, the US, and Sweden.
In her new role, Ms. Rea will focus on upcoming FDA submissions and defining the pathway to commercialization for (Z)-endoxifen across multiple indications.
Atossa Therapeutics (NASDAQ:ATOS), a clinical-stage biopharmaceutical company focused on breast cancer treatment and prevention, has appointed CORE IR as its strategic investor relations and communications partner. The collaboration aims to enhance investor awareness and strengthen shareholder engagement through comprehensive IR services.
Under the agreement, CORE IR will provide strategic messaging, non-deal roadshow support, investor targeting and outreach, and communication program support. The partnership reflects Atossa's commitment to improving market visibility and communicating its progress to both institutional and retail investors.
Atossa Therapeutics (NASDAQ:ATOS) has requested a Type C meeting with the FDA to discuss accelerating the development of low-dose (Z)-endoxifen for breast cancer risk reduction. The company expects to update shareholders on the meeting outcome by year-end 2025.
The potential market includes 1.6-2.1 million annual tamoxifen prescriptions in the U.S. across three settings: adjuvant therapy, DCIS risk reduction, and high-risk women without prior cancer. Atossa had $57.9 million in cash and no debt as of June 30, 2025.
(Z)-endoxifen shows equivalent anti-estrogen activity to tamoxifen but avoids CYP2D6 metabolism variability issues affecting up to 20% of women. The drug achieves target concentrations within hours versus weeks for tamoxifen, potentially offering a more predictable and faster-acting therapy.
Atossa Therapeutics (NASDAQ: ATOS), a clinical-stage biopharmaceutical company focused on breast cancer treatment and prevention, announced that CEO Dr. Steven Quay will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025.
During the presentation, Dr. Quay will discuss updates on the company's lead program (Z)-endoxifen, a Selective Estrogen Receptor Modulator (SERM) designed for breast cancer prevention and treatment. The discussion will cover multiple clinical studies progress and recent encouraging regulatory feedback that could accelerate development.
The presentation will be available via webcast with a 90-day replay period on Atossa's investor website. A preview video message from Dr. Quay is currently available.
Atossa Therapeutics (NASDAQ: ATOS) has selected PSI as its Contract Research Organization (CRO) for a pivotal Phase 2 dose-ranging study of (Z)-endoxifen in metastatic breast cancer. The study, designed with FDA guidance, will evaluate the drug's safety, pharmacokinetics/pharmacodynamics, and preliminary anti-tumor activity.
The company plans to file an Investigational New Drug (IND) application in Q4 2025, with patient enrollment following thereafter and topline data expected in 2026. The study aims to inform a subsequent Phase 3 trial. The market opportunity includes approximately 170,000 women living with metastatic breast cancer in the United States.
PSI, selected for its expertise in oncology trials, achieved a 93% on-time or ahead-of-schedule enrollment rate in 2024. Atossa is also advancing additional Phase 2 studies of (Z)-endoxifen in various breast cancer settings, with multiple clinical readouts expected in the coming months.