83.52BMarket Cap-13290P/E (TTM)
41.860High40.750Low14.27MVolume41.410Open41.480Pre Close590.12MTurnover0.71%Turnover Ratio10.67P/E (Static)2.03BShares63.64552wk High5.06P/B83.36BFloat Cap39.91052wk Low2.34Dividend TTM2.02BShs Float76.835Historical High5.68%Div YieldTTM2.68%Amplitude8.510Historical Low41.350Avg Price1Lot Size
Bristol-Myers Squibb Stock Forum
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
$Genfit(GNFT.US)$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD(IPSEY.US)$ : 🤔
⇨ Elafibranor
‣ Primary biliary cholangitis
‣ PDUFA date: 6/10/24
$Regeneron Pharmaceuticals(REGN.US)$ : 🤔
⇨ Kevzara (sarilumab)
‣ Polyarticular juvenile idiopathic arthritis
‣ PDUFA date: 6/10/24
$Bristol-Myers Squibb(BMY.US)$ : 🤔
⇨ Augtyro™ (Repotrectinib)
‣ PDUFA date: 6/15/24 (sNDA)
🗓️ Last week’s PDUFAs:
$GlaxoSmithKline(GSK.US)$ : Approved 6/7 🎉
⇨ Arexvy
‣ Respiratory s...
$GlaxoSmithKline(GSK.US)$ : Arexvy
$Genfit(GNFT.US)$ & $IPSEN SA SPONS ADR EA REPR 0.25 ORD(IPSEY.US)$ : Elafibranor
$Eli Lilly and Co(LLY.US)$ : Donanemab - AdCom meeting 🗓️
$Regeneron Pharmaceuticals(REGN.US)$ : Kevzara (sarilumab)
$Bristol-Myers Squibb(BMY.US)$ : Augtyro™ (Repotrectinib)
$Geron(GERN.US)$ : Imetelstat
$Merck & Co(MRK.US)$ : V116
$Amgen(AMGN.US)$ : BLINCYTO (blinatumomab)
$Sarepta Therapeutics(SRPT.US)$ : ELEVIDYS
$Merck & Co(MRK.US)$ : KEYTRUDA ...
FDA Approves Breyanzi as New CAR T Cell Therapy
for Relapsed or Refractory Mantle Cell Lymphoma
⇨ only CAR T cell therapy approved for 4 distinct subtypes of non-Hodgkin lymphoma 🩸
⇨ TRANSCEND NHL 001 trial (MCL cohort) 🧫
» delivered responses in 85.3% of patients with one-time infusion
$Merck & Co(MRK.US)$ $Bristol-Myers Squibb(BMY.US)$ $Johnson & Johnson(JNJ.US)$ $Pfizer(PFE.US)$ $Novo-Nordisk A/S(NVO.US)$ $AbbVie(ABBV.US)$
$Bristol-Myers Squibb(BMY.US)$ : 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...
⇒ $Larimar Therapeutics(LRMR.US)$ 🟢
‣ 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...
🗓️ 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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