FDA PDUFA Update…
🗓️ Last week’s PDUFAs:
$Supernus Pharmaceuticals(SUPN.US$ : CRL 4/8/24 🙁
⇒ SPN-830
⇒ OFF episodes in PD
⇒ NDA
⇒ PDUFA: 4/5/24
$Supernus Pharmaceuticals(SUPN.US$ : CRL 4/8/24 🙁
⇒ SPN-830
⇒ OFF episodes in PD
⇒ NDA
⇒ PDUFA: 4/5/24
$Legend Biotech(LEGN.US$ & $Johnson & Johnson(JNJ.US$ : Approved 🎉
⇒ CARVYKTI (cilta-cel)
⇒ Multiple myeloma
⇒ sBLA
⇒ PDUFA: 4/5/24
⇒ CARVYKTI (cilta-cel)
⇒ Multiple myeloma
⇒ sBLA
⇒ PDUFA: 4/5/24
$2seventy bio(TSVT.US$ & $Bristol-Myers Squibb(BMY.US$ : Approved 🎉
⇒ Abecma
⇒ Multiple myeloma
⇒ sBLA
⇒ Delayed PDUFA
⇒ Abecma
⇒ Multiple myeloma
⇒ sBLA
⇒ Delayed PDUFA
$Vanda Pharmaceuticals(VNDA.US$ : Approved 🎉
⇒ Fanapt® (iloperidone)
⇒ Bipolar I disorder
⇒ sNDA
⇒ PDUFA: 4/2/24
⇒ Fanapt® (iloperidone)
⇒ Bipolar I disorder
⇒ sNDA
⇒ PDUFA: 4/2/24
📌 Upcoming PDUFAs this month: 🚨
$ImmunityBio(IBRX.US$ ⇒ Anktiva (4/23)
$Aquestive Therapeutics(AQST.US$ ⇒ LIBERVANT (4/28)
$Neurocrine Biosciences(NBIX.US$ ⇒ INGREZZA (4/30)
$X4 Pharmaceuticals(XFOR.US$ ⇒ Mavorixafor (4/30)
$Day One Biopharmaceuticals(DAWN.US$ ⇒ Tovorafenib (4/30)
$Moderna(MRNA.US$ ⇒ mRNA-1345 (4/30)
$Liquidia(LQDA.US$ ⇒ YUTREPIA (4/30)
$ImmunityBio(IBRX.US$ ⇒ Anktiva (4/23)
$Aquestive Therapeutics(AQST.US$ ⇒ LIBERVANT (4/28)
$Neurocrine Biosciences(NBIX.US$ ⇒ INGREZZA (4/30)
$X4 Pharmaceuticals(XFOR.US$ ⇒ Mavorixafor (4/30)
$Day One Biopharmaceuticals(DAWN.US$ ⇒ Tovorafenib (4/30)
$Moderna(MRNA.US$ ⇒ mRNA-1345 (4/30)
$Liquidia(LQDA.US$ ⇒ YUTREPIA (4/30)
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Ginvest : Thank you for the timely info
Srav Reddy : $X4 Pharmaceuticals (XFOR.US)$ announcement was early on 29/4. But price receded. This is surprising to me.