Breaking News

Avadel Pharmaceuticals Provides Comment on Recent Trading Activity

Avadel Pharmaceuticals Provides Comment on Recent Trading Activity

Avadel Prescribed drugs plc

DUBLIN, Ireland, April 26, 2022 (Globe NEWSWIRE) — Avadel Prescription drugs plc (Nasdaq: AVDL), a biopharmaceutical organization focused on transforming medicines to transform life, currently provided a statement in response to the buying and selling volatility and subsequent short buying and selling halt of its shares that happened yesterday.

“The firm is not informed of any new information, such as relating to the ongoing evaluation of the FT218 NDA, that caused yesterday’s share selling price movement and transient trading halt,” stated Greg Divis, Main Executive Officer of Avadel Pharmaceuticals. “We are advancing our start preparations, and glance ahead to bringing this crucial remedy to people today with narcolepsy.”

About FT218

FT218 is an investigational formulation of sodium oxybate leveraging our proprietary drug shipping and delivery technological innovation and created to be taken as soon as at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in older people with narcolepsy.

In March 2020, Avadel concluded the Relaxation-ON review, a randomized, double-blind, placebo-controlled, pivotal Stage 3 demo, to assess the efficacy and safety of FT218 in individuals with narcolepsy. Among the three co-most important endpoints, FT218 demonstrated statistically major and clinically significant outcomes in EDS, the clinician’s in general assessment of the patient’s operating, and reduction in cataplexy attacks, for all a few evaluated does when in contrast to placebo.

In January 2018, the U.S. Foodstuff and Drug Administration (Fda) granted FT218 Orphan Drug Designation for the treatment method of narcolepsy dependent on the plausible speculation that FT218 might be safer than the 2 times-nightly formulation of sodium oxybate now authorised by the Fda due to the ramifications involved with dosing regimen of that product or service. FT218 is currently under critique by the Food and drug administration.

About Avadel Pharmaceuticals plc

Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company centered on transforming medicines to change life. Our technique incorporates applying progressive solutions to the growth of drugs that tackle the troubles people face with current cure options. Our latest direct drug applicant, FT218, is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technologies and built to be taken after at bedtime for the procedure of EDS and cataplexy in grownups with narcolepsy. For more details, please stop by

Cautionary Disclosure Relating to Forward-Looking Statements

This press launch features “forward-looking statements” inside the meaning of Area 27A of the Securities Act of 1933 and Area 21E of the Securities Exchange Act of 1934. These forward-on the lookout statements relate to our potential anticipations, beliefs, plans, methods, objectives, final results, disorders, fiscal general performance, prospects, or other activities. These types of forward-hunting statements consist of, but are not minimal to, expectations concerning the FDA’s overview of the NDA for FT218, the commercial launch of FT218 (if accepted), and the current market acceptance of FT218 (if approved). In some scenarios, forward-wanting statements can be determined by the use of terms these kinds of as “will,” “may,” “could,” “believe,” “expect,” “look ahead,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and equivalent expressions, and the negatives thereof (if applicable).

The Company’s ahead-hunting statements are based on estimates and assumptions that are produced within the bounds of our know-how of our organization and functions and that we take into consideration affordable. Nonetheless, the Company’s business and operations are issue to substantial pitfalls, and, as a outcome, there can be no assurance that real success and the effects of the company’s organization and operations will not differ materially from the outcomes contemplated in these types of ahead-wanting statements. Variables that could cause precise effects to differ from expectations in the Company’s ahead-looking statements consist of the hazards and uncertainties explained in the “Risk Factors” area of Section I, Merchandise 1A of the Company’s Once-a-year Report on Form 10-K for the year ended December 31, 2021, which was submitted with the Securities and Exchange Commission (SEC) on March 16, 2022, and subsequent SEC filings.

Forward-seeking statements communicate only as of the day they are made and are not assures of upcoming overall performance. Accordingly, you ought to not location undue reliance on ahead-searching statements. The Organization does not undertake any obligation to publicly update or revise our forward-looking statements, besides as expected by regulation.

Investor Get hold of:
Courtney Turiano
Stern Investor Relations, Inc.
[email protected]
(212) 698-8687

Media Speak to:
Nicole Raisch Goelz
Genuine Chemistry
[email protected]
(408) 568-4292