Vijay Raja
commented on
📣 3 PDUFAs left in April! See summary 👇
🗓️ Last week’s PDUFAs:
$Pfizer (PFE.US)$ : Approved 4/26 🎉
⇨ BEQVEZ (fidanacogene elaparvovec-dzkt)
▹ Hemophilia B
▹ BLA
▹ PDUFA date: Q2 2024
$Day One Biopharmaceuticals (DAWN.US)$ : Approved 4/23 🎉
⇨ OJEMDA (tovorafenib)
▹ Pediatric low-grade glioma
▹ NDA
▹ PDUFA date: 4/30/24
$ImmunityBio (IBRX.US)$ : Approved 4/22 🎉
⇨ Anktiva + BCG
▹ Bladder cancer
▹ resubmitted BLA
▹ PDUFA date: 4/23/24
$Abeona Therapeutics (ABEO.US)$ : CRL 4/22 🙁
⚠...
🗓️ Last week’s PDUFAs:
$Pfizer (PFE.US)$ : Approved 4/26 🎉
⇨ BEQVEZ (fidanacogene elaparvovec-dzkt)
▹ Hemophilia B
▹ BLA
▹ PDUFA date: Q2 2024
$Day One Biopharmaceuticals (DAWN.US)$ : Approved 4/23 🎉
⇨ OJEMDA (tovorafenib)
▹ Pediatric low-grade glioma
▹ NDA
▹ PDUFA date: 4/30/24
$ImmunityBio (IBRX.US)$ : Approved 4/22 🎉
⇨ Anktiva + BCG
▹ Bladder cancer
▹ resubmitted BLA
▹ PDUFA date: 4/23/24
$Abeona Therapeutics (ABEO.US)$ : CRL 4/22 🙁
⚠...
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Vijay Raja : BEQVEZ has the same problem that Roctavian has. Payers have not been sorted . Very slow uptake.