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🚨 This Week’s PDUFAs:
$Regeneron Pharmaceuticals (REGN.US)$ : 🤔
⇨ Linvoseltamab
‣ Multiple myeloma
‣ PDUFA: 8/22/24 (BLA)
🗓️ Last Week’s PDUFAs:
$Gilead Sciences (GILD.US)$ : Approved 8/14 🎉
⇨ Livdelzi (Seladelpar)
‣ Primary biliary cholangitis (PBC)
‣ PDUFA: 8/14/24 (NDA)
$Ascendis Pharma A/S (ASND.US)$ : Approved 8/12 🎉
⇨ YORVIPATH (palopegteriparatide)
‣ Hypoparathyroidism
‣ PDUFA: 8/14/24 (NDA)
$Syndax Pharmaceuticals (SNDX.US)$ & $Incyte (INCY.US)$ : Approved 8/14 🎉
⇨ Nikt...
$Regeneron Pharmaceuticals (REGN.US)$ : 🤔
⇨ Linvoseltamab
‣ Multiple myeloma
‣ PDUFA: 8/22/24 (BLA)
🗓️ Last Week’s PDUFAs:
$Gilead Sciences (GILD.US)$ : Approved 8/14 🎉
⇨ Livdelzi (Seladelpar)
‣ Primary biliary cholangitis (PBC)
‣ PDUFA: 8/14/24 (NDA)
$Ascendis Pharma A/S (ASND.US)$ : Approved 8/12 🎉
⇨ YORVIPATH (palopegteriparatide)
‣ Hypoparathyroidism
‣ PDUFA: 8/14/24 (NDA)
$Syndax Pharmaceuticals (SNDX.US)$ & $Incyte (INCY.US)$ : Approved 8/14 🎉
⇨ Nikt...
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🚨 1 AdCom & 3 PDUFA decisions this week:
$Genfit (GNFT.US)$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD (IPSEY.US)$ : 🤔
⇨ Elafibranor
‣ Primary biliary cholangitis
‣ PDUFA date: 6/10/24
$Regeneron Pharmaceuticals (REGN.US)$ : 🤔
⇨ Kevzara (sarilumab)
‣ Polyarticular juvenile idiopathic arthritis
‣ PDUFA date: 6/10/24
$Bristol-Myers Squibb (BMY.US)$ : 🤔
⇨ Augtyro™ (Repotrectinib)
‣ PDUFA date: 6/15/24 (sNDA)
🗓️ Last week’s PDUFAs:
$GlaxoSmithKline (GSK.US)$ : Approved 6/7 🎉
⇨ Arexvy
‣ Respiratory s...
$Genfit (GNFT.US)$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD (IPSEY.US)$ : 🤔
⇨ Elafibranor
‣ Primary biliary cholangitis
‣ PDUFA date: 6/10/24
$Regeneron Pharmaceuticals (REGN.US)$ : 🤔
⇨ Kevzara (sarilumab)
‣ Polyarticular juvenile idiopathic arthritis
‣ PDUFA date: 6/10/24
$Bristol-Myers Squibb (BMY.US)$ : 🤔
⇨ Augtyro™ (Repotrectinib)
‣ PDUFA date: 6/15/24 (sNDA)
🗓️ Last week’s PDUFAs:
$GlaxoSmithKline (GSK.US)$ : Approved 6/7 🎉
⇨ Arexvy
‣ Respiratory s...
