- The U.S. Food and Drug Administration (FDA) has approved Bluebird bio’s (NASDAQ: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 (NYSE: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 (NASDAQ: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 (NASDAQ: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 (NASDAQ: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 (NASDAQ: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 Omeros’ (NASDAQ:OMER) 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.
