Iterum rises on successful FDA meeting for oral UTI treatment

Iterum Therapeutics

28/09/2021 15:14

** U.S.-listed shares of Dublin-based drug developer
 ITRM.O  rise 4.2% to $0.57
    ** Co says it had a successful meeting with U.S. FDA
regarding the resubmission of its marketing application for oral
drug candidate, sulopenem, for the treatment of adult women with
uncomplicated urinary tract infections (UTI)   urn:newsml:reuters.com:*:nGNXbwvKjd
    ** In July, the FDA declined to approve sulopenem and called
for at least one additional clinical trial potentially using a
different comparator drug  urn:newsml:reuters.com:*:nL4N2P22FA
    ** Co says it is currently evaluating an optimal design for
an additional late-stage study to be conducted prior to the
potential resubmission of a marketing application
    ** Co's cash, cash equivalents and short-term investments
were at $91.5 mln at end of Q2
    ** Stock down ~42% YTD

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