Meltyy
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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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$Genmab(GMAB.US$ $AbbVie(ABBV.US$
EPKINLY (Epcoritamab) Now Approved for Patients w/ Follicular Lymphoma (FL)
» Positive results in Ph1/2 EPCORE® NHL-1 study for R/R FL
» Offers off-the-shelf T-cell therapy
» First-of-its-kind antibody for both R/R FL & DLBCL after prior treatments (2+ lines)
EPKINLY (Epcoritamab) Now Approved for Patients w/ Follicular Lymphoma (FL)
» Positive results in Ph1/2 EPCORE® NHL-1 study for R/R FL
» Offers off-the-shelf T-cell therapy
» First-of-its-kind antibody for both R/R FL & DLBCL after prior treatments (2+ lines)
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Meltyy
liked
🔥 3 PDUFA decisions this week! 👇
📌 This week’s PDUFAs:
$Merck & Co(MRK.US$ : 🤔
⇨ Patritumab deruxtecan
‣ Non-small cell lung carcinoma
‣ PDUFA date: 6/26/24 (BLA)
$Verona Pharma(VRNA.US$ : 🤔
⇨ Ensifentrine (Nebulized)
‣ Chronic obstructive pulmonary disease
‣ PDUFA date: 6/26/24 (NDA)
$Genmab(GMAB.US$ : 🤔
⇨ EPKINLY® (Epcoritamab)
‣ Follicular lymphoma
‣ PDUFA date: 6/28/24 (sBLA)
🗓️ Last week’s PDUFAs:
$Merck & Co(MRK.US$ : Approved 6/17 🎉
⇨ CAPVAXIVE (V116)
‣ Pneumo...
📌 This week’s PDUFAs:
$Merck & Co(MRK.US$ : 🤔
⇨ Patritumab deruxtecan
‣ Non-small cell lung carcinoma
‣ PDUFA date: 6/26/24 (BLA)
$Verona Pharma(VRNA.US$ : 🤔
⇨ Ensifentrine (Nebulized)
‣ Chronic obstructive pulmonary disease
‣ PDUFA date: 6/26/24 (NDA)
$Genmab(GMAB.US$ : 🤔
⇨ EPKINLY® (Epcoritamab)
‣ Follicular lymphoma
‣ PDUFA date: 6/28/24 (sBLA)
🗓️ Last week’s PDUFAs:
$Merck & Co(MRK.US$ : Approved 6/17 🎉
⇨ CAPVAXIVE (V116)
‣ Pneumo...
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Meltyy
liked and voted
$NVIDIA(NVDA.US$ has experienced a three-day decline, with a cumulative drop of 12.88% over the period, and a 16% correction from last Thursday's highs. The company's market capitalization has shrunk by over 430billion,fallingbelowthe3 trillion mark and ranking third. According to statistics, this is the largest three-day market capitalization drop for any publicly traded company. On June 18th, last Tuesday, NVIDIA briefly held...
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Meltyy
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$Sarepta Therapeutics(SRPT.US$ : ELEVIDYS
$Harmony Biosciences(HRMY.US$ : WAKIX (pitolisant)
$Bristol-Myers Squibb(BMY.US$ : KRAZATI (Adagrasib) + Cetuximab
$argenx SE(ARGX.US$ : VYVGART Hytrulo (Efgartigimod)
$Merck & Co(MRK.US$ : Patritumab deruxtecan
$Verona Pharma(VRNA.US$ : Ensifentrine (Nebulized)
$Rocket Pharmaceuticals(RCKT.US$ : KRESLADI (Marnetegragene autotemcel)
$Harmony Biosciences(HRMY.US$ : WAKIX (pitolisant)
$Bristol-Myers Squibb(BMY.US$ : KRAZATI (Adagrasib) + Cetuximab
$argenx SE(ARGX.US$ : VYVGART Hytrulo (Efgartigimod)
$Merck & Co(MRK.US$ : Patritumab deruxtecan
$Verona Pharma(VRNA.US$ : Ensifentrine (Nebulized)
$Rocket Pharmaceuticals(RCKT.US$ : KRESLADI (Marnetegragene autotemcel)
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Meltyy
voted
Hey, mooers!
