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, a clinical stage biopharmaceutical company focused on developing innovative medicines for breast cancer and other areas of significant unmet medical need in oncology, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. Michael Parks, Vice President of Investor and Public Relations at Atossa, will engage in a virtual fireside chat on Wednesday, October 16, 2024, at 12:00 p.m. EDT.
The company, traded on Nasdaq under the ticker ATOS, invites interested parties to register and access the live webcast of the conference through a provided link. This event presents an opportunity for investors and stakeholders to gain insights into Atossa's current developments and future prospects in the oncology field.
Atossa Therapeutics (Nasdaq: ATOS) is recognizing Breast Cancer Awareness Month this October, emphasizing the need for innovation in breast cancer treatment. The company highlights the importance of education, early detection, and research in combating this disease that affects approximately one in eight women.
Atossa, a clinical-stage biopharmaceutical company, is currently evaluating its lead asset, (Z)-endoxifen, in multiple phase 2 clinical trials. The Karisma-Endoxifen study is investigating its potential to reduce mammographic breast density in premenopausal women, with data expected in Q4 2024.
The company is also supporting the SMART study, a phase 2 trial validating an AI-driven breast cancer risk assessment model. This model could potentially serve as the foundation for a future phase 3 trial of (Z)-endoxifen in breast cancer prevention.
Atossa's efforts align with the FDA's recent implementation of updated mammography rules, which now require healthcare providers to notify women of their breast density results, a known risk factor for breast cancer.
Atossa Therapeutics (Nasdaq: ATOS) supports the FDA's final rule update to mammography regulations, effective Sept. 10, 2024. The rule requires mammography facilities to provide patients with a breast density assessment in patient-friendly terms. This is important as breast density is a known risk factor for breast cancer and can obscure tumor detection. The regulation aims to improve early breast cancer detection by empowering women with dense breast tissue to discuss supplemental screening options with healthcare providers.
Atossa, focusing on breast cancer therapies, is evaluating its lead asset, (Z)-endoxifen, in multiple phase 2 trials. The Karisma-Endoxifen study investigates its potential to reduce mammographic breast density in premenopausal women, with data expected by year-end 2024. Atossa also supports the SMART study, testing an AI-driven breast cancer risk assessment model, which could form the basis for a future phase 3 trial of (Z)-endoxifen in breast cancer prevention.
Atossa Therapeutics (Nasdaq: ATOS) has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024. The event will be held both in-person and virtually. Steven Quay, M.D., Ph.D., President and CEO of Atossa, will take part in a virtual fireside chat and meet with investors.
A recording of the fireside chat will be available at 7:00 a.m. EDT on Monday, September 9, 2024, on the conference website and in the Investors section of Atossa's website under Events & Presentations. Investors interested in one-on-one meetings with Atossa management should contact their H.C. Wainwright representative to arrange appointments.
Atossa Therapeutics (Nasdaq: ATOS) has been granted a new patent (U.S. Patent No. 12,071,391) by the United States Patent and Trademark Office (USPTO). This patent covers compositions comprising endoxifen (in free base or salt forms) and an enteric material, where at least 90% is (Z)-endoxifen. It also includes methods of administering these compositions to patients.
This is Atossa's fourth issued patent from the USPTO, expanding protection to include (Z)-endoxifen salt compositions and their usage methods. The company, a clinical-stage biopharmaceutical firm, focuses on developing innovative medicines for oncology, particularly breast cancer. CEO Steven Quay emphasized that this broader patent protection will create long-term stockholder value by further validating and expanding Atossa's patent portfolio beyond previously issued composition of matter patents.
Atossa Therapeutics (Nasdaq: ATOS) and Quantum Leap Healthcare Collaborative have dosed the first patient in their clinical trial evaluating Atossa's (Z)-endoxifen combined with abemaciclib (VERZENIO®) for ER+/HER2- breast cancer. The study, part of the I-SPY 2 Endocrine Optimization Pilot Protocol, aims to enroll 80 participants across two cohorts, focusing on patients with newly diagnosed ER+ invasive breast cancer. Participants will receive 80 mg (Z)-endoxifen daily and 150 mg abemaciclib twice daily for 24 weeks before surgery. The second cohort will also include ovarian function suppression for premenopausal women. Results are expected in 2026, potentially validating (Z)-endoxifen's safety and efficacy in both pre- and postmenopausal breast cancer patients.
Atossa Therapeutics (Nasdaq: ATOS) has appointed Michael Parks as Vice President of Investor and Public Relations. With nearly 30 years of experience in the biopharmaceutical and healthcare industries, Parks will oversee corporate communications, investor relations, and branding for the company. Atossa, a clinical-stage biopharmaceutical company, focuses on developing innovative medicines for breast cancer and other areas of unmet medical need in oncology.
Parks' extensive background includes roles at PAVmed, Lucid Diagnostics, Liquidia , and his own consulting firm, Pitch360. He also held positions at Johnson & Johnson's Centocor, Pfizer, Pharmacia, and Searle Pharmaceuticals. Dr. Steven Quay, Atossa's CEO, expressed excitement about Parks joining the team, highlighting his seasoned experience and multidisciplined approach to communications.
Atossa Therapeutics (NASDAQ: ATOS) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- Completed enrollment in 80mg PK Run-in Cohort for EVANGELINE trial
- Presented data showing 100% disease control rate after 24-week treatment with (Z)-Endoxifen in 40mg cohort of Phase 2 EVANGELINE study
- Completed Phase 2 Karisma-Endoxifen clinical trial dosing
- Ended Q2 with $79.5 million in cash and no debt
Financial results: Total operating expenses decreased to $7.1 million for Q2 2024, down from $7.8 million in Q2 2023. R&D expenses slightly decreased, while G&A expenses saw a significant reduction in compensation costs. Interest income increased to $1.1 million for Q2 2024.
Atossa Therapeutics (Nasdaq: ATOS) has completed enrollment for the 80mg pharmacokinetic run-in cohort in its Phase 2 EVANGELINE clinical trial. This study evaluates (Z)-endoxifen as a neoadjuvant treatment for ER+ / HER2- breast cancer. The cohort includes 12 pre-menopausal women who will receive 80mg/day of (Z)-endoxifen for four weeks. Key points:
- The full study aims to enroll 175 patients across 25 U.S. sites
- Previous 40mg cohort showed 92% average reduction in Ki-67 and 37% average target lesion decrease
- 80mg dose is expected to optimize PKCβ1 inhibition and enhance antitumor efficacy
- EVANGELINE compares (Z)-endoxifen to exemestane plus goserelin in pre-menopausal women with Grade 1 or 2 ER+ / HER2- breast cancer
Atossa Therapeutics has appointed Heather Rees as its new Chief Financial Officer (CFO). Rees, who has been with Atossa for seven years and previously served as Senior Vice President of Finance and Principal Accounting Officer, brings nearly 30 years of experience in accounting, business, and finance to this role. She first joined Atossa as Controller in 2017. Prior to Atossa, Rees led a consulting practice providing services to companies like Getty Images and Avalara, and served as Controller of the Americas for Irdeto Inc. Atossa's CEO, Steven Quay, praised Rees for her contributions, which have been key to the company's success. With multiple data milestones expected this year and sufficient working capital for approximately three years, Atossa is well-positioned to enhance shareholder value.
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