Phathom falls as FDA seeks more data on acid blocker drug

Phathom Pharmaceuticals

03/01/2023 23:03

** Shares of drug developer Phathom Pharmaceuticals  PHAT.O 
fall as much as 32% to $8.16 after the bell  
    ** Co says the U.S. Food and Drug Administration (FDA) will
not be taking any action on its marketing application for acid
blocking drug by the target date of Jan. 11 
    ** U.S. health regulator has asked for additional stability
data on the drug after co detected nitrosamine impurity in
commercial batches of the drug in August 
    ** Exposure to nitrosamine impurities above acceptable
levels and over long periods of time has been linked to
increased risk of cancer  
    ** PHAT is seeking approval for its drug, vonoprazan, as a
potential treatment for erosive esophagitis, which causes
inflammation of the esophagus and wears away its lining  
    ** Co says no longer expects to launch the drug in Q1 2023,
is in active discussions with the FDA regarding the additional
data
    ** Stock fell ~43% in 2022 
 (Reporting by Bhanvi Satija in Bengaluru)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))