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Atossa Therapeutics, Inc. (NASDAQ: ATOS) is a pioneering biopharmaceutical company headquartered in Seattle, Washington. Established in 2009, Atossa focuses on developing innovative and proprietary medicines targeting unmet medical needs in oncology, with a particular emphasis on breast cancer. The company is currently in the clinical stage, advancing several key programs designed to improve cancer treatment and prevention.
Atossa's core program is the development of (Z)-endoxifen, a potent metabolite of tamoxifen, crucial for treating and preventing breast cancer. Currently, (Z)-endoxifen is in Phase II clinical trials aimed at various breast cancer conditions, including estrogen receptor-positive breast cancer, ductal carcinoma in situ (DCIS), and mammographic breast density. The company is also exploring its efficacy in combination therapies with drugs like abemaciclib, a CDK 4/6 inhibitor.
In addition to breast cancer, Atossa has ventured into COVID-19 therapeutics with two potential treatments: AT-H201 for improving lung function in severe COVID-19 patients and AT-301, a nasal spray for at-home use.
Recently, Atossa has achieved several milestones, including the successful dosing of the first patient in the RECAST DCIS study, full enrollment of its Phase II Karisma-Endoxifen trial, and promising preliminary data from the 40mg cohort in the EVANGELINE study. The company also regained compliance with Nasdaq's minimum bid price requirement.
Atossa's collaborative efforts include partnerships with Quantum Leap Healthcare Collaborative and Weill Cornell Medicine, advancing studies in combination therapies and breast cancer risk assessment through innovative AI models. With a strong financial position, including $84 million in cash and no debt as of Q1 2024, Atossa is well-positioned to continue its groundbreaking work in oncology.
Atossa Therapeutics (Nasdaq: ATOS) has announced positive interim findings from an Expanded Access study of its oral Endoxifen for breast cancer treatment, which shows no recurrence of cancer in a patient after 18 months. The treatment did not cause common side effects associated with tamoxifen, and significant reductions in tumor markers Ki-67 (50%) and ER+ cells (22%) were observed. A Phase 2 study is ongoing, focusing on newly diagnosed patients, with all interim patients showing considerable Ki-67 reduction.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces a webinar on July 30, 2020, hosted by CEO Dr. Steven Quay. The 30-minute event will discuss the company's breast cancer programs and advancements in two COVID-19 treatments. Registration is free via Tribe Public's website. Dr. Quay, a prominent figure in medical research, holds multiple patents and has contributed significantly to COVID-19 and breast cancer solutions. The event aims to provide insights into Atossa's progress and engage with investors.
Atossa Therapeutics (NASDAQ: ATOS) has contracted with Avance Clinical to conduct a clinical study of its nasal spray drug candidate, AT-301, aimed at treating COVID-19 in non-hospitalized patients. The double-blinded, randomized, placebo-controlled study will evaluate the safety of AT-301 in 32 healthy adults. The primary goal is to assess tolerability and local irritation, while secondary objectives include bronchospasm evaluations. Atossa plans to file for further regulatory approvals and aims to begin the study soon. The company has also filed provisional patents for AT-301.
Atossa Therapeutics (Nasdaq: ATOS) has announced positive in vitro results for its COVID-19 nasal spray, AT-301. The drug candidate demonstrated the ability to inhibit SARS-CoV-2 infectivity in VERO cells, suggesting potential efficacy in blocking virus entry into nasal cells. AT-301 aims to create a protective mucosal barrier in the nasal cavity, which could lower COVID-19 symptoms and infectivity. A Phase 1 clinical study is expected to commence soon. Atossa has filed provisional patents related to AT-301's formulation and methods of use.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has announced the hiring of key personnel to enhance its clinical, regulatory, and chemistry manufacturing capabilities. Key hires include Heather Fraser, Ph.D., as vice president of clinical, regulatory and CMC; Natalie Farris, MS, as senior director of CMC; and Devon Payne as director of clinical operations. CEO Steven Quay emphasized that these acquisitions will accelerate the company's development pipeline, focusing on breast cancer and COVID-19 treatments, enhancing their strategic value creation efforts.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced promising in vitro test results for its COVID-19 drug candidate, AT-H201. The study indicates that AT-H201 significantly inhibits SARS-CoV-2 infectivity in VERO cells, showing it to be at least four times more potent than remdesivir and 20 times more potent than hydroxychloroquine. A provisional patent has been filed for AT-H201, although further safety and efficacy studies, as well as regulatory approvals, are required before commercialization.
Atossa Therapeutics (Nasdaq: ATOS) has initiated development of a second COVID-19 program using its proprietary nasal spray candidate, AT-301. This drug is designed for patients diagnosed with COVID-19 but not requiring hospitalization, aiming to reduce symptoms and slow infection rates. AT-301 targets essential human host proteases to inhibit SARS-CoV-2. The company plans to commence human clinical trials in Q3 2020, pending regulatory approvals. Summit Biosciences has been retained for product development. Provisional patent applications have been filed for AT-301.
Atossa Therapeutics (Nasdaq: ATOS) reported successful in vitro results for its COVID-19 drug candidate, AT-H201, demonstrating potent inhibition of SARS-CoV-2 infectivity in VERO cells. The study showed AT-H201 as the first submicromolar inhibitor identified, surpassing the potency of remdesivir by four times and hydroxychloroquine by twenty times. Dr. Steven Quay, CEO, expressed optimism for further clinical development. However, the company warns that these initial results do not guarantee success in human trials, with additional safety and efficacy studies necessary before commercialization.
Atossa Therapeutics (ATOS) reported its Q1 2020 financial results, revealing no sustainable revenue and total operating expenses of approximately $2.94 million, down 28% from Q1 2019. Key developments include the launch of the COVID-19 HOPE program to test AT-H201, aiming to improve lung function in COVID-19 patients. Positive interim results from the Phase 2 study of oral Endoxifen indicated a 74% reduction in tumor cell proliferation. The company is planning further clinical trials, with approximately $9.4 million in cash as of March 31, 2020.
Atossa Therapeutics (NASDAQ: ATOS) announced positive interim results from its Phase 2 study of oral Endoxifen for breast cancer, reporting a statistically significant 74% reduction in tumor cell proliferation (p = 0.031) over 22 days. All six patients showed a decrease in Ki-67, a key proliferation marker, with levels dropping below 25%. The study, conducted in Australia, aims to enroll 25 patients, and successful results may lead to a Phase 3 study. There were no safety concerns noted, and patients reported fewer side effects compared to traditional therapies.
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