
The U.S. Food and Drug Administration (FDA) has granted tentative approval to Avadel Pharmaceuticals’ (NASDAQ:AVDL) lead candidate LUMRYZ (FT218) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. Avadel shares traded in a range of $4.34 to $5.1 on a day volume of 1.99 million shares, closed regular trading session at $4.95. The company shares are currently trading at $5.01, up 1.21 percent in the after-hours trading session.
Clene Inc. (NASDAQ:CLNN) has received a positive opinion for its submission requesting Orphan Drug Designation for CNM-Au8® for the treatment of amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). Clene shares traded in a range of $4.52 to $4.86 on a day volume of 1.66 million shares, closed regular trading session at $4.68.