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Atossa says cannot begin enrolling patients in Phase 2 trial to reduce MBD » 08:19
04/02/20
04/02
08:19
04/02/20
08:19
ATOS

Atossa Genetics

$1.20 /

-0.13 (-9.77%)

The company said,…

The company said, "Updates on the company's planned Phase 2 trial to reduce MBD include: In February 2020, we applied with the Swedish regulatory authorities for approval to begin our Phase 2 clinical study of our oral Endoxifen to reduce MBD. The MPA provided questions about our application, as is typical, and we will be addressing those questions over the coming weeks. Because of the outbreak of COVID-19, health facilities in Sweden are not currently providing screening mammograms. As a practical matter, we cannot begin enrolling patients until screening mammograms recommence in Stockholm. We plan to begin this study as soon as we receive approval from the Swedish regulatory authorities and screening mammograms recommence. The company has manufactured all of the drug necessary for three months of dosing for the first 90 patients to be enrolled in the planned Phase 2 study. Additionally, Atossa submitted materials to the FDA in advance of its scheduled April 30 meeting, and has confirmed at least three years of stability data on its proprietary Endoxifen."

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Atossa treated 'sufficient' number of patients in WOO Phase 2 trial for report » 08:17
04/02/20
04/02
08:17
04/02/20
08:17
ATOS

Atossa Genetics

$1.20 /

-0.13 (-9.77%)

Atossa Therapeutics…

Atossa Therapeutics announced recent progress with its Phase 2 study administering oral Endoxifen in the "window of opportunity" between diagnosis of breast cancer and surgery, as well as the company's proposed Phase 2 clinical trial to reduce mammographic breast density. Updates on the company's "window of opportunity" Phase 2 trial include: Completed treating a sufficient number of patients to permit an initial report of study results from the pilot portion of the study. Contracted with Avance Clinical to open a second site for the study in Geelong, Victoria, Australia, with the goal of increasing the rate of enrollment. Applied to the Institutional Review Board for approval to open the second site in Geelong, Australia. Manufactured sufficient Endoxifen necessary for all patients expected to enroll in this study.

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Over a week ago
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Atossa Genetics CEO announces new COVID-19 HOPE clinical trial » 08:42
03/30/20
03/30
08:42
03/30/20
08:42
ATOS

Atossa Genetics

$1.06 /

-0.04 (-3.64%)

Physician-scientist and…

Physician-scientist and inventor Dr. Steven Quay, MD, PhD, is announcing a new combination treatment with the potential to improve pulmonary function and reduce or eliminate mechanical ventilation in patients with the coronavirus infection. The treatment uses two drugs previously approved by the FDA for other conditions: nebulized heparin combined with N-acetylcysteine, termed "H-NAC." Dr. Quay is making this new clinical trial protocol available for use by the worldwide medical community. Starting today, doctors around the world are invited to directly download the protocol free of charge at www.DrQuay.com. At the request of the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, and the National Institutes of Health, the protocol has been provided to the Infectious Disease Clinical Research Consortium in the United States. The basis for Dr. Quay's recommendation for this new potential treatment is four-fold: The SARS-CoV-2 virus has a Spike Protein on its surface that potentially interacts with three molecules on the surface of lung cells: heparin sulfate, furin, an enzyme for protein processing, and angiotensin converting enzyme 2, a cell surface receptor. These interactions are needed for the virus to infect cells. Like a vaccine which teaches the immune system to make antibodies to block these same interactions and prevent an infection, Dr. Quay expects H-NAC to also interfere with these interactions, based on an understanding of the genetics of the virus and the biophysics and biochemistry of the Spike Protein, and the surface of cells in the lungs, heart, and other organs which are attacked by this virus. Laboratory experiments with the current coronavirus, SARS-CoV-2, and previous human coronaviruses show that both drugs separately can interfere with infection in vitro. Twelve clinical trials in over 780 patients have been conducted with either nebulized heparin alone or in combination with NAC for the treatment of pulmonary damage in burn patients and in patients with Adult Respiratory Destress Syndrome. These trials showed efficacy, as measured by improved lung function and reduced need for mechanical ventilation, and demonstrated safety, with only clinically minor adverse events seen. Both drugs are currently FDA-approved for use by injection, are widely available, and are reasonably priced. NAC is also FDA-approved in an inhalation formulation for a wide range of pulmonary conditions, although not for COVID-19 patients.

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Earnings
Atossa Genetics reports FY19 EPS ($2.03), one est. ($2.03) » 08:24
03/26/20
03/26
08:24
03/26/20
08:24
ATOS

Atossa Genetics

$1.08 /

+0.1417 (+15.10%)

"We are very proud…

"We are very proud of our 2019 accomplishments, as we focused on developing our proprietary drug Endoxifen to reduce mammographic breast density and to treat breast cancer in the 'window of opportunity' - after a patient is diagnosed but before her surgery," said Dr. Steven Quay, Atossa's President and Chief Executive Officer. "We have received positive data from the expanded access patient taking our oral Endoxifen and from our Phase 2 study of our topical Endoxifen to reduce MBD, all while minimizing costs and managing our cash position."

