OpGen Stock Gains On FDA Approval, Interim Q3 Sales

  • The FDA has granted 510(k) clearance to OpGen Inc's OPGN Acuitas AMR Gene Panel.
  • The Company is finalizing preparations for its commercial launch in the U.S. in Q4 of 2021.
  • The Acuitas AMR Gene Panel detects 28 genetic antimicrobial resistance (AMR) markers in isolated bacterial colonies from 26 different pathogens. 
  • The Acuitas AMR Gene Panel expands the diagnostic capability of clinicians to rapidly and simultaneously test for select drugs in 9 classes of antibiotics.
  • Furthermore, the Company believes that the Acuitas AMR Gene Panel is the first FDA-cleared molecular diagnostic panel that detects a broad panel of AMR markers from isolates.
  • Also, OpGen reported interim Q3 revenue of approximately $1.2 million, up from $1.1 million a year ago.
  • Cash was approximately $25.4 million.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: OPGN stock is up 26.1% at $3.48 during the premarket session on the last check Monday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Date
ticker
name
Actual EPS
EPS Surprise
Actual Rev
Rev Surprise
Posted In:
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!