- Cyclerion Therapeutics CYCN announced positive topline data from its clinical study of CY6463 for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS) in individuals with stable schizophrenia on a stable, single, atypical antipsychotic regimen. Cyclerion shares traded in a range of $0.75 to $0.94 on a day volume of 318.66 thousand shares, closed regular trading session at $0.94. The company shares are currently trading at $0.87, down 7.45 percent in the after-hours trading session.
- Trevena TRVN revealed positive topline results from its post-approval study designed to assess the impact on cognitive function in subjects treated with OLINVYK compared to IV morphine. Trevena shares traded in a range of $0.26 to $0.29 on a day volume of 1.16 million shares, closed regular trading session at $0.26.
- Ionis Pharmaceuticals IONS announced positive topline results of the Phase 2b clinical trial of fesomersen in patients with end-stage renal disease (ESRD) on hemodialysis.Ionis shares traded in a range of $38 to $39.42 on a day volume of 557.38 thousand shares, closed regular trading session at $38.99.
- Better Therapeutics BTTX announced positive results from its pivotal clinical trial for BT-001, prescription digital therapeutic that is designed to use nCBT to treat c diabetes (T2D). Better Therapeutics shares traded in a range of $1.91 to $2.56 on a day volume of 45.4 million shares, closed regular trading session at $1.99. The company shares are currently trading at $1.97, down 1.01 percent in the after-hours trading session.
- Gilead Sciences GILD announced results reinforcing Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a highly efficacious treatment option for a broad range of people with HIV, including individuals with HIV/hepatitis B (HBV) coinfection. Gilead shares traded in a range of $59.62 to $61.11 on a day volume of 6.53 million shares, closed regular trading session at $60.4.
- The U.S. Food and Drug Administration (FDA) has accepted for review Acer Therapeutics’ ACER resubmission of New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension in the treatment of patients with urea cycle disorders (UCDs). The regulatory agency assigned a target action date of January 15, 2023. Acer shares traded in a range of $1.34 to $1.51 on a day volume of 122.53 thousand shares, closed regular trading session at $1.42.
- The U.S. Food and Drug Administration (FDA) announced clearance to Astria Therapeutics’ ATXS Investigational New Drug (IND) application for STAR-0215 for the treatment of Hereditary Angioedema (HAE). Astria Therapeutics shares traded in a range of $3.73 to $4.10 on a day volume of 124.62 thousand shares, closed regular trading session at $4.06.
- The U.S. Food and Drug Administration (FDA) accepted for review ImmunityBio’s IBRX Biologics License Application (BLA) for its lead asset N-803 in the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. The regulatory agency has assigned a target action date of May 23, 2023. ImmunityBio shares traded in a range of $4.01 to $4.31 on a day volume of 867.67 thousand shares, closed regular trading session at $4.28. The company shares are currently trading at $4.38, up 2.34 percent in the after-hours trading session.
- Icosavax ICVX announced the results from an end-to-end drug product investigation of IVX-411, a VLP vaccine candidate displaying the SARS-CoV-2 receptor-binding domain (RBD). The antigen component of IVX-411 found to be unstable; issue specific to molecule, with no evidence of read-through to other Icosavax programs. Icosavax shares traded in a range of $7.22 to $7.76 on a day volume of 22.14 thousand shares, closed regular trading session at $7.72. The company shares are currently trading at $7.56, down 2.07 percent in the after-hours trading session.
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