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Important Biotech Catalysts For September 13, 2022 - End Of The Day Summary

Benzinga · 09/13/2022 18:45
  • Akero Therapeutics (NASDAQ:AKRO) revealed topline data from HARMONY, a 24-week Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic nonalcoholic steatohepatitis (NASH), the study met its primary endpoint for both the 50mg and 28mg EFX dose groups. Akero Therapeutics shares traded as high as 142.3 percent, in a range of $25.01 to $29.73 on day volume of 49.46 million shares versus three months average volume of 406.52 thousand shares, closed regular trading session at $29.05. The company shares traded at $28.2, down 2.93 percent in the after-hours trading session.
  • Akouos (NASDAQ:AKUS) has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1/2, first in human, pediatric clinical trial of AK-OTOF for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss. Akouos shares traded as high as 37.14 percent, in a range of $3.15 to $4.80 on day volume of 333.75 thousand shares, closed regular trading session at $4.48. The company shares traded at $4.58, up 2.23 percent in the after-hours trading session.
  • The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Syros Pharmaceuticals (NASDAQ:SYRS) lead candidate SY-5609 for the treatment of pancreatic cancer. Syros shares traded as high as 27.4 percent, in a range of $0.75 to $0.93 on day volume of 25.71 million shares versus three months average volume of 748.44 thousand shares, closed regular trading session at $0.77. The company shares traded at $0.79, up 3.13 percent in the after-hours trading session.
  • Conformis (NASDAQ:CFMS) has received 510(k) clearance from the U.S. Food and Drug Administration for its Actera Hip System. Conformis shares traded as high as 3.85 percent, in a range of $0.25 to $0.27 on day volume of 737.39 thousand shares, closed regular trading session at $0.27. The company shares traded at $0.29, up 8.61 percent in the after-hours trading session.
  • Vaxxinity (NASDAQ:VAXX) announced that the first subjects have been dosed in a Phase 1 clinical trial of UB-313, a vaccine targeting calcitonin gene-related peptide (CGRP), for the preventive treatment of migraine. Vaxxinity shares traded as high as 4.65 percent, in a range of $2.06 to $2.25 on day volume of 293.22 thousand shares, closed regular trading session at $2.21.
  • Cidara Therapeutics (NASDAQ:CDTX) has initiated its Phase 2a trial to evaluate the pre-exposure prophylactic activity of CD388 against influenza virus. CD388 is a highly potent, long-acting antiviral designed to deliver universal prevention of seasonal and pandemic influenza. Cidara shares traded as high as 4.41 percent, in a range of $0.67 to $0.71 on day volume of 178.96 thousand shares, closed regular trading session at $0.71. The company shares traded at $0.73, up 2.23 percent in the after-hours trading session.
  • Oramed Pharmaceuticals (NASDAQ:ORMP) announced positive Phase 2 results from its multicenter trial to assess the safety and efficacy of its oral insulin candidate (ORMD-0801), to reduce liver fat content in Type 2 Diabetes (T2D) patients with non-alcoholic steatohepatitis (NASH). Oramed shares traded as high as 2.29 percent, in a range of $8.21 to $8.94 on day volume of 432.45 thousand shares, closed regular trading session at $8.89.  
  • The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to GENFIT’s (NASDAQ:GNFT) drug candidate GNS5611 (ezurpimtrostat) for the treatment of cholangiocarcinoma. GENFIT S.A. shares traded in a range of $4.3 to $4.5 on day volume of 25.93 thousand shares, closed regular trading session at $4.42. The company shares traded at $5, up 13.12 percent in the after-hours trading session.
  • Lyra Therapeutics (NASDAQ:LYRA) advanced into its Part 2 of the Phase 2 BEACON clinical trial of LYR-220 in adults with chronic rhinosinusitis (CRS) who have had a prior sinus surgery. Lyra shares traded in a range of $5.71 to $6.25 on day volume of 26.37 thousand shares, closed regular trading session at $6.15. The company shares traded at $5.91, down 3.9 percent in the after-hours trading session.
  • Health Canada has granted approval for Merck’s (NYSE:MRK) KEYTRUDA (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. Merck shares traded in a range of $86.12 to $87.61 on day volume of 7.65 million shares, closed regular trading session at $86.28.
  • The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for aTyr Pharma’s (NASDAQ:LIFE) lead therapeutic candidate, efzofitimod, for the treatment of systemic sclerosis (SSc)-associated, interstitial lung disease (ILD). aTyr Pharma shares traded in a range of $3.56 to $3.72 on day volume of 281.26 thousand shares, closed regular trading session at $3.69.