Phathom Pharma rises on plans to resubmit application for inflammation drug

Phathom Pharmaceuticals

04/04/2023 15:49

(Updates)
    ** Phathom Pharmaceuticals Inc's  PHAT.O  shares rise 6% to
$7.87, among biggest pct gainers on Nasdaq Biotechnology index
 .NBI 
    ** PHAT plans to re-submit marketing application of its drug
to treat inflammation in the food pipe by Q2 2023
    ** Company says received positive feedback based on
additional stability data related to drug and meeting with U.S.
FDA
    ** FDA declined to approve PHAT's drug in February due to
concerns over nitrosamine impurity, exposure to which has been
linked to increased risk of cancer
    ** Health regulator had asked Phathom for additional
stability data showing impurity levels remain at or below daily
acceptable intake limit throughout proposed shelf life of
products
    ** If approved, company plans to launch the drug in Q4 2023
    ** Including session gains, PHAT shares down ~30% YTD vs ~2%
decline in  .NBI 

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