Selective estrogen receptor modulators

Atossa Therapeutics Receives Approval from Swedish Regulators to Initiate Phase 2 Clinical Study of Oral Endoxifen to Reduce Mammographic Breast Density

Retrieved on: 
Friday, June 11, 2021

Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer.

Key Points: 
  • Additional studies show a correlation between reducing MBD and a reduction in the incidence of breast cancer.
  • This is a critical milestone in the development of our oral Endoxifen, commented Steven Quay, M.D., Ph.D., Atossas Chairman and CEO.
  • In addition to clinical data, regulators will require that we also develop preclinical information including toxicology studies and information about manufacturing oral Endoxifen prior to regulatory approval.
  • The primary objective of the MBD study is to determine the dose-response relationship of daily oral Endoxifen on mammographic breast density reduction, with secondary endpoints assessing safety and tolerability.

Atossa Therapeutics Announces Final Data from Phase 2 Endoxifen Breast Cancer Study Primary Endpoint Met: 65.1% Reduction in Biomarker Ki-67; Secondary Endpoint Met: Endoxifen Safe and Well Tolerated

Retrieved on: 
Wednesday, June 9, 2021

Secondary Endpoints Were as Follows:

Key Points: 
  • Secondary Endpoints Were as Follows:
    Safety and tolerability: All adverse events were mild and considered related to the study drug.
  • There were no abnormal laboratory findings (serum chemistry, hematology, coagulation, urinalysis) and no differences in vital signs, physical examinations and ECGs.
  • Based on these results, Endoxifen was considered safe and well tolerated in this study.
  • The American Cancer Society (ACS) estimates that in 2021, 281,550women will bediagnosed with breast cancer in the U.S. and 43,600 willdie.

Sermonix Pharmaceuticals Announces Breast Cancer Research Publication of Preclinical Lasofoxifene Study in Endocrine-Resistant Breast Cancer

Retrieved on: 
Monday, May 17, 2021

Sermonix Pharmaceuticals was founded in 2014 by David Portman, M.D., a leading clinical researcher and expert in women\xe2\x80\x99s health, menopause and selective estrogen receptor modulator (SERM) therapy.

Key Points: 
  • Sermonix Pharmaceuticals was founded in 2014 by David Portman, M.D., a leading clinical researcher and expert in women\xe2\x80\x99s health, menopause and selective estrogen receptor modulator (SERM) therapy.
  • The Sermonix management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process.
  • Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience in the oncology drug development arena.
  • Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lambert\xe2\x80\x99s Pharmaceutical Division.

Atossa Therapeutics to Participate at the Investor Summit Conference and Present to Investors on May 18, 2021

Retrieved on: 
Friday, May 14, 2021

b'SEATTLE, May 14, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, today announced that management will participate at the Investor Summit Conference on May 18, 2021.\nCEO Dr. Steven Quay and Kyle Guse, CFO and General Counsel will deliver a corporate presentation at 8:45am ET on May 18, 2021.\nInvestors can also request a one-on-one meeting with management to be arranged following the conclusion of the conference.\nAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19.

Key Points: 
  • b'SEATTLE, May 14, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, today announced that management will participate at the Investor Summit Conference on May 18, 2021.\nCEO Dr. Steven Quay and Kyle Guse, CFO and General Counsel will deliver a corporate presentation at 8:45am ET on May 18, 2021.\nInvestors can also request a one-on-one meeting with management to be arranged following the conclusion of the conference.\nAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19.
  • For more information, please visit www.atossatherapeutics.com\nForward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with development plans, any variation between interim, preliminary and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of AT-H201, AT-301 and Endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa\xe2\x80\x99s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, whether change in mammographic breast density is an approvable end point for oral Endoxifen, and other risks detailed from time to time in Atossa\xe2\x80\x99s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.\n'

Atossa Therapeutics Urges Shareholders to Vote on Proposals Ahead of its Annual Stockholder Meeting May 14, 2021 at 1:00 PM Pacific Time

Retrieved on: 
Tuesday, May 11, 2021

b'SEATTLE, May 11, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases urges stockholders to vote on proposals put forth in the proxy statement prior to the Company\xe2\x80\x99s May 14, 2021 annual stockholder meeting.\nAtossa stockholder as of the March 24, 2021 record date may vote by calling (833) 786-6488 Monday through Friday 9 a.m. to 9 p.m. Eastern Time.

