1 PDUFA & 1 AdCom left in October 🗓️

See FDA PDUFA update 👇

$Iterum Therapeutics (ITRM.US)$ : 🤔
⇨ Oral Sulopenem
‣ Uncomplicated Urinary Tract Infections
‣ PDUFA: 10/25/24

$Lexicon Pharmaceuticals (LXRX.US)$ : [Adcom] 🤔
⇨ ZYNQUISTA (sotagliflozin)
‣ Type 1 Diabetes
‣ Adcom: 10/31/24

📣 Last Week’s PDUFA Decisions:
$ZLDPF: CRL 10/8 ❌
⚠️ due to timing of a 3rd-party mfg. facility reinspection
⇨ Dasiglucagon
‣ Congenital Hyperinsulinism
‣ PDUFA: 10/08/24 (NDA)

$RRBHY: Approved 10/11 ✅
⇨ Itovebi™ (inavolisib)
‣ HR+/HER2- breast cancer w/ PIK3CA mutation
‣ PDUFA: 11/27/24

$Pfizer (PFE.US)$ : Approved 10/11 ✅
⇨ HYMPAVZI™ (Marstacimab)
‣ Hemophilia A and B
‣ PDUFA: 12/31/24