Assertio Therapeutics Provides Regulatory Update on Long-Acting Cosyntropin
21 Oktober 2019 - 3:05PM
Assertio Therapeutics, Inc. (NASDAQ: ASRT), today announced that
its development partner West Therapeutic Development, LLC (West)
has received a Complete Response Letter (CRL) from the U.S. Food
and Drug Administration (FDA) for its New Drug Application (NDA)
for its injectable formulation of long-acting cosyntropin
(synthetic adrenocorticotropic hormone, or ACTH). West is seeking
approval for use as a diagnostic drug in the screening of patients
presumed to have adrenocortical insufficiency.
The primary focus of the CRL relates to the FDA determination
that certain pharmacodynamic parameters were not adequately
achieved.
“West and Assertio will work together to determine how best to
address the CRL,” said Arthur Higgins, President and CEO of
Assertio. “In the meantime, we continue to focus on driving robust
adjusted EBITDA performance and generating strong cash flows.”
Long-acting cosyntropin is an alcohol-free formulation of a
synthetic analogue of ACTH, a hormone secreted from the pituitary
gland that is responsible for the stimulation of the adrenal
cortex. Cosyntropin is composed of the first 24 of 39 amino acids
of natural ACTH and retains the full steroidogenic activity of
natural ACTH.
About Assertio Therapeutics, Inc. Assertio
Therapeutics is committed to providing responsible solutions to
advance patient care in the Company’s core areas of neurology,
orphan and specialty medicines. Assertio currently markets three
FDA-approved products and continues to identify, license and
develop new products that offer enhanced options for patients that
may be underserved by existing therapies. To learn more about
Assertio, visit www.assertiotx.com.
"Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995 This news release contains
forward-looking statements. These statements involve inherent risks
and uncertainties that could cause actual results to differ
materially from those projected or anticipated, including risks
related to regulatory approval and clinical development of
long-acting cosyntropin, expectations regarding potential business
opportunities and other risks outlined in the Company's public
filings with the Securities and Exchange Commission, including the
Company's most recent annual report on Form 10-K and subsequent
Quarterly Reports on Form 10-Q. All information provided in this
news release speaks as of the date hereof. Except as otherwise
required by law, the Company undertakes no obligation to update or
revise its forward-looking statements.
Investor and Media Contact: John B. Thomas SVP,
Investor Relations and Corporate Communications
jthomas@assertiotx.com
Source: Assertio Therapeutics, Inc.
Assertio (NASDAQ:ASRT)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Assertio (NASDAQ:ASRT)
Historical Stock Chart
Von Mai 2023 bis Mai 2024