Assertio Announces Results of Rolvedon® (eflapegrastim-xnst) injection Same-Day Dosing Clinical Study
13 Décembre 2024 - 2:00PM
Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq:
ASRT), a pharmaceutical company with comprehensive commercial
capabilities offering differentiated products to patients,
announced yesterday results of a clinical trial investigating the
utility of Rolvedon
®
(eflapegrastim-xnst) injection when dosed the same day of
chemotherapy for patients with early stage breast cancer (ESBC).
The results were presented as part of the San Antonio Breast Cancer
Symposium by the American Association of Cancer Research and the
University of Texas Health Science Center at San Antonio.
In this open-label, single-arm study (NCT04187898), conducted
across 13 sites in the US, individuals received Rolvedon 30 minutes
post chemotherapy for ESBC. Rolvedon demonstrated 1.8 days to
neutrophil count recovery and a febrile neutropenia rate of 2%.
Zero patients required the need for hospitalization and/or
intervention for febrile neutropenia. No new safety signals were
identified.
"We are pleased with the expected, positive results from the
Rolvedon same day dosing trial and the evidence supporting our
belief that Rolvedon can make a meaningful difference for patients
undergoing chemotherapy. This milestone further underscores our
commitment to improving the lives of patients undergoing cancer
treatment by providing convenient and effective treatment options,"
said Brendan O’Grady, CEO of Assertio Therapeutics.
"The excellent safety and efficacy profile of Rolvedon in this
trial is very encouraging, providing clinical data indicating that
same day dosing outcomes are safe and effective for this unique
molecule," said Dr. Howard Franklin, SVP of Medical of
Assertio Therapeutics. "Our goal is to enhance patient outcomes and
quality of life (QoL), and these results support the potential of
Rolvedon to do just that.”
Details of the study and poster presentation can be found at the
SABCS website, https://sabcs.org/.
About Assertio
Assertio is a commercial pharmaceutical company with
comprehensive commercial capabilities offering differentiated
products to patients. We have built our commercial portfolio
through acquisition or licensing of approved products. Our
commercial capabilities include marketing through both a sales
force and a non-personal promotion model, market access through
payor contracting, and trade and distribution. To learn more about
Assertio, visit www.assertiotx.com.
Forward Looking Statements
Statements in this communication that are not historical facts
are forward-looking statements that reflect Assertio’s current
expectations, assumptions and estimates of future performance and
economic conditions. These forward-looking statements are made in
reliance on the safe harbor provisions of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. These forward-looking
statements relate to, among other things, future events or the
future performance or operations of Assertio, including risks
related to the subject matter of this communication and our ability
to realize the benefits from our operating model, deliver or
execute on our business strategy, including to expand or diversify
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“should,” “strategy,” “target,” “would,” “will,” “aim” or other
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forward-looking statements are not guarantees of future performance
and are subject to risks, uncertainties and other factors, some of
which are beyond the control of Assertio, including the risks
described in Assertio’s Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q filed with the U.S. Securities and Exchange
Commission (“SEC”) and in other filings Assertio makes with the SEC
from time to time.
Investors and potential investors are urged not to place undue
reliance on forward-looking statements in this communication, which
speak only as of this date. While Assertio may elect to update
these forward-looking statements at some point in the future, it
specifically disclaims any obligation to update or revise any
forward-looking-statements contained in this press release whether
as a result of new information or future events, except as may be
required by applicable law.
Investor Contact
Matt Kreps, Managing DirectorDarrow AssociatesM:
214-597-8200mkreps@darrowir.com
Assertio (NASDAQ:ASRT)
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