$Rocket Pharmaceuticals (RCKT.US)$Benzinga· 4 mins ago The FDA Issued Complete Response Letter To Rocket Pharmaceuticals' Kresladi (Marnetegragene Autotemcel), Gene Therapy For Severe Leukocyte Adhesion Deficiency-i, The FDA Requested Limited Additional CMC Information
$Rocket Pharmaceuticals (RCKT.US)$Reuters· 2 mins ago Rocket Pharmaceuticals Inc - Well-Tolerated Safety Profile in Pkd Patients up to 36 Months After Rp-L301 Treatment
Several highly anticipated PDUFA decisions are approaching..👇 Abeona Therapeutics ($Abeona Therapeutics (ABEO.US)$) Asset: Pz-cel (prademagene zamikeracel) PDUFA Date: May 25, 2024 Indication: Recessive dystrophic epidermolysis bullosa (RDEB) Technology: Autologous cell therapy, treatment uses gene transfer to deliver COL7A1 genes into an RDEB patient’s own skin cells then transplanting them back to the patient. Rocket Pharmaceuticals ($Rocket Pharmaceuticals (RCKT.US)$) ...
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The FDA Issued Complete Response Letter To Rocket Pharmaceuticals' Kresladi (Marnetegragene Autotemcel), Gene Therapy For Severe Leukocyte Adhesion Deficiency-i, The FDA Requested Limited Additional CMC Information
$Harmony Biosciences (HRMY.US)$ : 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)
$GlaxoSmithKline (GSK.US)$ : 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 ...
$Bristol-Myers Squibb (BMY.US)$ : 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...
Rocket Pharmaceuticals Inc - Well-Tolerated Safety Profile in Pkd Patients up to 36 Months After Rp-L301 Treatment
Abeona Therapeutics ( $Abeona Therapeutics (ABEO.US)$ )
Asset: Pz-cel (prademagene zamikeracel)
PDUFA Date: May 25, 2024
Indication: Recessive dystrophic epidermolysis bullosa (RDEB)
Technology: Autologous cell therapy, treatment uses gene transfer to deliver COL7A1 genes into an RDEB patient’s own skin cells then transplanting them back to the patient.
Rocket Pharmaceuticals ( $Rocket Pharmaceuticals (RCKT.US)$ ) ...
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