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See remaining FDA PDUFAs in May 👀👇
$Bristol-Myers Squibb(BMY.US$ : Breyanzi
‣ PDUFA date: 5/31/24 (sBLA)
$Moderna(MRNA.US$ : mRNA-1345
‣ PDUFA date: End of May 2024 (est.) (BLA)
📣 Buckle up & get ready for next month...
June brings 17 PDUFA decisions: 🔥 🔥
$Catalyst Pharmaceuticals(CPRX.US$ : FIRDAPSE® (Amifampridine)
$GlaxoSmithKline(GSK.US$ : Arexvy
$Genfit(GNFT.US$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD(IPSEY.US$ : Elafibranor
$Regeneron Pharmaceuticals(REGN.US$ : Kevzara (sarilumab)
$Bristol-Myers Squibb(BMY.US$ : Augtyro...
$Bristol-Myers Squibb(BMY.US$ : Breyanzi
‣ PDUFA date: 5/31/24 (sBLA)
$Moderna(MRNA.US$ : mRNA-1345
‣ PDUFA date: End of May 2024 (est.) (BLA)
📣 Buckle up & get ready for next month...
June brings 17 PDUFA decisions: 🔥 🔥
$Catalyst Pharmaceuticals(CPRX.US$ : FIRDAPSE® (Amifampridine)
$GlaxoSmithKline(GSK.US$ : Arexvy
$Genfit(GNFT.US$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD(IPSEY.US$ : Elafibranor
$Regeneron Pharmaceuticals(REGN.US$ : Kevzara (sarilumab)
$Bristol-Myers Squibb(BMY.US$ : Augtyro...
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Meltyy
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Keep an eye on these M&As: 👀
$Biogen(BIIB.US$ to acquire HI-Bio™
$Johnson & Johnson(JNJ.US$ to acquire Proteologix
OnKure, Inc. merger with $Reneo Pharmaceuticals(RPHM.US$
$Harmony Biosciences(HRMY.US$ acquired Epygenix Tx
What companies will be next? 🤔
$Biogen(BIIB.US$ to acquire HI-Bio™
$Johnson & Johnson(JNJ.US$ to acquire Proteologix
OnKure, Inc. merger with $Reneo Pharmaceuticals(RPHM.US$
$Harmony Biosciences(HRMY.US$ acquired Epygenix Tx
What companies will be next? 🤔
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$Biogen(BIIB.US$ 📣 Acquires Human Immunology Biosciences (HI-Bio)
⇨ Expands immunology portfolio 🧬
⇨ $1.15B upfront and up to $650M potential milestone payments 💰
⇨ Includes lead asset felzartamab, fully human anti-CD38 monoclonal antibody
» demonstrated clinical proof of concept in rare immune-mediated indications
» Planned Ph3 trial
⇨ Expands immunology portfolio 🧬
⇨ $1.15B upfront and up to $650M potential milestone payments 💰
⇨ Includes lead asset felzartamab, fully human anti-CD38 monoclonal antibody
» demonstrated clinical proof of concept in rare immune-mediated indications
» Planned Ph3 trial
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Meltyy
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$Amphastar Pharmaceuticals(AMPH.US$ 📣 Receives FDA Approval for Albuterol Sulfate Inhalation Aerosol
✨Bioequivalent and therapeutically equivalent to $TEVA ProAir® HFA Inhalation Aerosol
» ANDA approval
» Indication: Tx or prevention of bronchospasm 🫁
» Product launch in Q3 '24
✨Bioequivalent and therapeutically equivalent to $TEVA ProAir® HFA Inhalation Aerosol
» ANDA approval
» Indication: Tx or prevention of bronchospasm 🫁
» Product launch in Q3 '24
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🎯 Ph 2 readouts in Q2 2024...
$Iovance Biotherapeutics(IOVA.US$ Phase 2
$Supernus Pharmaceuticals(SUPN.US$ Phase 2a
$BRANDES INTERNATIONAL ETF(BINV.US$ Phase 2a
$MorphoSys(MOR.US$ Phase 2
$Nuvation Bio(NUVB.US$ Phase 2
$ALX Oncology(ALXO.US$ Phase 2
$BioXcel Therapeutics(BTAI.US$ Phase 2
$Purple Biotech(PPBT.US$ Phase 2
$Arcus Biosciences(RCUS.US$ Phase 2
$Medicenna Therapeutics(MDNAF.US$ Phase 2b
$Affimed NV(AFMD.US$ Phase 2
$Barinthus Biotherapeutics(BRNS.US$ Phase 2b...