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Atossa Genetics announces FDA meeting on April 30 to discuss endoxifen » 08:32
03/13/20
03/13
08:32
03/13/20
08:32
ATOS

Atossa Genetics

$0.77 /

-0.1098 (-12.48%)

Atossa Therapeutics…

Atossa Therapeutics announced that it will meet with the U.S. FDA on April 30, 2020. The objective of this meeting is to discuss the clinical development of oral Endoxifen to reduce mammographic breast density. Atossa's offices are located in Seattle, Washington and ongoing or planned clinical trials of Atossa's Endoxifen are located in Australia and Sweden. Despite the well-publicized impacts of the current COVID-19 outbreak, Atossa's operations, including clinical studies and the supply of Endoxifen, have not been negatively impacted. Sufficient quantities of the active pharmaceutical ingredient, Endoxifen, for the currently ongoing and planned clinical trials have been previously manufactured and are in secure storage. Management instituted a temporary policy of working from home, which has been in place since February 26, 2020, and of limited business travel. Finally, the Company has not been notified of any employee illness, as would be required by policy.

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Over a month ago
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Atossa files for Swedish approval to initiate Phase 2 study of endoxifen » 09:04
03/02/20
03/02
09:04
03/02/20
09:04
ATOS

Atossa Genetics

$1.23 /

-0.04 (-3.15%)

Atossa Therapeutics…

Atossa Therapeutics announced that it has filed with the Swedish Medical Product Agency and the Institutional Review Board to initiate a Phase 2 study of its oral Endoxifen for the reduction of mammographic breast density. MBD is an emerging public health issue affecting more than 10 million women in the United States. Studies conducted by others have shown that MBD increases the risk of developing breast cancer, and reducing MBD can reduce the incidence of breast cancer. Atossa has established both primary and secondary sources of manufacturing for the clinical supply of its oral Endoxifen capsules. With over three years of experience manufacturing and supplying the oral Endoxifen capsules for its completed clinical studies, Atossa believes adequate drug supply will be available to support this Phase 2 study. The primary objective of the study is to determine if breast density changes compared to placebo and among different doses, with secondary endpoints to assess and characterize safety and tolerability. South General Hospital in Stockholm will be conducting this study at multiple sites, after having recently completed the company's Phase 2 study of its topical form of Endoxifen. The study is being led by principal investigator Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

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Conference/Events
Atossa Genetics management to meet with CIBC » 04:55
02/28/20
02/28
04:55
02/28/20
04:55
ATOS

Atossa Genetics

$1.27 /

+0.015 (+1.20%)

Meetings to be held in…

Meetings to be held in Toronto, Canada on February 27 and in Montreal on February 28 hosted by CIBC.

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Conference/Events
Atossa Genetics management to meet with CIBC » 04:55
02/27/20
02/27
04:55
02/27/20
04:55
ATOS

Atossa Genetics

$1.26 /

+0.045 (+3.72%)

Meetings to be held in…

Meetings to be held in Toronto, Canada on February 27 and in Montreal on February 28 hosted by CIBC.

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Conference/Events
Atossa Genetics management to meet with CIBC » 08:34
02/25/20
02/25
08:34
02/25/20
08:34
ATOS

Atossa Genetics

$1.31 /

-0.04 (-2.96%)

Meetings to be held in…

Meetings to be held in Toronto, Canada on February 27 and in Montreal on February 28 hosted by CIBC.

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Hot Stocks
Atossa says advancing oral Endoxifen through phase 2 study primary goal in 2020 » 08:40
01/22/20
01/22
08:40
01/22/20
08:40
ATOS

Atossa Genetics

$1.50 /

-0.02 (-1.32%)

Atossa Therapeutics…

Atossa Therapeutics issued the following letter from Dr. Steven Quay, President and CEO, to Atossa shareholders. The letter read in part, "I begin this letter with a sense of great pride about our accomplishments at Atossa. During 2019, we focused on developing our proprietary drug Endoxifen to reduce mammographic breast density and to treat breast cancer after a woman is diagnosed but before her surgery. We advanced our goal of developing our intraductal microcatheter technology to deliver drugs and immunotherapies to treat breast cancer...Moving forward in 2020, we will continue to pursue our mission with vigor and dedication: Oral Endoxifen to Reduce MBD. Our primary goal in 2020 is advancing oral Endoxifen through a Phase 2 study to reduce MBD. The primary objective of this randomized, double-blinded, placebo-controlled study is to determine if there was a change in breast density compared to placebo and among different doses, with secondary endpoints to assess and characterize safety and tolerability. South General Hospital in Stockholm will be conducting this study at multiple sites, after having recently completed our Phase 2 study of our topical form of Endoxifen. The study is being led by principal investigator Dr. Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet. We expected to enroll approximately 1,000 pre-menopausal participants in four groups who will be dosed for six months. In 2019, we completed additional Phase 1 work using our capsule Endoxifen and a new modified-release form of our oral Endoxifen. Study results showed that the capsule and tablet were safe and well-tolerated. Because the pharmacokinetics of the tablet did not appear to be significantly improved over our capsule and because the capsule is more cost-effective to manufacture, we plan to use our capsule formulation of Endoxifen in our upcoming Phase 2 study to reduce MBD. Upcoming 2020 milestones with this program include receiving approval to open the study from the Institutional Review Board and Medical Products Authority in the first quarter 2020. We will then begin enrolling participants in the first or second quarter of 2020 and we expect to report periodically the progress with enrollment. Oral Endoxifen in the "Window of Opportunity" Between Diagnosis of Breast Cancer and Surgery. We plan to continue enrolling participants in this Phase 2 study being conducted in Australia. Intraductal Technology. We plan to continue our Phase 2 study using our intraductal technology to administer Fulvestrant and we will be conducting additional pre-clinical work to identify potential immunotherapy candidates. Gynecomastia. Completing our Phase 2 study of MBD will help inform next steps with our program to treat and/or prevent gynecomastia with our proprietary Endoxifen. Accordingly, we don't anticipate advancing our gynecomastia program in 2020."

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