FDA Cuts Sample Size in Narcolepsy Trial, AVDL Stock Goes Flying

AVDL stock

It’s only Monday, but Avadel Pharmaceuticals (NASDAQ:AVDL) is already making headlines. AVDL stock is soaring after the pharmaceutical company said the FDA cut its sample size in one of its trials.

Here’s everything we know.

AVDL Stock Goes Flying: The Details

On September 23, Avadel Pharmaceuticals, an Ireland-based company, said the FDA agreed to cut the sample size in its phase 3 trial of narcolepsy treatment. Instead of 264 patients, the trial will target 205 narcolepsy patients. According to the report, no modifications were made to the design of the study, which means the sample size still has the same goal: to show the significance for excessive daytime sleepiness and cataplexy in individuals with narcolepsy. Now that the FDA lowered this sample size, however, Avadel’s trial will have its estimated time reduced by up to 12 months. Even better: ADVL expects full enrollment for the narcolepsy trial to be finished by the end of the year.

“This REST-ON clinical trial update is a direct result of an overall strategic review of the entire FT218 program,” explained CEO of Avadel Greg Divis. “The addition of our recently appointed medical and clinical team members was instrumental in this important development and their contributions have put us on track to save significant time, resources and capital in the completion of the REST-ON clinical trial.”

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The news of the FDA cutting the sample size is good in itself, but things continued on an uptrend for Avadel Pharmaceuticals on Monday. After jumping roughly 22% in premarket trade, AVDL stock is trading at $4.36 as of 3:55 PM EDT on the Nasdaq Exchange; this puts AVDL stock up 29.67%. AVDL stock is also a Yahoo Finance trending ticker of the day.


What do you think about the FDA reducing Avadel’s sample size? Did you expect AVDL stock to jump as much as it did on the news? Let us know your thoughts in the comments below.

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