See summary 👇
📣 4 PDUFAs upcoming in May:
$Dynavax Technologies(DVAX.US$ : 🤔
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S(ASND.US$ : 🤔
⇒ YORVIPATH®
‣ hypoparathyroidism
‣ PDUFA date: 5/14/24 (NDA)
$Bristol-Myers Squibb(BMY.US$ : 🤔
⇒ Breyanzi®
‣ PDUFA dates: (sBLAs)
‣‣ 5/23/24 (r/r follicular lymphoma)
‣‣ 5/31/24 (r/r mantle cell lymphoma)
🗓️ Last week’s PDUFAs:
$X4 Pharmaceuticals(XFOR.US$ : Approved 4/29 🎉
⇨ XOLREMDI (mavorixafor)
‣ WHI...
📣 4 PDUFAs upcoming in May:
$Dynavax Technologies(DVAX.US$ : 🤔
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S(ASND.US$ : 🤔
⇒ YORVIPATH®
‣ hypoparathyroidism
‣ PDUFA date: 5/14/24 (NDA)
$Bristol-Myers Squibb(BMY.US$ : 🤔
⇒ Breyanzi®
‣ PDUFA dates: (sBLAs)
‣‣ 5/23/24 (r/r follicular lymphoma)
‣‣ 5/31/24 (r/r mantle cell lymphoma)
🗓️ Last week’s PDUFAs:
$X4 Pharmaceuticals(XFOR.US$ : Approved 4/29 🎉
⇨ XOLREMDI (mavorixafor)
‣ WHI...
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📣 3 PDUFAs left in April! See summary 👇
🗓️ Last week’s PDUFAs:
$Pfizer(PFE.US$ : Approved 4/26 🎉
⇨ BEQVEZ (fidanacogene elaparvovec-dzkt)
▹ Hemophilia B
▹ BLA
▹ PDUFA date: Q2 2024
$Day One Biopharmaceuticals(DAWN.US$ : Approved 4/23 🎉
⇨ OJEMDA (tovorafenib)
▹ Pediatric low-grade glioma
▹ NDA
▹ PDUFA date: 4/30/24
$ImmunityBio(IBRX.US$ : Approved 4/22 🎉
⇨ Anktiva + BCG
▹ Bladder cancer
▹ resubmitted BLA
▹ PDUFA date: 4/23/24
$Abeona Therapeutics(ABEO.US$ : CRL 4/22 🙁
⚠...
🗓️ Last week’s PDUFAs:
$Pfizer(PFE.US$ : Approved 4/26 🎉
⇨ BEQVEZ (fidanacogene elaparvovec-dzkt)
▹ Hemophilia B
▹ BLA
▹ PDUFA date: Q2 2024
$Day One Biopharmaceuticals(DAWN.US$ : Approved 4/23 🎉
⇨ OJEMDA (tovorafenib)
▹ Pediatric low-grade glioma
▹ NDA
▹ PDUFA date: 4/30/24
$ImmunityBio(IBRX.US$ : Approved 4/22 🎉
⇨ Anktiva + BCG
▹ Bladder cancer
▹ resubmitted BLA
▹ PDUFA date: 4/23/24
$Abeona Therapeutics(ABEO.US$ : CRL 4/22 🙁
⚠...
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4
$Aquestive Therapeutics(AQST.US$ 📣 FDA Approves Libervant™ (Diazepam) Buccal Film
in Pediatric Patients Ages 2 to 5
⇨ 🥇 1st and only FDA approved orally administered rescue product
⇨ for Tx of seizure clusters (ages 2-5)
in Pediatric Patients Ages 2 to 5
⇨ 🥇 1st and only FDA approved orally administered rescue product
⇨ for Tx of seizure clusters (ages 2-5)
4
The FDA PDUFA Calendar is a chronological calendar of PDUFA target dates as well as Advisory meetings (ADCOMM). PDUFA target dates are dates by which the FDA aims to deliver their decision regarding an NDA or BLA filing. These decisions can however come before the PDUFA target date.
$Pfizer(PFE.US$ $Dynavax Technologies(DVAX.US$ $Sandstorm Gold(SAND.US$ $Bristol-Myers Squibb(BMY.US$ $SPDR S&P Biotech ETF(XBI.US$
$Pfizer(PFE.US$ $Dynavax Technologies(DVAX.US$ $Sandstorm Gold(SAND.US$ $Bristol-Myers Squibb(BMY.US$ $SPDR S&P Biotech ETF(XBI.US$
10
1
$Teva Pharmaceutical Industries(TEVA.US$ & alvotechpr
📣 FDA approves SELARSDI (Ustekinumab-Aekn), biosimilar to Stelara® 🎉
▻ approved for both adult and pedia indications (plaque psoriasis & psoriatic arthritis)
▻ developed and manuf. using same type of cells and process used for Stelara 👨🔬
▻ to be marketed in US on or after 02/21/25 🗓️
📣 FDA approves SELARSDI (Ustekinumab-Aekn), biosimilar to Stelara® 🎉
▻ approved for both adult and pedia indications (plaque psoriasis & psoriatic arthritis)
▻ developed and manuf. using same type of cells and process used for Stelara 👨🔬
▻ to be marketed in US on or after 02/21/25 🗓️
3
1
$Travere Therapeutic(TVTX.US$ Phase 3
$CG Oncology(CGON.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$BioCardia(BCDA.US$ Phase 3
$Insmed(INSM.US$ Phase 3
$GlycoMimetics(GLYC.US$ Phase 3
$Annexon(ANNX.US$ Phase 3
$Lipocine(LPCN.US$ Phase 3
$FibroGen(FGEN.US$ Phase 3
$UroGen Pharma Ltd(URGN.US$ Phase 3
$Lyra Therapeutics(LYRA.US$ Phase 3
$Citius Pharmaceuticals(CTXR.US$ Phase 3
$Jaguar Health(JAGX.US$ Phas...
