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) has initiated the Phase 2 EVANGELINE study, dosing its first patient for a trial evaluating the efficacy of (Z)-endoxifen versus exemestane plus goserelin in treating ER+/HER2- breast cancer in premenopausal women. This randomized study aims to assess the endocrine sensitive disease rate after four weeks of treatment with approximately 175 participants across 25 sites in the U.S. The previous study showed (Z)-endoxifen reduced Ki-67 by 65.1%, indicating potential efficacy. Atossa is also exploring (Z)-endoxifen's application in reducing mammographic breast density, an important breast cancer risk factor.
Atossa Therapeutics (Nasdaq: ATOS) announced the granting of a new patent (No. 11,572,334) by the USPTO for (Z)-endoxifen encapsulated in an enteric capsule, enhancing its intellectual property related to this compound. This patent positions Atossa as the sole provider of orally delivered (Z)-endoxifen with an enteric capsule in the U.S., aimed at optimizing drug delivery. The company is advancing Phase 2 trials, including the EVANGELINE study with approximately 175 participants and the Karisma-Endoxifen study with 240 participants, targeting unmet needs in breast cancer treatment. The new patent is expected to create long-term value for shareholders.
Atossa Therapeutics (Nasdaq: ATOS) announced significant progress in 2022, focusing on its breast cancer program with the patented (Z)-endoxifen. Currently, Phase 2 studies are underway to prevent and treat breast cancer, particularly targeting ER+/HER2- patients. The FDA authorized the EVANGELINE study for neoadjuvant treatment, expecting to enroll 175 patients across 25 sites. The company reported a 65.1% reduction in Ki-67 levels from a prior study, suggesting improved outcomes. Atossa also invested $4.7 million in Dynamic Cell Therapies, enhancing its oncology portfolio. As of September 30, 2022, Atossa holds approximately $117 million in cash and equivalents, with no debt.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has appointed Eric Van Zanten as Vice President of Investor and Public Relations. With over 25 years in corporate communications, particularly in biopharmaceuticals, Van Zanten will enhance the company's investor and public messaging. His previous roles include leadership positions at Faron Pharmaceuticals and Bristol-Myers Squibb. CEO Steven Quay expressed confidence in Van Zanten's ability to articulate Atossa's mission in oncology. Atossa focuses on innovative cancer treatments, specifically targeting breast cancer and lung injury from therapies.
Atossa Therapeutics (Nasdaq: ATOS) reported its financial results for Q3 2022, showing no revenue but a notable increase in operating expenses of 59% year-over-year, totaling $8,205, driven mainly by a 134% rise in R&D expenses. The company received FDA authorization for a Phase 2 study of (Z)-endoxifen for premenopausal women with ER+/HER2- breast cancer and is pursuing new immuno-oncology opportunities. As of September 30, 2022, Atossa had approximately $117,477 in cash. The total operating expenses for the first nine months of 2022 were $19,553, a 25% increase compared to 2021.
Atossa Therapeutics (Nasdaq: ATOS) announced its investment of $2 million in Dynamic Cell Therapies, acquiring a 19.99% stake. This move aligns with Atossa's strategy to explore CAR-T therapies in the immuno-oncology space, particularly for difficult-to-treat cancers. Previously, $3 million was invested in DCT, making a total of $5 million. The transaction is set to close in Q4 2022. DCT, based in Boston, is focused on developing controllable CAR-T therapies to enhance safety and efficacy in cancer treatments.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced the appointment of Dr. Richard Graydon as interim chief medical officer. Dr. Graydon, previously with Johnson & Johnson, brings extensive experience in CAR-T cell therapy and oncology drug development. He aims to enhance Atossa's clinical programs, including the Phase 2 oral Endoxifen program for breast cancer. Atossa focuses on innovative treatments for oncology, highlighting the need for effective cancer therapies.
Atossa Therapeutics has announced the initiation of a Phase 2 neoadjuvant study for its proprietary drug, (Z)-endoxifen, in premenopausal women with early-stage ER+/HER2- breast cancer. The U.S. FDA has lifted the clinical hold, allowing this key trial to move forward, which will involve about 175 patients across 25 sites. The study aims to determine whether (Z)-endoxifen is non-inferior to the standard treatment of exemestane + goserelin. Atossa has also decided to discontinue its COVID-19 program to focus on this significant research.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is set to participate in the 24th Annual H.C. Wainwright Global Investment Conference from September 12-14, 2022, at the Lotte New York Palace. Kyle Guse, General Counsel and CFO, will represent the company and is available for one-on-one meetings.
Atossa focuses on developing innovative therapies for unmet medical needs in oncology and infectious diseases, particularly in breast cancer and COVID-19.
For meeting requests and conference registration, visit here.
Atossa Therapeutics (Nasdaq: ATOS) will host a webinar on August 25, 2022, featuring CEO Dr. Steven Quay and CFO Kyle Guse. The event, starting at 8 AM Pacific, will discuss new opportunities for AT-H201, an inhalation therapy aimed at treating lung injuries from cancer treatments. Attendees can participate in a Q&A session regarding the company's research programs and future plans. Registration for the complimentary event is available online.
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