Meltyy
liked
$Teva Pharmaceutical Industries(TEVA.US$ & 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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Meltyy
liked
$Travere Therapeutic(TVTX.US$ 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
liked and voted
$Apple(AAPL.US$
👉 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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Meltyy
liked
$S&P 500 Index(.SPX.US$ 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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Meltyy
liked
$Vertex Pharmaceuticals(VRTX.US$ $Alpine Immune(ALPN.US$
⚡ 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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Meltyy
liked
$SPDR S&P Biotech ETF(XBI.US$ $iShares Biotechnology ETF(IBB.US$
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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Meltyy
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
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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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