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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.
$Pfizer(PFE.US$ $Dynavax Technologies(DVAX.US$ $Sandstorm Gold(SAND.US$ $Bristol-Myers Squibb(BMY.US$ $SPDR S&P Biotech ETF(XBI.US$
$Pfizer(PFE.US$ $Dynavax Technologies(DVAX.US$ $Sandstorm Gold(SAND.US$ $Bristol-Myers Squibb(BMY.US$ $SPDR S&P Biotech ETF(XBI.US$
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$Teva Pharmaceutical Industries(TEVA.US$ & alvotechpr
📣 FDA approves SELARSDI (Ustekinumab-Aekn), biosimilar to Stelara® 🎉
▻ approved for both adult and pedia indications (plaque psoriasis & psoriatic arthritis)
▻ developed and manuf. using same type of cells and process used for Stelara 👨🔬
▻ to be marketed in US on or after 02/21/25 🗓️
📣 FDA approves SELARSDI (Ustekinumab-Aekn), biosimilar to Stelara® 🎉
▻ approved for both adult and pedia indications (plaque psoriasis & psoriatic arthritis)
▻ developed and manuf. using same type of cells and process used for Stelara 👨🔬
▻ to be marketed in US on or after 02/21/25 🗓️
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$Travere Therapeutic(TVTX.US$ Phase 3
$CG Oncology(CGON.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$BioCardia(BCDA.US$ Phase 3
$Insmed(INSM.US$ Phase 3
$GlycoMimetics(GLYC.US$ Phase 3
$Annexon(ANNX.US$ Phase 3
$Lipocine(LPCN.US$ Phase 3
$FibroGen(FGEN.US$ Phase 3
$UroGen Pharma Ltd(URGN.US$ Phase 3
$Lyra Therapeutics(LYRA.US$ Phase 3
$Citius Pharmaceuticals(CTXR.US$ Phase 3
$Jaguar Health(JAGX.US$ Phas...
$CG Oncology(CGON.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$BioCardia(BCDA.US$ Phase 3
$Insmed(INSM.US$ Phase 3
$GlycoMimetics(GLYC.US$ Phase 3
$Annexon(ANNX.US$ Phase 3
$Lipocine(LPCN.US$ Phase 3
$FibroGen(FGEN.US$ Phase 3
$UroGen Pharma Ltd(URGN.US$ Phase 3
$Lyra Therapeutics(LYRA.US$ Phase 3
$Citius Pharmaceuticals(CTXR.US$ Phase 3
$Jaguar Health(JAGX.US$ Phas...
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Meltyy
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$Apple(AAPL.US$
👉 Key Highlights:
📍 Apple plans to overhaul its Mac lineup with new M4 processors, focusing on artificial intelligence.
📍 The M4 chip will come in three main varieties, targeting updates across all Mac models.
📍 Mac sales experienced a 27% decline last fiscal year, with efforts to rejuvenate the lineup via the M3 launch.
📍 Apple aims to compete in the AI space, seen as trailing behind Microsoft and Google.
📍 Launch t...
👉 Key Highlights:
📍 Apple plans to overhaul its Mac lineup with new M4 processors, focusing on artificial intelligence.
📍 The M4 chip will come in three main varieties, targeting updates across all Mac models.
📍 Mac sales experienced a 27% decline last fiscal year, with efforts to rejuvenate the lineup via the M3 launch.
📍 Apple aims to compete in the AI space, seen as trailing behind Microsoft and Google.
📍 Launch t...
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$S&P 500 Index(.SPX.US$ climbs 0.9%, bouncing back from inflation concerns. $Nasdaq Composite Index(.IXIC.US$ surges 1.7%, with tech stocks driving gains. $Dow Jones Industrial Average(.DJI.US$ modestly up by 68 points or 0.2%.
Tech giants like $NVIDIA(NVDA.US$ and $Apple(AAPL.US$ lead with significant jumps. $Amazon(AMZN.US$ and $Alphabet-C(GOOG.US$ Alphabet also rally, boosting the tech sector.Apple enjoys its best day in 20...
Tech giants like $NVIDIA(NVDA.US$ and $Apple(AAPL.US$ lead with significant jumps. $Amazon(AMZN.US$ and $Alphabet-C(GOOG.US$ Alphabet also rally, boosting the tech sector.Apple enjoys its best day in 20...
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$Aditxt(ADTX.US$ to acquire Appili Tx
TuHURA Biosciences merger w/ $Kintara Therapeutics(KTRA.US$
$Johnson & Johnson(JNJ.US$ to acquire $ShockWave Medical(SWAV.US$
$Vertex Pharmaceuticals(VRTX.US$ to acquire $Alpine Immune(ALPN.US$
What companies will be next? 🤔
TuHURA Biosciences merger w/ $Kintara Therapeutics(KTRA.US$
$Johnson & Johnson(JNJ.US$ to acquire $ShockWave Medical(SWAV.US$
$Vertex Pharmaceuticals(VRTX.US$ to acquire $Alpine Immune(ALPN.US$
What companies will be next? 🤔
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$Vertex Pharmaceuticals(VRTX.US$ $Alpine Immune(ALPN.US$
⚡ Vertex buys Alpine in a $4.9B deal 💰
⇨ Acquisition for $65/sh or $4.9B in cash 🤑
▪ Transaction closes in Q2 2024
⇨ Includes ALPN lead product, povetacicep (ALPN-303)
▪ best-in-class potential in patients with IgA nephropathy
▪ Ph3 to initiate in H2 2024
⚡ Vertex buys Alpine in a $4.9B deal 💰
⇨ Acquisition for $65/sh or $4.9B in cash 🤑
▪ Transaction closes in Q2 2024
⇨ Includes ALPN lead product, povetacicep (ALPN-303)
▪ best-in-class potential in patients with IgA nephropathy
▪ Ph3 to initiate in H2 2024
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$SPDR S&P Biotech ETF(XBI.US$ $iShares Biotechnology ETF(IBB.US$
M&A in Q1 alone totaled 12 deals for $19.2 bil which is close to the 10 deals for $21.9 bil in all the 1H of 2023...
But one big caveat of this chart, it doesn't include $Pfizer(PFE.US$ 's $43 bil deal for $SGEN announced in Mar 2023 but didn't close until Dec bc of an FTC challenge,
The biggest biotech M&A deal so far this yr was $Gilead Sciences(GILD.US$ 's $4.3 b...
M&A in Q1 alone totaled 12 deals for $19.2 bil which is close to the 10 deals for $21.9 bil in all the 1H of 2023...
But one big caveat of this chart, it doesn't include $Pfizer(PFE.US$ 's $43 bil deal for $SGEN announced in Mar 2023 but didn't close until Dec bc of an FTC challenge,
The biggest biotech M&A deal so far this yr was $Gilead Sciences(GILD.US$ 's $4.3 b...
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🗓️ 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
$Vanda Pharmaceuticals(VNDA.US$...
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$Legend Biotech(LEGN.US$ $Johnson & Johnson(JNJ.US$
🔔 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
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