- The U.S. Food and Drug Administration (FDA) has approved expanded use of Vertex’s VRTX lead asset ORKAMBI (lumacaftor/ivacaftor) to include children with cystic fibrosis (CF) ages 12 to <24 months. Vertex shares traded in a range of $279.5 to $292 on day volume of 1.12 million shares, closed regular trading session at $281.04.
- PolyPid PYPD announced top-line results from the SHIELD I Phase 3 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. The study did not achieve its Primary Endpoint of reduction in surgical site infections and mortality. PolyPid shares traded as low as 68.83 percent, in a range of $1.12 to $1.68 on day volume of 6.43 million shares versus three months average volume of 21.5 thousand shares, closed regular trading session at $1.43. The company shares traded at $1.36, down 4.9 percent in the after-hours trading session.
- The Swiss Agency for Therapeutic Products (Swissmedic) has expanded its temporary authorization of Novavax’s NVAX lead drug Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in Switzerland for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents aged 12 through 17 and as a heterologous and homologous booster dose for adults aged 18 and older. Novavax shares traded as high as 1.22 percent, in a range of $30.33 to $32.34 on day volume of 3.61 million shares, closed regular trading session at $30.39.
- Immuneering IMRX submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its product candidate IMM-1-104 in development for the treatment of advanced RAS mutant solid tumors. Immuneering shares traded as high as 7.05 percent, in a range of $6.56 to $7.44 on day volume of 27.47 thousand shares, closed regular trading session at $7.44.
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