📣 ITRM AdCom 9/9 meeting ongoing 🚗
👀 stay tuned for updates on meeting outcomes
See 👇 for further info.
🚨 This Week’s AdCom:
$Iterum Therapeutics (ITRM.US)$ : Meeting ongoing 🤔
⇨ Sulopenem
‣ uUTI (Uncomplicated Urinary Tract Infection)
‣ AdCom: 9/9/24
🚨 Last Week’s PDUFAs:
$Travere Therapeutic (TVTX.US)$ : Approved 9/5 🎉
⇨ FILSPARI (Sparsentan)
‣ IgA nephropathy (IgAN)
‣ PDUFA: 9/5/24
$Avadel Pharmaceuticals (AVDL.US)$ : Awaiting decision 🤔
⇨ LUMRYZ (sodium oxybate)
‣...
👀 stay tuned for updates on meeting outcomes
See 👇 for further info.
🚨 This Week’s AdCom:
$Iterum Therapeutics (ITRM.US)$ : Meeting ongoing 🤔
⇨ Sulopenem
‣ uUTI (Uncomplicated Urinary Tract Infection)
‣ AdCom: 9/9/24
🚨 Last Week’s PDUFAs:
$Travere Therapeutic (TVTX.US)$ : Approved 9/5 🎉
⇨ FILSPARI (Sparsentan)
‣ IgA nephropathy (IgAN)
‣ PDUFA: 9/5/24
$Avadel Pharmaceuticals (AVDL.US)$ : Awaiting decision 🤔
⇨ LUMRYZ (sodium oxybate)
‣...
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🚀 Buckle up for upcoming PDUFAs in September! 👇
$Travere Therapeutic (TVTX.US)$ : FILSPARI (Sparsentan)
$Avadel Pharmaceuticals (AVDL.US)$ : LUMRYZ (FT218)
$Iterum Therapeutics (ITRM.US)$ : Sulopenem - AdCom 🗓️
$Sanofi (SNY.US)$ & $Regeneron Pharmaceuticals (REGN.US)$ : Dupixent
$Vanda Pharmaceuticals (VNDA.US)$ : Tradipitant
$Zevra Therapeutics (ZVRA.US)$ : Arimoclomol
$Heron Therapeutics (HRTX.US)$ : ZYNRELEF® Vial Access Needle
$Merck & Co (MRK.US)$ : KEYTRUDA+ chemotherapy
$Bristol-Myers Squibb (BMY.US)$ : KarXT (...
$Travere Therapeutic (TVTX.US)$ : FILSPARI (Sparsentan)
$Avadel Pharmaceuticals (AVDL.US)$ : LUMRYZ (FT218)
$Iterum Therapeutics (ITRM.US)$ : Sulopenem - AdCom 🗓️
$Sanofi (SNY.US)$ & $Regeneron Pharmaceuticals (REGN.US)$ : Dupixent
$Vanda Pharmaceuticals (VNDA.US)$ : Tradipitant
$Zevra Therapeutics (ZVRA.US)$ : Arimoclomol
$Heron Therapeutics (HRTX.US)$ : ZYNRELEF® Vial Access Needle
$Merck & Co (MRK.US)$ : KEYTRUDA+ chemotherapy
$Bristol-Myers Squibb (BMY.US)$ : KarXT (...
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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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🚨 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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$SPDR S&P Biotech ETF (XBI.US)$
» Is this a smid-cap biopharma buying opportunity? 🤔
Stock market sell-off, e.g., $NASDAQ, started late last week on weak jobs data
XBI/smid-cap biopharma were part of sell-off
But..
» Is this sell-off justified for smid-cap biopharma?
» Is this a buying opportunity for smid-cap biopharma?
💡 Lower economic/jobs data = more likely entering lowering interest rate cycle for Fed Reserve
Usually go...
» Is this a smid-cap biopharma buying opportunity? 🤔
Stock market sell-off, e.g., $NASDAQ, started late last week on weak jobs data
XBI/smid-cap biopharma were part of sell-off
But..
» Is this sell-off justified for smid-cap biopharma?
» Is this a buying opportunity for smid-cap biopharma?
💡 Lower economic/jobs data = more likely entering lowering interest rate cycle for Fed Reserve
Usually go...
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$Viking Therapeutics (VKTX.US)$
What drove stock move?
⇨ VK2735 oral 💊
» Oral dosing up to 80 mg looks tolerable enough to go to 100 mg
» No more catalyst drought with Obesity Week oral VK2735 readout added in Q4 (see 📸 for updated 2024 readouts)
» Should be an exciting Obesity Week 2024
⇨ VK2735 subq 💉
» Can go right to Ph3 based on FDA feedback - no Ph2b needed
» Testing monthly subq VK2735 based on PK data
⇨ VK2809 in NASH
» Still looking to partner Ph3/MACE
⇨ V...
What drove stock move?
⇨ VK2735 oral 💊
» Oral dosing up to 80 mg looks tolerable enough to go to 100 mg
» No more catalyst drought with Obesity Week oral VK2735 readout added in Q4 (see 📸 for updated 2024 readouts)
» Should be an exciting Obesity Week 2024
⇨ VK2735 subq 💉
» Can go right to Ph3 based on FDA feedback - no Ph2b needed
» Testing monthly subq VK2735 based on PK data
⇨ VK2809 in NASH
» Still looking to partner Ph3/MACE
⇨ V...
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$AstraZeneca (AZN.US)$
AdCom for IMFINZI (durvalumab) tomorrow 7/25 🗓️
» IMFINZI + platinum-containing chemo
» as Tx for non-small cell lung cancer (NSCLC)
Briefing docs for Thursday’s AdCom posted yesterday…
⚠️ FDA highlights concerns about Imfinzi for perioperative NSCLC:
» overtreatment risk
» uncertainty on treatment benefit
» inadequate trial design
» lack of overall survival benefit
» potential for unnecessary exposure
⏰ Meeting begins Thursday, 9 a.m. ET.
AdCom for IMFINZI (durvalumab) tomorrow 7/25 🗓️
» IMFINZI + platinum-containing chemo
» as Tx for non-small cell lung cancer (NSCLC)
Briefing docs for Thursday’s AdCom posted yesterday…
⚠️ FDA highlights concerns about Imfinzi for perioperative NSCLC:
» overtreatment risk
» uncertainty on treatment benefit
» inadequate trial design
» lack of overall survival benefit
» potential for unnecessary exposure
⏰ Meeting begins Thursday, 9 a.m. ET.
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$Sangamo Therapeutics (SGMO.US)$ stock is up after the company announced a successful late-stage trial.
This treatment for patients with hemophilia A appears to have the efficacy and safety metrics in place to warrant a potential approval.
Notably, Sangamo’s candidate is being developed alongside $Pfizer (PFE.US)$ , adding a layer of clout to the R&D behind the prospective treatment.
This treatment for patients with hemophilia A appears to have the efficacy and safety metrics in place to warrant a potential approval.
Notably, Sangamo’s candidate is being developed alongside $Pfizer (PFE.US)$ , adding a layer of clout to the R&D behind the prospective treatment.
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$Phathom Pharmaceuticals (PHAT.US)$ 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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