Key Points: 
  • b'SEATTLE, May 11, 2021 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases urges stockholders to vote on proposals put forth in the proxy statement prior to the Company\xe2\x80\x99s May 14, 2021 annual stockholder meeting.\nAtossa stockholder as of the March 24, 2021 record date may vote by calling (833) 786-6488 Monday through Friday 9 a.m. to 9 p.m. Eastern Time.
  • Details of the proposals, the stockholder meeting, and additional information on how to vote your shares can be found in the proxy statement, found here .
  • Holders of approximately 17.3 million shares of Atossa common stock as of the record date have entered into lock-up and voting agreements which require that they vote at the annual stockholder meeting.\nAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19.
  • For more information, please visit www.atossatherapeutics.com\nForward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with development plans, any variation between interim, preliminary and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies of AT-H201, AT-301 and Endoxifen, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa\xe2\x80\x99s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, whether reduction in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for oral Endoxifen, whether change in mammographic breast density is an approvable end point for oral Endoxifen, and other risks detailed from time to time in Atossa\xe2\x80\x99s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.\n'

Atossa Therapeutics Announces Ovarian Cancer Patient has Begun Treatment with Oral Endoxifen under FDA’s Expanded Access Pathway

Retrieved on: 
Thursday, April 8, 2021

The FDA previously issued a Safe to Proceed letter under their expanded access pathway, permitting the use of Atossas oral Endoxifen in this patient.

Key Points: 
  • The FDA previously issued a Safe to Proceed letter under their expanded access pathway, permitting the use of Atossas oral Endoxifen in this patient.
  • The patient has recurrent ovarian cancer and did not tolerate tamoxifen, which is sometimes prescribed for ovarian cancer as well as breast cancer, commented Steven Quay, M.D., Ph.D., Atossas President and CEO.
  • Under the FDA expanded access program, the use of Atossa's proprietary oral Endoxifen is restricted solely to this patient.
  • Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.

Global Bisphenol S Market Outlook to 2031: Plant Capacity, Production, Operating Efficiency, Technology, Demand & Supply, Application, End Use and Region - ResearchAndMarkets.com

Retrieved on: 
Friday, March 5, 2021

The "Global Bisphenol S Market: Plant Capacity, Production, Operating Efficiency, Technology, Demand & Supply, Application, End Use, Region, Competition, Trade, Customer & Price Intelligence Market Analysis, 2015-2031" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Bisphenol S Market: Plant Capacity, Production, Operating Efficiency, Technology, Demand & Supply, Application, End Use, Region, Competition, Trade, Customer & Price Intelligence Market Analysis, 2015-2031" report has been added to ResearchAndMarkets.com's offering.
  • The Global Bisphenol S Market has grown tremendously in the past five years and is estimated to grow at a CAGR of 11.50% during the forecast period.
  • The key advantages of Bisphenol S are that it is less acidic as compared to Bisphenol A.
  • In this report, the Global Bisphenol S Market has been segmented into the following categories:
    2.

Global Selective Estrogen Receptor Degrader (SERDs) Market Report 2021: A $2 Billion Opportunity by 2025 - Dosage, Price & Clinical Trials Insights

Retrieved on: 
Thursday, February 25, 2021

DUBLIN, Feb. 25, 2021 /PRNewswire/ -- The "Selective Estrogen Receptor Degrader (SERDs) Market, Dosage, Price & Clinical Trials Insight 2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Feb. 25, 2021 /PRNewswire/ -- The "Selective Estrogen Receptor Degrader (SERDs) Market, Dosage, Price & Clinical Trials Insight 2025" report has been added to ResearchAndMarkets.com's offering.
  • "Selective Estrogen Receptor Degrader (SERDs) Market, Dosage, Price & Clinical Trials Insight 2025" provides detailed insight on clinical and non clinical parameters involved in the development and expansion of the global SERD market.
  • The future novel products approved under selective estrogen receptor degrader therapy market are believed to contribute a large net sales and revenue generation, as the market brand will grow at extensive rate.
  • Selective Estrogen Receptor Degrader (SERDs) Market, Dosage, Price & Clinical Trials Insight 2025 Report Highlights:
    Clinical Pipeline Insight by Company, Country, Indication & Patient Segment
    Branded & Generic Drug Dosage, Price & Sales Insight

Atossa Therapeutics Announces Two-Year Update of FDA-Approved Expanded Access Treatment with Endoxifen

Retrieved on: 
Wednesday, February 3, 2021

At the end of 2018, the FDA authorized a single-patient study under its Expanded Access, or compassionate use program, for this breast cancer patient to receive Atossas oral Endoxifen in the window of opportunity between diagnosis of breast cancer and surgery.

Key Points: 
  • At the end of 2018, the FDA authorized a single-patient study under its Expanded Access, or compassionate use program, for this breast cancer patient to receive Atossas oral Endoxifen in the window of opportunity between diagnosis of breast cancer and surgery.
  • She has now taken Atossas oral Endoxifen for approximately 26 months and is continuing to take oral Endoxifen daily under these authorizations.
  • We are very encouraged by this patients experience with our Endoxifen over the past two years.
  • Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19.