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$Regeneron Pharmaceuticals (REGN.US)$
🔔 FDA Approves Kevzara® (sarilumab)
» for Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) 🦴
» sBLA approval in patients with pJIA weighing ≥ 63kg
» adds to Kevzara’s position in treating adult chronic inflammatory conditions of moderately to severely active rheumatoid arthritis & polymyalgia rheumatica
🔔 FDA Approves Kevzara® (sarilumab)
» for Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) 🦴
» sBLA approval in patients with pJIA weighing ≥ 63kg
» adds to Kevzara’s position in treating adult chronic inflammatory conditions of moderately to severely active rheumatoid arthritis & polymyalgia rheumatica
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🚨 This Week’s PDUFA:
$Humacyte (HUMA.US)$ : 🤔
⇨ Human Acellular Vessel (HAV)™
‣ Vascular Trauma
‣ PDUFA: 8/10/24 (BLA)
🗓️ Last Week’s AdCom & PDUFAs:
$Zevra Therapeutics (ZVRA.US)$ : Favorable AdCom 👍
🗳️ 11-5 votes in favor
⇨ Arimoclomol
‣ Niemann-Pick disease type C
‣ AdCom: 8/2/24 (NDA)
$Adaptimmune Therapeutics (ADAP.US)$ : Approved 🎉
⇨ TECELRA (afamitresgene autoleucel)
‣ Synovial sarcoma
‣ PDUFA: 8/4/24 (BLA)
$GlaxoSmithKline (GSK.US)$ : Approved 🎉
⇨ Jemperli
‣ Endometria...
$Humacyte (HUMA.US)$ : 🤔
⇨ Human Acellular Vessel (HAV)™
‣ Vascular Trauma
‣ PDUFA: 8/10/24 (BLA)
🗓️ Last Week’s AdCom & PDUFAs:
$Zevra Therapeutics (ZVRA.US)$ : Favorable AdCom 👍
🗳️ 11-5 votes in favor
⇨ Arimoclomol
‣ Niemann-Pick disease type C
‣ AdCom: 8/2/24 (NDA)
$Adaptimmune Therapeutics (ADAP.US)$ : Approved 🎉
⇨ TECELRA (afamitresgene autoleucel)
‣ Synovial sarcoma
‣ PDUFA: 8/4/24 (BLA)
$GlaxoSmithKline (GSK.US)$ : Approved 🎉
⇨ Jemperli
‣ Endometria...
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🔥 July: 3 PDUFAs & 1 AdCom
$Arcutis Biotherapeutics (ARQT.US)$ : ARQ-151 topical roflumilast cream
$Phathom Pharmaceuticals (PHAT.US)$ : VOQUEZNA® (vonoprazan)
$AstraZeneca (AZN.US)$ : Imfinzi + chemotherapy - AdCom
$BeiGene (BGNE.US)$ : TEVIMBRA (tislelizumab)
$Arcutis Biotherapeutics (ARQT.US)$ : ARQ-151 topical roflumilast cream
$Phathom Pharmaceuticals (PHAT.US)$ : VOQUEZNA® (vonoprazan)
$AstraZeneca (AZN.US)$ : Imfinzi + chemotherapy - AdCom
$BeiGene (BGNE.US)$ : TEVIMBRA (tislelizumab)
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$Tesla (TSLA.US)$ 85 is a good spot to enter which is the bottom of the trendline, buying above 100 is a guaranteed loss
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The Dow Jones Industrial Average jumped Thursday morning, rebounding from the index’s worst day since October as Treasury yields fell and the year-end rally resumed.
The 30-stock Dow climbed 282 points, or 0.76%. S&P 500 added 0.83%, while the Nasdaq Composite advanced 1.1%.
$Dow Jones Industrial Average (.DJI.US)$ $Nasdaq Composite Index (.IXIC.US)$ $S&P 500 Index (.SPX.US)$ $Invesco QQQ Trust (QQQ.US)$ $SPDR S&P 500 ETF (SPY.US)$
The 30-stock Dow climbed 282 points, or 0.76%. S&P 500 added 0.83%, while the Nasdaq Composite advanced 1.1%.
$Dow Jones Industrial Average (.DJI.US)$ $Nasdaq Composite Index (.IXIC.US)$ $S&P 500 Index (.SPX.US)$ $Invesco QQQ Trust (QQQ.US)$ $SPDR S&P 500 ETF (SPY.US)$
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$Tesla (TSLA.US)$ Does anyone's Futu software screen keep jumping? It's so dizzy.
Translated
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$SmileDirectClub (SDC.US)$ Hovering around the resistance and close to $1 could see nice rally
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