Phathom Pharma rises on plans to resubmit application for inflammation drug

Phathom Pharmaceuticals

04/04/2023 14:45

** Phathom Pharmaceuticals Inc's  PHAT.O  shares rise 9.7%
to $8.14
    ** Biopharmaceutical co plans to resubmit marketing
application of its drug to treat inflammation in food pipe by Q2
2023
    ** Co plans to resubmit its application after receiving
positive feedback based on its additional stability data and
meeting with U.S. FDA 
    ** In Feb, U.S. FDA has declined to approve PHAT's drug due
to concern over nitrosamine impurity, exposure to which has been
linked to increased risk of cancer 
    ** Health Regulator had asked the co for additional
stability data showing impurity levels remain at or below the
daily acceptable intake limit throughout the proposed shelf life
of the products
    ** If approved, co plans to launch the drug in Q4 2023
    ** As of last close, PHAT had fallen ~34% YTD

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