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 trading at $51.31, down 1.44 percent in the after-hours trading session.
Viking Therapeutics (NASDAQ:VKTX) announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD).The company expects to resume study enrollment in the coming weeks. Viking shares traded in a range of $3.34 to $3.62 on a day volume of 2.15 million shares, closed regular trading session at $3.52. The company shares are currently trading at $3.57, up 1.42 percent in the after-hours trading session.
Allena Pharmaceuticals, Inc. (NASDAQ:ALNA) reported completion of enrollment of the first two cohorts of its ALLN-346 Phase 2a Study 202 in gout patients with stage 2 (cohort A) and stage 3 (cohort B) chronic kidney disease (CKD). Artelo shares traded in a range of $0.15 to $0.16 on a day volume of 12.12 million shares, closed regular trading session at $0.15.
SCYNEXIS, Inc. (NASDAQ:SCYX) announced the presentation of positive outcomes from the CANDLE 304s nested sub-study investigating oral ibrexafungerp in patients with recurrent vulvovaginal candidiasis (RVVC) who failed fluconazole treatment. The results were presented during the International Society for the Study of Vulvovaginal Diseases (ISSVD) XXVI World Congress and International Vulvovaginal Disease Update 2022 held in Dublin, Ireland. SCYNEXIS shares traded in a range of $2.12 to $2.26 on a day volume of 245.77 thousand shares, closed regular trading session at $2.12.
Artelo Biosciences (NASDAQ: ARTL) announced the completion of enrollment of the first three cohorts in the Cancer Appetite Recovery Study (CAReS) and the initiation of a fourth cohort expected to complete the first stage of the Phase 1b clinical trial of ART27.13. Artelo shares traded in a range of $0.32 to $0.35 on a day volume of 269.24 thousand shares, closed regular trading session at $0.33.
Impel Pharmaceuticals (NASDAQ:IMPL) has dosed the first patient in a Phase 2a proof-of-concept study of INP105, nasal olanzapine, a widely used atypical, second-generation antipsychotic. Impel shares traded in a range of $8.13 to $8.49 on a day volume of 24.22 thousand shares, closed regular trading session at $8.35.
Capricor Therapeutics (NASDAQ:CAPR) initiated dosing of first patient in HOPE-3, a Phase 3 clinical trial investigating CAP-1002 for treating late-stage Duchenne muscular dystrophy (DMD). Capricor shares traded in a range of $4.47 to $4.7 on a day volume of 128.72 thousand shares, closed regular trading session at $4.61. The company shares are currently trading at $4.93, up 6.94 percent in the after-hours trading session.
Sorrento Therapeutics (NASDAQ:SRNE) announced that the U.S. Food and Drug Administration (FDA) has cleared the Phase 1 study of its candidate, STI-1558, in patients with impaired renal and hepatic function. Sorrento shares traded in a range of $2.47 to $2.72 on a day volume of 12.56 million shares, closed regular trading session at $2.72.
Belite Bio (NASDAQ:BLTE) submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to support Phase 3 development of its lead asset LBS-008 for treatment of Stargardt Disease (STGD1). Belite Bio shares traded in a range of $40.98 to $44.63 on a day volume of 111.56 thousand shares, closed regular trading session at $43.70.
Novavax (NASDAQ:NVAX) announced that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend the use of the Novavax COVID-19 Vaccine, Adjuvanted as a two-dose primary series in individuals aged 18 and older. Novavax shares traded in a range of $51.88 to $59.69 on a day volume of 13.66 million shares, closed regular trading session at $58.
Inozyme Pharma, Inc. (NASDAQ:INZY) announced positive preliminary biomarker, safety, and pharmacokinetic (PK) data from the first three subjects treated in the Phase 1 portion of its ongoing Phase 1/2 clinical trial of INZ-701 in adult subjects with ABCC6 Deficiency, which presents as pseudoxanthoma elasticum (PXE) in older individuals. Inozyme shares traded in a range of $5.28 to $5.54 on a day volume of 42.8 thousand shares, closed regular trading session at $5.45. The company shares are currently trading at $5.58, up 2.39 percent in the after-hours trading session.