$CG Oncology(CGON.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$United Therapeutics(UTHR.US$ Phase 3
$BioCardia(BCDA.US$ Phase 3
$Insmed(INSM.US$ Phase 3
$GlycoMimetics(GLYC.US$ Phase 3
$Annexon(ANNX.US$ Phase 3
$Lipocine(LPCN.US$ Phase 3
$FibroGen(FGEN.US$ Phase 3
$UroGen Pharma Ltd(URGN.US$ Phase 3
$Lyra Therapeutics(LYRA.US$ Phase 3
$Citius Pharmaceuticals(CTXR.US$ Phase 3
$Jaguar Health(JAGX.US$ Phas...
19
$Aditxt(ADTX.US$ to acquire Appili Tx
TuHURA Biosciences merger w/ $Kintara Therapeutics(KTRA.US$
$Johnson & Johnson(JNJ.US$ to acquire $ShockWave Medical(SWAV.US$
$Vertex Pharmaceuticals(VRTX.US$ to acquire $Alpine Immune(ALPN.US$
What companies will be next? 🤔
TuHURA Biosciences merger w/ $Kintara Therapeutics(KTRA.US$
$Johnson & Johnson(JNJ.US$ to acquire $ShockWave Medical(SWAV.US$
$Vertex Pharmaceuticals(VRTX.US$ to acquire $Alpine Immune(ALPN.US$
What companies will be next? 🤔
5
$Vertex Pharmaceuticals(VRTX.US$ $Alpine Immune(ALPN.US$
⚡ Vertex buys Alpine in a $4.9B deal 💰
⇨ Acquisition for $65/sh or $4.9B in cash 🤑
▪ Transaction closes in Q2 2024
⇨ Includes ALPN lead product, povetacicep (ALPN-303)
▪ best-in-class potential in patients with IgA nephropathy
▪ Ph3 to initiate in H2 2024
⚡ Vertex buys Alpine in a $4.9B deal 💰
⇨ Acquisition for $65/sh or $4.9B in cash 🤑
▪ Transaction closes in Q2 2024
⇨ Includes ALPN lead product, povetacicep (ALPN-303)
▪ best-in-class potential in patients with IgA nephropathy
▪ Ph3 to initiate in H2 2024
9
$SPDR S&P Biotech ETF(XBI.US$ $iShares Biotechnology ETF(IBB.US$
M&A in Q1 alone totaled 12 deals for $19.2 bil which is close to the 10 deals for $21.9 bil in all the 1H of 2023...
But one big caveat of this chart, it doesn't include $Pfizer(PFE.US$ 's $43 bil deal for $SGEN announced in Mar 2023 but didn't close until Dec bc of an FTC challenge,
The biggest biotech M&A deal so far this yr was $Gilead Sciences(GILD.US$ 's $4.3 b...
M&A in Q1 alone totaled 12 deals for $19.2 bil which is close to the 10 deals for $21.9 bil in all the 1H of 2023...
But one big caveat of this chart, it doesn't include $Pfizer(PFE.US$ 's $43 bil deal for $SGEN announced in Mar 2023 but didn't close until Dec bc of an FTC challenge,
The biggest biotech M&A deal so far this yr was $Gilead Sciences(GILD.US$ 's $4.3 b...
6
🗓️ Last week’s PDUFAs:
$Supernus Pharmaceuticals(SUPN.US$ : CRL 4/8/24 🙁
⇒ SPN-830
⇒ OFF episodes in PD
⇒ NDA
⇒ PDUFA: 4/5/24
$Legend Biotech(LEGN.US$ & $Johnson & Johnson(JNJ.US$ : Approved 🎉
⇒ CARVYKTI (cilta-cel)
⇒ Multiple myeloma
⇒ sBLA
⇒ PDUFA: 4/5/24
$AstraZeneca(AZN.US$ : Approved 🎉
⇒ Enhertu
⇒ HER2+ solid tumors
⇒ sBLA
⇒ PDUFA: Q2 2024
$2seventy bio(TSVT.US$ & $Bristol-Myers Squibb(BMY.US$ : Approved 🎉
⇒ Abecma
⇒ Multiple myeloma
⇒ sBLA
⇒ Delayed PDUFA
$Vanda Pharmaceuticals(VNDA.US$...
$Supernus Pharmaceuticals(SUPN.US$ : CRL 4/8/24 🙁
⇒ SPN-830
⇒ OFF episodes in PD
⇒ NDA
⇒ PDUFA: 4/5/24
$Legend Biotech(LEGN.US$ & $Johnson & Johnson(JNJ.US$ : Approved 🎉
⇒ CARVYKTI (cilta-cel)
⇒ Multiple myeloma
⇒ sBLA
⇒ PDUFA: 4/5/24
$AstraZeneca(AZN.US$ : Approved 🎉
⇒ Enhertu
⇒ HER2+ solid tumors
⇒ sBLA
⇒ PDUFA: Q2 2024
$2seventy bio(TSVT.US$ & $Bristol-Myers Squibb(BMY.US$ : Approved 🎉
⇒ Abecma
⇒ Multiple myeloma
⇒ sBLA
⇒ Delayed PDUFA
$Vanda Pharmaceuticals(VNDA.US$...
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