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Recap of Tuesday’s Biotech Catalysts – End of the Day Summary

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.

Neuronetics, Inc. (NASDAQ: STIM) announced clearance from the U.S. Food and Drug Administration (FDA) for a new indication for its transcranial magnetic stimulation (TMS) system – NeuroStar Advanced Therapy for Mental Health – to treat anxiety symptoms for adult patients who suffer from major depressive disorder (MDD), also known as anxious depression. Neuronetics shares traded in a range of $3.79 to $4.56 on a day volume of 26.53 million shares, closed regular trading session at $3.81. The company shares are currently trading at $3.65, down 4.2 percent in the after-hours trading session.

The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for Apellis Pharmaceuticals’ (NASDAQ: APLS) New Drug Application (NDA) for the intravitreal pegcetacoplan. The regulatory agency has assigned target action date of November 26, 2022. Apellis shares traded in a range of $51.26 to $56.92 on a day volume of 6.82 million shares, closed regular trading session at $52.06. The company shares are currently …

Full story available on Benzinga.com

Source: benzinga.com

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