It's time to talk trading! Ever heard of left-side and right-side trading? Want to find out which one aligns with your investment style? We're breaking down these styles to help you figure it out.
Before we dive in, be sure to hit like❤️ and save⭐ this post!
Ready to learn? Here we go!
1 | Understanding left-side and right-side trading
Left-side trading: Attempts to forecast market shifts
Left-side trading...
It's time to talk trading! Ever heard of left-side and right-side trading? Want to find out which one aligns with your investment style? We're breaking down these styles to help you figure it out.
Before we dive in, be sure to hit like❤️ and save⭐ this post!
Ready to learn? Here we go!
1 | Understanding left-side and right-side trading
Left-side trading: Attempts to forecast market shifts
Left-side trading...
+5
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106
Meltyy
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$Merck & Co(MRK.US$ 🎉
FDA Approves CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine)
⇨ for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults 🫁
» CAPVAXIVE (V116) protects against most strains causing illness in adults over 50. 🛡️
» Effective in people who've never had a pneumococcal vaccine or already have one as demonstrated in Ph3 trials.
FDA Approves CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine)
⇨ for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults 🫁
» CAPVAXIVE (V116) protects against most strains causing illness in adults over 50. 🛡️
» Effective in people who've never had a pneumococcal vaccine or already have one as demonstrated in Ph3 trials.
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1
Meltyy
liked
$AstraZeneca(AZN.US$ 🥳
📣 Imfinzi + chemotherapy gets approval for endometrial cancer
⇨ Imfinzi (durvalumab) + carboplatin & paclitaxel followed by Imfinzi mono in adult patients w/ primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR)
⇨ based on DUO-E Ph3 trial results 🧬
» showed reduced risk of disease progression or death by 58% 🆚 chemotherapy
📣 Imfinzi + chemotherapy gets approval for endometrial cancer
⇨ Imfinzi (durvalumab) + carboplatin & paclitaxel followed by Imfinzi mono in adult patients w/ primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR)
⇨ based on DUO-E Ph3 trial results 🧬
» showed reduced risk of disease progression or death by 58% 🆚 chemotherapy
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Meltyy
liked
$Amgen(AMGN.US$ 🚨
FDA approves Blincyto® for a specific type of leukemia* in consolidation phase
*CD19-Positive Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia (B-All)
» Blincyto® + chemo cuts death risk by 58% in consolidation phase 👏
» superior survival vs. chemo alone
» 1st BiTE® therapy for consolidation, regardless of MRD status
» marks the 3rd indication for BLINCYTO
FDA approves Blincyto® for a specific type of leukemia* in consolidation phase
*CD19-Positive Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia (B-All)
» Blincyto® + chemo cuts death risk by 58% in consolidation phase 👏
» superior survival vs. chemo alone
» 1st BiTE® therapy for consolidation, regardless of MRD status
» marks the 3rd indication for BLINCYTO
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$Bristol-Myers Squibb(BMY.US$
FDA Approves Augtyro (repotrectinib) 🎉
⇨ next-gen. Tyrosine Kinase Inhibitor (TKI) ⚛️
⇨ the only FDA-approved treatment for NTRK-positive tumors 👏
⇨ accelerated approval (sNDA) marks its 2nd indication in the US
⇨ based on Ph1/2 TRIDENT-1 trial 🧫
» effective in both TKI-naïve & TKI-pretreated patients across solid tumors
» showed significant response rates
FDA Approves Augtyro (repotrectinib) 🎉
⇨ next-gen. Tyrosine Kinase Inhibitor (TKI) ⚛️
⇨ the only FDA-approved treatment for NTRK-positive tumors 👏
⇨ accelerated approval (sNDA) marks its 2nd indication in the US
⇨ based on Ph1/2 TRIDENT-1 trial 🧫
» effective in both TKI-naïve & TKI-pretreated patients across solid tumors
» showed significant response rates
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