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) announced that the USPTO issued U.S. Patent No. 12,479,790 B2 on Dec 9, 2025, titled "Methods for Making and Using Endoxifen."
The patent includes 100 claims covering enteric oral formulations of highly pure (Z)-endoxifen free base, specific solid oral dosage forms, scalable manufacturing processes, and methods of use for hormone-dependent breast disorders and other estrogen-related conditions. The company says this grant adds to its existing U.S. patents and worldwide applications to support late-stage trials and potential commercialization of (Z)-endoxifen across prevention and treatment settings.
Atossa Therapeutics (Nasdaq: ATOS) completed a Type C meeting with the FDA on November 17, 2025 to review regulatory strategy for (Z)-endoxifen. The FDA provided feedback on potential expedited pathways and development options across metastatic, neoadjuvant ER+/HER2-, and breast cancer risk-reduction settings, focusing on clinical design, endpoints, and streamlined registrational approaches. Atossa said FDA input clarified routes to accelerate development and regulatory review.
Key program items: a metastatic dose-ranging study is in preparation and an IND was submitted for the metastatic program (awaiting feedback); the Phase 2 EVANGELINE neoadjuvant trial is enrolling; risk-reduction work targets low-dose effects on mammographic density. Atossa reported completing multiple trials involving nearly 800 participants and expects additional INDs in 2026.
Atossa Therapeutics (Nasdaq: ATOS) and Insilico Medicine published a joint AI-driven study in Nature Scientific Reports on Dec 2, 2025 identifying (Z)-endoxifen as a potential therapeutic candidate for glioblastoma (GBM).
The study used Insilico's PandaOmics across >900 cancer indications and multi-omic methods, ranked GBM as a top opportunity, found >1,400 shared genes reversed by endoxifen, and reported in vitro suppression of GBM cell proliferation exceeding high-dose temozolomide plus tolerable in vivo dosing. Insilico also cited 20 preclinical nominations with a 12–18 month average turnaround.
Atossa (Nasdaq: ATOS) highlighted a newly published peer‑reviewed hypothesis article and an invited scientific presentation supporting the investigational therapy (Z)-endoxifen for Duchenne muscular dystrophy (DMD) and symptomatic female carriers (D‑CAPs).
The paper maps multi‑pathway mechanisms — ER modulation, PKC‑β1 inhibition, AKT/mTOR and NF‑κB effects — and notes potential advantages over tamoxifen due to more consistent exposure. Atossa plans preclinical validation and fit‑for‑purpose clinical studies focused on safety, PK/PD, functional and cardiac endpoints; a follow‑up manuscript on utrophin modulation is under review.
Atossa Therapeutics (Nasdaq: ATOS) reported Q3 2025 results and corporate updates on Nov 12, 2025. Key items: operating expenses of $9.3M for Q3 2025 (vs $6.4M Q3 2024); prioritized IND-targeted programs for (Z)-endoxifen with a planned IND filing in Q4 2025 and an FDA Type C meeting scheduled for Nov 17, 2025. The company selected PSI as CRO for a global Phase 2 dose-ranging mBC study with enrollment post-IND and topline data expected in 2026. Hires include a new SVP R&D and a CFO to support regulatory and commercial readiness. The Israeli patent No. 304863 issued July 2, 2025; two U.S. patents face post-grant challenges.
Atossa Therapeutics (Nasdaq: ATOS) announced four abstracts featuring (Z)-endoxifen research were accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), Dec 9-12, 2025 in San Antonio, TX. The company will present four posters on Dec 11-12 covering DCIS management, a low-dose I-SPY2 endocrine pilot, ESR1 mutant activity, and a Phase 2 neoadjuvant EVANGELINE trial.
Presentations include scheduled poster sessions on Dec 11 (12:30pm–2:00pm CT) and Dec 12 (7:00am–8:30am CT and 12:30pm–2:00pm CT).
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.