Recap Of Wednesday's Biotech Catalysts - End Of the Day Summary

Recap Of Wednesday's Biotech Catalysts - End Of the Day Summary
  • The U.S. Food and Drug Administration (FDA) has approved Bluebird bio’s BLUE lead asset ZYNTEGLO (betibeglogene autotemcel) to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. Bluebird shares traded in a range of $6.13 to $8.18 on a day volume of 27.26 million shares, closed regular trading session at $6.78. The company shares are currently trading at $7.25, up 6.93 percent in the after-hours trading session.
  • Samsung Bioepis and Organon OGN announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab). HADLIMA will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. Organon shares traded in a range of $30.61 to $31.13 on a day volume of 1.09 million shares, closed regular trading session at $30.87.
  • The European Commission has granted Orphan Drug Designation to RedHill Biopharma’s  RDHL lead asset RHB-204 for the treatment of nontuberculous mycobacteria (NTM) disease. RedHill shares traded in a range of $1.01 to $1.12 on a day volume of 4.25 million shares, closed regular trading session at $1.07.
  • The New Zealand's Medsafe has granted expanded provisional approval for Novavax’s NVAX lead asset  Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a heterologous and homologous booster dose in adults aged 18 and older. Novavax shares traded in a range of $39.26 to $42.65 on a day volume of 5.79 million shares, closed regular trading session at $39.37.
  • Palisade Bio PALI has dosed first patient in its Phase 3 study evaluating lead asset LB1148 to accelerate the return of bowel function in adult patients undergoing gastrointestinal surgery. Palisade shares traded in a range of $0.15 to $0.19 on a day volume of 34.44 million shares, closed regular trading session at $0.16.
  • Blueprint Medicines BPMC announced positive top-line results from the registrational Part 2 of the PIONEER clinical trial of AYVAKIT (avapritinib) in patients with non-advanced systemic mastocytosis (SM). Blueprint shares traded in a range of $52 to $64.44 on a day volume of 6.96 milion shares, closed regular trading session at $61.17. The company shares are currently trading at $59.08, down 3.42 percent in the after-hours trading session.
  • The United States Food and Drug Administration (FDA) provided an interim response to OmerosOMER formal dispute resolution request submitted to the Agency, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Omeros shares traded in a range of $6.37 to $7.2 on a day volume of 950.28 thousand shares, closed regular trading session at $6.63.

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