Atossa Therapeutics Receives FDA Feedback on Two Ongoing Programs
May 07 2020 - 8:00AM
Atossa Therapeutics, Inc. (NASDAQ:
ATOS), 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, today
announced it has received feedback from the U.S. Food and Drug
Administration (FDA) regarding two ongoing programs.
The FDA recently provided written input on Atossa’s clinical
path for oral Endoxifen to reduce mammographic breast density, or
MBD. The input was provided pursuant to a pre-IND meeting request
which was scheduled for April 30, 2020. The input received from the
FDA was very useful and will inform Atossa’s clinical trial
strategy and study design both in the U.S. and in Stockholm, Sweden
where Atossa is planning a Phase 2 study to reduce MBD. The
upcoming study in Stockholm is subject to approval by the European
Medical Product Authority (MPA) and the re-opening of mammography
clinics in Stockholm following the COVID-19 closures.
“We are very grateful to the Agency for its feedback on the
development of our oral Endoxifen program, which will be extremely
useful in our continued planning for our upcoming Phase 2 MBD
study,” said Steven Quay, M.D., Ph.D., President and CEO of Atossa.
“The input from the FDA is essential and guides our continued
development of medicines to save lives and meet unmet medical
needs. For example, based in part on the FDA’s input, our proposed
Phase 2 study will be designed to examine if oral Endoxifen can be
used as an adjunct to mammography.”
In addition, Atossa recently applied to the FDA for approval to
commence the COVID-19 HOPE Study of Atossa’s proprietary drug
AT-H201 which Atossa plans to study to improve pulmonary function
in COVID-19 patients on ventilators, reduce time on ventilators and
increase survival. The FDA has requested, among other things, that
Atossa submit additional pre-clinical and other information on
AT-H201 before approving the study. Atossa is in the process of
gathering the data and information requested and plans to provide
it to the FDA as soon as possible. There can be no assurance that
Atossa will be able to provide the information requested by the FDA
nor that the FDA will approve the COVID-19 HOPE Study.
About Atossa Therapeutics
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. For more information, please visit
www.atossatherapeutics.com.
Forward-Looking Statements
Forward-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 any variation between
interim 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 such as the COVID-19
HOPE Study, lower than anticipated rate of patient enrollment,
estimated market size of drugs under development, the safety and
efficacy of Atossa's products, performance of clinical research
organizations and investigators, obstacles resulting from
proprietary rights held by others such as patent rights, and other
risks detailed from time to time in Atossa's 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.
Atossa Therapeutics Company Contact:
Atossa Therapeutics, Inc.Kyle GuseCFO and General Counsel(O)
800-351-3902kyle.guse@atossainc.com
Investor Relations Contact:CoreIROffice:
516.222.2560IR@atossainc.com
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