$Phathom Pharmaceuticals(PHAT.US$ FDA Approves VOQUEZNA® for Relief of Heartburn
Associated w/ Non-Erosive GERD in Adults
» now approved for Non-Erosive GERD ✨
» demonstrated rapid heartburn relief in Ph3 trials
» represents the 1st major GERD innovation in 30 years
» the only FDA-approved Tx of its kind available 👏
Associated w/ Non-Erosive GERD in Adults
» now approved for Non-Erosive GERD ✨
» demonstrated rapid heartburn relief in Ph3 trials
» represents the 1st major GERD innovation in 30 years
» the only FDA-approved Tx of its kind available 👏
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$AstraZeneca(AZN.US$ : AdCom 🤔
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom: 7/25/24 (sBLA)
$BeiGene(BGNE.US$ : 🤔
⇨ TEVIMBRA (tislelizumab)
‣ Esophageal squamous-cell carcinomas (1L)
‣ PDUFA: July 2024 (sBLA)
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom: 7/25/24 (sBLA)
$BeiGene(BGNE.US$ : 🤔
⇨ TEVIMBRA (tislelizumab)
‣ Esophageal squamous-cell carcinomas (1L)
‣ PDUFA: July 2024 (sBLA)
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$ROCHE HOLDING AG(RHHBY.US$
📣 Roche News Snippet:
» CT-996 led to significant weight loss (-7.3%) after 4 weeks 🆚 placebo (-1.2%)
» data supports once-daily oral dosing regimen
» Safety profile was similar to other GLP-1 drugs; no unexpected safety issues observed
Did you see today's sell-off? 🔴
$Eli Lilly and Co(LLY.US$ $Novo-Nordisk A/S(NVO.US$ $Structure Therapeutics(GPCR.US$ $Viking Therapeutics(VKTX.US$ $Lipocine(LPCN.US$
📣 Roche News Snippet:
» CT-996 led to significant weight loss (-7.3%) after 4 weeks 🆚 placebo (-1.2%)
» data supports once-daily oral dosing regimen
» Safety profile was similar to other GLP-1 drugs; no unexpected safety issues observed
Did you see today's sell-off? 🔴
$Eli Lilly and Co(LLY.US$ $Novo-Nordisk A/S(NVO.US$ $Structure Therapeutics(GPCR.US$ $Viking Therapeutics(VKTX.US$ $Lipocine(LPCN.US$
5
Don't miss out! 🎯👇
$Phathom Pharmaceuticals(PHAT.US$ : 🤔
⇨ VOQUEZNA® (vonoprazan)
‣ Non-Erosive GERD
‣ PDUFA: 7/19/24 (NDA)
$AstraZeneca(AZN.US$ : AdCom 🤔
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom: 7/25/24(sBLA)
$BeiGene(BGNE.US$ : 🤔
⇨ TEVIMBRA (tislelizumab)
‣ Esophageal squamous-cell carcinomas
‣ PDUFA: July 2024 (BLA)
$Phathom Pharmaceuticals(PHAT.US$ : 🤔
⇨ VOQUEZNA® (vonoprazan)
‣ Non-Erosive GERD
‣ PDUFA: 7/19/24 (NDA)
$AstraZeneca(AZN.US$ : AdCom 🤔
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom: 7/25/24(sBLA)
$BeiGene(BGNE.US$ : 🤔
⇨ TEVIMBRA (tislelizumab)
‣ Esophageal squamous-cell carcinomas
‣ PDUFA: July 2024 (BLA)
5
Moo moo's climbin' TV's list and I'm here for the tea 🍵.
App's user-friendly but still sussing it out.
Left a review with my honest vibes.
Join in?
App's user-friendly but still sussing it out.
Left a review with my honest vibes.
Join in?
1
1 PDUFA this week! 🔥
$Arcutis Biotherapeutics(ARQT.US$ : pending decision 🤔
⇨ ARQ-151 topical roflumilast cream
‣ Atopic Dermatitis (aged 6 & older children)
‣ PDUFA date: 7/7/24 (sNDA)
Upcoming PDUFAs & AdCom in July: 📅👇
$Phathom Pharmaceuticals(PHAT.US$ : 🤔
⇨ VOQUEZNA® (vonoprazan)
‣ Non-Erosive GERD
‣ PDUFA date: 7/19/24 (NDA)
$AstraZeneca(AZN.US$ : AdCom 🤔
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom date: 7/25/24(sBLA)
$BeiGene(BGNE.US$ :...
$Arcutis Biotherapeutics(ARQT.US$ : pending decision 🤔
⇨ ARQ-151 topical roflumilast cream
‣ Atopic Dermatitis (aged 6 & older children)
‣ PDUFA date: 7/7/24 (sNDA)
Upcoming PDUFAs & AdCom in July: 📅👇
$Phathom Pharmaceuticals(PHAT.US$ : 🤔
⇨ VOQUEZNA® (vonoprazan)
‣ Non-Erosive GERD
‣ PDUFA date: 7/19/24 (NDA)
$AstraZeneca(AZN.US$ : AdCom 🤔
⇨ Imfinzi + chemotherapy
‣ Neoadjuvant treatment NSCLC
‣ AdCom date: 7/25/24(sBLA)
$BeiGene(BGNE.US$ :...
6
🔥 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)
7
2
$Genmab(GMAB.US$ $AbbVie(ABBV.US$
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)
3
🔥 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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$Sarepta Therapeutics(SRPT.US$ : 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)
14