$Iovance Biotherapeutics(IOVA.US$ Phase 2
$Supernus Pharmaceuticals(SUPN.US$ Phase 2a
$BRANDES INTERNATIONAL ETF(BINV.US$ Phase 2a
$MorphoSys(MOR.US$ Phase 2
$Nuvation Bio(NUVB.US$ Phase 2
$ALX Oncology(ALXO.US$ Phase 2
$BioXcel Therapeutics(BTAI.US$ Phase 2
$Purple Biotech(PPBT.US$ Phase 2
$Arcus Biosciences(RCUS.US$ Phase 2
$Medicenna Therapeutics(MDNAF.US$ Phase 2b
$Affimed NV(AFMD.US$ Phase 2
$Barinthus Biotherapeutics(BRNS.US$ Phase 2b...
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Clinical Updates💉
⇒ $Larimar Therapeutics(LRMR.US$ 🟢
‣ FDA removes partial clinical hold
‣ Nomlabofusp (CTI-1601) #FA
‣ Protein replacement therapy
‣ Interim data from OLE in Q4 '24 🔔
Clinical readouts 📢
⇒ $Citius Pharmaceuticals(CTXR.US$ 🟢
‣ Positive Ph3 topline results
‣ Mino-Lok® #CLABSI #CRBSI
‣ Antibiotic lock solution
‣ Overall treatment success in 57.1% patients
Regulatory Update🎯
⇒ $Halozyme Therapeutics(HALO.US$ $Bristol-Myers Squibb(BMY.US$
‣ FDA Reassigned PDUFA data to 12/29/24
‣ Subcutane...
⇒ $Larimar Therapeutics(LRMR.US$ 🟢
‣ FDA removes partial clinical hold
‣ Nomlabofusp (CTI-1601) #FA
‣ Protein replacement therapy
‣ Interim data from OLE in Q4 '24 🔔
Clinical readouts 📢
⇒ $Citius Pharmaceuticals(CTXR.US$ 🟢
‣ Positive Ph3 topline results
‣ Mino-Lok® #CLABSI #CRBSI
‣ Antibiotic lock solution
‣ Overall treatment success in 57.1% patients
Regulatory Update🎯
⇒ $Halozyme Therapeutics(HALO.US$ $Bristol-Myers Squibb(BMY.US$
‣ FDA Reassigned PDUFA data to 12/29/24
‣ Subcutane...
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📣 2 PDUFAs left in May!
🗓️ Last week’s PDUFAs:
$Amgen(AMGN.US$ : Approved 5/16 🎉
⇒ Imdelltra (Tarlatamab-dlle)
‣ extensive-stage SCLC
‣ PDUFA date: 6/12/24 (BLA)
$Bristol-Myers Squibb(BMY.US$ : Approved 5/15 🎉
⇒ Breyanzi®
‣ Follicular lymphoma
‣ PDUFA date: 5/23/24 (sBLAs)
$Dynavax Technologies(DVAX.US$ : CRL 5/14 🙁
⚠️ insufficient data
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S(ASND.US$ : Review extended to 8/14/24 🤔
⇒ YORV...
🗓️ Last week’s PDUFAs:
$Amgen(AMGN.US$ : Approved 5/16 🎉
⇒ Imdelltra (Tarlatamab-dlle)
‣ extensive-stage SCLC
‣ PDUFA date: 6/12/24 (BLA)
$Bristol-Myers Squibb(BMY.US$ : Approved 5/15 🎉
⇒ Breyanzi®
‣ Follicular lymphoma
‣ PDUFA date: 5/23/24 (sBLAs)
$Dynavax Technologies(DVAX.US$ : CRL 5/14 🙁
⚠️ insufficient data
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S(ASND.US$ : Review extended to 8/14/24 🤔
⇒ YORV...
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Meltyy
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» Holdings: 87
» Holdings in Top 20: 86.71%
» Qtr over Qtr Change**: -9.29%
Top Holdings:
$Incyte(INCY.US$
$BeiGene(BGNE.US$
$ACADIA Pharmaceuticals(ACAD.US$
$Madrigal Pharmaceuticals(MDGL.US$
$Rhythm Pharmaceuticals(RYTM.US$
$Revolution Medicines(RVMD.US$
$Kymera Therapeutics(KYMR.US$
$AbCellera Biologics(ABCL.US$
$Bicycle Therapeutics(BCYC.US$
$Edgewise Therapeutics(EWTX.US$
$Immunocore(IMCR.US$
$Kodiak Sciences(KOD.US$
$Roivant Sciences(ROIV.US$
» Holdings in Top 20: 86.71%
» Qtr over Qtr Change**: -9.29%
Top Holdings:
$Incyte(INCY.US$
$BeiGene(BGNE.US$
$ACADIA Pharmaceuticals(ACAD.US$
$Madrigal Pharmaceuticals(MDGL.US$
$Rhythm Pharmaceuticals(RYTM.US$
$Revolution Medicines(RVMD.US$
$Kymera Therapeutics(KYMR.US$
$AbCellera Biologics(ABCL.US$
$Bicycle Therapeutics(BCYC.US$
$Edgewise Therapeutics(EWTX.US$
$Immunocore(IMCR.US$
$Kodiak Sciences(KOD.US$
$Roivant Sciences(ROIV.US$