Shares of Avadel Pharmaceuticals plc (AVDL) are soaring over 37% in pre-market today, after the company announced positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.
The REST-ON trial, under a Special Protocol Assessment agreement with the FDA, met its three co-primary efficacy endpoints at all three doses demonstrating highly significant, clinically meaningful improvements on the Maintenance of Wakefulness Test (MWT), Clinical Global Impression-Improvement (CGI-I) and mean weekly cataplexy attacks.
The stock has been trading between $1.03 and $10.75 in the past one year, and closed Friday's trade at $9.83, down 4 cents or 0.41%. AVDL is currently trading at $13.49, up $3.66 or 37.23% in the pre-market trading session.
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