Avadel Pharmaceuticals (NASDAQ:AVDL) jumps 30% premarket on average volume in reaction to positive results from a Phase 3 clinical trial, REST-ON,
evaluating lead candidate FT218, a once-nightly formulation of sodium
oxybate, for the treatment of excessive daytime sleepiness and cataplexy
in patients with narcolepsy.
The study met all three co-primary endpoints at
all three doses tested demonstrating statistically significant
improvements in sleep latency, sleepiness scores and fewer cataplexy
attacks, all at week 13, compared to placebo.
Detailed data will be submitted for presentation at future medical conferences and publication.
The company plans to share the results with the FDA.
Management will host a conference call this morning at 8:30 am ET to discuss the outcome.
Narcolepsy-related tickers: Axsome Therapeutics (NASDAQ:AXSM) (+37%), Takeda (NYSE:TAK) (+5%), Jazz Pharmaceuticals (NASDAQ:JAZZ) (down a fraction).
https://seekingalpha.com/news/3564570-avadel-up-30-premarket-on-positive-data-on-lead-drug
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