FDA PDUFA Update…

🚨 This Week’s PDUFAs:
$Regeneron Pharmaceuticals (REGN.US)$ : 🤔
⇨ Linvoseltamab
‣ Multiple myeloma
‣ PDUFA: 8/22/24 (BLA)

🗓️ Last Week’s PDUFAs:
$Gilead Sciences (GILD.US)$ : Approved 8/14 🎉
⇨ Livdelzi (Seladelpar)
‣ Primary biliary cholangitis (PBC)
‣ PDUFA: 8/14/24 (NDA)

$Ascendis Pharma A/S (ASND.US)$ : Approved 8/12 🎉
⇨ YORVIPATH (palopegteriparatide)
‣ Hypoparathyroidism
‣ PDUFA: 8/14/24 (NDA)

$Syndax Pharmaceuticals (SNDX.US)$ & $Incyte (INCY.US)$ : Approved 8/14 🎉
⇨ Niktimvo (Axatilimab)
‣ Chronic Graft-Versus-Host Disease (GVHD)
‣ PDUFA: 8/28/24

$scPharmaceuticals (SCPH.US)$ : Approved 8/12 🎉
⇨ FUROSCIX (furosemide)
‣ Heart Failure
‣ PDUFA: Aug 2024

🎯 10+ PDUFAs in September: 🔥
$Travere Therapeutic (TVTX.US)$ FILSPARI (Sparsentan)
$Avadel Pharmaceuticals (AVDL.US)$ LUMRYZ (FT218)
$Sanofi (SNY.US)$ & $REGN 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)
$Sanofi (SNY.US)$ Sarclisa®
$ROCHE HOLDING AG (RHHBY.US)$ OCREVUS (ocrelizumab) w/ ENHANZE