Avadel Pharmaceuticals Provides Comment on Recent Trading Activity
April 26 2022 - 7:30AM
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical
company focused on transforming medicines to transform lives, today
provided a statement in response to the trading volatility and
subsequent brief trading halt of its shares that occurred
yesterday.
“The company is not aware of any new information, including
regarding the ongoing review of the FT218 NDA, that caused
yesterday’s share price movement and brief trading halt,” said Greg
Divis, Chief Executive Officer of Avadel Pharmaceuticals. “We are
advancing our launch preparations, and look forward to bringing
this important treatment to people with narcolepsy.”
About FT218
FT218 is an investigational formulation of sodium oxybate
leveraging our proprietary drug delivery technology and designed to
be taken once at bedtime for the treatment of excessive daytime
sleepiness (EDS) or cataplexy in adults with narcolepsy.
In March 2020, Avadel completed the REST-ON study, a randomized,
double-blind, placebo-controlled, pivotal Phase 3 trial, to assess
the efficacy and safety of FT218 in patients with narcolepsy. Among
the three co-primary endpoints, FT218 demonstrated statistically
significant and clinically meaningful results in EDS, the
clinician’s overall assessment of the patient’s functioning, and
reduction in cataplexy attacks, for all three evaluated does when
compared to placebo.
In January 2018, the U.S. Food and Drug Administration (FDA)
granted FT218 Orphan Drug Designation for the treatment of
narcolepsy based on the plausible hypothesis that FT218 may be
safer than the twice-nightly formulation of sodium oxybate already
approved by the FDA due to the ramifications associated with dosing
regimen of that product. FT218 is currently under review by the
FDA.
About Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical
company focused on transforming medicines to transform lives. Our
approach includes applying innovative solutions to the development
of medications that address the challenges patients face with
current treatment options. Our current lead drug candidate, FT218,
is an investigational formulation of sodium oxybate leveraging our
proprietary drug delivery technology and designed to be taken once
at bedtime for the treatment of EDS and cataplexy in adults with
narcolepsy. For more information, please visit www.avadel.com.
Cautionary Disclosure Regarding Forward-Looking
Statements
This press release includes “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. These
forward-looking statements relate to our future expectations,
beliefs, plans, strategies, objectives, results, conditions,
financial performance, prospects, or other events. Such
forward-looking statements include, but are not limited to,
expectations regarding the FDA’s review of the NDA for FT218, the
commercial launch of FT218 (if approved), and the market acceptance
of FT218 (if approved). In some cases, forward-looking statements
can be identified by the use of words such as “will,” “may,”
“could,” “believe,” “expect,” “look forward,” “on track,”
“guidance,” “anticipate,” “estimate,” “project,” “next steps” and
similar expressions, and the negatives thereof (if applicable).
The Company’s forward-looking statements are based on estimates
and assumptions that are made within the bounds of our knowledge of
our business and operations and that we consider reasonable.
However, the Company’s business and operations are subject to
significant risks, and, as a result, there can be no assurance that
actual results and the results of the company’s business and
operations will not differ materially from the results contemplated
in such forward-looking statements. Factors that could cause actual
results to differ from expectations in the Company’s
forward-looking statements include the risks and uncertainties
described in the “Risk Factors” section of Part I, Item 1A of the
Company’s Annual Report on Form 10-K for the year ended December
31, 2021, which was filed with the Securities and Exchange
Commission (SEC) on March 16, 2022, and subsequent SEC filings.
Forward-looking statements speak only as of the date they are
made and are not guarantees of future performance. Accordingly, you
should not place undue reliance on forward-looking statements. The
Company does not undertake any obligation to publicly update or
revise our forward-looking statements, except as required by
law.
Investor Contact:Courtney TurianoStern Investor
Relations, Inc.Courtney.Turiano@sternir.com (212) 698-8687
Media Contact:Nicole Raisch GoelzReal
Chemistryngoelz@realchemistry.com (408) 568-4292
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