Phathom shares up as FDA sets action date for inflammation drug

Phathom Pharmaceuticals

12/06/2023 16:01

** Phathom Pharmaceuticals Inc's shares  PHAT.O  rise 1.5%
to $13.2 
    ** Drug developer says the U.S. FDA has accepted the
resubmitted marketing application for co's experimental drug
based on acid-blocker compound vonoprazan to treat inflammation
in esophagus
    ** The regulator is expected to decide on approval for the
drug by Nov. 17
    ** In Feb, U.S. FDA declined to approve co's drug citing
safety concerns related to exposure to nitrosamine impurities
above acceptable levels and over long periods of time has been
linked to increased risk of cancer
    ** Co's resubmission is based on additional stability data
showing impurity levels remain at or below the daily acceptable
intake limit throughout the proposed shelf life of the products
    ** Including session gains, stock had risen ~17% YTD 

 (Reporting by Khushi Mandowara in Bengaluru)
 ((Khushi.Mandowara@thomsonreuters.com;))