- The U.S. Food and Drug Administration (FDA) has announced clearance to Insulet’s (NASDAQ:PODD) Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D). Insulet shares traded in a range of $260.13 to $266.73 on day volume of 200.86 thousand shares versus three months average volume of 476.99 thousand shares, closed regular trading session at $261.89.
- Pfizer (NYSE:PFE) and BioNtech SE (NASDAQ:BNTX) have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. BioNTech SE shares traded as high as 1.74 percent, in a range of $145.91 to $150.5 on day volume of 727.31 thousand shares, closed regular trading session at $148.30.
- Minerva Neurosciences (NASDAQ:NERV) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roluperidone in the treatment of negative symptoms for patients with schizophrenia. Minerva shares traded as high as 66.88 percent, in a range of $3.1 to $5.19 on day volume of 17.49 million shares versus three months average volume of 721.15 thousand shares, closed regular trading session at $4.59.
- Takeda (NASDAQ:TAK) announced its dengue vaccine, QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003), was approved by the Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), for the prevention of dengue disease caused by any serotype in individuals six years to 45 years of age. Takeda shares traded in a range of $13.75 to $13.92 on day volume of 1.93 million shares, closed regular trading session at $13.82.
- Travere Therapeutics (NASDAQ:TVTX) announced that the EMA has accepted for review the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN, a rare kidney disorder and a leading cause of end-stage kidney disease (ESKD), review decision on a potential approval is expected in the second half of 2023. Travere shares traded as high as 1.02 percent, in a range of $25.77 to $26.79 on day volume of 394.97 thousand shares, closed regular trading session at $26.70.
- Tonix Pharmaceuticals (NASDAQ:TNXP) has initiated patient enrolment in the Phase 2 PREVAIL study of TNX-102 SL for patients with Long COVID syndrome (Long COVID). Tonix shares traded as high as 3.08 percent, in a range of $1.25 to $1.34 on day volume of 2.48 million shares, closed regular trading session at $1.30.
- Belite Bio (NASDAQ:BLTE) has initiated enrollment for the U.S. Phase 3 clinical trial of its lead asset LBS-008 in patients with Stargardt Disease (STGD1), a progressively blinding disease with no approved treatment. Belite shares traded as high as 22.73 percent, in a range of $23.1 to $27 on day volume of 87.23 thousand shares, closed regular trading session at $26.84.
- Cue Biopharma (NASDAQ:CUE) has dosed the first patient in a Phase 1 dose escalation study evaluating CUE-102 for the treatment of patients with Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers. Cue shares traded as high as 1.31 percent, in a range of $2.83 to $3.09 on day volume of 229.98 thousand shares, closed regular trading session at $3.05. The company shares traded at $2.99, down 1.97 percent in the after-hours trading session.
- Kronos Bio (NASDAQ:KRON) has initiated patient dosing in a Phase 1b/2 clinical trial of lanraplenib in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML). Kronos shares traded in a range of $3.95 to $4.24 on day volume of 270.61 thousand shares, closed regular trading session at $4.00.
- Geron Corporation (NASDAQ:GERN) has dosed first patient in IMproveMF study evaluating imetelstat in combination with ruxolitinib for patients with frontline myelofibrosis (MF). Geron shares traded as high as 2.69 percent, in a range of $2.17 to $2.29 on day volume of 3.28 million shares, closed regular trading session at $2.18. The company shares traded at $2.22, up 1.83 percent in the after-hours trading session.
