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LEGN Legend Biotech

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47.120
-1.710-3.50%

Close Apr 18 16:00 ET

8.57BMarket Cap-16027P/E (TTM)

Legend Biotech Stock Forum

Meltyy

Apr 9 10:48

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
$Legend Biotech(LEGN.US)$ & $Johnson & Johnson(JNJ.US)$ : Approved 🎉
⇒ CARVYKTI (cilta-cel)
⇒ Multiple myeloma
⇒ sBLA
⇒ PDUFA: 4/5/24
$AstraZeneca(AZN.US)$ : Approved 🎉
⇒ Enhertu
⇒ HER2+ solid tumors
⇒ sBLA
⇒ PDUFA: Q2 2024
$2seventy bio(TSVT.US)$ & $Bristol-Myers Squibb(BMY.US)$ : Approved 🎉
⇒ Abecma
⇒ Multiple myeloma
⇒ sBLA
⇒ Delayed PDUFA
$Vanda Pharmaceuticals(VNDA.US)$...

isaiahlilo

Apr 4 09:36

$Legend Biotech(LEGN.US)$
waiting patiently for fda 😌🙏✨

Meltyy

Apr 1 21:41

FDA PDUFA Update…

🗓️ Last week’s PDUFAs:
$Akebia Therapeutics(AKBA.US)$ : Approved 🎉
⇒ Vafseo (Vadadustat)
⇒ Anemia due to CKD
⇒ NDA
⇒ PDUFA: 3/27/24
$Merck & Co(MRK.US)$ : Approved 🎉
⇒ WINREVAIR (sotatercept)
⇒ Pulmonary arterial hypertension
⇒ BLA
⇒ PDUFA: 3/26/24
$AstraZeneca(AZN.US)$ : Approved 🎉
⇒ Ultomiris (ravulizumab)
⇒ NMOSD
⇒ sBLA
$Regeneron Pharmaceuticals(REGN.US)$ : CRL 🙁
⇒ Odronextamab
⇒ r/r FL and r/r DLBCL
⇒ BLA
⇒ PDUFA: 3/31/24
📌 This week’s PDUFAs: 🚨
$AstraZeneca(AZN.US)$ : 🤔
⇒...

Meltyy: PDUFA 日历-四月

Meltyy

Apr 1 03:25

PDUFA Calendar-April

The FDA PDUFA Calendar is a chronological calendar of PDUFA target dates as well as Advisory meetings (ADCOMM). PDUFA target dates are dates by which the FDA aims to deliver their decision regarding an NDA or BLA filing. These decisions can however come before the PDUFA target date.
$Vanda Pharmaceuticals(VNDA.US)$$Legend Biotech(LEGN.US)$$Supernus Pharmaceuticals(SUPN.US)$$ImmunityBio(IBRX.US)$$Aquestive Therapeutics(AQST.US)$$X4 Pharmaceuticals(XFOR.US)$$Liquidia(LQDA.US)$$Neurocrine Biosciences(NBIX.US)$$Moderna(MRNA.US)$$Day One Biopharmaceuticals(DAWN.US)$
...

Meltyy

Mar 14 05:23

AdCom for CARVYKTI on 3/15

$Legend Biotech(LEGN.US)$$Johnson & Johnson(JNJ.US)$
⇨ FDA’s briefing docs released today! 🔔
⚠️ Early deaths in cilta-cel arm raise FDA concern despite PFS benefit... 🤔
$LEGN trending up ~6% after doc release 📈
ℹ️ CARVYKTI (ciltacabtagene autoleucel)
⇒ multiple myeloma
⇒ CARTITUDE-4 study
⇒ sBLA
⇒ PDUFA: 4/5/24
❓AdCom Discussion & Question:
Discussion Topic:
⇒ Discuss whether the results of CARTITUDE-4 provided in the supplemental application are sufficient to support a positive...