Phathom Pharma tanks as FDA declines to approve inflammation drug

Phathom Pharmaceuticals

10/02/2023 15:34

(Updates)
    **  Shares of drug developer Phathom Pharmaceuticals Inc
 PHAT.O  down 29.2% at $8.18 in early trading hours
    ** Stock among top pct. losers across U.S. exchanges
    ** U.S. FDA declined to approve co's experimental drug based
on acid-blocker compound vonoprazan to treat inflammation in
esophagus 
    ** In August 2022, co detected nitrosamine impurity in
commercial batches of its already approved drugs to treat H.
pylori bacterial infection, which were also based on vonoprazan 
    ** Exposure to nitrosamine impurities above acceptable
levels and over long periods of time has been linked to
increased risk of cancer
    ** Regulator seeks additional stability data showing
impurity levels remain at or below the daily acceptable intake
limit throughout the proposed shelf life of the products
    ** FDA also stalls post-approval supplement changes to H.
pylori drug till receiving additional data 
    ** Co expects to meet FDA in Q1 to discuss resubmission plan
and timeline
    ** Stock fell 56% in last 12 months
 (Reporting by Aditya Samal)
 ((Aditya.Samal@thomsonreuters.com;))