- The U.S. Food and Drug Administration (FDA) has approved the expanded use of crest’s VRTX Lead asset ORKAMBI (lucaftor/ivacaftor) to enroll children with cystic fibrosis (CF) aged 12 to < 24 months. Vertex shares traded in a range of $279.5 to $292 on daily volume of 1.12 million shares and closed the regular trading session at $281.04.
- PolyPid PYPD announced top-line results from the Phase 3 SHIELD I study of D-PLEX100 for the prevention of postoperative wound infections (SSIs) in abdominal surgery. The study did not meet its primary endpoint of reducing postoperative wound infection and mortality. PolyPid shares were trading at just 68.83 percent, ranging from $1.12 to $1.68 on daily volume of 6.43 million shares versus a three-month average volume of 21.5,000 shares, ending the regular trading session at $1.43. The company’s shares traded at $1.36, down 4.9 percent in the after-hours trading session.
- The Swiss Agency for Therapeutic Products (Swissmedic) has extended its temporary approval Novavax‘s NVAX Lead drug Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in Switzerland for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in adolescents aged 12 to 17 years and as a heterologous and homologous booster dose for adults 18 years. Novavax shares traded up 1.22 percent in a range of $30.33 to $32.34 on daily volume of 3.61 million shares to close the regular trading session at $30.39.
- immunization IMRX filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its product candidate IMM-1-104, which is in development for the treatment of advanced solid tumors harboring RAS mutation. Immuneering shares traded up 7.05 percent in a range of $6.56 to $7.44 on daily volume of 27.47K shares to close the regular trading session at $7.44.
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