FDA PDUFA Update:

🚀 Buckle up for upcoming PDUFAs in September! 👇

$Travere Therapeutic (TVTX.US)$ : FILSPARI (Sparsentan)
$Avadel Pharmaceuticals (AVDL.US)$ : LUMRYZ (FT218)
$Iterum Therapeutics (ITRM.US)$ : Sulopenem - AdCom 🗓️
$Sanofi (SNY.US)$ & $Regeneron Pharmaceuticals (REGN.US)$ : Dupixent
$Vanda Pharmaceuticals (VNDA.US)$ : Tradipitant
$Zevra Therapeutics (ZVRA.US)$ : Arimoclomol
$Heron Therapeutics (HRTX.US)$ : ZYNRELEF® Vial Access Needle
$Merck & Co (MRK.US)$ : KEYTRUDA+ chemotherapy
$Bristol-Myers Squibb (BMY.US)$ : KarXT (xanomeline-trospium)
$Sanofi (SNY.US)$ & $Regeneron Pharmaceuticals (REGN.US)$ : Dupixent
$Sanofi (SNY.US)$ : Sarclisa®
$ROCHE HOLDING AG (RHHBY.US)$ : OCREVUS (ocrelizumab) w/ ENHANZE

🗓️ Last Week’s PDUFAs:
$Regeneron Pharmaceuticals (REGN.US)$ : CRL 8/20 🙁
⚠️ due to findings from pre-approval inspection at 3rd party mfg.
⇨ Linvoseltamab
‣ Multiple myeloma
‣ PDUFA: 8/22/24 (BLA)