Important Biotech Catalysts For September 13, 2022 - End Of The Day Summary - Syros Pharmaceuticals (NASDAQ:SYRS), Oramed Pharmaceuticals (NASDAQ:ORMP), Vaxxinity (OTC:VAXX), Genfit (NASDAQ:GNFT)

Akero Therapeutics 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 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 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 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 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 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 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 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 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 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 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.