What does this news mean/signify?
Srav Reddy
commented on
See remaining FDA PDUFAs in May 👀👇
$Bristol-Myers Squibb(BMY.US$ : Breyanzi
‣ PDUFA date: 5/31/24 (sBLA)
$Moderna(MRNA.US$ : mRNA-1345
‣ PDUFA date: End of May 2024 (est.) (BLA)
📣 Buckle up & get ready for next month...
June brings 17 PDUFA decisions: 🔥 🔥
$Catalyst Pharmaceuticals(CPRX.US$ : FIRDAPSE® (Amifampridine)
$GlaxoSmithKline(GSK.US$ : Arexvy
$Genfit(GNFT.US$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD(IPSEY.US$ : Elafibranor
$Regeneron Pharmaceuticals(REGN.US$ : Kevzara (sarilumab)
$Bristol-Myers Squibb(BMY.US$ : Augtyro...
$Bristol-Myers Squibb(BMY.US$ : Breyanzi
‣ PDUFA date: 5/31/24 (sBLA)
$Moderna(MRNA.US$ : mRNA-1345
‣ PDUFA date: End of May 2024 (est.) (BLA)
📣 Buckle up & get ready for next month...
June brings 17 PDUFA decisions: 🔥 🔥
$Catalyst Pharmaceuticals(CPRX.US$ : FIRDAPSE® (Amifampridine)
$GlaxoSmithKline(GSK.US$ : Arexvy
$Genfit(GNFT.US$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD(IPSEY.US$ : Elafibranor
$Regeneron Pharmaceuticals(REGN.US$ : Kevzara (sarilumab)
$Bristol-Myers Squibb(BMY.US$ : Augtyro...
![Picture](https://ussnsimg.moomoo.com/sns_client_feed/70042970/20240524/379768a290c342f7abf6741d0c98442d.png/thumb?area=100&is_public=true)
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Srav Reddy
commented on
🗓️ 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
$Vanda Pharmaceuticals(VNDA.US$...
$Supernus Pharmaceuticals(SUPN.US$ : 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
$Vanda Pharmaceuticals(VNDA.US$...
![FDA PDUFA Update…](https://ussnsimg.moomoo.com/sns_client_feed/70042970/20240409/2e9a177a5e6149cc9a0b6b7d4b9181f1.png/thumb?area=100&is_public=true)
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Srav Reddy
liked and commented on
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.
$Pfizer(PFE.US$ $Dynavax Technologies(DVAX.US$ $Sandstorm Gold(SAND.US$ $Bristol-Myers Squibb(BMY.US$ $SPDR S&P Biotech ETF(XBI.US$
$Pfizer(PFE.US$ $Dynavax Technologies(DVAX.US$ $Sandstorm Gold(SAND.US$ $Bristol-Myers Squibb(BMY.US$ $SPDR S&P Biotech ETF(XBI.US$
![PDUFA Events for May 2024](https://ussnsimg.moomoo.com/sns_client_feed/70042970/20240428/3fd8528afbcd4d5fa3a4f48fb3fca905.png/thumb?area=100&is_public=true)
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Srav Reddy
liked
$RTX Corp(RTX.US$ i’m wondering how high this is going to go on Monday? i’m thinking 3% to 5% next week.
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Srav Reddy
liked
$Legend Biotech(LEGN.US$ $Johnson & Johnson(JNJ.US$
🔔 FDA approves CARVYKTI® label expansion 🎉
⇨ 1st and only BCMA-targeted CAR-T cell therapy
for 2nd-line Tx of multiple myeloma
⇨ based on CARTITUDE-4 study
⇨ 11:0 favorable FDA AdCom votes
🔔 FDA approves CARVYKTI® label expansion 🎉
⇨ 1st and only BCMA-targeted CAR-T cell therapy
for 2nd-line Tx of multiple myeloma
⇨ based on CARTITUDE-4 study
⇨ 11:0 favorable FDA AdCom votes
![Picture](https://ussnsimg.moomoo.com/sns_client_feed/70042970/20240409/1fa4a32ca0e740a6bd758a47bae873b9.png/thumb?area=100&is_public=true)
![Picture](https://ussnsimg.moomoo.com/sns_client_feed/70042970/20240409/9f5d98647ae64712b9c86d32473d684f.png/thumb?area=100&is_public=true)
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Srav Reddy
commented on
🗓️ 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: 🚨
$AstraZeneca(AZN.US$ : 🤔
⇒...
$Akebia Therapeutics(AKBA.US$ : 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: 🚨
$AstraZeneca(AZN.US$ : 🤔
⇒...
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Srav Reddy
liked
See Biotech companies with cancer assets 👇
⇨ held by 5 biopharma-focused hedge funds! 🔥
$Arcellx(ACLX.US$ : Anito-cel (Ph 2)
$Adaptimmune Therapeutics(ADAP.US$ : Afami-cel (PDUFA) ⏳
$Bicycle Therapeutics(BCYC.US$ : BT8009 (Ph 1/2)
$Centessa Pharmaceuticals(CNTA.US$ : LB101 (Ph 1/2)
$Day One Biopharmaceuticals(DAWN.US$ : Tovorafenib (PDUFA) (check comments for details)
$Fate Therapeutics(FATE.US$ : FT576 (Ph 1)
$Fusion Pharmaceuticals(FUSN.US$ : FPI-2265 (Ph 2)
$GRCL: ...
⇨ held by 5 biopharma-focused hedge funds! 🔥
$Arcellx(ACLX.US$ : Anito-cel (Ph 2)
$Adaptimmune Therapeutics(ADAP.US$ : Afami-cel (PDUFA) ⏳
$Bicycle Therapeutics(BCYC.US$ : BT8009 (Ph 1/2)
$Centessa Pharmaceuticals(CNTA.US$ : LB101 (Ph 1/2)
$Day One Biopharmaceuticals(DAWN.US$ : Tovorafenib (PDUFA) (check comments for details)
$Fate Therapeutics(FATE.US$ : FT576 (Ph 1)
$Fusion Pharmaceuticals(FUSN.US$ : FPI-2265 (Ph 2)
$GRCL: ...
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Srav Reddy : Any idea? Nothing can be found till now