Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA
19 Agosto 2024 - 6:00AM
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases, today announced
that the U.S. Food and Drug Administration (FDA) has acknowledged
the resubmission of the new drug application (NDA) for its
apomorphine infusion device (SPN-830) for the continuous treatment
of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).
The resubmission is now considered filed, with a user fee goal date
(PDUFA date) of February 1, 2025.
About Supernus Pharmaceuticals,
Inc.
Supernus Pharmaceuticals is a biopharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases.
Our diverse neuroscience portfolio includes
approved treatments for epilepsy, migraine, ADHD, hypomobility in
Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea,
and dyskinesia in PD patients receiving levodopa-based therapy. We
are developing a broad range of novel CNS product candidates
including new potential treatments for hypomobility in PD,
epilepsy, depression, and other CNS disorders.
For more information, please visit
www.supernus.com.
Forward-Looking Statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements do not convey historical
information but relate to predicted or potential future events that
are based upon management's current expectations. These statements
are subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by
such statements. In addition to the factors mentioned in this press
release, such risks and uncertainties include, but are not limited
to, the Company’s ability to sustain and increase its
profitability; the Company’s ability to raise sufficient capital to
fully implement its corporate strategy; the implementation of the
Company’s corporate strategy; the Company’s future financial
performance and projected expenditures; the Company’s ability to
increase the number of prescriptions written for each of its
products and the products of its subsidiaries; the Company’s
ability to increase its net revenue; the Company’s ability to
commercialize its products and the products of its subsidiaries;
the Company’s ability to enter into future collaborations with
pharmaceutical companies and academic institutions or to obtain
funding from government agencies; the Company’s product research
and development activities, including the timing and progress of
the Company’s clinical trials, and projected expenditures; the
Company’s ability to receive, and the timing of any receipt of,
regulatory approvals to develop and commercialize the Company’s
product candidates, including SPN-830; the Company’s ability to
protect its intellectual property and the intellectual property of
its subsidiaries and operate its business without infringing upon
the intellectual property rights of others; the Company’s
expectations regarding federal, state and foreign regulatory
requirements; the therapeutic benefits, effectiveness and safety of
the Company’s product candidates; the accuracy of the Company’s
estimates of the size and characteristics of the markets that may
be addressed by its product candidates; the Company’s ability to
increase its manufacturing capabilities for its products and
product candidates; the Company’s projected markets and growth in
markets; the Company’s product formulations and patient needs and
potential funding sources; the Company’s staffing needs; and other
risk factors set forth from time to time in the Company’s filings
with the Securities and Exchange Commission made pursuant to
Section 13 or 15(d) of the Securities Exchange Act of 1934, as
amended. The Company undertakes no obligation to update the
information in this press release to reflect events or
circumstances after the date hereof or to reflect the occurrence of
anticipated or unanticipated events.
CONTACT:
Jack A. Khattar, President and CEOTimothy C. Dec, Senior Vice
President and CFOSupernus Pharmaceuticals, Inc.(301) 838-2591
Or
INVESTOR CONTACT:
Peter VozzoICR Westwicke(443)
213-0505peter.vozzo@westwicke.com
Supernus Pharmaceuticals (NASDAQ:SUPN)
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