The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia Therapeutics’ NTLA lead asset NTLA-2002, for the treatment of hereditary angioedema (HAE). Intellia shares traded in a range of $56.52 to $60.06 on day volume of 901.43 thousand shares, closed regular trading session at $59.97. The company shares traded at $60.96, up 1.65 percent in the after-hours trading session.
VaxartVXRT announced positive top-line data from the first part of a planned two-part Phase 2 study of its Wuhan S-only oral pill COVID-19 vaccine candidate, VXA-CoV2-1.1-S. Vaxart shares traded as high as 2.26 percent, in a range of $2.91 to $3.17 on day volume of 5.23 million shares versus three months average volume of 2.57 million shares, closed regular trading session at $3.15. The company shares traded at $3.10, down 1.59 percent in the after-hours trading session.
The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has been scheduled for October 28, 2022 to review Y-mAbs Therapeutics’ YMAB Biological License Application (BLA) for its product candidate, OMBLASTYS (omburtamab) for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. Y-mAbs shares traded in a range of $15.23 to $16.06 on day volume of 157.04 thousand shares, closed regular trading session at $16.01.
NovavaxNVAX announced that Nuvaxovid (NVX-CoV2373) COVID-19 vaccine has been recommended for expanded conditional marketing authorization (CMA) in the European Union (EU) as a homologous and heterologous booster for active immunization to prevent COVID-19 caused by SARS-CoV-2 for adults aged 18 and older. Novavax shares traded in a range of $30.69 to $32.93 on day volume of 4.73 million shares, closed regular trading session at $31.95.
PfizerPFE and BioNTech SEBNTX announced a 30-µg booster dose of their Omicron BA.1 Bivalent COVID-19 Vaccine has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals 12 years and older. Pfizer shares traded as high as 3.14 percent, in a range of $45.14 to $46.65 on day volume of 19.13 million shares, closed regular trading session at $46.63.
ModernaMRNA announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization for Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), targeting the Omicron variant of concern (BA.1). Moderna shares traded as high as 5.09 percent, in a range of $130.11 to $139 on day volume of 6.65 million shares versus three months average volume of 4.92 million shares, closed regular trading session at $138.95.
Cue HealthHLTH announced that it has made a de novo submission to the U.S. Food and Drug Administration (FDA) for full clearance of the Cue Flu Molecular Test for at-home and point-of-care (POC) use. Cue Health shares traded as high as 5.71 percent, in a range of $3.21 to $3.52 on day volume of 435.38 thousand shares, closed regular trading session at $3.50.
Pliant TherapeuticsPLRX announced a positive safety review of the ongoing INTEGRIS-IPF Phase 2a trial of PLN-74809 at 320 mg once-daily dose in patients with idiopathic pulmonary fibrosis (IPF) from a regularly scheduled meeting of its independent Data Safety Monitoring Board (DSMB). The DSMB recommended the INTEGRIS-IPF trial continue without modification. Pliant shares traded as high as 6.64 percent, in a range of $18.91 to $20.56 on day volume of 434.08 thousand shares, closed regular trading session at $20.30.
Axsome TherapeuticsAXSM has enrolled the first patient in the EMERGE trial of its lead candidate AXS-07 for the acute treatment of migraine. Axsome shares traded in a range of $60.86 to $63.99 on day volume of 1.06 million shares, closed regular trading session at $62.59. The company shares traded at $63.5, up 1.45 percent in the after-hours trading session.
Werewolf TherapeuticsHOWL has initiated patient dosing in a Phase 1/1b clinical trial evaluating WTX-124, its lead INDUKINET molecule targeting IL-2 for the treatment of solid tumors. Werewolf shares traded as high as 21.74 percent, in a range of $4.90 to $6.16 on day volume of 97.59 thousand shares, closed regular trading session at $6.05. The company shares traded at $5.63, down 6.94 percent in the after-hours trading session.
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