Australia's Invex hits record low on U.S. FDA response on clinical trial plan

Invex Therapeutics

15/06/2021 02:45

** Invex Therapeutics Ltd  IXC.AX  falls as much as 22.1% to
A$0.510, hitting a record low
    ** The pharma company receives responses from the U.S. Food
FDA on co's proposed Phase III clinical trial design for
Presendin for the treatment of Idiopathic Intracranial
Hypertension  urn:newsml:reuters.com:*:nFWN2NW0TM
    ** IXC says for intracranial pressure (ICP), FDA considered
co's measure as an appropriate secondary endpoint, but not a
primary endpoint that would support approval of Presendin in IIH
    ** Co says this advice contrasts with that from the European
Medicines Agency (EMA), which considered a lowering of ICP as an
appropriate primary endpoint 
    ** IXC says will meet with regulatory advisors to understand
FDA response
    ** Stock posts its biggest intraday percentage fall since
March 23, 2020
    ** More than 652,000 shares change hands, compared with the
30-day average volume of about 81,000
    ** Stock down 8.4% this year, as of last close

 (Reporting by Rashmi Ashok in Bengaluru)
 ((Rashmi.Ashok@thomsonreuters.com; +918061822604;))