Avenue Therapeutics feels the sting as FDA panel votes against painkiller

Avenue Therapeutics

16/02/2022 13:05

** Shares of drug developer  ATXI.O  fall 57.3% to $0.26
premarket, biggest pct loser across all U.S. exchanges
    ** U.S. FDA panel reviewing co's intravenous formulation of
painkiller tramadol has agreed that ATXI has not submitted
adequate information to show that benefits of treatment outweigh
risks
    ** FDA has declined to approve the painkiller twice 
    ** Agency had scheduled the Advisory Committee meeting after
Avenue submitted a formal dispute resolution (FDR) request
    ** An FDR is a pathway through which applicants can seek to
resolve scientific and/or medical dispute, such as deficiencies
cited in a complete response letter
    ** FDA's Office of New Drugs will respond to co's FDR within
30 days of panel meeting
    ** ATXI has fallen 32.8% this year, as of last close

 (Reporting by Mrinalika Roy in Bengaluru)
 ((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325;))