Australia's Cyclopharm sees worst day ever on FDA response to drug application

Cyclopharm

28/06/2021 06:00

** Pharmaceutical firm's shares  CYC.AX  plunge as much as
43.4% to A$1.55, on track for worst session ever
    ** Company says U.S. Food and Drug Administration (FDA) was
unable to provide New Drug Application (NDA) for its product,
Technegas, in its present form  urn:newsml:reuters.com:*:nASXbcqy6M
    ** Cyclopharm says FDA has provided a definitive list of
items and recommendations for outstanding elements to be
addressed within a year
    ** Developed by the company, Technegas is inhaled by
patients to detect respiratory diseases
    ** Company expects to resolve all outstanding issues and
aims to secure approval for commercial sales of Technegas in the
U.S. market in 2022
    ** About 1.4 mln shares change hands vs 30-day avg of 21,990
shares
    ** Stock on track for second consecutive session of
declines, hits lowest since September 2020
    ** Company's shares up 9.6% this year, as of last close

 (Reporting by Tejaswi Marthi in Bengaluru)
 ((tejaswi.marthi@thomsonreuters.com))