Nymox hits 7-yr low after FDA refuses marketing application of lead drug

Nymox Pharmaceutical

23/05/2022 15:52

** Shares of drug developer  NYMX.O  plunge as much as 70.6%
to an over 7-yr low of 37 cents; among top three pct. losers
across U.S. exchanges
    ** NYMX says it received a refuse-to-file (RTF) letter from
the U.S. FDA for its marketing application of its lead drug
candidate Fexapotide Triflutate (FT)  urn:newsml:reuters.com:*:nGNX9S0CwP
    ** Co developed FT as an injectable for benign prostate
hyperplasia, a condition that causes enlarged prostate glands
and urinary issues in older men; co had submitted the
application in March
    ** FDA issues RTF letters because of significant
deficiencies in applications that cannot be resolved promptly
    ** The agency's letter indicated that co had to submit
longer-term safety data of as long as 6 years in its application
- NYMX
    ** Co says it has submitted long-term data of 2-3 years from
some of its late-stage trials
    ** "Nymox's position is that clarifications remain to be
resolved at a follow-up meeting and that some significant
inconsistencies were involved" - NYMX
    ** Stock has slumped 28% over the past 12 months through
last close

 (Reporting by Ruhi Soni in Bengaluru)
 ((Ruhi.Soni@thomsonreuters.com
Twitter: https://twitter.com/ruhithere))